Pasteur laboratories PVT. LTD.

INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.
1 | P a g e DiptarcoSinghafrom GuruNanakInstitute of Pharmaceutical Science& Technology

Pharmacy is the art, practice of profession of preparing, preserving, compounding, & dispensing a substance or drug
meant for social and pharmacological welfare.
The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals for use as medications.
Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of
lawsand regulationsthatgovernthe patenting, testing, safety, efficacy and marketing of drugs. The government started to
encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.
However,economicliberalizationin90s bythe formerPrime MinisterP.V.NarasimhaRao and the then Finance Minister, Dr.
Manmohan Singhenabledthe industrytobecome what it is today. This patent act removed composition patents from food
and drugs, and though it kept process patents, these were shortened to a period of five to seven years.
In a word, the pharmaceutical industryisresponsibleforthe development, production and marketing of medications. Thus,
its immense importance as a global sector is evident.
Workplace training, also known as trade or industry training, involves learning and earning money while you work.
Apprenticeships are one type of workplace training. You can do workplace training in a range of hands-on industries.
Workplace training usually combines on-the-job and off-the-job training. You'll have to:
1. attend all courses that are part of the industry training – these may be block courses, evening courses or day release
classes, and are offered by a polytechnic or other education provider
2. Complete on-the-job assessments to show you are competent doing practical tasks, and to work towards your national
certificate
3. Complete off-the-job assessments to work towards completing your qualification.
The IndustryTrainingAuthorityisaprovincial governmentagencyinthe province of BritishColumbia, Canada. Established in
2004, to replace the Industry, Training and Apprenticeship Commission (ITAC), its mandate is to facilitate training in the
trades and industry occupations in the province.
We are thankful to Pasteur laboratories Pvt. Ltd., for conducting this training program during our undergraduate course in
pharmacy & also for their precious knowledge & guidance throughout the training.
We are highly grateful as this knowledge would be an enormous help to our career in future days.

I, DiptarcoSinghafromGURUNANAK INSTITUTE OF PHARMACEUTICALSCIENCE& TECHNOLOGY,PANIHATI,KOLKATA is
representingthisprojectaftersuccessfullycompletingourvocational trainingat Pasteur LaboratoriesPvt. Ltd.
I am highlygrateful to PasteurLaboratoriesPvt. Ltd. forcomplete guidance andsupervision.Itwasa treatto workand learn
underthe guidance of Mr. Tuhin Saha.Hisvast knowledgeregardingthe subjectwasimmenselyhelpful andgave aclearview
aboutthe pathin future.
I wouldlike toexpressmygratitude toall the membersof Pasteur Laboratories Pvt.Ltd. Fortheirkindco-operation,
encouragementandafriendlyenvironmentthathelpedme tocomplete myproject.
We wouldespeciallylike tothankthe followingpeoplewithoutwhomitwouldn’thave been possible tocompletethis
project.
 Late Mr. M.C. Law (Director,Manufacturing)
 Mr. K.Law (Director, Administration&Finance)
 Mr. D. Law (Director,Sales&Marketing)
 Mr. S.Law (Director,Research& Development)
 Mr. A.K. Nandi (FactoryManager)
 Mr. TuhinSaha(qualityAssurance Manager;UnitI)
 Mr. S.Das (QualityControl InCharge;UnitI)
 Mr. T.K.Pal (QualityControl Chemist;UnitI)
 Mrs. Mousumi Bhattacharya (ProductionSupervisor;UnitI)
 Mr. U. Chowdhuri (ManufacturingChemist;UnitI)
 Mr. R. Sikdar(ManufacturingChemist;UnitI)
 Mr. S.k.Mondal (InCharge; Unit II)
 Mr. P.Simlai (QualityControl Chemist;UnitII)
 Mr. T. DeyMondal (FactorySuperintendent)

Serial No. Contents Page No.
01 About the Company
02 Industrial Hazards& SafetyMeasures
03 Environmental impactof Pharmaceutical & Personal Care
04 Demineralization(D.M) Plant& Waste Water Treatment
Plants
05 Calibration
06 Validation
07 Qualification
08 Management
09 BCG AnalysisorBCG Matrix
10 SWOT Analysis
11 Schedules
12 QualityControl & QualityAssurance
13 Apparatusin Q.CDepartment
14 Apparatusin MicrobiologyDepartment
15 Preparationof Tablet
16 Preparationof Ointment
17 Machineriesfor Productionat UnitI
18 Machineriesfor Productionat UnitII
19 Products
20 Conclusion

PASTEUR LABORATORIES PVT. LTD.
WITH THE ENTHUSIAM OF A GROUP OF EXPERTS HEADED BY LATE MC.LAW PASTEUR LABORATORIES PVT. LTD.
WAS ESTABLISHED WAY BACK ON 19TH OF MARCH 1947AT IT’S PRESENT ADDRESS OF KOLKATA.
THE SOLE IDEA OF FORMIMING THE COMPANY WAS TO MAKE THE MEDICINES AVAILABLE TO COMMON PEOPLE
AT A REASONABLE PRICE AS WELL AS TO UTILIZE THE EXPERTISE OF A GROUP OF PERSONS AVAILABLE TO OUR
FOUNDER MANAGING DIRECTOR LATE MC .LAW FROM THE VERY BEGINNING THE COMPANY HAD INTRODUCED
AND CONCENTRATED ON VARIOUS DERMATOLOGICAL PREPARATIONS & TRANSFUSION FLUIDS ALONG WITH
OTHER INJECTABLE AND ORAL PREPARATIONS.
THOUGH IT IS A SMALL SCALE COMPANY BUT FROM THE INCEPTION IT WAS ESTABLISHED AS A PIONEER
COMPANY IN MANUFACTURING OF TRANSFUSION FLUIDS AND DERMATOLOGICAL PREPARATIONS.
TODAY BY INFLUX OF TIME, THE COMPANY HAS ACQUIRED GMP CERTIFICATION & HAS CONCENTRATION IT’S
PREPARATIONS. ESPECIALLY ON DERMATOLOGICAL RANGE ALONG WITH OTHER PREPARATIONS.
PRESENTLYWITH A GROUP OF STRONG SALES FORCE BACKED BY MODERN LABORATORYTHEY ARE MARKING
OUR PRODUCTS TO A LARGE SEGMENT OF OUR COUNTRY. WITH THE BACKDROP THE COMPANY IS MARCHING
AHEAD NEW PRODUCTS , MODERN IDEAS FOR A BRIGHT FUTURE.

Introduction:Industrial Hazardisa termassociatedwithasubstance that islikely tocause aninjuryina given
environmentorsituation. Industrial hazard maybe defined asanyconditionproducedby industries thatmaycause injuryor
deathto personnel orlossof productor property. Industrial hazardmay alsobe definedasanyconditionproducedby
industriesthatmaycause injuryordeathto personnel orlossof productor property. Safetyinsimpletermsmeansfreedom
fromthe occurrence of riskor injuryor loss.Industrial safetyreferstothe protectionof workersfromthe dange rof industrial
accidents.
Accidents:
Human factoris the contributingcause of accidentsinmostsituations.Forpeople whoare likelytohave accidents,the
treatmentisdividedintothreemaincategories
 Medical assistance- in13 percentcases
 Personalityreadjustment- in22 percent cases
 Operating defects- the remaining65percentcases
Accident reduction:
Accidentpronenessisacceptable toacertain extent;itdoesnotmeanthat nothingcan be done to reduce the numberof
accidents
Accidentscanbe reducedbytwoapproaches
 Actuarialapproach- Itinvolvesstudyingthe statisticstodetermineaccidentsbasedonactual data. The factors
relatedtothe accidentfrequencyshouldbe identified.The violationsof safetyrulesmustbe clearlyidentified.
 Safetyeducationalcampaign -Safetyeducationmustbe conductedbymanagementtothe employee groups.
Types of Industrial Hazards:
1. Chemical hazards
2. Physical hazards
3. Biological hazards

 Chemical Hazard: A chemical hazard isany substance thatcan cause harm, primarilytopeople.
Chemicalsof all kindsare storedinour homesandcan resultinseriousinjuriesif notproperlyhandled.Household
itemssuchas bleachcan resultinharmful chlorine gasorhydrochloricacidif carelesslyused.

Hazard pictographs are a type of labeling system that alerts individuals efficiently at a quick glance if there are
hazardous chemicals present. The symbols help identify if the chemicals that are going to be in use may potentially
cause physical harm or hard to the environment. The symbols are distinctive as they are shaped like a diamond
with red borders. These signs can be divided into:
1. Explosive (exploding bomb)
2. Flammable (flame)
3. Oxidizing (flame above a circle)
4. Corrosive (corrosion of table and hand)
5. Acute Toxicity (skull and crossbones)
6. Hazardous to environment (dead tree and fish)
7. Health Hazard/ Hazardous to the ozone layer (Exclamation mark)
8. Serious Health Hazard (Cross on a human silhouette)
9. Gas Under Pressure (Gas cylinder
Chemical safety isthe applicationof the bestpracticesforhandling chemicalsandchemistryprocessestominimizerisk,
whethertoa person,facility,orcommunity.Itinvolvesunderstandingthe physical, chemical,andtoxicological hazardsof
chemicals.
Physical hazard meansa chemical forwhichthere isscientificallyvalidevidence thatitisa combustible liquid,acompressed
gas, explosive,flammable,anorganicperoxide,anoxidizer,pyrophoric,unstable(reactive) orwater-reactive.
 Flammable LiquidsandCombustible Liquids.
 Examples:Ethanol,Acetone.
 CompressedGases

Management of over-exposure
Managementof over-exposure to chemicalsperformedby:–
 Removal fromexposure- Promptremoval of personto exposure site,airrespiratorsandlifelinesare mandatoryfirst
aid.
 Decontamination- A victimwhose skinorclothinghasbeencontaminatedrequiresimmediate removal of garments
and shoes.
 SymptomaticTreatment- like dehydrationarrhythmias.
Dust Explosion:-
A dust explosionisthe rapidcombustionof fine particlessuspendedinthe air,
oftenbutnot alwaysinan enclosedlocation. Dustexplosionscanoccur where
any dispersedpowderedcombustible material ispresent inhighenough
concentrationsinthe atmosphere orotheroxidizinggaseousmedium
such as oxygen.
Other Hazards include:-

10 | P a g e Diptarco SinghafromGuru NanakInstituteof Pharmaceutical Science& Technology
MostEffective HazardControls:-
The best way to protect workers is to remove or eliminate the hazard from the workplace using the
following hazard control methods: Substitution. Substitute dangerous chemicals, equipment or work methods with
safer and less hazardous ones to eliminate the hazard altogether.
Other Requirements:-
 Building Constructions,
 Exit point,
 Fire alarm,
 Sprinkler System
Special Safety Protection Equipment:-
 For protectionof Head & Eyes:- Goggles,HelmetsorCovers,Hooks,Masks.
 For protectionof Hands, Arms,Legs & Feet:- RubberGloves,RubberBoots,Aprons&otherclothing,Shoes.
 For preventionof breathingofpoisonousgases:- Respirative Protective Devices.
Safety programs involves:-

As the populationincreases,use of wateralsohave increasedandcreatingacorrespondingrise inwaste quantity.This
increasedwateruse andprocesswastewatergenerationrequiresmore efficientremovalbyproductsandpollutantsthat
allowsforeffluentwithinestablishedenvironmentalregulatorylimits.
The determinationof wastewaterquantitysetforthinenvironmental permitshasbeenestablishedsince the 1970s ina series
of laboratorytestsfocusedonfourmajorcategories:
1. Organics- A determinationof the concentrationof Carbon-based(i.e.organic)compoundsaimedatestablishingthe
relative strengthof wastewater(biological oxygendemand[BOD],chemical oxygen demand[COD],Total organiccarbon
[TOC],oil andgrease[O&G]).
2. Solids-A measurementof the concentrationof particulatessolidsthatcandissolvedorsuspendinwastewater(e.g. Total
solid[TS],Total suspended solid[TSS],Total dissolved solid[TDS],Total volatilesolids[TVS],Total fixed solids[TFS]).
3. Nutrients- A measurementof the concentrationof targetnutrients(e.g.nitrogen,phosphorus)thatcancontribute tothe
accelerationof eutrophication(e.g.temperature,colour,turbidity,odour).
4. Physical propertyandotherimpactof the parameters- Analytical testdesignedtomeasure avariedgroupof constituents
directlyimpactwastewatertreatability(e.g. temperature,colour,turbidity,andodour).
Informationpertainingtothe transportandfate of these hormonesandtheirmetabolitesinthe dairy waste disposal isstill
beinginvestigated,yetresearchsuggestthatthe landapplicationof solidwastesislikelylinkedwithmore hormone
contaminationproblems.Notonlydoesthe pollutionfromPPCPsaffectmarine ecosystems,butalsothose habitatsthat
dependonthispollutedair.
There are variousconcernsaboutthe effectsof pharmaceuticalsfoundinsurface watersandspecificallythe threatsagainst
rainbowexposedtotreatedsewageeffluents.
Routes into environment:-
Pharmaceutical residuesmayreachthe environmentbyanumberof differentroutes.Itisa generallyassumedthatthe
productionof pharmaceuticalsinindustrialisedcountriesiswellcontrolledandunharmful tothe environment,due tolocal
legal res.The majorroute for pharmaceutical residuestoreachthe aquaticenvironmentismostprobablybyexcretionfrom
patientsundergoingpharmatreatment.Since manypharmaceutical substancesare notmetabolisedinthe bodybuttheymay
be excretedinbiologically active form,usuallyviathe urine.Furthermore,manypharmaceuticalsubstancesare notfully
takenup fromthe intestine intotheirbloodstream.The fractionsnottakenupintothe bloodstreamwill remaininginthe gut
and eventuallyexcretedviathe faces.Hence,bothurineandfacesfromtreatedpatientscontainpharmaceutical residues.

ENVIRONMENTAL
While the full effectsof mostPPCPsonthe environmentare notunderstood,there isconcernaboutthe potential theyhave
for harm because theymayact unpredictablywhenmixedwithotherchemicalsfromthe environmentorconcentrate inthe
foodchain.Additionally,some PPCPsare activate atverylow concentrationandare oftenreleasedcontinuouslyinlarge
quantities.Becauseof the highsolubilityof PPCPs,aquaticorganismsare especiallyvulnerable totheireffects.Researchers
have foundthat a classof antidepressantmaybe foundinfrogsand can significantlyslow theirdevelopment.The increased
presence of oestrogenandsynthetichormonesinwaste waterdue tobirthcontrol andhormonal therapieshasbeenlinked
to increasedfeminizationof exposedfishandotheraquaticorganisms.The chemicalswithinthese PPCPproductscould
eitheraffectthe feminizationormasculinizationof differentfishes,therefore impactingtheirreproductive rates.Inaddition
to beingfoundonlyinwaterways,the ingredientsof some PPCPscanalsobe foundinthe soil .Since some of these
substancestake a longtime or cannotbe degradedbiologically,theymake their wayupthe foodchain.
Fate of pharmaceuticalsinthe sewage treatmentplants
Sewage treatmentplantsmayofferavarietyof techniquesfordiminishingthe amountandharmful activityof itsbiological
contents.Usuallythe sewage treatmentsplantsare equippedwithaninitial mechanical separationof solidparticles(socks,
underwear,12holeraarticlesetc.)Appearinginthe incoming.
Followingthistheremaybe filtersparticleseitheroccurringinthe incomingwater.
Or waterwithflocculatingagents.ManySTPsalsoinclude one orseveral stepsof biological treatment.Bystimulatingthe
activityof variousstrainsof microorganismsphysicallytheiractivitymaybe promotedtodegrade the organiccontentof the
sewage byupto 90% or more.In certaincasesmore advancedtechniquesare usedaswell .Suchtechniquesmaycomprise
UV treatmentof the water,or additionof ozone.Ineithercase,these methodswill degrade organicmaterial nottakencare
of bythe microorganism.Optimal treatmentwithsuchmethodsmaydestroyupto80% or more of pharma residuesinthe
water.A final stepwith13holera13dcarbon mayeliminate possible reactivate degradationproductsfromthe UV orozone
treatment.Several researchprojectsare runningtooptimize the use of advancedsewagetreatmenttechniquesafter
differentconditions.The advancedtechniqueswill increase the costsforthe sewage treatmentsubstantially.
It istherefore importanttodefinebestavailabletechnique before extensive infrastructureinvestmentsare introducedona
wide basis.The fate of incomingpharmaceutical residuesinthe STPisunpredictable.Some substancesseemtobe more or
lesscompletelyeliminated.While otherspassthe differentstepsinthe unaffected.There isnosystematicknowledge athand
to predicthowand whythishappens.Pharmaceutical residuesthathave beenconjugatedbefore beingexcretedfromthe
patientsmayundergode-conjugationinthe STP,yieldinghigherlevelsof free pharmaceutical substance inthe outletfrom
the STP than initsincomingwater.Some pharmaceutical withlarge scale volumeshave notbeendetectedinthe incoming
waterto STP, indicatingthatcomplete metabolismanddegradationmusthave occurredalreadyinthe patientorduringthe
transportof sewage fromthe householdtothe STP.

Demineralizationisthe processof removingmineral saltsfromwaterbyusingthe ionexchange process.
Demineralizedwateriswater completelyfree (oralmost) of dissolvedmineralsas a result of one of the following
processes:
 Distillation
 Deionization
 Membrane filtration( reverseosmosis orNanofiltration)
 Electrodyalisis
 Or othertechnologies
DemineralizedwateralsoknownasDeionizedwater,waterthathasitsmineral ionremoved.Mineral ionsuchascationsof
sodium,calcium,iron,copperetc.andanionssuchas chloride,sulphate,nitrate etc.are commonionspresentinwater.
Deionizationisaphysical processwhichusesspecially-manufacturedionexchange resinswhichprovidesionexchangesite
for the replacementof the mineral saltsinwaterwithwaterforming H+ andOH- ions.Because of the majorityof water
impuritiesare dissolvedsalts,deionizationproduceshighpuritywaterthatisgenerallysimilartodistilledwater.
Demineralizationisthe provenprocessfortreatmentof water.A DMwatersystemproducesmineral free waterbyoperating
on the principlesof ionexchange,degasificationandpolishing.Demineralizedwatersystemfindswideapplicationinthe fie ld
of steam, power,processandcooling.
PRINCIPLE
Raw waterispassedviatwo small polystyrene beadfilled(ion exchangeresin) beds.While the cationsgetexchangedwith
hydrogenionsinfirstbed,the anionsare exchangedwithhydroxyl ionsinthe secondone.

Biochemical oxygendemand (BOD) (alsocalled biological oxygendemand) isthe amountof dissolved oxygenneeded(i.e.,
demanded) byaerobicbiological organismstobreakdown organicmaterial presentinagivenwatersample atcertain
temperature overaspecifictime period.
 The term alsoreferstoa chemical procedure fordeterminingthisamount.Thisisnota precise quantitative test,
althoughitiswidelyusedasan indicationof the organicqualityof water.
 The BOD value ismostcommonlyexpressedinmilligramsof oxygenconsumedper literof sample during5daysof
incubationat20 °C and is oftenusedasa robustsurrogate of the degree of organic pollutionof water.
 BOD5 iscalculatedby:( Dilutionmethod)
Unseeded:BOD5 = (DO – D5)
P
Seeded:BOD5 = (DO-D5) – ( B0 – B5 )F
P
 where: DO isthe dissolvedoxygen(DO) of the dilutedsolutionafterpreparation(mg/l); D5 isthe DO of the diluted
solutionafter5 dayincubation(mg/l);P isthe decimal dilutionfactor; B0 isthe DO of dilutedseedsample after
preparation(mg/l) ; B5 is the DO of dilutedseedsampleafter5day incubation(mg/l) ;Fisthe ratioof seedvolume
indilutionsolutiontoseedvolumeinBODteston seed.
Test Procedure:-
1. 5 beakerswere labellingwithA,B,C,D and E.
2. 100 mL of pond waterare collectedandpourinto beakerA.
3. The D.O probe was placedinthe beakerA to read the initial D.OConcentrationdirectly.
4.The resultwas recordedinData LoggerSpreadsheetProgram.
5. Steps1 to 4 were repeatedbyusingdifferentsamplesof water whichare drainwater,distilled water,aquarium
waterand pipe waterwhichthe samplesof waterispouredintobeakerB,C,D and E respectively.
6. The sampleswere letuntil 5daysand D.O probeswere placedagaininthese samplestoreadthe final D.O
concentration.

7. BOD value wasdeterminedbythe followingformula:
B.O.Dvalue = Final D.O– Initial D.O
p
*Note that, before put the sensor into the next sampleof water, rinse the sensor with distilledwater.
Results if plotted gives:-

What is DO (Dissolved Oxygen)?
Dissolvedoxygen(DO) referstomicroscopicbubblesof gaseous oxygen(O2) thatare mixedinwaterandavailable toaquatic
organismsforrespiration—acritical processforalmostall organisms.Primarysources of DOinclude the atmosphere and
aquaticplants.
DO Flow:-
COD (Chemical Oxygen Demand):-
In environmental chemistry,the chemical oxygendemand(COD) testiscommonlyusedtoindirectlymeasure the amountof
organiccompoundsinwater.Most applicationsof CODdetermine the amountof organicpollutantsfoundinsurface water
(e.g.lakesandrivers) orwastewater,makingCODauseful measure of waterquality.Itisexpressedinmilligramsperliter
(mg/L),whichindicatesthe massof oxygenconsumedperliterof solution. Chemical OxygenDemand(COD) isameasure of
capacityof waterto consume Oxygenduringthe decompositionof organicmatterandthe oxidationof inorganicchemicals
such as ammonia& nitrite.
 It isexpressedinmilligramsper liter(mg/L) alsoreferredtoasppm(parts permillion),whichindicatesthe massof
oxygenconsumedperliterof solution.
 The followingformulaisusedtocalculate COD:
COD= {8000(b-s) n}/ Samplevolume

 Where b isthe volume of FASusedinthe blanksample, sisthe volume of FASinthe original sample,and n isthe
normalityof FAS.If millilitersare usedconsistentlyforvolume measurements,the resultof the CODcalculationis
giveninmg/L.
 The COD can alsobe estimatedfromthe concentrationof oxidizable compoundinthe sample,basedonits
stoichiometricreactionwithoxygentoyieldCO2 (assumeall Cgoesto CO2),H2O(assume all H goesto H2O),and
NH3 (assume all N goesto NH3),usingthe followingformula:
 COD = (C/FW)(RMO)(32)Where C= Concentrationof oxidizable compoundinthe sample,FW=Formulaweightof the
oxidizable compoundinthe sample, RMO= Ratio of the # of molesof oxygento# of molesof oxidizablecompoundin
theirreactiontoCO2, water,andammonia. Forexample,if asample has500 wppmof phenol:
 C6H5OH + 7O2 → 6CO2 + 3H2OCOD = (500/94)(7)(32) = 1191 wppm
TOC (Total Organic Carbon):-
Total organic carbon (TOC) is the amountof carbon foundinan organic compoundandisoften usedas a non-specific
indicatorof waterqualityorcleanlinessof pharmaceutical manufacturingequipment.

 The theory of constraints (TOC) is a managementparadigmthatviewsanymanageablesystemasbeinglimitedin
achievingmore of itsgoalsby a verysmall numberof constraints.
 Total OrganicCarbon(TOC) is an indirectmeasure of organicmoleculespresentinwaterand measuredascarbon.
Organicmoleculesare introducedintothe waterfromthe source water,frompurification,andfrom distribution
systemmaterials.TOCismeasuredforbothprocesscontrol purposesandtosatisfyregulatoryrequirements.
 One approach usedtomeasure TOC involvessubtractingthe measuredinorganiccarbon(IC) fromthe measuredtotal
carbon (TC),whichis the sum of organic carbonand inorganiccarbon:TOC = TC – IC.

Calibrationisthe setof operations thatestablish,underspecifiedconditions,the relationshipbetweenvaluesindicatedbya
measuringinstrument,ameasuringsystemorvaluesrepresentedbyamaterial measure,andthe correspondingknown
values/standardvalue of ameasurement.
Steps:-
1. Identifyinstruments/glassware
2. Identifysourcesof calibrationfacility/procedures
3. Calibrationprocedure
4. Documentation
5. sourcesof error
6. correction
The set of operationswhichestablishunderspecificconditions,the relationshipbetweenvaluesindicatedbymeasuring
instrumentormeasuringsystemorvalue representedbyamaterial measure ora reference material,andthe corresponding
value of a quantityrealizedbyareference standard.

Need of Calibration:-
The main objectivesof calibration servicesare:
 To maintainqualitycontrol andqualityassurance inproduction.
 To complywithrequirementsof global trade.
 To meetthe requirementof ISOguides.
 To promote internationalrecognition.
 For trackingback measurementresultstonational standards.
Benefits of Calibration:-
 It fulfills the requirementsof traceabilitytonational /internationalstandardslikeISO9000, ISO 14000 etc.
 As a proof that the instrumentisworking.
 Confidence inusingthe instruments.
 Traceabilitytonational measurementstandard.
 Interchangeability.
 Reducedrejection,failure rate thushigherreturn.
 Improvedproductandservice qualityleadingtosatisfiedcustomers.
 Powersaving.
 Cost Saving.
 Safety.
The Basic Requirements for Calibration:-
 Reference /CalibrationStandards&otherinstruments/equipments
 ControlledEnvironmentConditions.
 Competence of CalibrationLabpersonnel.

 Traceabilityof Reference /Calibrationstandards.
 Documentation.
Serial No. Name Of Instrument Calibration Frequency
01 Thermometer Every 6 Months
02 Digital Balance Every Time on usage
03 Ph. meter Every day
04 Karl Fisher Every Time on usage
05 Polari meter Every 3 months
06 Friabilator Every month
07 Conductivity meter Every 15 days
08 Hardness tester Every year
09 Disintegration apparatus Every month
10 Dissolution apparatus Every 3 months
11 U.V Spectrophotometer Every 3 months
Sources of error in calibration:-
• Stabilization
• Normal position
• Avoid sourcesof interference
• Avoid traces of leftover
**Calibration accuracy shouldbe 3 to 10 timesthe accuracy requiredfor the measurement

Concept of Validation:-
GMP- definitionisthe validationof “establishingdocumentedevidence thatestablishesahighdegree of certaintythata
particularprocesswill consistentlyaproductthat providesthe previouslyestablishedspecifications&qualityattributes are
available.
 The collectionandevaluationof data,fromthe processdesignstage throughcommercial production,which
establishesscientificevidence thataprocessis capable of consistentlydeliveringqualityproducts. (FDA)
 Documentedevidencewhichprovidesahighdegree of assurance thata specificprocesswillconsistentlyresultina
productthat meetspredeterminedspecificationsandqualitycharacteristics.(WHO)
 The documentedevidence thatthe process,operatedwithinestablishedparameters,canperformeffectivelyand
reproducibly toproduce amedicinal productmeetingitspredetermined specificationsandqualityattributes.(EMA)
Types of process validation and dossier requirements:-

Documentations associated with Validation:-
 SOP(StandardOperatingProcedures),
 Specifications,
 ValidationMasterPlan(VMP),
 ValidationProtocols&Reports
Validation Protocol Standards:-
The followingmethodof constructionmustbe used.The over-allprotocol standardsare showninthe SOP’sforthe different
protocols,here we are concernedaboutthe testingelementalone.All testingmustbe detailedandpre-approvedbya
qualifiedpersontoensure the systemundertesthasbeenadequatelytested.Eachtestmustcomprise of;

MainSub-headingsinTest Script:-
 A Rationale;givingthe reasonand or objectof the test.
 A detailed TestMethod.
 DetailedAcceptance criteria;thatthe testsmustproduce.
 A Test Result;confirmingwhetherthe testresult,satisfiedthe acceptance criteria.
General detailsthat must be adheredto:-
 The test resultmustbe initialed(orsigned)bythe personexecutingthe tests,oncompletionorateach significant
stage.
 Each test mustbe designedtoverifyanelementof the equipmentfunctionality.
 Each test musta have a resultthatisclear,unambiguous andknown.
 The test methodmustcall up forthe recordingof the testresultparameters.(Noticksortickboxes,nogeneralities).
 Each test mustbe witnessedorthe resultsmustbe reviewedbyacompetentperson.
 The overall testresultsmustbe approvedbya competentperson.
Standard Protocol Inter-relationships:-

Actionof providing&documentingthatanypremises,systems&equipmentare properlyinstalled,&/orworkcorrectly&
leadto expectedresults.
Qualificationisoftenapart (the initial stage) of validation,butQualificationalone donotconstitute processvalidation.
Qualificationisapart of validation
 Accordingto the Foodand Drug Administration(FDA),the goal of validationisto: “Establishdocumentedevidence
whichprovidesahighdegree of assurance thata specificprocesswill consistentlyproduceaproductmeetingits
predeterminedspecificationsandqualityattributes.”
 It isa requirementforGoodManufacturingPracticesandotherregulatoryrequirements.
Types of Qualification:-
Validationisbrokendowninto5mainphases,
 Designqualification(DQ).
 Installationqualification(IQ).
 Operational qualification(OQ).
 Performance qualification(PQ).
 Maintenance Qualification(MQ)
 Componentqualification(CQ).
Vendor Time Line:-

Quality Management equipment qualification:-
Equipment Qualification:-
It isa basicrequirementof goodanalytical chemistrythatbalancesandotheranalytical instrumentsmustbe suitable forthe
purpose forwhichtheyare usedand that theymustbe appropriatelycalibrated.Asaconsequence,EquipmentQualification
isgainingmore and more importance inensuringthe validityof results. Regulatorybodiesalsoseemtobe turningtheir
attentionincreasinglytothisarea,andmanufacturersof analytical equipmentare forcedtoplaya significantrole inthe
variousstepsof EquipmentQualification.
The 5 steps of Equipment Qualification:-

Step 1: DesignQualification(DQ) definesthe functionalandoperationalspecificationsof abalance or instrument.
Step 2: Installation Qualification(IQ) ensuresthata balance or instrumentisreceivedasdesignedandspecified.It
documentsthe installationinthe selecteduserenvironment.
Step 3: Operational Qualification(OQ) demonstratesthatabalance or instrumentwill functionaccordingtoitsoperational
specificationinthe selectedenvironment.
Step 4: Performance Qualification(PQ) demonstratesthatabalance or instrumentconsistentlyperformsaccordingtoa
specificationappropriate toitsroutine use.
Step 5: Maintenance Qualification(MQ) describesanddocumentsanymaintenance requiredonthe equipment.
Design qualification (DQ):-
Installation Qualification (IQ):-

Installationqualification (IQ) isthe processof checkingthe installation,toensure thatthe componentsmeetthe approved
specificationandare installedcorrectly,andtosee how that informationisrecorded. The purpose istoensure thatall
aspects(staticattributes) of the facilityorequipmentare installedcorrectlyandcomplywiththe original design.
All of the instrumentationcomponentsare identifiedandcheckedagainstthe manufacturer’scomponentlisting.
The workingenvironmentconditionsare documentedandcheckedtoensure thattheyare suitable forthe operationof the
instrument.
InstallationQualificationestablishesthatthe instrumentisreceivedasdesignedandspecified,thatit isproperlyinstalledin
the selectedenvironment,andthatthisenvironmentissuitable forthe operationanduse of the instrument.
Before installation:
- Obtainmanufacturer'srecommendationsforinstallationsite requirements.
- Checkthe site forthe fulfillmentof the manufacturer'srecommendations(utilitiessuchaselectricity,waterandgasesplus
environmental conditionssuchashumidity,temperature,vibrationlevel anddust).
- Allowsufficientshelf space forthe equipmentitself,related SOPs,operatingmanuals,logbooksandsoftware.
Operation Qualification (OQ):-

Operational qualification(OQ) isthe processof testingtoensure thatthe individual andcombinedsystemsfunctiontomeet
agreedperformance criteriaandtocheckhow the resultof testingisrecorded. The purpose istoensure thatall the dynami c
attributescomplywiththe original design.Eachof the instrument’sfunctionare checkedtoensure thattheyconformtothe
manufacturer’sspecifications.
Thisincludesthe use of certified,traceable electrical simulatorsandstandardstoverifythatthe equipmentisprocessing
inputsignalscorrectly.
Performance Qualification (PQ):-

Performance qualification (PQ),alsocalledprocessqualification,isthe processof testingtoensure thatthe individual and
combinedsystemsfunctiontomeetagreedperformance criteriaona consistentbasisandtocheck how the resultof testing
isrecorded. The purpose isto ensure thatthe criteriaspecifiedcanbe achievedonareliable basisoveraperiodof time.
The performance of the equipmentforitsroutine analytical use ischeckedtoensure thatthiscomplieswithitsspecification.
 The temperature sensorreadingsare comparedwithacertifiedreference thermometer.Aftercalibration,the
conductivitysensorreadingsare comparedusingcertified,traceable control standards.
 Control Standardsof similarvaluestothe intendedtestsamplesmustbe usedforPQ.
 Performance Qualification(PQ) isthe processof demonstratingthataninstrumentconsistentlyperformsaccording
to a specificationappropriate toitsroutine use.
 Importanthere isthe word consistently.The testfrequencyismuchhigherthanforOQ. Anotherdifference isthatPQ
shouldalwaysbe performedunderconditionsthatare similartoroutine sample analysis.
 PQ shouldbe performedonadaily(orat leasta weekly) basis, orwheneverthe instrumentisused.The test
frequencydependsnotonlyonthe stabilityof the equipmentbutalsooneverythinginthe systemthatmay
contribute tothe analysisresults.
1. Define the performance criteriaandtestprocedures.
2. Selectcritical parameters.
3. Define the testintervals
Maintenance Qualification (MQ):-

The MQ describesanddocumentsanymaintenance requiredonthe equipment.Thisincludesroutine servicingandany
repairsnecessary.Detailsof anymaintenance contracts are alsodocumentedinthissection,togetherwithalistof
authorizedservice engineers.Inaddition,the MQincludesthe routine cleaningof the equipmentandalsoitsultimate
disposal.
Component qualification (CQ):-
 Componentqualification(CQ) –isa relativelynewtermdevelopedin2005. Thisterm referstothe manufacturingof
auxiliarycomponentstoensure thattheyare manufacturedtothe correct designcriteria.Thiscouldinclude
packagingcomponentssuchasfoldingcartons,shippingcases,labelsorevenphase change material.All of these
componentsmusthave some type of randominspectiontoensure thatthe thirdpartymanufacturer'sprocessis
consistentlyproducingcomponentsthatare usedinthe worldof GMP at drug or biologicmanufacturer.
Instrument Re-Qualification:-
 InstrumentValidationshouldnotbe viewedasa one-off event–confidence inanalytical resultsis requiredforthe
whole of the instrument’sworkinglife.
 To ensure thatthisconfidence isretained,the instrumentvalidationprocessshouldbe repeatedatregularintervals
duringthe instrumentsoperational life.
 The difference betweenInstallationValidationandRe-Qualification isthatIQ is omittedforthe Re-Qualification
 Re-Qualificationshouldbe performedatleast annuallyandshouldbe performedmore frequentlyforapplications
whose testresultshave critical implications
Managementinbusiness&organizationssthe functionthatcoordinatesthe effortof people toaccomplishgoals&
objectivesbyusingavailableresourcesefficiently&effectively.
Managementincludes planningorganization,staffingleadingordirecting&controllinganorganizationtoaccomplishthe
goal.Resourcingencompassesthe development&manipulationof humanresources,financial resources,technological
resources& natural resources.Managementisalsoanacademicdiscipline,asocial science whoseobjectiveistostudy
social organization.

Management Key Concepts:-
Organizations:People workingtogetherandcoordinatingtheiractionstoachieve specificgoals.
Goal:A desiredfuture conditionthatthe organizationseekstoachieve.
Management:The processof usingorganizational resourcestoachieve the organization’sgoals
Resourcesare organizational assetsand include:
Man,
Machinery,
Materials,
Money
Managers - to meetits goals.
Organizational Performance:-
Managers use resourceseffectivelyandefficientlytosatisfycustomers and to achieve goals.
Efficiency:A measure of how well resourcesare used to achieve a goal.
Effectiveness:A measure of the appropriatenessof the goalschosen, and the degree towhich they are
achieved.
Characterization:-
 One of the mostimportanthumanactivitiesismanaging.
 Managing hasbeenessentialtoensure the coordinationof individualefforts.
 Task of managershas beenrisinginimportance.
CONCEPT OF MANAGEMENT:-
The term management isusedinthree alternative ways:
• Managementas a discipline,
• Managementas a groupof people,and
• Managementas a process.

WHAT IS MANAGEMENT?
1. FieldofStudy -Managementprinciples,techniques,functions,etc.-Profession
2. Team or Class of people-Individual whoperformsmanagerialactivitiesormaybe a groupof persons
3. Process-Managerial activities -planning,organizing,staffing,directing,controlling.
 Differentcontextof definingmanagement:
There are foursuch orientationshave beenadoptedindefiningmanagementprocess:
• Production-orefficiency-oriented,
• Decision-oriented,
• People-oriented,and
• Function-oriented.
NATURE AND SCOPE OF MANAGEMENT:-
The natureof managementcan bedescribed as follows:
• Multidisciplinary
• Dynamicnature of principles
• Relative,notabsoluteprinciples
• Management:Science orArt
• Managementas profession
• Universalityof management
IMPORTANCE OF MANAGEMENT:-
The importanceof managementmay betraced in the following contexts:
• Effective Utilizationof Resources
• Developmentof Resources
• To incorporate Innovations
• IntegratingVariousInterestGroups
• Stabilityinthe Society

Functions of Management:-
The followingare the functionsof management:
 Planning,
 Organizing,
 Staffing,
 DirectingorLeadingand
 Controlling.
The growth–share matrix (akathe Product PortfolioMatrix,BostonBox,BCG-matrix,Bostonmatrix, BostonConsulting
Group analysis, andportfolio diagram)isachart that was createdby Bruce D. Henderson forthe BostonConsultingGroupin
1970 to helpcorporationstoanalyze theirbusinessunits,thatis,their productlines.Thishelpsthe companyallocate
resourcesandisusedas an analytical tool inbrandmarketing, productmanagement, strategicmanagement,and portfolio
analysis. Some analysisof marketperformance byfirmsusingitsprincipleshascalleditsusefulnessintoquestion.
To use the chart,analystsplota scatter graph to rankthe businessunits(orproducts) onthe basisof theirrelative market
sharesand growthrates.
 Cash cow iswhere a companyhas highmarketshare ina slow-growingindustry.Theseunitstypicallygenerate
cash inexcessof the amountof cash neededtomaintainthe business.Theyare regardedasstaidandboring,ina
"mature"market,yetcorporationsvalue owningthemdue totheircashgeneratingqualities.Theyare tobe "milked"
continuouslywithaslittleinvestmentaspossible,since suchinvestmentwouldbe wastedinanindustrywithlow
growth.
 Dogs, more charitablycalled pets,are unitswithlow marketshare ina mature,slow-growingindustry.Theseunits
typically"breakeven",generatingbarelyenoughcashtomaintainthe business'smarketshare.Thoughowninga
break-evenunitprovidesthe social benefitof providingjobsandpossiblesynergiesthatassistotherbusinessunits,
froman accountingpointof viewsucha unitisworthless,notgeneratingcashforthe company.Theydepressa
profitable company's returnonassets ratio,usedbymanyinvestorstojudge how well acompanyisbeing
managed. Dogs,itis thought,shouldbe soldoff.
 Question marks (alsoknownas problemchildren) are businessesoperatingwithalow marketshare ina high
growthmarket.Theyare a startingpointfor mostbusinesses.Questionmarkshave apotential togainmarketshare
and become stars,andeventuallycashcowswhenmarketgrowthslows.If questionmarksdonotsucceedin
becomingamarketleader,thenafterperhapsyearsof cash consumption,theywill degenerate intodogswhen
marketgrowthdeclines.Questionmarksmustbe analyzedcarefullyin ordertodetermine whethertheyare worth
the investmentrequiredtogrowmarketshare.

 Starsare unitswitha highmarketshare in a fast-growingindustry.Theyare graduated questionmarks witha
marketor niche leadingtrajectory,forexample:amongstmarketshare front-runnersinahigh-growthsector,and/or
havinga monopolisticorincreasinglydominant unique sellingproposition withburgeoning/fortuitous proposition
drive(s) from:novelty(e.g. Last.FMuponCBS Interactive due diligence),fashion/promotion(e.g.newly
prestigious celebritybrandedfragrances), customerloyalty (e.g.Greenfield ormilitary/gangenforcement backed,
and/orinnovative, grey-market/illicitretailof addictivedrugs,forinstance the BritishEastIndiaCompany's,late-
1700s opium-basedQianlongEmperorembargo-busting,CantonSystem), goodwill(e.g.monopsonies)
and/orgearing(e.g. oligopolies,forinstance Portlandcementproducers nearboomtowns), etc.The hope isthatstars
become nextcashcows.
Stars require highfundingtofightcompetitionsandmaintainagrowthrate.Whenindustrygrowthslows,if theyremaina
niche leaderorare amongstmarketleaderstheyhave beenable tomaintaintheircategoryleadershipstarsbecome cash
cows,else theybecome dogsdue tolow relative marketshare.

Benefits of the BCG matrix:-
The keybenefitsof the BCGmatrix are:
 It isverysimple touse and explain,asthere are onlytwodimensionsandfourquadrants
 It isa reputable andlong-standingstrategicmodel thathasprovedto be robustovertime and significantchangesin
the competitive environment
 Usuallythe measurements required –marketgrowthand relative marketshare –are available tothe company,along
withcompetitivemeasures,makingitrelativelyeasytoexecute and prepare
 Clearguidance isprovided foreachquadrant intermsof the approach toinvestmentandsupportof businessunits
(or brandsor products) – perhapswiththe exceptionof the questionmarkquadrant(please seediscussionof the
questionmarkquadrant)
 It isan importantmodel forallocatingresourcesforfirmspursuingmarketshare goalsandseeking experience curve
benefits
 The firmhas a basisforallocatingresourcesacrossitsbusinessunits,basedupon competitive position andmarket
opportunity–makingfor a more strategicbaseddecision
 Althoughthe matrix isdevelopedbaseduponhistorical/currentposition,the fourquadrantsof the BCG matrix
provide some strategicguidance forthe future
 The matrix is more beneficial forlarge-scale manufacturingoperationswhere experience curve benefitscanbe
realized –that is,where theyisa strongcorrelationbetweenmarketshare profitability
 For students,itprovidesagoodunderstandingof the conceptof aligningcompetitivestrengthswithmarket
opportunitiesinthe developmentof a suitable strategyforthe organization.
Limitations of the BCG-Matrix:-
 It neglectsthe effectsof synergiesbetweenbusinessunits.
 Highmarket share isnot the onlysuccessfactor.
 Market growthis notthe only indicatorforattractivenessof amarket.
 SometimesDogscanearnevenmore cash as CashCows.
 The problemsof gettingdataon the marketshare and marketgrowth.
 There isno cleardefinitionof whatconstitutesa“market”.
 A highmarketshare doesnot necessarilyleadtoprofitabilityall the time.

 The model usesonlytwodimensions –marketshare and growthrate.This maytemptmanagementtoemphasize a
particularproduct,or to divestprematurely.
 A businesswithalowmarketshare can be profitable too.
 The model neglectssmall competitorsthathave fastgrowingmarketshares.

What Does A SWOT Evaluate?
What are Strengths?
Strengths:
 What advantages(forexample,skills,educationorpersonal industry connections) dotheyhave thatothersdon’t
have?
 What do theydobetterthan anyone else?
 What personal resourcesdotheyhave accessto?
 What do otherpeople (andtheirsuperiorsinparticular) see astheirstrengths?
 In lookingatyouremployees strengths,thinkabouttheminrelationtothe otheremployees
Example:if an RSM is making call attainmentand theotheremployeesaround themarenot,then this is likely to be
strengthin their currentrole.
What are Weaknesses?
 What shouldthey avoid?
 What could your employeesimprove?

 What thingsare the people around themlikelyto see as weaknesses? (qualitiesthatthe employee maybe
unaware of) Do co-workersconsistentlyout-performthemin keyareas?
 It isbest to be realisticnow, and helpthem face any unpleasanttruths if possible.
 Examples– unorganizedbinders,toocasual dress, poorrapport, poor time management.
What are Opportunities?
Opportunities:
 A useful approach to lookingat opportunitiesisalso to look at employees’strengthsand ask you whetherthese
openup any opportunities.
 Alternatively,lookat theirweaknessesand ask whetherthey couldopen up opportunitiesbyeliminatingthem.
Changesin technology,markets and our company on both a broad and narrow scale
 Changesin the company’s needfor future managers – havingmanagerial skillsorwantingto improve their
managementskills(FastTrack Candidate)
 Changes insocial patterns, populationprofiles,lifestyle changes,etc.
What are Threats?
Threats:
 What obstaclesdo they face?
 What are the people around themdoing?
 Is their job (or the demand for the thingsthey do) changing?
 Is changing technologythreateningtheir position?
 Could theirweaknessesseriouslythreaten them? Today’s standard of technical competence will be tomorrow’s
level ofincompetence.The technological landscape requiresconstant upgrading of skillsand proficiencies.
 Example:RSM can’t sendin success storiesby e- mail and is not trying to learn how to improve computer skills

SWOT AnalysisWorksheet for an RSM:-
Strengths:
• Has managementexperience indrivingresultsand promotions
• Very goodsellingskills& analytical abilities
• College degree & recentnewhire
• Speaks two or more languages
Weaknesses:
• Dressestoo casually
• PerceivedasCareer not important / unmotivated
• Books and Bag not organized
• Lacks professionalisminthe business
Opportunities:
• Possible FastTrack candidate
• Instruct on how to improve communicationskills
• ASM career opportunitiesifskillscontinue to be tutored
• International managementopportunities
Threats:
• Has no previousoutside marketing/salesexperience
• Has limitedExcel,Word,PowerPoint, or e-mail skills
• Large territory requiresovernightsand extensive driving
• Competitive jobmarkets – career vs. money $
Private Personal Issues(not criteria):
• RetirementAge
• Memberof Rotary Club
SWOT Analysis

• Has small childrenat home
• Prior medical conditionsor issues
Use of SWOT Analysis:-
A SWOT (strengths,weaknesses,opportunitiesandthreats) analysislooksatinternal andexternal factorsthatcanaffectyour
business.Internal factorsare yourstrengthsandweaknesses.Externalfactorsare the threatsand opportunities.If anissue or
situationwouldexistevenif yourbusinessdidn't(suchaschangesintechnologyora majorflood),itisan external issue.
 Strategicplanning,brainstorminganddecisionmaking
 Buildingonstrengths
 Minimizingweaknesses
 Seizingopportunities
 Counteractingthreats
 Addressingindividualissues

What is Quality?
 In manufacturing,ameasure of excellence orastate of beingfree fromdefects,deficiencies andsignificantvariations.Itis
broughtabout bystrict and consistentcommitmenttocertainstandardsthatachieve uniformity of aproductinorderto
satisfy specificcustomeroruserrequirements.
The totalityof features andcharacteristics of aproduct or service thatbearsitsability tosatisfystatedorimplied needs.
(ISO8402-1986)
Qualityisfitnessforuse
• Qualityismeetingcustomers’ expectations
• Qualityisexceedingthe customers’ expectations
• Qualityissuperioritytocompetitors
Quality Control (QC)
The standard(s) towhichthe constructionor assemblyof abuildingcomponenthasbeen
incorporatedintothe project’sdesign.
• Qualitycontrol isconcernedwiththe operationalactivitiesandtechniquesthat
are usedto fulfil the requirementsof quality.
• The qualitycontrol processincludesthe activitieswhichensureahighquality
product.These activitiesfocusonidentifyingdefectsinthe actual productbeing
produced.
Qualitycontrol functionsstartonce the projectworkhas begun.Qualitycontrol isareactive approachand helpsyoufind
defectsindeliverables.
Quality Assurance (QA)
• Are all those plannedandsystematicactionsnecessaryto provide adequate
confidence thatanentitywill fulfil requirementsforquality
• Qualityassurance isa processbasedapproachwhose prime objective isto
preventdefectsindeliverablesinthe planningprocessitselftoavoidthe
rework,whichcostsa lot.

• Qualityassurance isa proactive process,anditstarts at the verybeginningof the projecttounderstandthe product’s
statedand non-statedrequirementsandexpectations,andthendevelopthe plantomeetthese requirementsand
expectations.
• Quality auditisan example of aqualityassurance process.Otherexamplesof qualityassurance are training,process
definition,selectionof tools,etc.
The Difference between Quality Assurance and Quality Control:-
The Benefits of Quality Assurance and Quality Control:-
• It givesyoua highqualityoutput.
• It increasesthe efficiencyof operations.
• It bringscustomersatisfaction,whichaffectsyourbrandandhelpsyougrow your business.
• If your productis of good quality,youwill notneedmuchreworkandthere will notbe muchafter-salesupport
required.Thiswill helpyousave alotof money.
• A highlevel of confidence andamotivatedteam.

Apparatus in pharmaceutical Quality control:-
Muffle Furnace:-
A muffle furnace (sometimes,retort furnace) inhistorical usage isafurnace in
whichthe subjectmaterial isisolatedfromthe fuel andall of the productsof
combustion,includinggasesandflyingash.
Today,a muffle furnace is(usually) afront-loadingbox-typeovenorkilnfor
high-temperature applicationssuchasfusing glass,
creatingenamel coatings, ceramicsandsolderingandbrazingarticles.Theyare
alsousedinmany researchfacilities,forexampleby chemistsinorderto
determine whatproportionof asample isnon-combustibleandnon-volatile
(i.e.,ash).Some digitalcontrollersallowRS232 interface andpermitthe
operatorto program upto 126 segments,suchasramping,soaking,sintering,
and more.Also,advancesinmaterialsforheatingelements,suchas
molybdenumsilicide,can nowproduce workingtemperaturesupto1,800
degreesCelsius(3,272degreesFahrenheit),whichfacilitatemore sophisticated
metallurgical applications.
A muffle furnace isalsocalledaretortfurnace.
Disintegration apparatus:-
 For a drug to be readilyavailabletothe body, itmustbe insolution.
 For mosttablets,the firstimportantsteptowardsolutionisbreakdownof the tablet
into smallerparticlesorgranules,aprocesscalled disintegration.
The U.S.P. device totestdisintegrationuses6glasstubesthatare 3 incheslong;openatthe
top and10 mesh screens atthe bottomend.To test fordisintegrationtime,one tabletis
placedineach tube andthe basketrack ispositionedina1-L beakerofwater, simulated
gastric fluidor simulatedintestinal fluidat 37 ± 20
C such thatthe tabletremain2.5 cm below
the surface of liquidontheirupwardmovementandnotcloserthan2.5 cm from the bottomof
the beakerintheirdownwardmovement.Move the basketcontainingthe tabletsupanddown
througha distance of 5-6 cm at a frequencyof 28 to 32 cyclesperminute.Floatingof the
tabletscan be preventedbyplacingperforatedplasticdiscsoneachtablet.
 To be incompliance withUSP standards,the tabletmustdisintegrate andall particles
mustpass throughthe 10 meshscreeninthe time specified.If anyresidue remains,itmust
have a soft masswithno hard core.

 Complete disintegrationisastate in whichany residue remains isasoftmass havingnopalpable firmcore except
fragmentsof insoluble coatingremainingonthe screenof the apparatus.
 Proceduresare statedforrunningdisintegrationtimesforuncoated tablets, plaincoated tablets,entericcoated
tablets,buccul tabletsandsublingual tablets.
 UncoatedUSP tabletshave disintegrationtime aslow as5 minutes, butthe majorityhas max. Disintegration time of
30 minutes.
 Disintegrationtest: we startwith6 tablets( each tabletineachtube) , if one or two tabletsfailedtodisintegrate
completely, testshouldbe repeatedforadditional 12tablets,the requirementmetif notfewerthan16 of the total
18 are disintegrated.
 Entericcoatedtabletsare similarly tested. Exceptthatthe tabletsare testedinsimulatedgastricfluidforone hour,
afterwhichno signof disintegration,crackingor softeningmustbe seen.Theyare immersedinsimulatedintestinal
fluidforthe time specifiedinthe monograph,duringwhichtime the tabletsdisintegratecompletelyforapositive
test.
Photoflurometer:-
A fluorimeterorfluorimeterisadevice usedtomeasure parametersof fluorescence:its
intensityandwavelengthdistributionof emissionspectrumafterexcitationbyacertain
spectrumof light.These parametersare usedtoidentifythe presence andthe amountof
specific Fluorescence analysiscanbe ordersof magnitude more sensitivethanother
techniques.Applications
includechemistry/biochemistry, medicine, environmental monitoring.Forinstance,
theyare usedtomeasure chlorophyll fluorescence toinvestigate entryof Light
sourcesfor fluorometersare oftendependentonthe type of sample beingtested.
Amongthe most commonlightsource forfluorimeteristhe low-pressuremercury
lamp.Thisprovidesmanyexcitationwavelengths,makingitthe mostversatile.
However,thislampisnota continuoussource of radiation.The xenonarclamp is used
whena continuoussource of radiationisneeded.Bothof these sourcesprovideasuitable spectrum
of ultravioletlightthatinduces chemiluminescence.Theseare justtwoof the manypossible lightsources.
Glassand silicacellsare oftenthe vesselsinwhichthe sample isplaced. The scientistmustbe verycareful tonotleave
fingerprintsoranyothersort of mark on the outside of the cell.

Tablet Hardness Tester:-
Tablet hardnesstesting,is a laboratorytechnique usedbythe pharmaceutical industrytotestthe breakingpoint and
structural integrityof a tablet"underconditionsof storage,transportation,andhandlingbefore usage" The breakingpointof
a tabletisbasedon itsshape. It issimilarto friability testingbuttheyare notthe same thing.
Tablethardnesstestersfirstappearedinthe 1930s. In the 1950s, the Strong-
Cobbtesterwasintroduced.ItwaspatentedbyRobertAlbrechtonJuly21,
1953. and usedanair pump.The tabletbreakingforce wasbasedonarbitrary
unitsreferredtoas Strong-Cobbs.The newone gave readingsthatwere
inconsistenttothose givenbythe oldertesters. Later,electro-mechanical testing
machineswere introduced.Theyoftenincludemechanismslike motordrives,
and the abilitytosendmeasurementstoacomputeror printer.
There are 2 main processestotesttablethardness:compressiontestingand3
pointbendtesting.Forcompressiontesting,the analystgenerallyalignsthe
tabletina repeatable way,andthe tabletissqueezedby2 jaws.The first
machinescontinuallyappliedforce withaspringandscrew threaduntil the tablet
startedto break.Whenthe tabletfractured,the hardnesswasreadwitha sliding
scale.
There are several devicesusedtoperformthistask:
 The Monsanto testerwasdeveloped50years ago.The designconsistsof "abarrel containingacompressible spring
heldbetween2plungers".The tabletisplacedonthe lowerplunger,andthe upperplungerisloweredontoit.
 The Strong-Cobbtesterforcesananvil againsta stationaryplatform.Resultsare viewedfroma hydraulicgauge. The
resultsare verysimilartothat of the Monsantotester.
 The Pfizertestercompressestabletbetweenaholdinganvil andapistonconnectedtoa force-readinggauge when
itsplier-like handlesare gripped.
 Erwekatestertestsa tablet placedonthe loweranvil anda weightmovingalongarail transmitspressure slowlyto
the tablet.
 The Dr.SchleunigerPharmatrontesteroperatesinahorizontal position.Anelectricmotordrivesananvil tocompress
a tabletat a constantrate.The tabletispushedagainstastationaryanvil until itfractures.A readingistakenfroma
scale indicator.
Karl Fischer:-
Karl Fischer titration isa classictitrationmethodin analytical chemistry that
usescoulometricorvolumetrictitrationtodeterminetrace amountsof waterin

a sample.Itwas inventedin1935 by the German chemist Karl Fischer. Today,the titrationisdone withanautomatizedKarl
Fischertitrator.

Polarimeter:-
A Polarimeterisa scientificinstrumentusedtomeasure the angle of
rotation causedby passing polarizedlightthroughan optically
active substance.
Some chemical substancesare opticallyactive,andpolarized
(unidirectional) lightwillrotate eithertothe left(counter-clockwise) or
right(clockwise) whenpassedthroughthese substances.The amount
by whichthe lightisrotatedisknownas the angle of rotation
Other apparatus are:-
Dissolutionapparatus,
Potentiometrictitrimeter,
pH Meter,
Spectrophotometeretc.
1. Hot Air Oven for Sterilization:
It isusedfor sterilizationof glassware’s,suchastesttubes,pipettesandpetri dishes.Suchdrysterilizationisdone onlyfor
glassware’s.Liquidsubstances,suchaspreparedmediaandsaline solutionscannotbe sterilizedinoven,astheylose water
due to evaporation.
The glassware’sare sterilizedat180°C for3 hours.An oven(Figure 3.2) hasa thermostat-control,usingwhichthe required
constanttemperature canbe obtainedbytrial and error.The thermostatdial readingisapproximate andthe exact
temperature is readbyintroducingathermometerintothe ovenorona built-inL-shapedthermometer.

In a modernoven(Figure 3.3),there isa digital temperature displayandautomatictemperature controllertosetthe desired
temperature easily.Time issetbya digital timer.Afterloadingthe glassware’s,the doorisclosedandovenswitchedon.

The requiredtemperature isset.Afterthe ovenattainsthe settemperature,the requiredtime of sterilizationissetonthe
timer.The ovenswitchesoff automaticallyafterthe settime.The ovenisopened,onlyafteritstemperature comesdown
nearto room temperature.Otherwise,if the doorisopened,whilethe inside of the ovenisstill veryhot,coldairmayrush in
and crack the glassware’s.
2. Drying Oven:
For preparationof certainreagents,the glassware’s,afterpropercleaningandrinsingwithdistilledwater,are requiredtobe
dried.Theyare driedinside the dryingovenat100°C till the glassware’sdryupcompletely.
3. Autoclave:
Autoclave isthe nucleusof amicrobiologylaboratory.Itisusednotonlytosterilize liquidsubstancessuchaspreparedmedia
and saline (diluents) solutions,butalsotosterilize glassware’s,whenrequired.
It has the same workingprinciple asadomesticpressure cooker.The maximumtemperature thatcanbe obtainedbyboiling
waterin an opencontaineris100°C (boilingpointof water).
Thistemperature issufficienttokill onlythe non-sporeformers,butitisdifficulttokill the spore-formingbacteriaatthis
temperature,astheyescape byformingheatresistantspores.Ittakesverylongtime tokill the sporesatthistemperature.
On the otherhand,whenwaterisboiledina closedcontainer,due toincreasedpressure insideit,the boilingpointelevate s
and steamtemperature muchbeyond100°Ccan be obtained.Thishightemperatureisrequiredtokill all the bacteria
includingthe heatresistantspore-formers.Steamtemperature increaseswithincrease insteampressure (Table3.1).
Table 3.1: Temperaturesattainable at differentsteampressures:
In operatingastandardvertical autoclave,(Figure 3.4) sufficientwaterispouredintoit.If wateristoo less,the bottom of the
autoclave getsdriedduringheatingandfurtherheatingdamagesit.

If it has in-builtwaterheatingelement,(Figure 3.5) waterlevel shouldbe maintainedabove the element.Onthe otherhand,
if there istoo much water,ittakeslongtime to reachthe requiredtemperature.

The materialstobe sterilizedare coveredwithcraftpaperandarrangedon an aluminiumorwoodenframe keptonthe
bottomof the autoclave,otherwise if the materialsremainhalf-submergedorfloating,theytumble duringboilingandwater
may enter.The autoclave isclosedperfectlyairtightonlykeepingthe steamrelease valve open.
Then,itis heatedoverflame orbythe in-builtheatingelement.Airinsidethe autoclave shouldbe allowedtoescape
completelythroughthisvalve.Whenwatervapourisseentoescape throughthe valve,itisclosed.
Temperature andpressure inside goesonincreasing.The pressure increase isobservedonthe pressure dial.Usually
sterilizationisdone at121 °C (a pressure of 15 poundspersquare inchi.e.15 psi) for15 minutes.The requiredtimeis
consideredfromthe point,whenthe requiredtemperature-pressureisattained.
Once requiredtemperature-pressure isattained,itismaintainedbycontrollingthe heatingsource.Afterthe specifiedtime
(15 minutes),heatingisdiscontinuedandsteamrelease valveslightlyopened.If fullyopenedimmediately,due tosuddenfall
inpressure,liquidsmayspill outfromthe containers.
Gradually,the steamrelease isopenedmore andmore,soas to allow all steamtoescape.The autoclave isopenedonlyafter
the pressure dropsback to normal atmosphericpressure(0psi).The autoclave shouldneverbe opened,whenthere isstill
pressure inside.The hotsterilizedmaterialsare removedbyholdingthemwithapiece of cleanclothor asbestos- coated
handgloves.
In case of a steam-jacketedhorizontal autoclave,aboilerproducesthe steam(Figure 3.6).Itisreleasedata designated
pressure,intothe outerchamber(jacket).Airisallowedtoescape andthenitssteamrelease valveisclosed.

The hot jacketheatsthe innerchamber,therebyheatingthe materialstobe sterilised.Thispreventscondensationof steam
on the materials.Now,steamunderpressure isreleasedfromthe jacketintothe innerchamberandairisallowedtoescape
fromit.
Then,itssteamrelease valve isclosed.The steamunderpressure inthe innerchamberreachestemperaturesinexcessof
100°C, whichcan sterilise the materialskeptinsideit.The autoclave alsohasautomaticshuttingsystemi.e.unless
temperature andpressure comesdownneartoroomconditions,the doorcannotbe opened.
Besidesthe pressure dial,italsohasseparate temperature dialtoindicate the temperature inside the innerchamber.
Moreover,the autoclave maintainsthe temperature andpressureautomaticallyandswitchesoff afterthe settime of
sterilization.
4. Microbiological Incubator:
Profuse growthof microbesisobtainedinthe laboratorybygrowingthematsuitable temperatures.Thisisdone by
inoculatingthe desiredmicrobe intoasuitableculture mediumandthenincubatingitatthe temperature optimumforits
growth.
Incubationisdone inan incubator(Figure 3.7),whichmaintainsaconstanttemperature specificallysuitable forthe growth of
a specificmicrobe.Asmostof the microbespathogenictomangrow profuselyatbodytemperature of normal humanbeing
(i.e.37°C),the usual temperature of incubationis37°C.

The incubatorhas a thermostat,whichmaintainsaconstanttemperature,setaccordingtorequirement.The temperature
readingonthe thermostatisapproximate.Accurate temperature canbe seenonthe thermometerfixedonthe incubator.
Exact temperature,asperrequirement,issetbyrotatingthe thermostatknobbytrial and errorand notingthe temperature
on the thermometer.
Most of the modernincubators(Figure 3.8) are programmable,whichdonotneedtrial anderror temperature setting.Here,
the operatorsetsthe desiredtemperatureandthe requiredperiodof time.
The incubatorautomaticallymaintainsitaccordingly.Moisture issuppliedbyplacingabeakerof waterinthe incubator
duringthe growthperiod.A moistenvironmentretardsthe dehydrationof the mediaandthereby,avoidsspurious
experimental results.

5. BOD Incubator (Low Temperature Incubator):
Some microbesare to be grownat lowertemperaturesforspecificpurposes.The BODlow temperature incubator(Figure
3.9), whichcan maintaintemperaturesfrom50°C to as low as 2-3°C is usedforincubationinsuchcases.

The constant desiredtemperature issetbyrotatingthe knobof the thermostat.Rotationof the thermostatknobmovesa
needle onadial showingapproximatetemperature.Exactrequiredtemperatureisobtained,byrotatingthe knobfinelyby
trial and error andnotingthe temperature onthe thermometerfixedonthe incubator.
Most of the modernBOD incubators(Figure 3.10) are programmable,whichdonotneedtrial anderrortemperature setting.
Here,the operatorsetsthe desiredtemperatureandthe requiredperiodof time.The incubatorautomaticallymaintainsit
accordingly.

6. Fridge (Refrigerator):
It servesasa repositoryforthermolabilechemicals,solutions,antibiotics,serumsandbiochemical reagentsatcooler
temperaturesandevenatsub-zerotemperatures(atlessthan0°C).Stockculturesof bacteriaare also storedinitbetween
sub-culturingperiods.Itisalsousedforthe storage of sterilizedmedia,soasto preventtheirdehydration.
7. Deep-fridge:
It isusedto store chemicalsandpreserve samplesatverylow sub-zerotemperatures.
8. ElectronicTop-pan Balance:
It isusedfor weighing large quantitiesof mediaandotherchemicals,where precise weighingisnotof muchimportance.
9. ElectronicAnalytical Balance:
It isusedto weighsmall quantitiesof chemicalsandsamplespreciselyandquickly.
10. Double-panAnalytical Balance:
It isusedto weighchemicalsandsamplesprecisely.Weighingtakesmore time,forwhichitisusedinemergencyonly.
11. DistilledWaterPlant:
Water isusedinthe preparationof mediaandreagents.If the mediaare preparedusingtapwater,the chemical impurities
presentinitmay interfere withthe growthof the microorganismsinthe media.Moreover,the higheristhe bacteriacontent
of the media,the longeristhe time requiredfortheirsterilizationandgreateristhe chance of survival of some bacteria.
Distilledwater,thoughnotbacteria- free,containslessnumberof bacteria.Thatiswhy;it ispreferredinthe preparationof
microbiological media.Itisalsousedinthe preparationof reagents,because the chemical impuritiespresentintapwater
may interfere withthe properfunctioningof the reagentchemicals.
As manufacture of distilledwaterbyLiebigcondenserisatime-takingprocess,inmostlaboratories,itispreparedby‘distilled
waterplants’.Usuallyadistilledwaterplantismade of steel orbrass.It isalso calleddistilledwaterstill.
It has one inlettobe connectedtothe water tap andtwo outlets,one fordistilledwatertodropintoa containerandthe
otherfor the flowoutof hotcoolingwaterintothe sink.The still isinstalledonthe wall.Itisheatedbyin-builtelectric
heatingelements(immersionheater).
The still worksefficiently,whenthe waterin-flow issoadjustedthat,the temperature of the coolingwaterflowingoutfrom
the still intothe sinkisneithertoohighnortoo low i.e.,warmwatershouldflow out.The distilledwatermaycontaintraces
of metalscorrodedfromthe steel orbrasscontainer.
To get metal-free distilledwater,glassdistillationapparatusisusedandstill betterisquartzdistillationapparatus.However,
for a microbiologylaboratory,asteel orglassdistillationapparatusissufficient.Forprecisionanalyses,double- ortriple-
distilledwaterisused.
12. Ultrapure WaterPurificationSystem:

For precisionanalyticalworks, now-a-days,insteadof usingdouble- ortriple-distilledwater,micro- filteredwaterisused.In
case of distilledwater,there ischance that,fewvolatile substancespresentinthe watergetvolatilizedduringheatingof the
waterand subsequentlygetcondensedintothe distilledwatercollected.
Thus,there may be traces of such substancesinthe distilledwater.Toovercome this,ultrapure waterisused.Here,wateri s
allowedtopassthroughveryfine microscopicpores,whichretainthe microscopicsuspendedparticle includingthe microbes.
Then,the waterpassesthroughtwocolumnsof ion exchange resins.The anionexchange resinadsorbsthe captionspresent
inthe water,while the captionexchange resinadsorbsthe anions.The waterthatcomesout is extremelypure.
13. Homogenizer:
For microbiological analysis,liquidsamplesare directlyused,whereassolidsampleshave tobe mixedthoroughlywitha
diluents(usuallyphysiological saline),soastoget a homogenoussuspensionof bacteria.Thissuspensionisassumedto
containbacteriahomogenously.
The mixingof solidsamplesanddiluentsisdone byahomogenizer,inwhichamotor rotatesan impellerwithsharpbladesat
highspeedinside the closedhomogenizercupcontainingthe sampleandthe diluents.Ithasa speedregulatorforcontrolling
the speedof rotationof the impeller.
In some laboratoriesmixingisdone manuallybysterilizedpestleandmortar.In modernlaboratories,adisposablebagis
used,inside whichthe solidsampleandliquiddiluentsare putasepticallyandmixedmechanicallybyperistalticactionof a
machine onthe bag. Thismachine iscalledstomacher.
14. pH Meter:
A pH meterisan instrumentfordeterminingthe pHof liquidmedia,liquidsamplesandbuffers.Ithasa glass pH electrode.
Whennot inuse,itshouldbe kepthalf immersedinwatercontainedinasmall beakerandpreferablybe coveredbyabell jar
to avoiddustaccumulationinthe waterand lossof waterthroughevaporation.
Before use,the meteriscalibratedusingtwostandardbuffersof knownpH.Usuallybuffersof pH4.0, 7.0 and 9.2 are
available commercially.The instrumentisswitchedonandleftfor30 minutestowarmup. The temperature calibrationknob
isrotatedto the temperature of the solutionswhose pHistothe measured.
Then,the electrode isdippedintothe buffer(pH7.0).If the readingisnot 7.00, the pH calibrationknobisrotatedtill the
readingis7.00. Then,the electrode isdippedinanotherbuffer(pH4.0 or 9.2).
If the readingissame as the pH of the bufferused,the instrumentisworkingproperly.Otherwise,the electrode isactivated
by dippingin0.1 N HC1 for 24 hours.Aftercalibration,the pHof samplesisdeterminedbydippingthe electrode intothem
and notingthe reading.
Everytime,before dippingintoanysolution,the electrode shouldbe rinsedwithdistilledwater.The samplesshouldnot
containany suspendedstickymaterials,whichmayformacoatingon the tip of the electrode andreduce itssensitivity.
The old model pHmetershave double electrodes(one of themactingasreference electrode),while new modelshave single
combinedelectrode.Moreover,toovercome the problemof temperaturecorrection,now pHmeterswithautomatic
temperature correctionare available.

Here,another‘temperature electrode’isalsoputintothe solutionalongwiththe pHelectrode,whichmeasuresthe
temperature of the solutionandautomaticallycorrectsthe influence of temperaturevariations.
SophisticatedpHmetershave single gel electrode.Suchelectrodeshave verylittlechance of breakage,astheyare almost
completelyenclosedinahard plasticcasingexceptatthe tip.The tiphas bothpH and temperature sensors.
Moreover,theyare easyto maintain,astheydo notrequire constantdippingindistilledwater,because the electrodetipis
closedwitha plasticcapcontainingsaturatedsolutionof potassiumchloride,whennotinuse.However,inpreparationof
microbiological media,pHisdeterminedbynarrow-range pHpapersandisadjustedtothe requiredpHbyaddingacidsor
alkalisasrequired.
15. Hot Plate:
Hot plate isusedto heatchemicalsandreagents.The hotplate ismade of an ironplate,whichgetsheatedbyanelectric
heatingelementfrombelow.The requireddegreeof heatingisobtainedbyaregulator.
16. Shaking Water Bath:
Sometimes,heatingatveryprecise temperaturesisrequired.Suchprecise temperaturescannotbe obtainedinanincubator
or oven,inwhichtemperature fluctuates,thoughslightly.However,precisetemperaturescanbe maintainedinawaterbath,
whichprovidesastable temperature.
A waterbath consistsof a containercontainingwater,whichisheatedbyelectricheatingelements.The requiredwater
temperature isobtainedbyincreasingordecreasing the rate of heatingbyrotatingthe thermostatbytrial and error.
In a shakingwaterbath,the substance isheatedat the requiredtemperature andatthe same time,itis shakenconstantly.
Shakingisdone bya motor,whichrotatesand movesthe containerstoandfro ineach rotation.The rate of shakingisagain
controlledbyaregulator.Shakingagitatesthe substance andenhancesthe rate of the process.
Most modernwaterbathsare programmable anddo notneedtrial anderror temperature setting.A desiredwater
temperature canbe maintainedoveradesiredperiodof time byprogrammingaccordingly.Itisusedforcultivationof
bacteriainbroth mediumata specifictemperature.
17. QuebecColonyCounter:
In enumerationof bacteriainsamples,itisassumedthata single bacteriumgivesrise toasingle visible colony,whengrown
on a plate of solidifiednutrientmedium.Thus,bycountingthe numberof colonies,the numberof bacteriainasample can be
estimated.
Sometimes,coloniesare verysmall andtoomuchcrowdedmakingitdifficulttocount.Countingbecomeseasy,whena
mechanical handcounter,calledQuebeccolonycounter(Figure3.11),isused.It dividesthe plate intoseveral square
divisionsandthe coloniesare magnified1.5timesbya magnifyingglass,whichmakescountingeasy.

18. Electronic ColonyCounter:
Electroniccolony counter is oftwo types:
(1) Hand-heldelectroniccolonycounterand
(2) Table-topelectroniccolonycounter.
The hand-heldelectroniccolonycounterisa pen-style colonycounterwithaninkingfelt-tipmarker.Forcountingof colonies
of bacteriagrownina petri dish,itiskeptinan invertedposition,sothatthe coloniesare visible throughthe bottomsurface
of the petri dish.
The coloniesare markedbytouchingthe glasssurface of the petri dishwiththe felt-tipof the colonycounter.Thus,each
colonyismarkedby a dot made bythe inkof the felt-tiponthe bottomsurface of the petri dish.Ina single motion,the
electroniccolonycountermarks,countsand confirmswithabeepsound.

The cumulative countof coloniesisdisplayedonafour-digitLEDdisplay.Incase of table-topelectroniccolonycounter,the
petri dishcontainingthe coloniesof bacteriaisplacedonan illuminatedstage andthe countbar isdepressed.The precise
numberof coloniesisinstantlydisplayedonadigital readout.
19. Magnetic Stirrer:
In the preparationof solutions,certainchemicalsrequirestirringforlongtime,tobe dissolvedincertainsolvents.Magne tic
stirrerisused to dissolve suchsubstanceseasilyandquickly.A small teflon- coatedmagnet,called‘stirringbar’,isputintoa
containercontainingthe solventandthe solute.
Then,the containerisplacedonthe platformof the magneticstirrer,below whichamagnetrotatesat highspeedbya motor.
Attractedby the rotatingmagnet,the teflon-coatedmagnetrotatesinsidethe containerandstirsthe contents.Now,the
solute dissolvesquickly.
The tefloncoatingpreventsthe magnetfromreactingwiththe solution,whichcomesincontactwithit.Aftercomplete
dissolution,the teflon-coatedmagnetisremovedfromthe solutionbymeanof a longretriever,called‘stirringbarretriever’.
20. Sonicator:
It isusedto rupture cellsusinghighfrequencywaves.
21. Vortex Mixer:
It isan instrumentusedforthoroughmixingof liquidsintesttubes.Ithasa rotor,whose speedcanbe controlled.Onthe tip
of the rotor isa foam-rubbertop.Whenthe bottomof a testtube ispresseduponthisfoam-rubbertop,the rotorstarts
rotating,therebyrotatingthe bottomof the testtube at highspeed.
Due to centripetal force,the solutiongetsmixedthoroughly.Itisparticularlyhelpful duringserial dilutioninenumerationof
bacteria,whichneedshomogenoussuspensionof bacteriacells.
21. Laminar FlowChamber:
It isa chamber(Figure 3.12) usedforaseptictransferof sterilizedmaterials,aswell asforinoculationof microbes.Dust
particlesfloatinginthe airharbourmicrobes.These microbe-ladendustparticlesmayenterintothe sterilizedmediaand
contaminate them,whentheyare openedforshortperiodsof time duringinoculationof microbe ortransferfromone
containertoanother.

To overcome this,wheninoculationisdone inopenair,the airof the small inoculating areaissterilizedbythe flame of a
bunsenburner.The heatedairbecomeslightandmovesupwards,therebypreventingthe dustparticlesfromfallingonthe
mediaduringthe shortopeningprocess.
To furtherreduce the chance of contaminationbythe microbe-ladenair,alaminarflow chamberisused.Itis a glass-fitted
cuboidal chamber.Anairblowerblowsairfromthe surroundingandpassesitthrougha HEPA filter(HighEfficiency
Particulate Airfilter),soasto make it dustfree (microbe-free).
Thismicrobe-freeairpassesthroughthe chamberina laminarmannerandcomesout fromthe chamberthroughthe open
frontdoor. Thislaminarflowof microbe-free airfromthe chambertooutside throughthe opendoorpreventsthe outsideair
fromenteringinto the chamber.
Thus,the chamberdoesnotget contaminatedwiththe microbespresentinthe outside air,thoughthe dooriskeptopened
duringinoculationortransferof media.AnUV lampfittedinside the chambersterilizesthe chamberbefore operation.
It has a stainlesssteelplatformwithprovisionforgaspipe connectionforabunsenburner.Before use,the platformis
cleanedanddisinfectedwithlysol,the bunsenburnerisconnectedandthenthe glassdooris closed.
The UV lightisswitchedonfor10 minutestosterilisethe environmentinsidethe chamberandthenswitchedoff.The glass
door shouldneverbe openedwhenthe UV lightison,because UV lighthasdetrimental effectonskinandvision.The blower
isswitchedonand thenthe glassdoor is opened.
Now,the bunsenburnerislightedandmediatransferorinoculationiscarriedoutinthe chamberaseptically.If extremely
hazardousmicrobesare to be handled,alaminarflow chamberwithglovesprojectingintothe chamberfromthe frontglass
door isused,as inoculationhastobe done keepingthe frontdoorclosed.
22. Electronic Cell Counter:
It isusedto directlycountthe numberof bacteriaina givenliquidsample.Anexample of electroniccell counteristhe
‘Coultercounter’.Inthisequipment,asuspensionof bacteriacellsisallowedtopassthrougha minute orifice,acrosswhich
an electriccurrentflows.
The resistance atthe orifice iselectronicallyrecorded.Whenacell passesthroughthe orifice,beingnon-conductor,it
increasesresistance momentarily.The numberof timesresistance increasesmomentarilyisrecordedelectronically,which
indicatesthe numberof bacteriapresentinthe liquidsample.
23. Membrane FiltrationApparatus:
Certainsubstanceslike ureadisintegrate and lose theiroriginal properties,if sterilizedbyheat.Suchsubstancesare sterilized
by membrane filtrationapparatus.Inthisapparatus,the solutionof the substance tobe sterilizedisfilteredthrougha
membrane filter,whichdoesnotallowbacteriacellstopassdown.Filtrationisdone undersuctionpressure toincrease the
rate of filtration(Figure2.19,page 30).
24. Microscopes:
Differenttypesof microscopesare usedforvisual observationof morphology,motility,stainingandfluorescentreacti onsof
bacteria.

25. Computers:
Computersare generallyusedforanalysisof results.Theyare alsousedforidentificationof bacteriaeasilywithinfewhours.
Otherwise,identificationof bacteriaisatediousprocessandtakesdaystogethertoidentify one bacteriaspecies.
The computersusedforidentificationof bacteriaare Apple II,IBMPC andTRS-80 and theirmodernvariants.Eachresearch
personnel of the laboratoryshouldbe providedwithacomputer,alongwithinternetfacility.
26. Spectrophotometer:
It isan instrumentformeasuringthe differencesincolorintensitiesof solutions.A beamof lightof a particularwavelengthis
passedthroughthe testsolutionandthe amountof lightabsorbed(ortransmitted) ismeasuredelectronically.
A simple visiblespectrophotometercanpasslightwithwavelengthswithinvisible range,whereasaUV-cum-visible
spectrophotometercanpasslightwithwavelengthsinultravioletaswell asinvisiblerange.Inmicrobiologylab,itisused for
directcountingof bacteriainsuspensionaswell asforotherpurposes.
27. Electrical Devices:
A fluctuationof electricvoltage inthe laboratoryisone of the mostimportantreasons,whichreducesthe longevityof the
equipmentsandsometimesdamage them.Therefore,all the voltage-sensitive equipmentsshouldbe providedwithvoltage
protectiondeviceslike stabilizers,servostabilizersorconstantvoltage transformers(CVT) asperthe recommendationsof the
manufacturersof the equipments.
Computers,balancesandsome sophisticatedequipmentsshouldbe connectedthroughuninterruptedpowersupply(UPS),as
any breakdowninthe electricpowersupplyduringtheiroperationmayseverelydamage some of theirsensitivecomponents.
The laboratoryshouldhave a highcapacitygeneratorto supplyelectriccurrenttothe whole laboratoryincase of power
failure.Thisisbecause,powerfailurenotonlybringsthe activitiesof the laboratorytoa standstill,italsobringsabout
undesirableirreversiblechangesinthe samplesstored inthe deep-fridgesandrefrigerators.
28. Automatic Bacteria IdentificationSystem:
It isan instrumentusedforautomaticcomputer-assistedidentificationof bacteria(Figures3.13and 3.14). The conventional
methodof identificationof bacteriaisvery lengthyandcumbersome.

It mainlyinvolvesstaining,motilitytest,cultural characteristics,aseriesof biochemical testsandfinallysearchingthe name of
the bacteriain ‘Bergey’sManual of Determinative Bacteriology’bymatchingthe resultswiththoseavailableinthe manual.
The automaticbacteriaidentificationsystemautomaticallyidentifiesthe bacteriainveryshorttime.
The system,like VITEK2 (Figure 3.14) usesdisposable cards.One cardisrequiredforthe identificationof one bacteria.The
systemcan accommodate a seriesof cards,whichcan be arrangedon a cassette,thusenablingthe identificationof several
bacteriaat a time.

Each card has several rowsof wells.Usuallythere are 8rows of 8 wellseach(8X8=64 wells).The wellscontaindifferent
dehydratedmediarequiredfordifferentbiochemical tests.A capillarytube isfixedtoeachcard, whichsucksthe suspension
of bacteriatobe identifiedanddispensesintoall the wells.
The dehydratedmediainthe wellsbecome hydratedby the suspensionliquid,therebyallowinggrowthof the bacteria.After
a prescribedperiodof incubation,the colourchangesinall the wellsare recordedautomaticallyinthe system.
The resultsof the color changesgo to a computerattachedto the system.The computerautomaticallycomparesthe results
withthose available initslibraryfordifferentbacteriaandfinallygivesthe name of the bacteriawithadefiniteprobability.
For identification,the givenbacteria,grownasisolatedcolonyonaplate or as pure culture grownon a slantare taken.A
lapful of the bacteriaistransferredasepticallyintosterilesalinesolutioninatesttube and a suspensionof the bacteri ais
made.
The suspensionshouldcontainaprescribeddensityof bacteria,asdeterminedbyadensitometer.The testtube isfixedtothe
cassette anda card isfixednearit,suchthat the tip of the suctioncapillarytube of the cardremainsdeeplysubmergedin the
suspension.
Several suchtesttubesandcards are fixedtoeachcassette,dependingonthe numberof bacteriatobe identified.The
cassette isput inthe vacuumchamber of the system.A highvacuum iscreatedinside the chamber,whichforcesthe bacteria
suspensiontobe suckedintothe capillarytubesanddispensedintothe wellsof the cards.
The cassette istakenout and putinside the incubationandanalysischamber.Here,the capillarytubesare cutand the cut
endssealedautomatically.Then,the incubationprocessstartsata prescribedtemperature foraprescribedperiodof time,
whichisprogrammedbythe control panel.Duringincubation,inevery15minutes,eachcard automaticallygoestothe color
reader,whichreadsthe colorchangesin the wellsandrecordsthem.
The recordedresultsgoto the computer,whichautomaticallycomparesthemwiththose,available initslibraryfordifferent
bacteria.Finally,itgivesthe namesof the bacteriawithdefinite probabilities.The usedcardsfall intothe waste disposal
chamberof the systemforremoval andfinal disposal aftersterilization.
The renownedautomaticbacteriaidentificationsystemsare VITEK2 and API.While VITEK2 workson the above principle,the
API(Analytical ProfileIndexing) system(Figure 3.13) usesa slightlydifferentmethodforthe automaticidentificationof
bacteria,whichinvolvesmanual inoculationandexternalincubation.
29. PCR Thermocycler,RefrigeratedCentrifuge,Ultra-centrifuge,GasChromatography(GC),High Performance Liquid
Chromatography (HPLC), Thin Layer Chromatography (TLC), Paper Chromatography, ColumnChromatography and
ElectrophoresisUnit:
These are instrumentsusedforisolation,purificationandidentificationof biochemical substances,suchasbacterial DNA,
plasmids,microbialtoxinsetc.Polymerase chainreaction(PCR) isanimportanttool innucleicacidbasedmethods.Itisa
workhorse inmodernmicrobiologyandbiotechnologylaboratories.

Tabletisdefinedasa compressedsoliddosage formcontainingmedicamentswithorwithoutexcipients.Accordingtothe
IndianPharmacopoeiaPharmaceutical tabletsare solid,flatorbiconvexdishes,unitdosage form, preparedbycompressinga
drug or a mixture of drugs,withor withoutdiluents
The advantages of the Tablet dosage form are:-
• Theyare unitdosage formand offerthe greatestcapabilitiesof all oral dosage formforthe greatestdose precision
and the leastcontentvariability.
• Cost islowestof all oral dosage form.
• Lighterand compact.
• Easiestand cheapesttopackage and strip.
• Easy to swallowingwithleasttendencyforhang-up.
• Sustainedreleaseproductispossiblebyentericcoating.Objectionable odourandbittertaste canbe maskedby
coatingtechnique.
• Situable forlarge scale production.
• Greatestchemical and microbial stabilityover all oral dosage form.
• Product identificationiseasyandrapidrequiringnoadditionalstepswhenemployinganembossedand/or
monogrammedpunch face.
Disadvantages of Tablet dosage form are:-
• Difficulttoswallow incase of childrenandunconsciouspatients.
• Some drugs resistcompressionintodense compacts,owingto amorphousnature, low densitycharacter.
• Drugs withpoor wetting,slow dissolutionproperties,optimumabsorptionhighinGITmay be difficulttoformulate
or manufacture asa tabletthatwill still provideadequateorfull drugbioavailability.
• Bittertestingdrugs,drugswithan objectionable odorordrugsthat are sensitive tooxygenmayrequireencapsulation
or coating.In suchcases,capsule may offerthe bestandlowestcost.

Different types of Tablets:-
(A) Tabletsingestedorally:
1. Compressedtablet,e.g.Paracetamoltablet
2. Multiple compressedtablet
3. Repeatactiontablet
4. Delayedrelease tablet,e.g.EntericcoatedBisacodyl tablet
5. Sugarcoated tablet, e.g.Multivitamintablet
6. Filmcoatedtablet,e.g.Metronidazoletablet
7. Chewable tablet,e.g.Antacidtablet
(B) Tabletsusedinoral cavity:
1. Buccal tablet,e.g.Vitamin-ctablet
2. Sublingual tablet,e.g.VicksMenthol tablet
3. Trochesor lozenges
4. Dental cone
(c) Tabletsadministeredbyotherroute:
1. Implantationtablet
2. Vaginal tablet,e.g.Clotrimazole tablet
(D) Tabletsusedto prepare solution:
1. Effervescenttablet,e.g.Dispirintablet (Aspirin)
2. Dispensingtablet,e.g.Enzyme tablet (Digiplex)
3. Hypodermictablet
4. Tablettrituratese.g.Enzyme tablet(Digiplex)
Tablet Ingredients:-
Inadditiontoactive ingredients,tabletcontainsanumberof inertmaterialsknownasadditivesorexcipients.Different
excipientsare:
1. Diluent

2. Binderandadhesive
3. Disintegrents
4. Lubricantsandglidants
5. Coloringagents
6. Flavoringagents
7. Sweeteningagents
EXCIEPIENTS- functions:-
• Impart weight,accuracy,& volume(itsallow accuracy of dose)
• Improve solubility
• Increase stability
• Enhance bioavailability
• Modifyingdrugrelease
• Assistpdtidentification
• Increase patientacceptability
• Facilitate dosage formdesign
1. Diluent: Diluentsare fillersusedtomake requiredbulkof the tabletwhenthe drugdosage itself isinadequateto
produce the bulk.Secondaryreasonistoprovide bettertabletpropertiessuchasimprove cohesion,topermituse of direct
compressionmanufacturingortopromote flow.A diluentshouldhave followingproperties:
1. Theymust be non-toxic
2. Theymust be commerciallyavailableinacceptable grade
3. Theircost mustbe low
4. Theymust be physiologicallyinert
5. Theymust be physically&chemicallystable by themselves&incombinationwiththe drugs.
6. Theymustbe free fromall microbial contamination.
7. Theydo not alterthe bioavailabilityofdrug.
8. Theymust be colorcompatible.

Commonlyusedtablet diluents:-
1. Lactose-anhydrousandspraydriedlactose
2. Directlycompressedstarch-StaRx 1500
3. Hydrolyzedstarch-Emdex andCelutab
4. Microcrystalline cellulose-Avicel (PH101andPH 102)
5. Dibasiccalciumphosphate dehydrate
6. Calciumsulphate dihydrate
7. Mannitol
8. Sorbitol
9. Sucrose- Sugartab,DiPac,Nutab
10. Dextrose
2. Bindersand Adhesives: These materials are added eitherdry or in wet- form to form granulesor to formcohesive
compacts for directlycompressedtablet.
• Example:Acacia,tragacanth- Solutionfor10-25% Conc.
• Cellulose derivatives- Methyl cellulose,Hydroxypropyl methyl cellulose,Hydroxypropyl cellulose
• Gelatin- 10-20% solution
• Glucose- 50% solution
• Polyvinylpyrrolidone (PVP) - 2%conc.
• Starch paste-10-20%solution
• Sodiumalginate
• Sorbitol
3. Disintegrents: Addedto a tablet formulationto facilitate its breaking or disintegrationwhenit contact inwater in
the GIT.
• Example:Starch- 5-20% of tabletweight.
• Starch derivative –Primogel andExplotab(1-8%)
• Clays- VeegumHV,bentonite10%level incoloredtabletonly

• Cellulose
• Cellulose derivatives- Ac- Di-Sol (sodiumcarboxymethyl cellulose)
• Alginate
• PVP(Polyvinylpyrrolidone),cross-linked
Superdisintegrants: Swellsup to ten foldwithin 30 secondswhencontact water.
4. Lubricant and Glidants: Lubricantsare intendedtopreventadhesionof the tabletmaterials to the surface of dies
and punches,reduce inter particle friction and may improve the rate of flowof the tablet granulation.
5. Coloring agent: The use ofcolors and dyesin a tablet has three purposes:
(1) Maskingof off color drugs
(2) ProductIdentification
(3) Productionof more elegantproduct
6. Flavoring agents: Forchewable tablet- flavor oil are used
7. Sweetening agents:For chewable tablets:Sugar, mannitol.
TABLET MANUFACTURING
PROCESS:-

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