Protocol for compressed air validation

Validation Guru Pvt. Ltd.
PERFORMANCE QUALIFICATION
Equipment Name Compressed Air With Drier Equipment ID
Protocol Number Version No
Effective Date Page No. 1 of 18[
PERFORMANCE QUALIFICATION PROTOCOL OF
COMPRESSED AIR WITH DRIER
CHANGE HISTORY:
Version No. Effective date Reason For revision
00 1. First Issue

TABLE OF CONTENTS
S. No. Description Page No.
1.0 Approval Signatures 3
2.0 Objective 4
3.0 Scope 4
4.0 Responsibility 4
5.0 Pre Requisites 5
6.0 Training Record 5
7.0 Safety Precautions 5
8.0 Equipment / Materials Required For Validation / Qualification 6
9.0 System Description 6
10.0 Validation methodology 7-17
10.2.1 Oil content test 7-8
10.2.2 Water vapour test 9-10
10.2.3 Carbon monoxide content teat 10-12
10.2.4 Air born particle count 12-13
10.2.5 Viable particle count test 14-15
11.0 Validation Plan and Matrix 16
12.0 Requalification Criteria 16
13.0 Evaluation of results 16
14.0 Documentation 17
15.0 Abbreviations 17
16.0 Reference 18

1.0 APPROVAL SIGNATURES
Signing of this performance qualification approval page indicates agreement with the performance
qualification approach described in this document. Should modifications to the performance qualification
become necessary, an addendum or revised version shall be prepared and approved.
Name / Designation Signature Date
Prepared by
Checked by
Approved by

2.0 OBJECTIVE
The objective of this validation protocol is to provide high degree of confidence that the Compressed
Air generation and Distribution system is able to generate and distribute the compressed air within
the specified quality attributes when operated as per the Standard Operating Procedure and to
distribute the compressed air to the user point within the acceptance criteria.
3.0 SCOPE
This qualification protocol is applicable for the qualification of Compressed air system at Validation
Guru Pvt. Ltd. India.
4.0 RESPONSIBILITY
Members from Engineering, Production, Microbiology and QA departments shall form a team to
conduct the Performance Qualification of Compressed Air with Drier.
Executive – Engineering& utility
Executive – Quality Assurance
Shall prepare the Qualification Protocol as per the
guideline of Validation Master Plan and conduct the
validation, compilation and Summary preparation.
Technical Assistant / Designee -
Engineering
Shall ensure the calibration and evaluation of the
equipment and required Instruments.
Executive / Sr. Executive – Quality
Assurance & Micro biology Department
Shall arrange the sampling and testing of validation
samples
Asst. Manager- Engineering& utility
Shall review the protocol, summary and results of
executed protocol to check the compliance and
corrective action for any discrepancies found.
Asst. Manager - Microbiology
Manager - Production
Manager – Quality Assurance
Vice President - Quality Shall approve the over all summary Report

5.0 PRE REQUISITES
All the operation controls, calibrations shall be verified before proceeding to the validation procedure
and recorded in Annexure - I.
5.1 Verification Of Operation Controls
S. No. Description of Control
1 Completion of IQ and OQ of equipment.
2 Availability of SOP ‘Operation of Air compressor & Drier’.
3 Availability of SOP ‘Preventive maintenance of Air Compressor’.
4 Availability of Equipment related logbooks / Formats.
5.2 Verification Of Calibration Status
S. No.
Name of the measuring
instrument
Instrument ID Location
1 Pressure gauge
2 Pressure gauge
3 Pressure gauge
4 Pressure gauge
All the calibration reports, as applicable, shall be attached. Ensure that master equipments /
instruments used in validation activity are duly calibrated and copy of calibration certificates shall be
enclosed.
6.0 TRAINING RECORD
Ensure all the personnel involved in the validation activity are trained on their relevant SOPs. The
persons involved in validation activity shall be trained on the protocol and documented accordingly.
7.0 SAFETY PRECAUTIONS
7.1 Persons involved in compressed air qualification shall fallow proper written procedures for
equipment operation.
7.2 Personnel should follow PPE while collecting sample.

8.0 EQUIPMENT/ MATERIALS REQUIRED FOR VALIDAITON / QUALIFICATION
8.1 Compressed air flow meter
8.2 Compressed air regulator
8.3 GASTEC Oil Mist detection tube, GASTEC Water vapour detection tube and GASTEC
carbon monoxide detection tube
8.4 Non viable particle counter
8.5 Viable particle count test kit and Air sampler bag
9.0 SYSTEM DESCRIPTION
9.1 Equipment Identification
9.1.1 Name of the Equipment : Compressed air generator
9.1.2 In-house Identification :
9.2 Area Description
9.2.1 The Compressed air generator is located in the Utility block.
9.2.2 The equipment is located such that, it can be attended easily for routine operational,
monitoring and maintenance purpose.
9.3 Description of operation
9.3.1 The non-lubricated air compressor draws air from atmosphere into the cylinder through
air cleaner during the downward stroke of the piston by means of an electrical motor.
The air is compressed on the upward stroke as two valves remain closed and air is
compressed to high pressure. At the end of the compression stroke the delivery valve
opens and air is delivered to a storage tank through cooler and dryer.
9.3.2 The compressed air is maintained at high pressure in the lines to the points of use.
Consequently there is possibility of liquid being carried over in to the plant air line. To
remove any condensed water affecting the operation of the pneumatic devices.

9.4 Standard Operating Procedure
The Compressor & Drier shall be operated as per SOP ‘Operation of Air compressor & Drier’.
10.0 VALIDATION METHODOLOGY
Qualification tests
Compressed air system shall be considered qualified for consistent and reliable performance
(Validated) on successful completion of the following tests:
 Oil content test
 Water vapor test
 Carbon monoxide content test
 Air born particle count test
 Viable particle count
The equipment shall fulfill the acceptance criteria described in the individual test procedures to
qualify the above tests.
After successful completion of tests, the data generated shall be compiled together to evaluate the
capability, repeatability and reliability of compressed air system to meet the pre-determined
acceptance criteria, when operated in accordance with the current version of SOP.
10.1 Oil content test
10.1.1 Objective
The objective is to ensure that oil content in compressed air is within the acceptance
criteria.
10.1.2 Equipments/Instruments used
10.1.2.1 Gastec oil mist detection tube
10.1.2.2 Compressed air flow meter
10.1.2.3 Compressed air regulator
10.1.2.4 Tube

10.1.3 Procedure
10.1.3.1 Connect the air regulator to the sampling point of compressed air line.
10.1.3.2 Connect the Flow meter inlet to air regulator with tube as given in Fig.#
1.0.
10.1.3.3 Break tips of fresh oil content detector tube and insert the tube into a
rubber tube holder.
10.1.3.4 Attach the rubber tube holder to outlet of flow meter
10.1.3.5 Open the compressed air line value and Set the flow rate 1 liter/minute on
air regulator.
10.1.3.6 Pass the air through the oil content detector tube for 20 minutes.
10.1.3.7 Observe the oil content detector tube immediately for colour change.
10.1.3.8 If Compressed air consists oil, the indicator tube shall change colour from
Pale Red to Pale Blue.
10.1.3.9 Read the value of oil concentration with reference to the colour change in
mg/ M3.
10.1.3.10 Carry of the test for all the identified user sampling points. The
Sampling Points is as given in Section 11.0.
Fig. # 1.0 Set Up for Determination of Oil Content
GASTEC
Oil Mist
Detection tube
Compressed Air
Regulator
Tube
Flow meter
Compressed Air
line

10.1.4 Acceptance Criteria
Oil content should be less than 0.1mg/m3
.
10.1.5 Record of Results
Record the observations in Annexure – II.
10.2 Water Vapour content test
10.2.1 Objective
The Objective is to ensure that water vapour in compressed air is within the
acceptance criteria.
10.2.2 Equipments / Instruments Used
10.2.2.1 Gastec water vapor detection tube
10.2.2.3 Compressed air flow regulator
10.2.2.4 Tube
10.2.3 Procedure
10.2.3.1 Connect the air regulator to the sampling point of compressed air line.
10.2.3.2 Connect the Flow meter in let to air regulator with tube as given in Fig.#
2.0.
10.2.3.3 Break tips off fresh water vapor content detector tube and insert the tube
into a rubber tube holder.
10.2.3.5 Open the compressed air line value and Set the flow rate 1 liter/minute on
air regulator.
10.2.3.6 Pass the air through the water vapor content detector tube for 20 minutes
10.2.3.7 Observe the water vapor detector tube immediately for colour change.
10.2.3.8 If compressed air consists of water vapor, the indicator tube shall change
colour from Yellow to purple.
10.2.3.9 Read the value of concentration with reference to the colour change in
mg/m3
.
10.2.3.10 Carry of the test for all the identified user Sampling points. The Sampling
Points is as given in Section 11.0.

Fig. # 2.0 Set Up for Determination of Water Vapour Content
Water vapor should be less than 30 mg/m3
.
Record the observations in Annexure - III.
10.3 Carbon Monoxide Content test
10.3.1 Objective
The Objective is to ensure that carbon monoxide content in compressed air is within
the acceptance criteria.
10.3.2 Equipment Used
10.3.2.1 Gastec carbon monoxide content detection tube
10.3.2.3 Compressed air regulator
10.3.2.4 Tube
GASTEC
Water vapour
Detection tube
Compressed Air
Regulator
Tube
Flow meter
Compressed Air
line

10.3.3 Procedure
10.3.3.1 Connect the air regulator to the sampling point of compressed air line
10.3.3.2 Connect the Flow meter in let to air regulator with tube as given in Fig.#
3.0.
10.3.3.3 Break tips off fresh carbon monoxide detector tube and insert the tube
into a rubber tube holder.
10.3.3.5 Open the compressed air line value and Set the flow rate 100ml/minute
on air regulator
10.3.3.6 Pass the air through the carbon monoxide content detector tube for 3
minutes.
10.3.3.7 Observe the carbon monoxide detector tube immediately for colour
change
10.3.3.8 If Compressed air consists Carbon Monoxide, the colour of indicator tube
shall change colour from white to pale pink.
10.3.3.9 Read the value of concentration with reference to the colour change in
mg/M3
10.3.3.10 Carry of the test for all the identified user sampling points. The Sampling
Points is as given in Section 11.0.
Fig. # 3.0 Set Up for Determination of Carbon Monoxide Content
GASTEC
Carbon monoxide
Detection tube
Compressed Air
Regulator
Tube
Flow meter
Compressed Air
line

The Carbon Monoxide content should be less than 5ppm.
Record the observations in Annexure - IV.
10.4 Non viable Particle Count Test
10.4.1 Objective
To ensure that air born particle count in compressed air is within acceptance criteria.
10.4.2 Equipment / Instruments Used
10.4.2.1 Calibrated particle counter
10.4.2.2 Air regulator using a suitable adapter and tubing.
10.4.3 Procedure
10.4.3.1 Initially flush the compressed air for 2-3 minutes at the testing sampling
point.
10.4.3.2 Connect the regulator to sampling point.
10.4.3.3 Connect the particle counter to the out let of regulator.
10.4.3.4 Set the particle counter for the following parameters.
10.4.3.5 Sampling volume: 1000 liters.
10.4.3.6 Sampling rate: 50 liters/minute.
10.4.3.7 Sampling time: 20 minutes.
10.4.3.8 Slowly open the regulator knob to release the compressed air at required
pressure.
10.4.3.9 Start the particle counter and take the particle count reading.
10.4.3.10 Carry of the test for all the identified user sampling points. The Sampling
Points is as given in Section 11.0

Fig. # 4.0 Setup for particle count test
10.4.4 Acceptance criteria
The air born particle count shall meet the ISO 5 / class 100 specification.
Particle size ≥0.5µ ≥5 µ
Particle count concentration 3520 29
Record the observations in Annexure - V.
10.5 Viable Particle Count Test
10.5.1 Objective
To lay down the Procedure for sampling and testing of Compressed Gases.
10.5.2 Equipment / Instruments Used
10.5.2.1 0.1% of Sterile Peptone Water.
10.5.2.2 100 mL of Sterilized Soybean Casein Digest Medium (SCDM)
10.5.2.3 100 mL of Fluid Thioglycollate Medium (FTGM)
10.5.2.4 Pre incubated Soybean Casein Digest Media.
10.5.2.5 Sterilized 0.45µ Membranes.
Compressed Air
Regulator
Tube
Non viable
Particle
counter
Compressed Air
line

10.5.3 Preparation of Pre requisites
10.5.3.1 Prepare Soybean Casein Digest agar, 0.1% of Peptone Water, Soybean
Casein Digest Medium and Fluid Thioglycollate Medium as per the label
claim.
10.5.3.2 Sterilize required number of Silicon Tubing’s for sampling of compressed
gases as per the validated load Pattern.
10.5.4 Bioburden Test
10.5.4.1 Enter into sampling area through respective entry and exit procedure where
ever applicable.
10.5.4.2 Transfer the sampling aids to the respective area through the Pass box
where ever applicable.
10.5.4.3 Identify the sampling Point as per the schedule and Label the container
with 0.1% of Peptone water with the sampling Point, Signature of the
analyst and date.
10.5.4.4 Connect the sterilized silicon tubing to the gas pendent carefully avoid
intact of sampling end of the silicon tubing.
10.5.4.5 Release the gas for NLT 2 Min before Purging to 0.1% of Peptone Water.
10.5.4.6 Regulate the Pressure valve carefully to avoid spillage of 0.1% of Peptone
water from the container while collecting the sample.
10.5.4.7 Dip the sampling end of the silicon tubing to the container containing 0.1%
of Peptone water and release the gas for NLT 2 Min.
10.5.4.8 Ensure the bubbles shall observe during sampling.
10.5.4.9 Close the valve and transfer the sampling container carefully to the
microbiology department for analysis.
10.5.4.10 Arrange the sterilized filtration assembly with 0.45µm membrane and pre
wet the membrane with 100 mL of 0.1% of Peptone Water.
10.5.4.11 Transfer the entire quantity of sample through 0.45µm Membrane and rinse
the membrane with 100 mL of 0.1% of Peptone Water.
10.5.4.12 Perform a Negative control by filtering 100 mL of 0.1% Peptone water.
10.5.4.13 Remove the filtration Assembly and hold the membrane carefully with
sterilized forceps.
10.5.4.14 Roll the membrane carefully on pre incubated Soybean Casein Digest Agar
Plates.
10.5.4.15 Incubate the plates in upright condition at 20 – 25°C for 72 hrs followed by
30 – 35°C for 48 hrs.
10.5.4.16 Record the results for Bioburden as mentioned in Bioburden Test Report.

10.5.5 Sterility Test
10.5.5.1 Enter into sampling area through respective entry and exit procedure where
ever applicable.
10.5.5.2 Transfer the sampling aids to the respective area through the Pass box
where ever applicable.
10.5.5.3 Identify the sampling Point as per the schedule and Label the container
with 0.1% of Peptone water with the sampling Point, Signature of the
analyst and date.
10.5.5.4 Connect the sterilized silicon tubing to the gas pendent carefully avoid
intact of sampling end of the silicon tubing.
10.5.5.5 Release the gas for NLT 2 Min before Purging to 0.1% of Peptone Water.
10.5.5.6 Regulate the Pressure valve carefully to avoid spillage of 0.1% of Peptone
water from the container while collecting the sample.
10.5.5.7 Dip the sampling end of the silicon tubing to the container containing 0.1%
of Peptone water and release the gas for NLT 2 Min.
10.5.5.8 Ensure the bubbles shall observe during sampling.
10.5.5.9 Close the valve and transfer the sampling container carefully to the
microbiology department for analysis.
10.5.5.10 Arrange the sterilized filtration assembly with 0.45µm membrane and pre
wet the membrane with 100 mL of 0.1% of Peptone Water.
10.5.5.11 Transfer the entire quantity of sample through 0.45µm Membrane and rinse
the membrane with 100 mL of 0.1% of Peptone Water.
10.5.5.12 Perform a Negative control by filtering 100 mL of 0.1% Peptone water.
10.5.5.13 Remove the filtration Assembly and hold the membrane carefully with
sterilized forceps.
10.5.5.14 Cut the membrane with two equal half’s and transfer one half of membrane
in 100 mL of Soybean Casein Digest Medium and the other half in 100 mL
of Fluid Thioglycollate Medium.
10.5.5.15 Incubate SCDM tubes at 20 – 25°C for 14 Days and FTGM tubes at 30 –
35°C for 14 Days.
10.5.5.16 After completion of incubation observe the tubes for sterility and record the
results as mentioned in Sterility Test Report.

10.5.6.1 No Turbidity shall be observed in SCDM and FTGM after 14 days of
incubation.
10.5.6.2 Not more than 100 CFU / 100 mL shall be observed for the Bioburden
Sample after 5 Days of Incubation.
10.5.7 Observations and results
Record the observations in Annexure – VI and Annexure – VII.
11.0 VALIDATION PLAN AND MATRIX
The qualification tests shall be conducted as per the validation plan as described in validation
methodology. The list of Sampling points / Locations / Area is described in Validation matrix below:
S. No. Location Room Name Sampling point ID
01 Formulation
Vial Sealing area
Terminal sterilizer area
Component preparation area
Washing area
Formulation area
Vial washing room
Vial filling room
12.0 REQUALIFICATION CRITERIA
12.1 Scheduled Qualification
Routine compressed air qualification shall be performed at every 12 + 1month.
12.2 Unscheduled Qualification
12.2.1 Substitution of existing new sampling point.
12.2.2 Replacement of compressed air generator.
12.2.3 Any major modification in the existing system.
12.2.4 Frequent surpassing of the alert or action limits of routine monitoring parameters

13.0 EVALUATION OF RESULTS
13.1 Results recorded in PQ record shall be evaluated against the acceptance criteria and shall
arrive at proper conclusion.
13.2 All test results meeting the acceptance criteria shall establish the satisfactory performance of
Compressed air system when operated as per SOP.
14.0 DOCUMENTATION
14.1 Validation Protocol
14.2 Training record of all the personnel involved in execution of protocol.
14.3 Validation Raw Data
14.4 List of Annexure:
Annexure No. Title
I Pre Requisites Checklist
II Oil Content Test
III Water Vapour Content Test
IV Carbon Monoxide Test
V Non Viable Particle Count
VI Bioburden Test Report
VII Sterility Test Report
VIII Non Viable Particle Count-Test Data Sheet
14.5 Validation Reports
14.6 Summary Report
15.0 ABBREVIATIONS
15.1 CA - Compressed air with Drier
15.2 LAF - Laminar Air Flow
15.3 m3
- Meter cube
15.4 SOP - Standard operation procedure
15.5 SCDM - Soybean Casein Digest Medium
15.6 FTGM - Fluid Thioglycollate Medium
15.7 ppm - Parts per million
15.8 CFU - Colony forming unit
15.9 mg - Milligram

16.0 REFERENCES
16.1 Validation master plan
16.2 ISO 8573 Part 1 to ISO 8573 Part 5 for classification for testing procedures
16.3 European pharmacopeia
16.4 SOP of ‘Operation of Air Compressor’.
END OF DOCUMENT

Annexure-1
PERFORMANCE QUALIFICATION RECORD
Ref. Protocol
No./Version No.
Annexure No. I
Annexure Title
Pre Requisites Checklist and Test
Instrument Calibration Record
Annexure Version No. 00
Effective Date Page No. 1 of 1
Name Department Sign / Date
Checked By
Verified By
Pre Requisites Checklist and Test Instrument Calibration Record
Date of Checking: ______________
Pre requisites:
Type of Document Document Ref. No. Status / Remarks
Installation qualification
Document
Operation qualification
document
Availability of SOP
‘Operation of Air compressor
& Drier
Availability of ‘Preventive
maintenance of Air
Compressor’
Availability of Equipment
related logbooks/Formats
Verification of calibration status:
Name of the
Measuring Instrument
Instrument ID Location Calibration done on Calibration due on
Pressure gauge
Pressure gauge
Pressure gauge
Pressure gauge

Annexure-II
Ref. Protocol
No./Version No.
Annexure No. II
Annexure Title Oil Content Test Annexure Version No. 01
Oil Content Test
Date of Test
Indicator Used Compressed Air Pressure
Flow Rate (LPM) Exposed Time
Sampling Points and Results
S. No.
Sampling
point ID /
Location
Colour Change
Observed
(Yes / No)
Oil Content
(mg/m3)
Acceptance
Criteria
Result Sampled By Tested By
Formulation
1 < 0.1mg/m3
Pass / Fail
2 < 0.1mg/m3
Pass / Fail
3 < 0.1mg/m3
Pass / Fail
4 < 0.1mg/m3
Pass / Fail
5 < 0.1mg/m3
Pass / Fail
6 < 0.1mg/m3
Pass / Fail
7 < 0.1mg/m3
Pass / Fail
8 < 0.1mg/m3
Pass / Fail
 If Compressed air consists oil, the indicator tube colour changes from Pale Red to Pale Blue.
Result:
The Oil Content in the compressed air MEETS / DOES NOT MEET the acceptance criteria.
Hence as all sampling points of compressed air system PASSES / FAILS in the above mentioned
test.
Checked By
Verified By

Annexure-III
Ref. Protocol
No./Version No.
Annexure No. III
Annexure Title Water Vapor Content Test Annexure Version No. 01
Water Vapor Content Test
S. No.
Sampling
point ID /
Location
Colour
Change
Observed
(Yes / No)
Water
Vapor
Content
(mg/m3
)
Acceptance Criteria Result
Sampled
By
Tested
By
Formulation
1 Less than 30 mg/m3
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
 If Compressed air consists water vapor, the indicator tube colour changes from Yellow to purple.
Result:
The Water Vapor content in the compressed air MEETS / DOES NOT MEET the acceptance criteria
hence all sampling points of compressed air system PASSES / FAILS in the above mentioned test.
Checked By
Verified By
Date of Test

Annexure-IV
Ref. Protocol
No./Version No.
Annexure No. IV
Annexure Title Carbon Monoxide Content Test Annexure Version No. 01
Carbon Monoxide Content Test
Date of Test
S. No.
Sampling
point ID /
Location
Colour
Change
Observed
(Yes / No)
Carbon
Monoxide
Content
(ppm)
Acceptance
Criteria
Result Sampled By Tested By
Formulation
1 <5ppm Pass / Fail
2 <5ppm Pass / Fail
3 <5ppm Pass / Fail
4 <5ppm Pass / Fail
5 <5ppm Pass / Fail
6 <5ppm Pass / Fail
7 <5ppm Pass / Fail
8 <5ppm Pass / Fail
 If Compressed air consists of water vapor, the indicator tube colour changes from white to pale pink.
Result: The carbon monoxide contents in the compressed air MEETS / DOES NOT MEET the acceptance
criteria .hence, all sampling points of Compressed Air system PASSES / FAILS in the above
mentioned test.
Checked By
Verified By

Annexure-V
Ref. Protocol
No./Version No.
Annexure No. V
Annexure Title Non Viable Particle count test Annexure Version No. 01
Non Viable Particle Count Test
Date of Test Instrument Used
Particle Counter
Calibration Done on Calibration Due on
Set parameters:
Sampling Time Sampling Volume Sampling Rate
Sampling
point ID /
Location
Observed Particle
Concentration (Cubic
Meter)
Acceptance Criteria Result Sampled By
0.5µ 5 µ >0.5µ >5 µ
Formulation
3520 29
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Pass / Fail
Result: The Non Viable Particle Counts in the compressed air MEETS / DOES NOT MEET the acceptance
criteria. Hence, all the sampling points of Compressed Air system PASSES / FAILS in the above
mentioned test.
Checked By
Verified By

Annexure-VI
Ref. Protocol
No./Version No.
Annexure No. VI
Annexure Title Bioburden Test Report Annexure Version No. 00
Date of Sampling Sampled By (Name)
Diluent Used Diluent Lot No
Media Used Media Lot No
Membrane Make Membrane Lot No
Accessories Load No Vol .of Rinsing Fluid
20 – 25°C for 72 hrs 30 – 35°C for 48 hrs
Incubator ID No Incubator ID No
Incubation Start Date Incubation Start Date
Incubation Start Time Incubation Start Time
Incubation End Date Incubation End Date
Incubation End Time Incubation End Time
Observed By(Sign / Date) Observed By(Sign / Date)
Sampling Point
Bioburden
20 – 25°C
30 – 35°C
CFU / Membrane
Acceptance Criteria
Bioburden
Limit
NMT 25 CFU / Membrane
Remarks:
Analysed By: Checked By:
Sign / Date: Sign / Date:

Annexure-VII
Ref. Protocol No./Version
No.
Annexure No. VII
Annexure Title Sterility Test Report Annexure Version No. 00
Date of Sampling Sampled By (Name)
Diluent Used Diluent Lot No
Volume of Sample Accessories Load No
Membrane Make Membrane Lot No
LAF ID No. Volume of Rinsing Fluid
20 – 25°C for 14 Days 30 – 35°C for 14 Days
Incubator ID No Incubator ID No
Incubation Start Date Incubation Start Date
Incubation Start Time Incubation Start Time
Incubation End Date Incubation End Date
Incubation End Time Incubation End Time
Observed By(Sign / Date) Observed By(Sign / Date)
SCDM Details FTGM Details
Medium lot No Medium lot No

Annexure-VII
Ref. Protocol No./Version
No.
Annexure No. VII
Annexure Title Sterility Test Report Annexure Version No. 00
Sampling Point Observed By
(Sign / Date)Days SCDM FTGM SCDM FTGM SCDM FTGM
1st
Day
2nd
Day
3rd
Day
4th
Day
5th
Day
6th
Day
7th
Day
8th
Day
9th
Day
10th
Day
11th
Day
12th
Day
13th
Day
14th
Day
Negative Control
Legends:” -Ve’ – Indicates No Growth / “+Ve” – Indicates Growth
Remarks:
Analyzed By Checked By
(Sign / Date) (Sign / Date)

Annexure-VIII
Ref. Protocol
No./Version No.
Annexure No. VIII
Annexure Title
Non Viable Particle Count -Test
Data Sheet
Annexure Version No. 00
Location: Location:
Result: The Non Viable Particle Counts in the compressed air MEETS / DOES NOT MEET the acceptance
criteria. Hence, all the sampling points of Compressed Air system PASSES / FAILS in the above
mentioned test.
Done By
Checked By
Verified By

Protocol for compressed air validation

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