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Microbial Limit Test- An Over view

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Microbial Limit test for pharmaceutical formulation & Raw materials:) : for NEOPHARMA LLC, UAE

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Microbial Limit Test- An Over view

  1. 1. June 2014 Sreenath.SSreenath.S QC-Micro WelcomeWelcome MicrobialMicrobial Limit TestLimit Test
  2. 2. The Microbial Limit Tests are designed to perform the qualitative and quantitative estimations of viable microorganisms present in samples..
  3. 3. Prior to 2006, The USP,EP and JP used test methods to ensure microbial safety of non-sterile pharmaceutical products that were similar in intent, but widely variable in execution and acceptance criteria. HARMONIZED MLT: These three pharmacopoeia collaborated over the course of years to harmonize their testing methods and specifications for non-sterile pharmaceutical products.
  4. 4. The pharmacopeias released two chapters in 2006 entitled “Microbiological Examination of Non- Sterile Products: Microbial Enumeration Tests” (TVAC) and “Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms.” (Pathogens) These tests were historically referred to as “Microbial Limit Tests” and appeared in USP chapter <61> and JP 4.05.
  5. 5. With the advent of the harmonization, the structure of the USP and JP were altered and the two chapters are now USP <61> and <62>, and JP 4.05 sections I and II. The EP had a structure similar to the harmonized chapters, and those tests are still found in EP 2.6.12 and 2.6.13.
  6. 6. The pharmacopeias set the scheduled implementation of the new harmonized methods to August 1, 2007, however the implementation was delayed to allow more time for users to comply with the new requirements. The new harmonized methods become official in 2009
  7. 7.    Enumeration Methods  Membrane Filtration Method, Plate Count Method MPN method 
  8. 8.    Sample Size   Water Soluble products – 1 in 10 dilution  Non fatty products insoluble in water- 1 in 10 dilution with 1g/L of polysorbate 80 (surface active agent) Fatty products – Dissolve in Isopropyl myristate sterilized by filtration (if req, heat up to 40°C-NMT45°C)
  9. 9.    Microbial Enumeration Tests (TVAC- TAMC & TYMC) Sample prep:  10 g /10mL of sample in 100 mL SCDM - & Mix      1 mL each Transfer to  petriplates in duplicates Pour 20-25mL of   Sterile media at 45ºC  TAMC- SCDA (30-35ºC/5days)   TYMC-SDA (20-25ºC/7days) Incubate the plates -ve Control with diluent (30-35ºC/18-24 hrs)
  10. 10.    Limits: For FP/RM For TAMC- NMT 1000 CFU/g For TYMC- NMT 100 CFU/g For FP Liquid prod. For TAMC- NMT 100 CFU/mL For TYMC- NMT 10 CFU/mL TVAC- Results & Interpretation Avg No. of Colonies observed on the plate X Dil Factor For Ex. Plate-1 +Plate-2 X 10 4 + 3 X 10  = 35 CFU/g or mL 2 2 If there is No Growth observed in the plates Report it as <10 CFU/g or mL
  11. 11.    Tests for Specified Microorganisms (Pathogens) Bile-Tolerant Gram-Negative Bacteria E .Coli Salmonella sp Pseudomonas aeruginosa Staphylococcus aureus Clostridia Candida albicans
  12. 12.    Tests for Specified Microorganisms (Pathogens) BT G-ve Bacteria: From Sample prep. (after 2 hrs (to NMT 5 hrs) of incubation in RT/20-25°C) Transfer 10mL to 100mL EEBM (Incubate at 30-35ºC/ 24-48 Hrs ) Subculture  on VRBGA (30-35ºC/ 18-24 Hrs ) EEBM & VRBGA- Only Boiling
  13. 13.    Tests for Specified Microorganisms (Pathogens) Candida albicans From Sample prep. (SCDM) Transfer 10mL to 100mL SDB (Incubate at 20-25ºC/ 3 - 5 days ) Subculture  on SDA (20-25ºC/ 24-48 Hrs )
  14. 14.    Tests for Specified Microorganisms (Pathogens) E. coli After 18-24 Hrs, From Sample prep. (SCDM) Transfer 1 mL to 100mL MCB (Incubate at 42- 44ºC/ 24-48 Hrs) Subculture  on MCA (30-35ºC/ 18-72 Hrs )
  15. 15.    Tests for Specified Microorganisms (Pathogens) Salmonella. sps After 18-24 Hrs, From Sample prep. (SCDM) Transfer 0.1 mL to 10 mL RVSEM (Incubate at 30- 35ºC/ 18-24 Hrs) Subculture  on XLDA (30-35ºC/ 18-48 Hrs ) XLDA- Only Boiling
  16. 16.    Tests for Specified Microorganisms (Pathogens) Pseudomonas. aeruginosa After 18-24 Hrs, From Sample prep. (SCDM) Subculture on CA (Incubate at 30- 35ºC/ 18-72 Hrs)
  17. 17.    Tests for Specified Microorganisms (Pathogens) Staphylococcus. aureus After 18-24 Hrs, From Sample prep. (SCDM) Subculture on MSA (Incubate at 30- 35ºC/ 18-72 Hrs)
  18. 18.    Tests for Specified Microorganisms (Pathogens) Clostridia After 18-24 Hrs, From Sample prep. (SCDM) Transfer 10 mL to 100 mL RIMC in duplicates (Incubate at 30- 35ºC/ 48 Hrs-Anaerobic condition) Subculture  on COA (30-35ºC/ 48-72 Hrs) Heat one tube at  80ºC for 10min (for spore) Second tube- as such (vegetative)
  19. 19.    CAUSIONS Antimicrobial activity of products-Neutralization Beta-lactam products- Sterile Penicillinase enzyme  Boiling of media – EEBM/ VRBGA/ XLDA Incubation of initial sample preparation-SCDM (2- NMT 5 Hrs.) Aseptic Technique- Analysis in LAF  FUTURE CHALLENGE:  Burkholderia cepacia 
  20. 20.    Do U Really Wanna Screw UP….???? 
  21. 21.    THANKS THANKS  FOR YOUR FOR YOUR  KIND ATTENTIONKIND ATTENTION

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