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Sterility testing Slide 1 Sterility testing Slide 2 Sterility testing Slide 3 Sterility testing Slide 4 Sterility testing Slide 5 Sterility testing Slide 6 Sterility testing Slide 7 Sterility testing Slide 8 Sterility testing Slide 9 Sterility testing Slide 10 Sterility testing Slide 11 Sterility testing Slide 12 Sterility testing Slide 13 Sterility testing Slide 14 Sterility testing Slide 15 Sterility testing Slide 16 Sterility testing Slide 17 Sterility testing Slide 18
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Sterility Testing of Pharmaceuticals

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Sterility testing

  1. 1. STERILITY TESTING OF PHARMACEUTICALS 1 Made by: Netal Patel (09) Pharm D. 3rd year Parul Institute of Pharmacy
  2. 2. INTRODUCTION • Sterilisation: Is the process of making something free from bacteria or other living microorganisms. • Sterility Testing: Are done to detect if viable forms of micro-organisms are present or not on or in the pharmaceutical preparations. 2
  3. 3. INTRODUCTION Which products undergo sterility tests? • The test is applied to substances or preparations which, according to the Pharmacopoeia, are required to be sterile. For example ✦ Injections ✦ Implants ✦ Syringes ✦ Bandages ✦ Dressings ✦ Surgical Instruments ✦ Needles ✦ Injectables ✦ Bulk Solids ✦ Ophthalmic Products..etc 3
  4. 4. INTRODUCTION What precautions should be taken while performing sterility tests? • The tests for sterility are carried out in aseptic regions to avoid accidental contamination by microorganisms. • The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls. 4
  5. 5. PRINCIPLE • If microorganisms are placed in a media that provides nutrients and water and kept at a favourable temperature the organism will grow and their growth can be indicated by turbidity in originally clear medium. • The sterility tests provide optimum conditions for the growth and multiplication of organisms, spores, etc that might be a contaminant. • It is not possible to claim that a batch of products is sterile unless the entire content of each batch has been tested. • But these conditions are not possible because the article or the preparation under test is either made unstable (like a syringe) or is destroyed (like an injectable solution). • Thus only a part of the batch can be sampled for testing. 5
  6. 6. STEPS INVOLVED IN STERILITY TESTING 1. Selection of the sample size. 2. Selection of the quantity of the product. 3. Method of testing. 4. Observation and Results. 6
  7. 7. 1. SELECTION OF SAMPLE SIZE Quantity per Container Minimum quantity to be used for each medium unless otherwise justified and authorised Parenteral preparations: • Not more than 100 containers • More than 100 but not more than 500 containers • More than 500 containers • 10 per cent or 4 containers whichever is greater • 10 containers • 2 per cent or 20 containers (10 containers for large- volume parenterals) whichever is less Ophthalmic and other non-injectable: • Not more than 200 containers • More than 200 containers • If the product is presented in the form of single- dose containers, apply the scheme shown above for preparations for parenteral use • 5 per cent or 2 containers whichever is greater • 10 containers Bulk solid products: • Up to 4 containers • More than 4 containers but not more than 50 containers • More than 50 containers • Each container • 20 per cent or 4 containers whichever is greater • 2 per cent or 10 containers whichever is greater 7
  8. 8. 2. SELECTION OF QUANTITY OF THE PRODUCT Quantity per Container Minimum quantity to be used for each medium unless otherwise justified and authorised Liquids: • Less than 1ml • 1-40ml • Greater than 40ml and not greater than 100ml • Greater than 100ml Antibiotics • Whole contents of each container • Half contents of each container but not less than 1ml • 20ml • 10 per cent of the contents of the container but not less than 20ml • 1ml Insoluble preparations, creams and ointments to be suspended or emulsified Use the contents of each container to provide not less than 200mg Solids: • Less than 50mg • 50mg or more but less than 300mg • 300mg-5g • Greater than 5g • The whole contents of each container • Half the contents of each container but not less than 50mg • 150mg • 500mg 8
  9. 9. 3. TEST METHODS • Method A: Membrane Filtration method • Method B: Direct Inoculation method 9
  10. 10. MEMBRANE FILTRATION METHOD • Membrane has a nominal pore size not greater than 0.45 micron and diameter of approximately 50mm. • This method basically involves filtration of sample through membrane filters. • The filtration is assisted under Vacuum after filtration completion the membrane is cut into 2 halves and one halve is placed in two test tubes containing FTM, SCDM medium. • Incubate the media for not less than 14 days. • Used for: ‣An oil or oily preparation. ‣Ointments that can be put into solutions. ‣Soluble powder. ‣Liquid products where volume in a container is 100ml or more. ‣Non bacteriostatic solid not readily soluble in culture media. 10
  11. 11. CULTURE MEDIUM • Properties: Must initiate and maintain vigorous growth of small numbers of aerobic or anaerobic bacteria including spores. Thus, must provide sufficient moisture, adequate pH, nutrients, suitable Redox potential. • Classification: 1. For detection of AEROBES: Peptone Broth Glucose Peptone Broth 2. For detection of ANAEROBES: Cooked Meat Medium Semi Fluid Meat Medium Liver Broth 11
  12. 12. CULTURE MEDIUM 3. For both AEROBES and ANAEROBES: Fluid Thioglycolate Media Thioglycolate Broth Media Corn Steep Liquor-Sodium Thioglycolate Media Semi-FLuid Hydrosulphite Media 4. For detect of AEROBIC and LOWER FUNGI: Soybean Caesin Digest Media Sabourould’s Media 12
  13. 13. THIOGLYCOLATE MEDIUM L-Cystine Agar Sodium chloride Glucose monohydrate/anhydrous Yeast extract (water-soluble) Pancreatic digest of casein Sodium thioglycollate or Thioglycollic acid Resazurin sodium solution (1 g/l of resazurin sodium), freshly p Water R Sterilise in autoclave at 121 C for 20 mins pH after sterilization 6.9 to 7.3. 0.5 g 0.75 g 2.5 g 5.5/5.0 g 5.0 g 15.0 g 0.5 g 0.3 ml 1.0 ml Upto 1000 ml 13
  14. 14. ALTERNATIVE THIOGLYCOLATE MEDIUM • Contains no agar and Indicator. • Used with: Turbid suspensions and viscid products (creams). For devices having tubes with small Lumina. 14
  15. 15. SOYBEAN CAESIN DIGEST MEDIUM Pancreatic digest of casein Papaic digest of soya-bean meal Sodium chloride Dipotassium hydrogen phosphate Glucose monohydrate/anhydrous Water R pH after sterilization 7.1 to 7.5. 17.0 g 3.0 g 5.0 g 2.5 g 2.5/2.3 g Upto 1000 ml 15
  16. 16. DIRECT INOCULATION METHOD • It involves a direct inoculation of required volume of a sample in two test tubes containing a culture medium that is FTM, SCDM. • Volume of the preparation under examination is not more than 10% of the volume of the medium. • Incubate the inoculated media for not less than 14 days. 16
  17. 17. 4. INTERPRETATION OF RESULTS After incubation and during the incubation period If growth is not observed If growth is observed Passes the sterility test (preparation sterile) Containers are reserved and re-test is performed as in the original test If growth is not observed (sample passed) If growth is observed If they are not readily distinguishable from those growing in containers reserved in the first test If they are readily distinguishable from those growing in containers reserved in the first test Preparation fails the test Second re-test is performed using twice the no. of samples If growth is not observed If growth is observed Preparation passes the test Preparation fails the test 17
  18. 18. REFERENCES • • TestForSterility-RevGenMethod_QAS11-413FINALMarch2012.pdf • • products-testing/sterility-test/ • • Indian Pharmacopoeia,2010, Vol-I,p:56-63,36-37,28-33,196-198 • Lachman. L, Liberman HA, Kaniz JL, the theory and practice of industrial pharmacy, Third Edition, Indian Edition p:635-638 • Mehta RM, Pharmaceutics-1,p:305, 311-315. 18
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Sterility Testing of Pharmaceuticals


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