Sterility Testing PDF

Sterility Testing By: Marwa Mohamed khalifa Lecturer of microbiology and immunology Introduction Sterilization: Is the process of making something free from bacteria or other living microorganisms. Sterility Testing: A test that critically assesses whether a sterilized pharmaceut...

Sterility Testing By: Marwa Mohamed khalifa Lecturer of microbiology and immunology Introduction Sterilization: Is the process of making something free from bacteria or other living microorganisms. Sterility Testing: A test that critically assesses whether a sterilized pharmaceutical products is free from contaminating microorganism. Sterility testing is a crucial requirement in GMP microbiology for ensuring the safety of sterile pharmaceuticals, medical devices, and materials. It is performed to detect viable microorganisms before their release and administration.  Which products undergo sterility tests? ✦ Injections ✦ Implants ✦ Syringes ✦ Bandages ✦ Dressings ✦ Surgical Instruments ✦ Needles ✦ Injectables ✦ Bulk Solids ✦ Ophthalmic Products  Precautions while performing sterility tests Ventilated aseptic rooms/regions supplied with bacteriologically cleaned air to avoid accidental contamination by microorganisms. Highly trained staff 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. STEPS INVOLVED IN STERILITY TESTING 1. Selection of the sample size. 2. Selection of the quantity of the product. 3. Media requirements 4. Method of testing. 5. Observation and Results. 1. SELECTION OF SAMPLE SIZE(IP) Quantity per Container Minimum quantity to be used for each medium unless otherwise justified and authorised Parenteral preparations: Not more than 100 containers 10 per cent or 4 containers whichever is More than 100 but not more than 500 greater containers 10 containers More than 500 containers 2 per cent or 20 containers Ophthalmic and other non-injectables: Not more than 200 containers 5 per cent or 2 containers More than 200 containers 10 containers Bulk solid products: Up to 4 containers Each container More than 4 containers but not more than 20 per cent or 4 containers whichever is greater 50 containers More than 50 containers 2 per cent or 10 containers whichever is greater 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 Whole contents of each container 1-4ml Half contents of each container 5ml or more but less than 20ml 2ml 20ml or more but less than 50ml 5ml 50ml or more but less than 100ml 10ml Antibiotics 1ml Insoluble preparations, creams and Use the contents of each container ointments to be suspended or to provide not less than 200mg emulsified Solids: Less than 50mg The whole contents of container 50mg or more but less than 200mg Half the contents of each container but not less than 50mg 200mg/Greater 100mg  3. Media requirements It is used with clear fluid products. 1) Fluid FTM is primarily intended for the Thioglycollate culture of anaerobic bacteria; however Medium(FTM) it will also detect aerobic bacteria. Used with turbid or viscid products? 2) Alternative Thioglycollate Has the same growth promotion Medium(ATM)/ properties as the standard FTM Thioglycolate Broth 3) Soybean-Casein Used for turbid or viscid products Digest Medium (SCDM) or For both fungi and aerobic bacteria (Trypticase Soy Broth) (TSB) ❖ Medium 1 & 2 are adjusted to pH 7.1+0.2 ❖ Medium 3 is adjusted to 7.3+0.2  Prior to test, make sure that: Media is sterile (Autoclave at 121°C for 20mins) Media supports growth of Media microorganisms Validation 2 components in Media validation: Media sterility Test Growth Promotion Test  1) Media sterility test Negative Control - may be used to identify a “false positive” test result Incubate for 14 days prior to use, may be conducted concurrently with test 30 - 35°C for Fluid Thioglycollate medium (FTM) 20 - 25°C for Soybean Casein Digest Medium (SCDM) Acceptance criteria: Should be sterile, no growth observed If the negative control shows any microbial growth, it indicates contamination in the testing procedure or environment 2) Growth Promotion Test A known quantity of microorganisms is deliberately introduced into the testing system to ensure the culture media can support microbial growth. The media should be inoculated with