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Questions and Answers
What is the minimum quantity required for liquids that are 1-4ml?
What is the minimum quantity required for liquids that are 1-4ml?
How much of an antibiotic should be used as a minimum quantity?
How much of an antibiotic should be used as a minimum quantity?
For solids that are 50mg or more but less than 200mg, what is the minimum quantity that must be used?
For solids that are 50mg or more but less than 200mg, what is the minimum quantity that must be used?
What is the minimum quantity that needs to be used for insoluble preparations, creams, and ointments?
What is the minimum quantity that needs to be used for insoluble preparations, creams, and ointments?
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What does Thioglycollate Medium (FTM) primarily culture?
What does Thioglycollate Medium (FTM) primarily culture?
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Which medium is specifically used for turbid or viscid products?
Which medium is specifically used for turbid or viscid products?
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What is the incubation temperature for the media sterility test of Fluid Thioglycollate Medium (FTM)?
What is the incubation temperature for the media sterility test of Fluid Thioglycollate Medium (FTM)?
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What indicates contamination in the testing procedure during the media sterility test?
What indicates contamination in the testing procedure during the media sterility test?
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What is the purpose of the Growth Promotion Test?
What is the purpose of the Growth Promotion Test?
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What is the acceptance criterion for the media sterility test?
What is the acceptance criterion for the media sterility test?
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What is the primary purpose of sterility testing in microbiology?
What is the primary purpose of sterility testing in microbiology?
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Which of the following products typically requires sterility testing?
Which of the following products typically requires sterility testing?
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What is a required precaution when performing sterility tests?
What is a required precaution when performing sterility tests?
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What is the recommended minimum quantity of containers for testing when more than 500 parenteral preparation containers are present?
What is the recommended minimum quantity of containers for testing when more than 500 parenteral preparation containers are present?
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For ophthalmic products, what is the minimum quantity to be tested when there are more than 200 containers?
For ophthalmic products, what is the minimum quantity to be tested when there are more than 200 containers?
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Which medium is mentioned as a requirement for sterility testing?
Which medium is mentioned as a requirement for sterility testing?
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What aspect of the testing environment is critical for preventing contamination?
What aspect of the testing environment is critical for preventing contamination?
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Which of these conditions is NOT a step involved in sterility testing?
Which of these conditions is NOT a step involved in sterility testing?
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Study Notes
Sterilization
- The process of eliminating bacteria and microorganisms from an object.
Sterility Testing
- A test to ensure sterile pharmaceutical products are free of microorganisms.
- Essential in GMP microbiology to ensure the safety of sterile products like injectables, medical devices, and materials.
- Performed to detect viable microorganisms before release and administration.
Products Tested
- Injections
- Implants
- Syringes
- Bandages
- Dressings
- Surgical Instruments
- Needles
- Injectables
- Bulk Solids
- Ophthalmic Products
Sterility Testing Precautions
- Performed in ventilated aseptic rooms/regions with bacterially cleaned air to avoid contamination.
- Requires highly trained staff.
- Work spaces are monitored regularly by sampling and appropriate controls.
Steps Involved in Sterility Testing
- Selection of sample size
- Selection of product quantity
- Media requirements
- Testing method
- Observation and Results
Sample Size (IP)
-
Parenteral preparations:
- Not more than 100 containers: 10% or 4 containers, whichever is greater.
- More than 100 but not more than 500 containers: 10 containers.
- More than 500 containers: 2% or 20 containers, whichever is greater.
-
Ophthalmic and other non-injectables:
- Not more than 200 containers: 5% or 2 containers, whichever is greater.
- More than 200 containers: 10 containers.
-
Bulk solid products:
- Up to 4 containers: Each container.
- More than 4 containers but not more than 50 containers: 20% or 4 containers, whichever is greater.
- More than 50 containers: 2% or 10 containers, whichever is greater.
Product Quantity
-
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 ointments to be suspended or emulsified: Use the contents of each container to provide not less than 200mg.
-
Solids:
- Less than 50mg: The whole contents of the container.
- 50mg or more but less than 200mg: Half the contents of each container but not less than 50mg.
- 200mg/Greater: 100mg.
Media Requirements
-
Fluid Thioglycollate Medium (FTM):
- Used with clear fluid products.
- Primarily for anaerobic bacteria but also detects aerobic bacteria.
-
Alternative Thioglycollate Medium (ATM)/Thioglycollate Broth:
- Same growth promotion properties as FTM.
-
Soybean-Casein Digest Medium (SCDM) or (Trypticase Soy Broth) (TSB):
- Used for turbid or viscid products.
- For both fungi and aerobic bacteria.
Media pH Adjustments
- FTM and ATM are adjusted to pH 7.1 + 0.2.
- SCDM is adjusted to pH 7.3 + 0.2.
Media Validation
- Media must be sterile (autoclaved at 121°C for 20 minutes).
- Media must support the growth of microorganisms.
-
Components:
- Media sterility test
- Growth promotion test
Media Sterility Test
- Negative Control: Used to identify false positive test results.
- Incubation:
- 14 days for FTM at 30-35°C.
- 14 days for SCDM at 20-25°C.
- Acceptance criteria: No growth should be observed.
- Note: Microbial growth in the negative control indicates contamination in the testing procedure or environment.
Growth Promotion Test
- A known quantity of microorganisms is deliberately introduced into the testing system to ensure the culture media can support microbial growth.
- This step ensures the media is capable of supporting the growth of the microorganisms tested.
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Description
This quiz covers the essential aspects of sterility testing for pharmaceutical products. It includes the importance of sterility, types of products tested, precautions required during testing, and the steps involved in the process. Perfect for those interested in GMP microbiology and product safety.
