Sterility Testing
A critical test to confirm the absence of viable microorganisms in a pharmaceutical product.
Aseptic Technique
Procedures used to prevent contamination of sterile products and media during handling and testing.
Membrane Filtration Method
A sterility test where product is filtered, and the filter membrane is incubated in culture media.
Direct Inoculation Method
A sterility test where the product is directly added to and incubated in culture media.
Tryptic Soy Broth (TSB)
A general-purpose culture medium used to detect aerobic bacteria and fungi in sterility testing.
Fluid Thioglycollate Medium (FTM)
A culture medium used to detect anaerobic bacteria and some aerobic bacteria in sterility testing.
Incubation Period
The specified time and temperature (e.g., 14 days; 20-25°C for TSB, 30-35°C for FTM) for microbial growth.
Positive Control
A control containing known microorganisms used to confirm the growth promotion capabilities of the culture media.
Negative Control
A control using sterile media and diluents, without the test product, to confirm no extraneous contamination during the test.
False Positive Result
An erroneous result indicating microbial growth due to contamination introduced during the testing procedure.
False Negative Result
An erroneous result indicating sterility when viable microorganisms are actually present in the product.
Sterility Assurance Level (SAL)
The probability that a single unit in a batch remains non-sterile after sterilization, typically 10^-6.
USP <71>
The United States Pharmacopeia general chapter outlining the requirements and procedures for sterility testing.
European Pharmacopoeia (EP)
A collection of monographs and general chapters providing standards for medicines in Europe, including sterility testing.
Growth Promotion Test
A test performed on each batch of culture media to confirm its ability to support the growth of specified microorganisms.
Product Suitability Test
A validation study to confirm that the product itself does not inhibit microbial growth or interfere with the test, ensuring test validity.
Isolator
A sealed, contained environment providing a high level of aseptic control for sterility testing, minimizing human intervention.
Laminar Airflow (LAF) Hood
A workstation that provides a continuous flow of HEPA-filtered air to maintain an aseptic environment for testing.
Microbial Growth
Visual evidence (e.g., turbidity, colonies) in culture media indicating the presence of viable microorganisms.
Turbidity
Cloudiness or haziness in the culture medium, often a visual sign of microbial proliferation.
Good Manufacturing Practices (GMP)
Regulatory guidelines and requirements for the manufacturing and testing of pharmaceutical products to ensure quality.
Sterile Product
A product that is entirely free of all viable microorganisms.
Test Volume
The specified quantity of product required for sterility testing, dependent on batch size and regulatory guidelines.
Validation
The documented act of proving that a procedure, process, equipment, material, activity, or system consistently achieves specified results.
Batch Release
The formal approval that a batch of product meets all quality specifications, including sterility, before distribution.