What is USP 71 sterility testing?
What is USP 71 sterility testing?
USP <71> Sterility Tests is a general chapter enforceable by regulatory agencies and is applied to substances, preparations, and articles required to be sterile. This chapter demonstrates process control and is a general indicator of the microbiological quality of a product.
How sterility of pharmaceutical products are tested?
There are two recommended methods of sterility testing for pharmaceuticals: membrane filtration and direct inoculation.
What is Bacteriostasis and Fungistasis test?
The bacteriostasis/fungistasis test is designed to validate the procedure used to test a product for sterility by demonstrating that microorganisms present on the product will be detected in the course of the sterility test.
How many types of sterility tests are there?
The three methods of Sterility Testing are membrane filtration, Direct Transfer (Product Immersion) and Product Flush.
Why sterility test is performed for 14 days?
Sterility testing require 14 days of long incubation time because there are some bacteria which are very slow growing like Propionibacterium acne. P. acne is gram positive, rod shaped, slow growing bacteria which is found in the acne of humans.
Which media is used for sterility testing?
Soybean-Casein Digest Medium (Trypticase Soy Broth, TSB) is suitable for the culture of both fungi and aerobic bacteria. This medium is used for sterility testing by membrane filtration or by direct inoculation. It is also used as pre-enrichment broth for nonsterile products.
How is sterility measured?
Sterility is measured by the Sterility Assurance Level (SAL) of the device or the material. The SAL, expressed as 10−N, is the expected probability of surviving organisms. Typical SALs are 10−6, meaning that the expected probability of any surviving microorganism after sterilization is 10−6.
What is bacteriostatic and Fungistatic?
Bacteriostatic: a chemical that inhibits the growth of bacteria. Fabric that has been impregnated with a bacteriostat will stop the growth of germs, which eventually die in time. • Fungistatic: a chemical that inhibits the growth of fungi.
What is fluid k?
Fluid K is a sterile diluent used for rinsing membranes during sterility testing by filtration. It is formulated to meet the USP requirements and is recommended for use with substances containing petrolatum/oil.
What are the 4 steps to sterility assurance?
Sterility Assurance Levels (SALs): Irradiation
- A terminal sterilization process.
- Sterilization of components, followed by sterile filtration and aseptic filling into a sterilized container.
- A combination of chemical/physical sterilization and aseptic processing.
What is DZ and F value?
The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. While the D-value gives us the time needed at a certain temperature to kill an organism, the z-value relates the resistance of an organism to differing temperatures.
