Table of Contents
What is pharmaceutical sterility testing?
Sterility testing is a GMP microbiology testing requirement used to confirm sterile products do not contain viable microorganisms before release and patient administration.
What is pharmaceutical sterility?
Sterility testing of sterile pharmaceuticals is an important part of GMP microbiology, and is used to ensure that pharmaceutical and biopharmaceutical therapeutics are actually sterile and safe for human use. USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics.
What is the method of sterility test?
Direct Inoculation and Membrane Filtration Methods. Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.
Which is the first steps involved in sterility testing?
Sterility Test Methods First is membrane filtration, which is defined in USP <71> as the preferred method, provided the drug product being tested is filterable. This method involves passing a quantity of drug product through two canisters, each housing a filter designed to retain microorganisms.
What are the benefits of sterility testing of pharmaceutical products?
Direct Transfer Sterility Testing All microorganisms have biological repair mechanisms that can take advantage of environmental conditions conducive to growth. The direct transfer method benefits these damaged microorganisms. The entire product should be immersed in test fluid.
How long does sterility testing take?
14 days
Final Results in 7 Days: The traditional sterility test is 14 days, but the Growth Direct System can produce final results in half the time. Considering that certain manufacturing processes can require sterility tests at multiple stages, the time savings can be significant.
Why should pharmaceutical products be sterile?
Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile in order to avoid the possibilities of microbial degradation or infection occurring as a result of their use. Sterilization processes concentrate on the destruction or removal of microorganisms.
Which sterility testing method is used for oily products and cream?
Membrane filtration is the Pharmacopoeia method of choice for sterility testing. Viscous products, such as creams and ointments, can be difficult to filter and are normally diluted in a sterile solvent, such as Isopropyl Myristate (IPM).
Why is validation of sterility test done?
The Objective of this validation is to establish documented evidence that the test for sterility by membrane filtration method will produce the consistent results when analyzed as per the Standard Operating Procedure.
What is bioburden test?
Bioburden testing, or total viable count testing, is the measure of microbial contamination levels on or in a product. Bioburden can be introduced from the raw materials used in the manufacturing process, or be introduced via the workforce or manufacturing environment.
Which is the correct media for sterility testing?
Sterility Culture Media Soybean-Casein Digest Medium (Trypticase Soy Broth) 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.
What are examples of sterile products?
Other sterile products include ophthalmic preparations, creams and dusting powders….Sterile pharmaceutical products.
| Dressing | Uses | Method of sterilization |
|---|---|---|
| Absorbent cotton gauze | Absorbent wound dressing | Any method |
| Gauze pads | Swabbing, dressing, wound packing | Any method |
| Absorbent viscose wadding | Wound cleaning, swabbing, skin antiseptic | Any method |
What kind of sterility test is used for pharmaceuticals?
USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics. Before beginning the sterility test, a method suitability test should take place.
How is sterility testing used in GMP microbiology?
Sterility testing of sterile pharmaceuticals is an important part of GMP microbiology, and is used to ensure that pharmaceutical and biopharmaceutical therapeutics are actually sterile and safe for human use. USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics.
How to check the sterility of a product?
If there is any colony of microorganism present, then batches will be separated and type of microorganism will be identified. Preparations which cannot undergo filtration can be checked using this method. Sterility media includes casein digest medium, fluid thioglycollate medium, etc.
When to use membrane filtration for sterility testing?
The membrane filtration must be used for such products where the volume in a container is either 100 mL or more. One may, however, select the exact number of samples to be tested from Table 8.1 ; and subsequently use them for the respective culture medium suitably selected for microorganisms and the culture medium appropriately selected for fungi.