When are Sterility test required?
Sterile products must be free of living organisms, including yeast, mold spores, bacteria, and other cells. Reliable sterility tests are crucial steps in producing safe and effective drugs during the drug development process. Sterile media production, cell culture, and nucleic acid extractions have a high risk of cross-contamination if the procedure is not followed precisely. Sterility test are done when: 1. Sterile drug products are manufactured in the pharmaceutical labs and after specific environmental changes. Sterility test should be done when new equipment is installed or used for manufacture to avoid contamination of the drugs. 2. Sterile products are required for use in humans. Sterile products include most injections, surgical devices, and implants such as heart valves and pacemakers, intraocular lenses, and joint replacements. 3. Sterilized vaccines or blood products are required for use in humans. This is usually achieved by treatment with ionizing radiation or ethylene oxide. 4. Sterile products are required for use in animals. Sterile products include some animal vaccines, some antibiotics, and diagnostic kits. 5. Products that can support the growth of microorganisms need to be checked before use to make sure that they will not grow on storage. These include antibiotics, vaccines, and blood products. Sterility test are usually done before these products are stored. How are Sterility test done? Effective molecular biology services make it easier to produce therapeutic proteins or vaccines that are not available commercially or in quantities adequate for a particular patient’s needs. These tests can be done through either direct or indirect methods. Direct Sterility test detect the presence of microorganisms by use of culture techniques or physical methods that reveal living cells. They can be done using either the microbial limit test method or the membrane filtration test. Indirect test methods are performed by incubating sterile products with living microorganisms before and after treatment with the sterilant to determine if any microorganisms survived (contamination).
Comments