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The tests are mainly carried out in the Biological Analysis Unit are:
- Sterility testing,
- Microbial limit testing
- Bacterial endotoxin testing and
- Microbiological Assay.
Sterility test
Performed on all pharmaceutical products required to be sterile before their use in humans or animals can be sanctioned. Such include: all injectable drug samples, products for intravenous infusion, sterile wound dressings, needles, syringes and eye preparations. The test is performed to determine presence of any viable microbial contaminants in these preparations that may be harmful to patients treated using them.
Microbial limit tests
This is carried out in all syrups, suspensions and other liquid dosage forms to ensure that the microbial count limit is not exceeded in any preparation.
Microbiological Assay
This is carried out on antibiotics and antifungals using specific culture media and microorganisms to determine the content of active ingredients.
Bacterial Endotoxin Testing
Carried out using the Limulus Amebocyte Lysate (LAL) testing kit to ensure the amount of bacterial endotoxins are within the allowed limits for perentral products and medical devices.
Currently carrying out Condom Testing on male/female condoms to ensure they comply with international standards of ISO and WHO in terms of dimensions, physical characteristics and the package integrity.
The unit plans to introduce the testing of surgical gloves, syringes and needles.
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