Biosafety Testing

 Sterility Testing

• This procedure is performed to determine if the test material is free from bacterial and fungal contamination. A statistically valid number of samples are taken from each final production lot according to BP 1993. The sterility test is performed according to USP 25. Samples are aseptically transferred directly into Thioglycollate and Tryptone Soya Broth and incubated at room temperature and 37°C. Samples are then screened on a regular basis for signs of microbial growth over a period of 14 days. The media is validated with control organisms - Candida albicans, Bacillus subtillis, Bacteriodes vulgatus.

Endotoxin

• This assay is performed to determine if bacterial endotoxins are present in the test material.Samples are taken from the beginning, middle and end of each lot. Samples must be collected in pyrogen free containers. (Please note collection into polypropylene tubes can inhibit the LAL assay.) A quantitative gel clot assay is performed, with known amounts of endotoxin, in parallel with dilutions of the test material and the level of bacterial endotoxin is determined.

Mycoplasma

• This assay is performed to detect mycoplasma contamination in biological material.
• The test for mycoplasma is based on the method of Barile and Kern. Samples are inoculated into mycoplasma broth and incubated at 37°C for 42 days. Sub-cultures are taken on to agar plates on day 0,7,14 and 21. The agar plates are incubated at 37°C with4-6% CO2. At day 28, the plates are examined for mycoplasma colonies.

 Contact us at antibodies@harlan.com for biosafety testing pricing and additional information.