Highest Manufacturing Quality Standards

Tests are performed on representative samples using the membrane filtration procedure in accordance with the US Pharmacopoeia or EP Pharmacopoeia. Culture media used are fluid thioglycollate medium (FTM) and trypticase soy broth (TSB). All tested media must pass growth promotion testing before use. The test samples are filtered and the filters are immersed in FTM and TSB. TSB cultures are incubated at 22.5°C +/- 2.5°C. FTM cultures are incubated at 32.5°C +/- 2.5°C. The cultures are incubated for 14 days, during which they are periodically examined and sterility results are recorded.

Media and supplements are tested for their growth promoting properties using primary, diploid, and heteroploid cell lines unless other cells are appropriate based on the product use. Results are obtained using the Lowry protein method or manual cell count to assess cell replication. Visual screening of cultures is also done to ensure characteristic cell morphology and lack of toxicity. Additional testing for toxicity, function and/or activity may also be conducted if one or more is required in the product release specifications.

This is a powder specific test. We are committed to offering the same high quality powdered media as you have come to expect with our liquid media. We utilize a unique micronization manufacturing process, which produces powder in a controlled environment, guaranteeing maximum stability and minimum degradation due to chemical oxidation.

Media and supplements are tested for their growth promoting properties using primary, diploid, and heteroploid cell lines unless other cells are appropriate based on the product use. Results are obtained using the Lowry protein method or manual cell count to assess cell replication. Visual screening of cultures is also done to ensure characteristic cell morphology and lack of toxicity. Additional testing for toxicity, function and/or activity may also be conducted if one or more is required in the product release specifications.

Products are tested for endotoxin content using the Kinetic-QCL™ Assay. Test dilutions used are screened for inhibition and enhancement in the Kinetic-QCL™ Assay. Endotoxin levels for these products are available on Certificates of Analysis.

Samples from each lot of standard product are retained and stored at label temperature in the event follow-up testing is required. Subsequent testing may be in response to your inquiry or for shelf life studies. Shelf life data is not included but is available for some products and upon request. Shelf life is generally between 6 and 24 months for liquid products and 24 months for powder products.

With a comprehensive range of bottles and bags we can offer standard off-the-shelf or customized containment from 0.5 liters up to 1,000 liters.

We offer a wide range of powder containers from 125 g bottles up to several 100 kg. We also provide ready-to-use solutions such as pre-weighted powder in bags, media kits, etc.