Quality Control Test Suspensions - Growth Promotion

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NAMSA Quality Control (QC) Test Suspensions are ready-to-use microbial suspensions containing a consistent number of microorganisms delivering exceptional accuracy for Qualitative Microbiological Quality Control. A large number of strains are available with application in the pharmaceutical, medical de-vice, food and water testing industries. QC Test Suspensions can be used as qualitative reference standards in most USP, EP and JP industry methods and pharmacopeial chapters.

Some of the most common testing applications are listed below:

Growth Media Testing: QC Test Suspensions provide a quality control challenge to each batch or lot of medium, ensuring its growth promot- ing qualities, whether it is prepared internally from basic ingredients or purchased commercially prepared. Inoculate each batch or lot of medium, directly without rehydration, dilution or reconstitution. Visible growth after incubation indi- cates the culture media is conducive to organism growth.

Sterility Assurance Testing: QC Test Suspensions meet the requirements of USP <71>, EP 2.6.1 and JPXV 4.06 Sterility Tests. All suspensions comply with the requirement for population of <100 colony forming units (CFU) and are guaranteed to be within five passages of an original stock culture.

Antimicrobial Effectiveness Testing: QC Test Suspensions can be used when antimicrobial activity is required to prevent microbial proliferation or to limit the effect of contamination. • All suspensions comply with the requirement for population of <100 colony forming units (CFU) and are guaranteed to be within five passages of an original stock culture • QC Test Suspensions are provided as pure cultures in 2.5 mL or 10 mL volumes containing 25 or 100 doses (0.1 mL each). • Store suspensions under refrigerated conditions between 2˚C to 8˚C • QC Test Suspensions are sold in glass vials with screw-top caps containing a septum. The screw-top cap with sep tum allows for access using either a pipette or a needle and syringe • The organisms can be used to manufacture suspensions with population levels up to 106 /0.1 mL or higher. Please inquire for information on population levels greater than 100 colony forming units (CFU’s) /0.1 mL for the QC Test Suspension organisms. NAMSA also manufactures highly concentrated suspensions for validation of heat sensitive products. Please contact us for more information.

Quality Control Test Suspension Strains

NAMSA Code Organism Cell Line Shelf-Life Vial Size

GP-01 Bacillus subtilis 6633 14 months 10 mLGP-02 Clostridium sporogenes 11437 14 months 10 mL GP25-03 Candida albicans 10231 12 weeks 2.5 mLGP-04 Aspergillus brasiliensis 16404 7 months 10 mLGP-06 Geobacillus stearothermophilus 7953 24 months 10 mLGP25-07 Pseudomonas aeruginosa 9027 8 weeks 2.5 mLGP25-08 Staphylococcus aureus 6538 8 weeks 2.5 mLGP25-09 Escherichia coli 8739 10 weeks 2.5 mLGP-10 Bacillus atrophaeus 9372 18 months 10 mLGP25-11 Salmonella enterica 14028 12 weeks 2.5 mL

Quality Control Test Suspensions