Pharmaceutical products are microbiologically tested on different culture media.

Tests like the Growth Promotion Test (PT) must be carried out according to the European Pharmacopoeia to test if the used media are of sufficient quality.
This test must be performed on each batch of culture media.

Biosisto can provide ready-made Certified Reference Materials (CRM) that you can easily use for these tests.
The specific strains in the CRM comply with
the European Pharmacopeia.

Micro-organismCRMWDCMEquivalentStandard
Staphylococcus aureusCRM-SAU.00032MM00032ATCC 6538European Pharmacopoeia (Ph. Eur.) TSA
Pseudomonas aeruginosaCRM-PA00026ATCC 9027European Pharmacopoeia (Ph. Eur.) TSA
Bacillus subtilisCRM-BSUBT00003ATCC 6633European Pharmacopoeia (Ph. Eur.) TSA
Candida albicansCRM-CAL.00054MM00054ATCC 10231European Pharmacopoeia (Ph. Eur.) SDA
Aspergillus brasiliensisCRM-ABR.00053MM00053ATCC 16404European Pharmacopoeia (Ph. Eur.) SDA
Escherichia coliCRM-ECO.00012MM00012ATCC 8739European Pharmacopoeia (Ph. Eur.) TSA
Salmonella TyphimuriumCRM-ST00031ATCC 14028European Pharmacopoeia (Ph. Eur.) TSA
Clostridium sporogenesnot available yet00008ATCC 19404not available yet

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Biosisto - Quality in Control

Microbiological laboratories should be able to receive reliable analysis without much overhead. A microbiological analyst must be able to focus on the primary activities, for example analysis of the sample material. Quality control should support the analyst in a logical and simple manner. By using modern information technology, process control and quality assurance are designed smarter and more effective.

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