ISO 11133 Compliance
CertaMedia culture media are produced and quality controlled according to the principles described in ISO 11133 — the international standard for microbiological culture media.
What is ISO 11133?
ISO 11133 – Preparation, production, storage and performance testing of culture media is the international standard that defines the quality requirements for microbiological culture media. It describes how culture media must be prepared, produced, tested, stored and validated to ensure reliable microbiological results.
CertaMedia culture media are produced and quality controlled according to the principles described in ISO 11133.
Standard
ISO 11133:2014
Quality Control at CertaMedia
Every batch of CertaMedia culture media undergoes comprehensive quality control before release. The following tests are routinely performed:
pH Verification
Every batch is tested against the specified pH value to ensure optimal growth conditions.
Sterility Testing
Full sterility testing to confirm that no contamination risk is present in the final product.
Growth Promotion Testing
Demonstrates that the medium adequately supports the growth of target organisms.
Selectivity Testing
For selective media: verification that non-target organisms are adequately inhibited.
Productivity Testing
Comparison of productivity against an approved reference medium.
Batch Traceability
Complete documentation of every batch for full traceability and audit readiness.
Controlled Storage Conditions
Storage under controlled temperature and humidity conditions as per specification.
Certified Reference Strains
Certified reference strains are used for performance testing. These strains are sourced from recognised culture collections (ATCC) and ensure reproducible and comparable test results.
| Organism | Strain |
|---|---|
| Escherichia coli | ATCC 25922 |
| Staphylococcus aureus | ATCC 25923 |
| Salmonella Typhimurium | ATCC 14028 |
| Listeria monocytogenes | ATCC 19111 |
| Listeria innocua | ATCC 33090 |
| Enterococcus faecalis | ATCC 29212 |
| Enterococcus faecium | ATCC 6569 |
| Pseudomonas aeruginosa | ATCC 27853 |
| Bacillus subtilis | ATCC 6633 |
| Bacillus cereus | ATCC 11778 |
| Clostridium perfringens | ATCC 13124 |
| Campylobacter jejuni | ATCC 33291 |
| Yersinia enterocolitica | ATCC 9610 |
| Candida albicans | ATCC 10231 |
| Aspergillus brasiliensis | ATCC 16404 |
This is just a small overview of the reference strains we work with. Contact us for a complete list.
Every Batch is Tested
Before any batch of CertaMedia culture media is released, it undergoes a complete quality testing protocol. All test results are documented and available upon request.
Visual Inspection
pH Measurement
Sterility Test
Growth Promotion Test
Recovery Comparison with Reference Media
Available Documentation
Upon request, we provide comprehensive quality documentation to support audits, accreditations, and internal quality assurance processes.
Certificate of Analysis
Batch-specific document with all QC test results.
Batch Traceability
Full traceability from raw materials to finished product.
QC Test Results
Detailed results of all quality control tests performed.
Storage and Shelf Life Information
Recommended storage temperatures and minimum shelf life data.
Request Quality Documentation
Need a Certificate of Analysis, QC test results, or technical information about our culture media? Contact us and we will be happy to assist.