Ethylene oxide residual analysis
Non-sterile pharmaceutical products are required to meet specific guidelines relating to the dosage form categories the product is covered under.
Principle of test
For the total aerobic microbial count and yeast and mould count the product is diluted with a validated neutralising diluent. This inactivates any preservatives or inhibitory substances present. The product is then tested by pour plate, spread plate or membrane filtration method.
Testing of objectionable / indicator organisms is performed by an enrichment process. The product is suitably diluted and enriched by direct broth enrichment or membrane filtration.
The enriched product is then streaked onto various selective agar plates to isolate Bile-tolerant Gram negative bacteria, Gram negative bacteria, Staphylococcus spp, Pseudomonads, Salmonella spp and Coliforms.
A confirmation process is performed if typical growth is detected by sub-culturing onto selective media agars. Further identification can also be performed using our phenotypic ID system (MALDI-TOF) or genetic sequencing system (comparison against our Eurofins IDmyk Comparative Sequence Index).
Products are also able to be tested by specific client methods provided we are given clear instructions and/or standard operating procedures are provided.
SAMPLE REQUIREMENTS
- Validation: 20g or 20ml for each test
- Total aerobic, yeast and mould count: 20g or 20ml
- Bile-tolerant gram negative bacteria count: 10g or 10ml
- Index organisms: 20g or 20ml
- Salmonella: 10g or 10ml
- E.coli: 10g or 10ml
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