Pharmaceutical Products Testing
BACKGROUND:
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 neutralizing 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
|
Test Description |
Turnaround Time (TAT) |
|
Validation for plate counts & enrichment |
5-7 days |
|
Total aerobic count |
3-5 days |
|
Yeast and mould count |
5-7 days |
|
Bile-tolerant Gram negative bacteria count |
4-5 days |
|
S. aureus, coliforms, Pseudomonads (Index organisms) |
3-5 days |
|
Salmonella spp. |
3-4 days |
|
E.coli |
3-5 days |
