 |
||
 |
||
 |
 |
|
 |
 |
|
||||||||||||||||||||||
Pharmaceutical Product Testing |
||||||||||||||||||||||
 BACKGROUND:
Non-sterile pharmaceutical products are required to meet specific guidelines relating to the dosage form categories the product is covered by. As of 2010, the Australian Therapeutic Goods Administration will follow the Therapeutic Goods Order no. 77 Microbiological Standards for Medicines.
This order requires medicines to comply with the harmonized methods of microbiological quality of non-sterile products: microbial enumeration tests as well as the harmonized method for specified micro-organisms. The Australian TGA has taken the view that specified organisms should include Pseudomonads rather than just Pseudomonas aeruginosa.
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 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 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 biochemical test kits or genetic profiling using the Riboprinter® (see organism identification page).
Products are also able to be tested by specific client methods provided we are given clear instructions and/or standard operating procedures are provided.
Validation: 5g/ml for each test
Total aerobic, yeast and mould count: 20g/ml
Index organisms: 20g/ml
Salmonella: 10g/ml
Test description
Test Code
Turnaround time
Validation for plate counts & enrichment
TMPC 100
1 week
Total aerobic count
TMPC 101
3 days
Yeast and mould count
TMPC 102
5 days
S. aureus, coliforms, Pseudomonads (Index org)
TMPC 103
4 – 5 days
Salmonella spp.
TMPC 106
4 – 5 days
E.coli
TMPC 105
2 – 5 days
|
||||||||||||||||||||||