QP04 Pharmaceutical Microbiology Flashcards
Microbial Limits - 8 Dosage forms
TAMC 1000cfu/g (or ml) TYMC 100cfu
Oral Tablets (absence E.coli)
Rectal
Substances for Pharmaceutical Use
TAMC 100cfu/g (or ml) TYMC 10cfu
Oral liquids (a E.coli)
Oral dispersible films (a E.coli, Staph, Pseud)
Inhalation (a Staph, Pseud, Bile Tolerant GNR)
Cutaneous/ Gingival/ Oromucosal/ Nasal/
Auricular (a Staph, Pseud)
Transdermal patch ( a Staph, Pseud)
Vaginal (a Staph, Pseud, Candida)
What does PET stand for and what situations will it be used
Preservative efficacy test - a topical cream contained in a pot that the user dips their fingers into will be affected differently to a cream contained in a tube applied directly to the skin. If any of the components change, it is necessary to re-evaluate how the preservatives will continue to perform.
The PET method is relatively straightforward: efficacy is evaluated by challenging the preparation (in its final container whenever possible) with a suitable range of micro-organisms. Samples are taken at set time intervals and the surviving organisms are enumerated.
Where do you find the specs for the PET in the
- Ph.Eur/BP
- USP
- European Pharmacopoeia 7.0, Efficacy of Antimicrobial Preservation (5.1.3.): www.drugfuture.com/Pharmacopoeia/EP7/DATA/50103E.PDF (2011).
- United States Pharmacopoeia (USP 35), Chapter 51, Antimicrobial Effectiveness Testing: www.pharmacopeia.cn/v29240/usp29nf24s0_c51.html.
When should you perform the PET?
PET should be conducted as soon as possible after the manufacture of a new product to ensure the preservative is compatible with the formulation.
A second challenge test is recommended after manufacture, often a few months later, to make sure the preservative has not broken down and lost effectiveness with time. It is also crucial to revisit PET whenever the formulation, manufacturing process or packaging of an existing product changes, as any of these can impact preservative performance.
