Pharmaceutical product testing
Pharmaceutical microbiology is a specific field concerned with raw material analysis, process control, environmental monitoring, and final products. It can be used to ensure product sterility (e.g., antibiotics, Injectable water) or compliance to microbial limits (e.g., oral, and nasal use). NAWAH laboratories has provide broad range of Pharmacopeia test method stated in Egyptian Drug Authority (EDA) regulation.
1. Sterility test
The sterility of a product is defined by the absence of viable and actively multiplying microorganisms when tested in specified culture media.
This test is one of the quality control tests specified for the release of a batch of sterile products and applied to substances, preparations, or articles that, according to the Pharmacopoeia, are required to be sterile.
Types of Media used:
- Fluid thioglycolate medium
- Tryptic soy broth
- Incubation Period: 14 days
The Test is performed in accordance with USP 43:71 Sterility Test
2. Microbial Enumeration Test
The microbial enumeration test is a quantitative test that determines the Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) present in the test product.
Microbial Enumeration Test is carried out on pharmaceutical products, cosmetics, personal care products, textile, and other miscellaneous products to be checked for their safety before releasing the product to the market
The test is performed by Plate count method or Membrane filtration method in accordance with USP 43: 61 Microbial examinations of non-sterile products.
3. Antimicrobial effectiveness testing is price independent
Preservatives are antimicrobial additives that are incorporated into product formulations to help maintain the quality of a product by inhibiting and reducing microbial contamination. The Antimicrobial Effectiveness Test (AET) is performed to gauge the performance of those preservatives.
To evaluate the antimicrobial effectiveness of a product, the product is inoculated with a prescribed quantity of specified microorganisms.
The common five USP AET test organisms are C. Albicans, S. Aureus, E. Coli, P. aeruginosa, and A. brasiliensis
The test is performed in accordance with USP 43: 51 Antimicrobial effectiveness testing
4. Both MIC & MBC / MFC
Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) testing define a test material’s potency in terms of the concentration at which it will inhibit growth of (Minimum Inhibitory Concentration, or MIC) or completely kill (Minimum Bactericidal Concentration, or MBC) 1 x 106 challenge microorganisms during an 18-to-20-hour period of incubated (35 ± 2°C) exposure.
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