Microbiology
ChemicalAnalysis offers a comprehensive range of microbiological service for pharmaceuticals, agricultural products, cosmetics, neutraceuticals, water and finished products.
Microbiological analysis helps to ensure products are safe, meet quality specifications and regulatory compliance as required.
Our microbiological testing includes:
- Non-sterile
- Sterile (include Spore strip (Biological Indicators detection and media trials)
- Endotoxin (LAL)
- Environmental Monitoring
- Preservative Efficacy
- Disinfectant Efficacy testing
Non-Sterile microbiological testing encompasses:
- Microbiological quality of pharmaceuticals: Categories 1-4
- Microbial bioburden assesment during shelf life of pharmaceutical products
- Tablet and capsules, creams and ointments, solutions and transdermal patches
- Pre Phase I to Phase II pharmacokinetic data
- Pharmacopeial guidelines relevant to microbiology and non-sterile manufacturing
- Validation of test methods to international monographs (USP-BP-EP-JP)
- Pharmaceutical Water testing
- Spore strip (Biological Indicators) Enumeration
- Sterility Isolator with VHP generator
- Endotoxin (chromogenic and turbidimetric) testing
- Air sampler
- Microbiology incubators
Equipped with BioQuell VHP Generator and the latest sterility isolator model from Extract Technology, our sterility isolator is designed to perform sterility testing in an aseptic environment providing assurance of process integrity. Unlike traditional clean rooms where samples are introduced into the rooms directly with simple surface sterilization, samples introduced into our sterility isolator are decontaminated by a controlled Vapourised Hydrogen Peroxide (VHP) cycle. This ensures that the samples introduced are free of surface contamination. All of our sterility methods are validated initially and at the end of the sterility testing to ensure no false positive or negative results are given.
Chemical Analysis offers a comprehensive range of non-sterile pharmaceutical (including cosmetics, sunscreens, OTC and complementary medicines) testing and method validation (compliant to current BP, EP, USP, ICH and FDA requirements) which include the following analyses:
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mould Count (TYMC)
- Staphylococcus aureus
- Bile Tolerant Gram-negative Bacteria (Enterobacteriaceae)
- Pseudomonads and Pseudomonas aeruginosa
- Coliforms and E.coli
- Salmonella
- Candida albicans
- Clostridia
- Bioburden
- Biological Indicators (spore strips)
- Preservative Efficacy Testing (PET, Efficacy of Antimicrobial Preservation)
- Disinfectant Efficacy Testing
- Pharmaceutical Water Testing
- Microbiological Quality of Finished Products for Stability Studies
- Environmental Monitoring (Air Sampling, Settle Plates, Contact Plates and Swabs)
- Endotoxins are potentially toxic compounds released from the cell wall of Gram-negative bacteria that can be a potential health risk to humans. In large doses, Endotoxins can cause shock and death in humans.
- Chemical Analysis can provide both quantitative and qualitative Bacterial Endotoxins Testing (BET, LAL) using turbidimetric and chromogenic methods. Our bacterial endotoxins testing methods and 21 CFR Part 11 compliant software comply with the current BP, EP, USP, and FDA requirements.
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