Microbiology Division
– Tamilnadu Test House
Tamilnadu Test House 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
Microbiology
- Non-sterile 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
Tamilnadu Test House 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)
Microbiology - Bacterial Endotoxins
(LAL) Testing
- 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.
- Tamilnadu Test House 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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