Microbiology
Sterility, TAMC, TYMC and antimicrobial effectiveness.
Our Class A microbiology lab (EU GMP) performs the full range of pharmacopoeial tests — from routine TAMC/TYMC through the 14-day sterility test to preservative challenge testing (Ph. Eur. 5.1.3).
What we measure
- Total Aerobic Microbial Count (TAMC) — Ph. Eur. 2.6.12
- Total Yeasts and Molds Count (TYMC) — Ph. Eur. 2.6.12
- Sterility test for injectables and ophthalmics — Ph. Eur. 2.6.1
- Specific pathogen detection (E. coli, Salmonella, P. aeruginosa, S. aureus, C. albicans)
- Bacterial endotoxins test (LAL, kinetic-turbidimetric) — Ph. Eur. 2.6.14
- Antimicrobial effectiveness / challenge test — Ph. Eur. 5.1.3
- Production environment monitoring (settle plates, air sampling)
Sterility test samples accepted in original sealed packaging. For TAMC/TYMC: minimum 10 units or 10 g. Controlled transport (2–8 °C for most, RT for dry forms).
Instruments + methods
Technical specs- Cleanroom
- ISO 5 (class A), continuous monitoring
- Incubators
- 30–35 °C, 20–25 °C, 42 °C (2 units each)
- Autoclaves
- 2 × 150 l, 121 °C / 20 min + 134 °C / 5 min
- LAL reader
- Charles River Endosafe PTS
- Media
- Ph. Eur. compliant (FTM, SCDM, Sabouraud)
- Accreditation
- ISO/IEC 17025 (scope AL-1142/micro)
from 28 900 ISK
7 days (TAMC/TYMC) · 14 days (sterility) · 28 days (challenge test)
Related questions
02 Q- 01
How long does the sterility test take?
14 days incubation per Ph. Eur. 2.6.1. No growth = positive result. Report issued on day 15 after sample receipt. Shortening this period is not accredited.
- 02
Do you perform bacterial endotoxins (LAL)?
Yes, kinetic-turbidimetric LAL per Ph. Eur. 2.6.14. Result within 2 h. We accept blood samples, injectables, infusion solutions, medical devices.