We provide our customers with fast, professional and reliable services in the field of chemical and physical quality control and microbiological testing. Pharmaceutical raw materials and finished products are tested under GMP conditions. Sterile and non-sterile preparations are tested in various dosage forms (solid, semi-solid and liquid). When carrying out microbiological testing of non-sterile products, our experts act in accordance with national and international pharmacopoeias. The microbiological methods used are validated before use.
Microbiological tests:
- Sterility testing according to Eur. 2.6.1
- Endotoxin testing according to Eur. 2.6.14
- Bacterial count determination Ph. Eur. 2.6.12
- Total aerobic microbial count (TAMC)
- Total combined yeast/mold count (TYMC)
Validation of microbiological methods
- Method development as required
- Preparation of validation plan/report
- For sterility, Ph. Eur. validation with 6 test germs on a commercial lot
- For endotoxin validation, gel-clot or kinetic turbidimetry method on three commercial lots
The above tests are performed by GMP certified subcontracted laboratories.
Contact:
Dr. Tolokán Antal
+3618723634
tolokan.antal@laboratorium.hu
