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Microbiological Testing
If contaminated with pathogens medical devices or pharmaceutical peprations may be the source of human infection. Microbiological testing is employed to minimize or exclude the risk of infection for patients or users. These tests provide information about the germ load of a product as it undergoes the manufacturing process or information to evaluate the effectiveness of sterilization or disinfection measures.The range of microbiological tests we perform include:
- Validation of sterilization pocesses (DIM EN ISO 11737 -1,2; Pharm. Eur. 2.6.1.):
- Validating sterility
- Determining the population of microorganizms on a product
- Testing for sufficient preservation (Pharm. Eur. 5.1.3)
- Testing of packaging materials for their microbial barrier properties (DIN 58953, section 6)
- Microbiological testing of non-sterile products (Pharm. Eur. 2.6.12, 2.6.13)
- Identification of microorganisms
- Detection of mycoplasma using PCR (Pharm. Eur. 2.6.7)