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)