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Microsart® ATMP Bacteria/Fungi & ATMP Sterile Release

Microsart Package

Principle: Detects bacterial and fungal contamination within three hours, using the proven real-time PCR method.

Automation: No

Approvals: EP 5.1.6 and USP <1223>, EP 2.6.7and USP 63

Suitability: Fast Bacterial and Mycoplasma Contamination of Products

Capital equipment required: No

Description:

Rapid Bacteria and Fungi Detection in Only 3 Hours with Microsart® ATMP Sterile Release, fast filtration rates


Key Points:

Microsart® ATMP Sterile Release Kit, a combination of Microsart® ATMP Bacteria and of Microsart® ATMP Fungi, detects bacterial and fungal contamination within three hours, using the proven real-time PCR method.

  • Developed in close cooperation with authorities, and validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity, and robustness
  • TaqMan® probes ensure the highest level of qPCR specificity
  • Lyophilized, inactivated or non-viable validation standards for required bacterial and fungal species complete retention of microbes and viruses, due to the sieving and diffusion effect, with no loss of recovery.

Microsart® Mycoplasma qPCR detection kits offer a method for early detection of Mycoplasma contamination. The easy-to-follow protocol is aided by color-coded reagents that are both clear and concise. Additionally, the lyophilized reagents guarantee consistent quality without requiring freezer storage.

  • Validated according to EP 2.6.7and USP 63 for sensitivity, specificity, and robustness
  • TaqMan® probes ensure the highest level of qPCR specificity
  • Lyophilized, non-infectious Mycoplasma validation standards, each containing 10 CFU of the chosen Mycoplasma species
  • Applicable on any qPCR cycler suitable to detect FAM™ and ROX™ dyes

Areas:

    Pharmaceutical
Company contact details:

Sartorius AG view full details
37079 Goettingen
Germany

Website: Visit Website
Tel: +49.551.308.0