Microsart® ATMP Bacteria/Fungi & ATMP Sterile Release
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
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:
Tags:
Sartorius AG view full details
37079 Goettingen
Germany
Website: Visit Website
Tel: +49.551.308.0