BIOSAFETY

Laboratories or manufacturing facilities dealing with potentially pathogenic microorganisms have to meet specific requirements for contained use of organisms or for occupational safety in biotechnology.

Therefore, you have to implement a biosafety concept and to build a suitable infrastructure that has to be compliant with the requirement for biosafety level BSL-2 or BSL-3, depending of the type of micro-organisms.  Particularly strict requirements in terms of safety apply to the work with the microbes which can cause serious and potentially lethal disease via the inhalation route. For them, the special type facilities (BSL 3,) are required by law.

Thanks to our long-term expertise in this domain, PMSystem offer a complete package to support you successfully for:

Services

  • implementing an adequate and pragmatic biosafety concept
  • designing and qualifying your infrastructure or aligning the existing processes and premises to the expectations of the authorities.
  • dealing with the notification of your activities to the regulatory authorities
  • Conceptual design and qualification of BSL-2 or BSL-3 infrastructure
  • Implementation of biosafety concept
  • Preparation of all documents requested for the application of authorization
  • Systems Qualification
  • Validation of decontamination processes
  • Training
  • Third - party audit