Biosafety
Bio-RISK MANAGEMENT
Bio- SAFETY COMPLIANCE
Bio- CONTAINMENT ENGINEERING
Critical Systems Ltd personnel have more than 30 years expertise in the field of Bio-Hazard management, and are able to provide clients with a broad range of consulting and engineering services ranging from a single day’s consultancy to a fully integrated service linked in to your new project or operational facility. We have a high level of experience across the full range of containment levels from BSL 1-4, for process all research and process platforms including laboratories, safety cabinets and bio-reactors.
We provide practical experience to help ensure effective application of these standards and guidelines.
- EN 61511 family of standards for “Safety Instrumented Systems” (SIS) (2004)
- CWA 15793 Laboratory Bio-Risk Management Standard (2008)
- UK HSE/ACDP Guidance
- EN 12469:2000 “Biotechnology – performance criteria for microbiological safety cabinets”
OUR SERVICES
Critical Systems can provide a broad range of services, including :
- Advice on laboratory operations.
- Auditing of existing facilities and systems.
- Advice on regulatory standards & guidance.
- Advice on Bio-decontamination systems (HCHO, H2O2).
- Safety Design Reviews.
- Design of facilities and associated engineering systems.
- Risk Assessment and Failure Mode & Effect (Criticality) Analysis (FMEA & FMECA).
- Training.
BIO-SAFETY COMPLIANCE SERVICES- SAFETY QUALIFICATION
We can provide a complete SAFETY QUALIFICATION solution covering the following:
- Qualification Master Plans
- Criticality and risk assessments
- Design reviews and qualification
- Inspection & test protocol preparation.
- Practical testing.
- Document management.
- Supplier auditing & FAT.
- Commissioning plans.
- Engineering turnover packages
- Maintenance management.
BIO-WASTE SYSTEMS
We can provide experience and technical support for all types of bio-waste system, including chemical, batch and continuous thermal techniques:
- Design.
- Materials selection and specification.
- Procurement.
- Installation QC.
- Commissioning.
- Safety Qualification (including microbiological efficacy testing).