Setting the standard on Functional Safety Management in the Biosafety Industry

Over the years, ESC have worked with a number of organisations operating CL3 and CL4 laboratories facilitating research in animal and human health.

ESC have become the leading consultancy for delivering and implementing management systems across these specialist organisations.

Our expertise and experience in this industry has set the benchmark and defined the way Functional Safety is implemented across this industry.

Our specialist services within this industry include:

Risk Assessments

ESC’s expert facilitators have adapted traditional process hazard analysis techniques such as HAZOP and SWIFT etc. to assess risks associated with biological hazards looking at all aspects of operation, such as (not exhaustive list):

  • Effluent Decontamination Plants
  • Autoclaves
  • Incinerators
  • Air Handling Units/ HVAC Systems
  • Microbiological Safety Cabinets
  • Breathing Air Systems
  • Chemical Showers
  • Fumigation Chambers
  • Cabinet Lines

ESC are able to support and advise clients in the calibration of the organisation risk matrix and risk targets applying industry best practice and taking into account the specificity of handling dangerous pathogens.

Functional Safety Management Systems

Traditionally geared towards the oil and gas and chemical industry, IEC 61511 is now a key standard which the Regulators are focusing on when inspecting CL3 and CL4 facilities.

ESC have paved the way and set the standard for implementing IEC 61511 in this industry having worked with various organisations and continually engaging with the Regulators.

Delivering and implementing a Functional Safety Management System has included delivering (not exhaustive list):

  • Functional Safety Policy
  • Competency Guidance
  • Proof Testing Procedures
  • Verification and Validation activities
  • Design Reviews
  • Functional Safety Assessments

ESC have been awarded a number of Framework Contracts with key organisations as the preferred supplier for Functional Safety Services.

Cyber Security

Most recently, Cyber Security has been a focal area for Regulators inspecting high containment facilities.

Our Cyber Security specialists have been:

  • Conducting cyber security risk assessments in accordance with IEC 62443 or ISO 27005
  • Documenting the risk assessments using Bow Tie Analysis
  • Delivering and implementing Cyber Security Management System in accordance with IEC 62443, ISO 27001 or HSE OG 86

ISO 35001: Biorisk Management System

Published in 2019, ISO 35001 is the first internationally recognised standard for Biorisk Management for laboratories and other related organisations.

Our specialists (members of the ISTR) can provide support and guidance in implementing the ISO 35001 standard to fully integrate in the organisation’s existing management system by:

  • Conducting a gap analysis of the current documentation against the requirements of ISO 35001
  • Providing a road map to a fully compliant management system
  • Providing a framework which fully integrates the existing management systems and facility specific standards into one organisation wide biorisk management system

Further Information

If you’d like any further information or would like to talk to one of our consultants please Contact Us via our contact form and we’ll be glad to help.