Containment
The Life Sciences industries have , for many years, recognised that certain categories of medicinal products require special precautions during manufacturing, particularly penicillins, cytotoxic agents and potent steroids where good manufacturing practices require segregation and/or containment to effectively manage the occupational health and cGMP cross-contamination risk.
The focus of cGMP has been, and continues to be, product protection, the avoidance of cross contamination and quality, whereas that of industrial hygiene is operator protection and safety. Where any conflict exists between the two operating principles the priority lies with operator safety. Situations where such conflict could arise, for example are in the design and operation of systems handling potent sterile products.
The need to provide a safe working environment for operators as well as protection of the product (product quality) through good manufacturing practice requires a thorough understanding of the relevant processes and criticality of the elements of the process. When this is known risk assessments can be undertaken during design and/or installation to ensure compliance with design intentions and achievement of the dual objective of cGMP compliance and industrial hygiene practice.
In order to meet this challenge, Critical Systems provides important services in the following areas:-
Typical Hazards
- Biological Agents (Pathogens).
- Allergens & sensitisers (Dander & Bedding).
- Active Pharmaceutical Ingredients
- Solvents & Reagents.
- Fumigants (including formaldehyde, ethylene oxide, and hydrogen peroxide).
Range of services
- Analysis – Evaluation of existing operations and risk analysis.
- Audits – Facilities and proposed precautions.
- Design – Facility design and equipment selection.
- Policy & Strategies – Design and implementation of policies throughout multi-national companies, multiple or single sites, to ensure compliance with company policies.
- Airflow & Emissions – Detailed analysis of airflow patterns to ensure containment.
- Containment Technology – The use of containment techniques and contained material handling technology.