Environmental monitoring and specification of cleanrooms
Over 20 years’ experience performing environmental monitoring of cleanrooms
Environmental monitoring is a range of test methods used to identify and understand the microbial environment that exists within the manufacturing process. It involves the analysis of surfaces, air, water and chemicals used within the manufacturing space.
By monitoring the manufacturing environment from a microbial perspective, control of contamination can be demonstrated, thus reducing risk to products and sterilization failure.
Specification for class or grade of clean rooms are based on environmental monitoring as detailed in ISO 14644 or within the rules and guidance for pharmaceutical manufacturers and distributors (Orange Guide).
Environmental monitoring tests available
- Air samples – viable quantitative and qualitative, non-viable
- Microbial surfaces – contact and swabs
- Water testing – microbiological and chemical
- Compressed air monitoring – viable and non-viable
- Disinfectant qualification
- Equipment cleaning validation
Two flexible timely services available
- On-site monitoring package carried out by qualified STERIS Pharmaceutical Laboratories technicians at intervals and times suited to customer
- Monitoring “kits” and loan of testing instruments sent out, so Customers can perform their own monitoring
For both services, an initial site visit is available to discuss environmental monitoring requirements, sampling locations and to give guidance on the regulations covering clean areas (rooms).
Consultancy, training and auditing
STERIS Pharmaceutical Laboratories offer consultancy, training or facility auditing to either ISO 14644 or GMP to assist in the
- Commissioning of cleanrooms
- Risk assessments
- Setting up of environmental monitoring regime
- On-site training courses in microbiological good practice within cleanrooms and environmental monitoring
Industries and products suitable for environmental monitoring
Medical device and pharmaceutical manufacturing, packaging manufacturers and raw materials producers
Quality and methods used
ISO 13485, GMP (Orange Guide 2014), ISO 14644