Environmental Monitoring Testing Services
Environmental Monitoring (E/M) is a program designed to demonstrate the control of viable (living microorganisms) and non-viable particles in critical areas. These areas include clean-rooms, laminar flow hoods, biological safety hoods, isolators, glove boxes, molding machines, kit assembly lines.
The environmental monitoring process involves viable and not viable control: viable monitoring refers to testing for the detection and enumeration of bacteria, yeast and mold. It includes the monitoring of personnel, air and area surfaces for microbial contamination. And differs from non-viable environmental monitoring which is a reference for particle counts measured by a laser counter. Viable counts provide metrics on the potential for contamination of a company’s products as well as demonstrating the veracity that a clean room is functioning as designed and being properly maintained. Surface and air monitoring exhibit the asepsis of the product manufacturing operation.
Companies who have their clean room facilities monitored do so to ensure their desired/required quality standards are met.
The areas that are sampled in a clean room include:
- Personnel (gloves, gowning)
- Air (particle counts, viable counts, temperature and humidity, HEPA filters)
- Surfaces (floors, walls, equipment, swabs, contact)
- Visualization of airflows and directional verification (Smoke Test)
- Differential pressures of the classified rooms
- lighting level
- Water testing: microbiological and chemical
- Compressed air monitoring: viable and non-viable
- Disinfectant qualification
By monitoring the manufacturing environment from a microbial perspective, control of contamination can be demonstrated, reducing the both the risk to products and possible sterilization failures.
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 (USP or GMP).
Two flexible service options
- On-site monitoring package carried out by qualified STERIS technicians at intervals and times suited to the Customer
- Monitoring plates “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 (cleanrooms).
Specification of Cleanrooms
The operation performed in the cleanroom will define what class or grade of cleanroom is required. Environmental monitoring allows the cleanroom to be assessed to the limits outlined in the following table to define the cleanroom grade or class. The assessment is based on air particle counts and microbial contamination of air and surfaces within the cleanroom.
The limits for air particle counts for the different cleanroom specifications are detailed below.
ACCEPTANCE CRITERIA ISO 14644-1
|CLASS||0,1 µm||0,2 µm||0,3 µm||0,5 µm||1 µm||5 µm|
ACCEPTANCE CRITERIA EU GMP ANNEX 1
|GRADE||Maximum permitted number of particles for cubic meter|
|AT REST||IN OPERATION|
|0,5 µm||5 µm||0,5 µm||5 µm|
|D||3520000||29000||Not Defined||Not Defined|
Recommended limits for microbial contamination are detailed below
|Grade||Air Sample cfu/m3||Settle Plates(diam. 90 mm)cfu/4 hours||Contact Plates(diam. 55mm)cfu/plate||Glove Print 5 fingers Cfu/glove|
Consultancy, training and auditing
STERIS offer consultancy, training or facility auditing to either ISO 14644 or GMP to assist in:
- Commissioning of cleanrooms
- Risk assessments
- Trending of data
- Establishing alert/action limits
- Developing microbial test programs for products, processes and environments
- On-site training courses in microbiological good practice within cleanrooms and environmental monitoring
Environmental monitoring and cleanroom certification is offered for:
- Medical device manufacturing
- Pharmaceutical manufacturing
- Packaging manufacture
- Raw materials production