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
1 10 / / / / /
2 100 24 10 / / /
3 1000 237 102 35 / /
4 10.000 2.370 1.020 352 83 /
5 100.000 23.700 10.200 3.520 832 NA
6 1.000.000 237.000 102.000 35.200 8.320 293
7 NS NS NS 352.000 83.200 2.930
8 NS NS NS 3.520.000 832.000 29.300
9 NS NS NS 35.200.000 8.320.000 293.000
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
A 3520 20 3520 20
B 3520 29 352000 2900
C 352000 2900 3520000 29000
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
A <1 <1 <1 <1
B 10 5 5 5
C 100 50 25
D 200 100 50

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
Contact our team of experts to find out more about our Global Contract Sterilization Services