Environmental Monitoring Testing Services

Environmental monitoring is a range of test methods used to identify and understand the microbial environment that exists within the manufacturing process.

The environmental monitoring process 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, 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 EP).

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

Two flexible service options

  • On-site monitoring package carried out by qualified STERIS Laboratories technicians at intervals and times suited to the 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 (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.

Maximum concentration limits ( Particles/m3 of air) (at rest)

ISO 14644 classification number GMP Orange guide 2014 0.1μm 0.2μm 0.3μm 0.5μm 1 μm 5μm
 Class 1  10 2
 Class 2  100  24  10  4
 Class 3  1000  237  102  35  8
 Class 4  10000  2370  1020  352  83
 Grade A  3520  20
 Class 5  Grade B  100000  23700  10200  3520  832  29
 Class 6  1000000  237000  102000  35200  8320  293
 Class 7  Grade C  352000  83200  2930
 Class 8  Grade D  3520000  832000  29300
 Class 9  35200000  832000  293000

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 Laboratories 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
Available services vary between laboratories. Contact us to learn more about the services offered at each of our locations

Contact our team of experts to find out more about Cleanroom Testing and Consultancy