QA & Environmental Monitoring

 

Cleanroom Environmental Monitoring Services

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

SMTL hold UKAS (United Kingdom Accreditation Service) accreditation for the testing of controlled clean rooms and can offer classification of clean rooms to national and international standards as well as current guidance to good manufacturing practice (GMP).

SMTL have over 30 years experience in the field of environmental monitoring and have provided services to pharmaceutical manufacturing units, operating theatres and hospital sterile services. All tests are carried out by trained, responsible, competent and flexible staff working to documented test procedures to meet today's environmental legislation.

SMTL can provide both physical measurement (particulate concentration & air flows), and also microbiological monitoring (active air & surface monitoring) to ensure continued compliance with any required standards.

SMTL provide expert consultancy for all your cleanroom requirements. From unexpected results and assistance with documentation, to guidance with room designs and work flows, we work hard for our clients in order for them to achieve the highest standards attainable,

 

SMTL environmental monitoring services :

  • Measurement of air velocities and air change rates in clean rooms and clean air devices

  • Measurement of airborne particles

  • Microbial airborne contamination

  • Microbial surface sampling

  • Identification of microbial contaminants

  • Complete QA package, advice and consultation

Standard Tests:

BS EN ISO 14644Particle Monitoring;

Eudralex volume 4 annex 1Active Air & Surface Microbiological Testing.

 

Hazardous Substance Monitoring – EH40/2005 Workplace Exposure Limits

The COSHH (Control of Substances Hazardous to Health) regulations requires that all substances which have an Workplace Exposure Limit (WEL) should be monitored to ensure that staff are not exposed to significant risk.

SMTL can provide monitoring services for many hazardous substances, and have a wealth of experience of gas & dust monitoring within the hospital environment to enable compliance with the COSHH regulations.

It is a legal requirement under the COSHH Regs to undertake environmental monitoring if you are using substances that have workplace exposure limits (WEL's).

Many of today's cold sterilants, for example, contain ingredients that have WEL's that require monitoring such as hydrogen peroxide & chlorine dioxide. SMTL can provide testing reinforced with a technical report to ensure compliance with the COSHH Regs.

WEL's can not be exceeded, and monitoring records have to be produced to the HSE (Health & Safety Executive) on request. At SMTL we've a wealth of experience that can be utilised in order to gain advice with regards to testing requirements of any substances you may have concerns with.

 

SMTL COSHH Monitoring services:

  • Fumes from cold sterilants in endoscopy departments

  • Hazardous dust in estates or plaster rooms

  • Help & guidance on current Workplace Exposure Limits

  • Help & guidance on potential substances requiring testing

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