TESTING, COMMISSIONING & CERTIFICATION
Operating Theatres, laboratories, intensive care units and pharmacies are classified cleanrooms.
They are categorized as per ISO 14644 in categories 5 to 8, depending on the function of the area.
ISO 14644 and UK's HTM clarify that an Operating Theatre must be thoroughly tested, and also officially certified that it performs as per the standards and the design parameters.
Furthermore, the client should have an independent and professional verification that all works have been executed to the appropriate level reflecting the critical and accurate conditions required for the delicate operations within the controlled environment.
But Should we Test, Commission and Certify?
The European Committee of Standardization (CEN) has adopted the ISO 14644, as
EN ISO 14644 and enforce it for all the member countries since January 2016.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
The 3 principal reasons that led to the adoption of the standards and their practice are:
Preserve Patient Life
A Cleanroom must function as per design parameters to constitute a safe environment, and thus to preserve the life of the patient by eliminating the possibility of infection that could endanger human life.
A Cleanroom must function as per design parameters to constitute a safe environment, and thus to provide peace of mind to the operator that the outcome of the operation is entirely dependent on his skills, and that no external factors could cause unwanted complications.
Protect The Institution
A Cleanroom must function as per design parameters to constitute a safe environment, and to verify that all actions were executed in the correct environment. Such a practice protects the institution from malicious requests and claims.
should perform Test, Commission and Certification?
Such critical and delicate tests should only be performed by specialized engineers who have been trained and certified.
The governing body that trains and certifies that engineers are competent for such testing is the Cleanroom Testing and Certification Board International.
Our Engineers are Chartered by the UK Board IMechE, and have been certified by CTCB-I
We have extensive experience in the testing and commissioning of UCV systems toHTM03-1. Our staff have completed and passed the Cleanroom Test Certification to ISO14644 Standards
We are a non-biased, independent third party.
You will receive a detailed, clear report, with test method, results and summary, plus any recommendation for improvement.
You will receive a CERTIFICATION of compliance as per ISO 14644
We can support the periodical monitoring and certification services.
We are a trusted adviser with proven experience in operating theatres.
A variety of tests are performed with the latest technological and calibrated instruments. The selection of tests depends on the client needs, and the cleanroom classification level. The tests mostly performed are the below:
- Airflow volume & velocity to verify
balanced and proper air patterns
- Room air exchange rates to assure
that the area is meeting its design airflow
- Environmental Conditions to verify
Temperature, Humidity and Sound levels
-Pressure check to verify that room differential pressures are according to design
-HEPA filter integrity testing - tests HEPA filters and system for leaks
- Particle counting to report the amount of airborne particulates of a specified size
The design and testing certification procedures are described in:
Health Technical Memoranda HTM. Issued by the department of health (UK).
Health Technical Memoranda (HTMs) give comprehensive advice and guidance on the design, installation and operation of specialised building and engineering technology used in the delivery of healthcare.
The focus of Health Technical Memorandum guidance remains on healthcare-specific elements of standards, policies and up-to-date established best practice. They are applicable to new and existing sites, and are for use at various stages during the whole building lifecycle.
Healthcare providers have a duty of care to ensure that appropriate governance arrangements are in place and are managed effectively. The Health Technical Memorandum series provides best practice engineering standards and policy to enable management of this duty of care.
ISO 14644: Cleanrooms and associated controlled environments Parts 1, 2 and 3.
Part 1: ISO 14644-1:2015 - Classification of air cleanliness by particle concentration
this document specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones
Part 2: ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Part 2 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
Part 3: ISO 14644-3:2015 - Test Methods
It specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
PD 6609:2007: Environmental cleanliness in enclosed spaces. In situ high efficiency filter leak testing
PD 6609 is a Published Document (PD) that provides information supplementary to the provisions of BS EN ISO 14644-3:2005. In particular, it gives recommendations and explanatory guidance for in situ leak testing of high efficiency filters using an oil aerosol challenge and photometer. It also provides guidance on the procurement of replacement filters, and information that might be required in a test report.
The guidance contained in PD 6609 document is for the leak testing of high efficiency air filters that can be face scanned. The document does not provide information on other tests carried out on high efficiency filters installed in cleanrooms, such as pressure differentials, air supply volumes, and airflow uniformity.