Clean room audit

Clean rooms audit.

Clean rooms form an important part of any the modern hospital and in

fact from a part of the part of passive and active epidemiologic control.

This concept becomes even more important due to progression of the

multidrug resistant pathogens and ineffective antibiotics. Therefore

appropriate use of the clean room technology results in the safer and

cleaner hospital environments that are important medical and

engineering challenges.

Clean rooms by definition are environments where the particulate air

contamination is controlled. Such control is achieved by the appropriate

ventilation system with HEPA or ULPA filtration, that provides from

99,95% to 99,99995% filtration efficiency. This combined with the

appropriate air exchange rates, microclimate and air distribution with

overpressures, results in the environment where contaminating

particles are effectively diluted by the incoming stream of clean filtered

air.

Clean room system should comply to the appropriate class of the

international ISO 14644 standard, however there are certain challenges

that are associated with the medical industry that should be taken in to

account. Generally clean rooms in the hospitals are conditionally

separated in to three classes: Class Ia, class 1b and class II.

Apart from the classified clean rooms there might be a necessity to

include general areas that can't be classified as clean room but must

comply to the increased hygienic requirements. Sanitary sluices and

some technological rooms could be included in to this category.

Category Іа clean rooms: operating theaters with laminar air ceilings,

certain types of patient isolators (protected environment for bone

marrow transplantation) and some относятся production laboratories,

where cleanliness of the environment is required. Category Іа complies

to the class ISO-5/6 according to ISO 14644:2009 at rest.

Category Іb clean rooms: some operating rooms without laminar

ceiling, preoperation rooms, reanimation wards, patient isolators for

autologous transplantation, clean laboratories, clean and sterile zones

of the sterilization departments and others. Category Іb rooms are

supplied with calculated air exchange rates and comply to ISO-8

classification of the ISO 14644:2009 standard.

Category ІІ are non classified rooms that require use of special

hygienic surfaces and allow appropriate cleaning and disinfection

similar to classified clean rooms.

During the audit of the medical clean room projects, our auditors

inspect multitude of parameters including surfaces, ventilation, air

balances, filtration, energy conservation and compliance to the local

and international legislation and recommendations.

We are able to organize validation of the clean rooms with the

involvement of leading national or international specialists.