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
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
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.