www.PDHcenter.com PDH Course M143 www.PDHonline.

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case the area must be forced exhausted and air lock must be maintained at least one pressure

level difference higher than the adjacent areas.

The regulations mandate manufacturers to establish & maintain procedures to adequately control

environmental conditions. Lighting, ventilation, temperature, humidity, air pressure, filtration,

airborne contamination, and static electricity are among many conditions to be considered for

control. National and international health authorities carry out periodical inspections to ensure that

manufacturers comply with current regulations as laid out in EU-GMP and/or FDA. Few important

features of inspection are listed below that must be well taken care during design.

• Testing of the number of air changes The purpose of the air change in a clean room is to

ensure an optimum removal of any contamination from the operator or the product.

Further the ventilation in a clean room should maintain an acceptable working climate.

• Down flow test of UDF units In a clean room having zones with a room classification of

critical or class A, a UDF (Unidirectional airflow) cover is established, which means that

the whole critical production area is supplied with HEPA filtered air. The aim is that the air

is supplied as laminar as possible, and the “used” air should have a direction away from

the production area. The laminar flow is established by the smoke flow test for a visual

control of the airflow direction and is often video filmed for documentation.

• Room pressure differences: There is a concern with cross-contamination from one

production/process area to another and the potential for “tainted” product or a problem

with the integrity of packaging for drugs and medical devices. To prevent cross

contamination, the clean room must have a higher pressure than the surrounding lower

classified rooms. If the pressure direction between the clean room and a less clean room

is wrong, “you may install as many HEPA filters you would like, and still not reach the

desired room classification”.

• Testing of HEPA filters (leakage measurements): The “heart” of a clean room is the

HEPA filter. To obtain the required room classification, it is very important that the air is

optimally filtered. The condition of the filters is a very critical parameter in the clean room

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