Qualification of an aseptic processing facility is a complex project including qualification of the cleanrooms in the facility, IQ/OQ/PQ of the equipment and utilities in the facility, airflow visualization studies, personnel training and qualification, aseptic process simulations, process validation, conformance runs, and other validation activities. This article focuses on the activities involved in certification and qualification of the cleanroom itself.

Installation Qualification

Installation qualification activities for a new cleanroom typically include the following items:

• Verification that the materials of construction are as specified (e.g., Epoxy Terrazzo flooring, smooth hard walls compatible with cleaning chemicals such as phenolic compounds or sodium hypochlorite, etc.)
• Verification of adequate lighting (typically defined in user requirements) at work height
• Verification of appropriate installation of air handling units and ductwork or laminar flow units
• Verification that air handling ductwork has been adequately cleaned. This is very important, as improperly cleaned ductwork can cause HEPA leaks in some cases.
• Verification that the specified HEPA or ultra-low particulate air (ULPA) filters have been installed and installed properly Verification of location and size of returns
• Verification of instrumentation type, location, and installation
• Verification of installation of air handling units or laminar flow units.

Operational Qualification

Operational qualification for a clean room might include the following:

• Verification of proper operation of air handling units, humidifiers and dehumidifiers, duct heaters, smoke alarms, dampers, and other controls
• Verification of proper operation of the building management system (BMS) or other control system for the cleanroom
• Measurement of vibration and noise in the cleanroom
• Cleanroom classification activities

Cleanroom Qualification

Classification of a cleanroom is typically performed according to ISO 14644-1 and its supporting documents. Typical activities involved in classification of a cleanroom include the following:

• Certification of HEPA filters, as discussed in the previous column.
• Measurement of airflow velocity and airflow volume. For Grade A areas, airflow velocity is measured using an anemometer or micro manometer at several points across each filter.
• Air changes per hour are calculated by dividing the supply volume in cubic feet or cubic meters per hour by the room volume in cubic feet or cubic meters.
• Measurement of differential pressures between rooms. This is typically accomplished using an electronic micromanometer or differential pressure gauge.
• Particulate classification is performed per ISO 14644-1 and its associated documents, using a standard discrete particle counter (DPC). Each room in the complex should be verified as meeting the ISO Class or EU Grade for the activities performed in that room.
• Airflow visualization. This is performed in all Grade A processing areas to demonstrate that the airflow is appropriate for aseptic processing. Airflow visualization will be the topic of an upcoming column.