Charity

These versatile panels provide an economical way to divide a cleanroom or laboratory in multiple cleanliness zones or to create a dust-free area in an otherwise unclassified work space.

CLIN’s modular cleanroom panels serve as barrier walls that enable modification of existing space to multiple purposes.

“The Aseptic Core” discusses scientific and regulatory aspects of aseptic processing with an emphasis on aseptic formulation and filling. This column has been developed to provide practical advice to professionals involved in the qualification of aseptic processes and the myriad support processes involved.

A typical cleanroom or aseptic facility design and construction process can be divided into several phases: planning, design, construction, commissioning, and qualification.

On completion of the qualification phase, a submission is prepared and submitted to one or more regulatory agencies for approval. On receipt of approval, the facility enters an operational phase in which product is manufactured for sale and routine quality controls are in place.

There is not a single “right” way to construct an aseptic processing facility or cleanroom, as each should be designed to accommodate the processes and products contained in the cleanroom. There are, however, general principles of design that should be followed in constructing a cleanroom or aseptic processing facility.

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.