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.
Heating, Ventilation and Air Conditioning Systems (HVAC). CLIN AC modules maintain the narrow temperature range required by garbed personnel and sensitive equipment inside a modular cleanroom.
Several configurations are available, with return air recirculated through Vertical Air Return modules mounted outside the cleanroom or directly through the cleanroom panels.
Convert a existing office or room into an ISO class 4-8 cleanroom using Cleanroom Conversions a in a fraction of the time, and at a fraction of the cost, compared to new construction.
Double-wall modular steel cleanrooms are ideal for bio/pharmaceutical applications that require an easy-clean, aseptic environment. Completely free-standing, they require no external supports and can be specified and installed in a fraction of the time, at a fraction the cost, of conventional fixed-installation biopharmaceutical clean rooms.
Available in 304/316 stainless or powder-coated steel, these cleanrooms feature smooth internal surfaces without cracks or crevices that can harbor germ colonies. Clean room accessories include UV modules, air conditioning, humidification/dehumidification modules, and HEPA/ULPA fan/filter units (FFUs) to meet cleanliness requirements to Class 10/ISO 3.
FRP and C-PVC Cleanrooms provide the ideal contamination-free processing environment for bio or pharmaceutical and other operations requiring an environment that's easy to clean and sterilize.
One final item to discuss is the periodic tasks for demonstrating continued compliance of a cleanroom with ISO 14644 standards. These tasks include the following:
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.
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.
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.
“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.
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