Case studies

Cleanroom Complex—Pharmaceutical Product Development

Vectura, Chippenham
Class ‘C’ GMP cleanrooms with Class ‘A’ GMP control booths
400m²: £900,000
18 weeks duration

This new facility was built in an existing building. The whole structure was totally self-supporting by using a specially designed steel mezzanine. The room fabric consisted of a cleanroom partition system, walk-on type ceiling with wall/ceiling and wall/wall coving, vinyl flooring, with a fully equipped changing room.

The facility was designed as class C GMP turbulent flow with localised class A GMP powder control booths. The powder control booths were stainless steel. The pressure regime was designed so that process rooms were kept at a negative pressure to the main corridor to help prevent cross contamination.

The whole facility was designed to save on running costs and therefore used re-circulated air. This air passes through a bank of safe change HEPA filters before it passed back to the AHU for re-use.

Services included a compressed air system c/w pipework, nitrogen pipework and DI water pipework.

Air conditioning consisted of an air handling unit, chiller, chilled water pipework, humidifiers and controls (to meet industry standard 21 CFR part 11) to achieve the design criteria. This was mounted on the steel mezzanine.

From the customer’s various user requirement documents, a detailed validation procedure was produced and agreed, including DQ, IQ, OQ. The room was approved by the MHRA.