Cleanroom Design

European Union Good Manufacturing Practice EU GMP)(ref. Annex 1) and Medicines Healthcare products Regulatory Agency (MHRA) Guidance for ‘Specials’ Manufacturers provide requirements and guidance for cleanroom design and operation. A compliant cleanroom is not necessarily an effective one though.

At B. Braun Aseptic Consulting Services we can advise on the design of new aseptic suites or refurbishment of existing ones using lean manufacturing tools that will enhance the efficiency of the operation.

B. Braun will work with you to define detailed capacity forecasts using our in-house capacity planning models  that  will guide you in determining equipment requirements, containment requirements, room grading requirements as well as indicating personnel numbers over a period of time. Our process of cleanroom design planning evaluates the end to end process from materials and personnel entry to finished product storage. Taking this holistic approach to design we believe that an optimum facility that satisfies regulatory, productivity and user goals can be achieved cost effectively.

We have over the years developed relationships with key suppliers of cleanrooms, equipment and cleanroom support systems. We are able to offer full unit User Requirement Specifications (URS) and Design Qualification (DQ) to the writing and execution of Installation and Operational Qualifications (IQ/OQ). Working with the final user we are able to advise on Performance Qualification (PQ).

As an aseptic cleanroom operator ourselves we understand that the on-going costs of running a cleanroom need to be carefully considered and that by including at the design stage considerable long term costs savings can be achieved.

Cleanroom design and refurbishment can be time consuming. We can help you in the following areas, enabling you to maximise your time making critical products and releasing time to care but still maintain ownership of your operations development:

• Cleanroom Design
• Independent 3^rd party cleanroom design appraisals
• Assessment of existing cleanrooms and refurbishment options
• Redesign and configuration of existing cleanrooms 
• Qualification (URS, DQ, IQ, OQ, PQ)
• Energy and cost reduction opportunities
• Operational excellence and lean methodologies in design
• Capacity planning

Please contact us for more information…..