spacer
home > pmps > winter 2003 > designing biopharma and pharmaceutical cleanrooms
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Designing Biopharma and Pharmaceutical Cleanrooms

The design, specification and selection of cleanrooms is a complicated process which requires due consideration involving the impact on the final build solution and comparing different classes and finishes to show the advantages or disadvantages of each. With an overview to the key issues that need to be reviewed by a project team when developing a cleanroom for an existing or new pharmaceutical process, operation or product, this article gives an insight into the complex process of cleanroom design.

The 'cleanroom' has been defined by the International Organisation for Standardisation (ISO) new standard 14644-1 as:

"A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles inside the room and in which other relevant parameters, for example, temperature, humidity, and pressure, are controlled as necessary". (William Whyte, Cleanroom Technology, p1, 2001)

This definition may sound simple but when people, products, regulatory and pharmaceutical equipment, and operational/budget requirements are introduced into the equation, it becomes a complex problem to which there are many contributing factors. In addition, the production throughputs and flexibility required by the cleanroom suite will have an effect on a cleanroom's size and layout.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Richard Paley, Principal Architect and Pharmaceutical Consultant at Bovis Lend Lease

Richard Paley has been Principal Architect and Pharmaceutical Consultant for Bovis Lend Lease for 15 years and is experienced in the design of pharmaceutical, biopharma cleanrooms and R&D, QA/QC laboratory and process facilities. His previous experience includes working with international design and build contractors, architectural practices specialising in pharmaceutical manufacturing facilities and laboratories, as a lecturer for the PEAT course Facility Design Module at UMIST, Manchester, UK. Richard has designed projects across EMEA and Asia, and is a member of the ISPE, and the Irish Cleanroom Society.

spacer
Richard Paley
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Sustainability, plastics and Brexit: Keynote speakers set to inspire at PPMA Total Show 2019

Experts from IKEA, the British Plastics Federation and The Sunday Times to create a forum for education, knowledge-sharing and debate
More info >>

White Papers

Tightening Your Supply Chain Against Counterfeits

World Courier

As today’s global pharmaceutical supply chain grows increasingly longer and more complex, each link provides added opportunity for counterfeiters. While pending regulatory changes promise to tighten the supply chain with respect to production and distribution entities and new packaging technologies will make the identification of counterfeit products easier, the logistics of global distribution remains a weak link. How can the pharmaceutical shipper ensure the security of the supply chain over thousands of miles and extended periods of time when the product is no longer in his possession?
More info >>

 
Industry Events

PPMA Total Show

1-3 October 2019, Birmingham

About PPMA Total Show PPMA Total is one of UK’s largest processing and packaging machinery exhibitions. Building on the success of the PPMA Show in 2018, PPMA Total returns to the NEC, Birmingham, on 1-3 October 2019 for another show-stopping event.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement