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

Pharmaceutical Packaging and Labelling Summit in Zurich; ACG presentation

At next week’s Pharmaceutical Packaging and Labelling Summit in Zurich (18-19 June), Dr. Eugen Hertel from ACG will be speaking on: Challenges for Global Pharma companies to Implement Anti-Counterfeit Strategy for Russian Track & Trace Regulation. This presentation will include details around ‘the fight against counterfeit medicine - there have been and still are worldwide initiatives to make the supply chain and the safety of medicines secure. After large markets such as the USA and Europe passed their laws and regulations for the pharmaceutical manufacturing companies and established the IT infrastructure, Russia is now next on the move.
More info >>

White Papers

Clinical Trials in Ukraine: Orange Paper Overview and 1st Half Year 2014

Synergy Research Group

The Orange Paper is an analytical report about the clinical trials market in Russia, published quarterly by the contract research organization Synergy Research Group. The first edition of Orange Paper was released in 2006, and at the moment 31 issues have already published. Now, thanks to Synergy Group Ukraine, obtaining information about the market of clinical trials in Ukraine has become possible. In Ukraine, during the period from 1996 to 2013, applicants had obtained 3,864 positive conclusions about the possibility of conducting clinical trials of drugs, both for domestic and foreign manufacturers, including conduct of multinational multi-center clinical trials (hereinafter – MMCTs)
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement