Pharmaceutical Technology Europe - December 2010 - (Page 2)
Cleanrooms: uncovering the challenges and presenting the solutions
leanrooms and aseptic areas are important facilities for the bio/ pharmaceutical industry, but they also pose many unique challenges. According to respondents of a survey recently conducted by PTE (Figure 1), the main challenge associated with cleanrooms is personnel training — a crucial issue considering that the cleanroom operator can be considered as the main source of potential contaminants. However, there are also many other challenges involved in implementing and maintaining cleanrooms. How can the stringent regulations be met? Can both the facility and the equipment be successfully validated? What is the best way to prepare for an audit? How can companies ensure they select the best solutions from the start?
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These are some of the issues that experts discuss in this month’s special feature on cleanrooms. This feature in its entirety, including additional expert opinions on modular cleanrooms and cleanroom packaging, can be accessed at: www.pharmtech.com/ptedigital1210
Figure 1: Results of Pharmaceutical Technology Europe poll Q: What is the most important feature of pharma secondary packaging?*
Regulations 4% Personnel training 30% Facility Design 18% Equipment cost 14% Cleaning and maintenance 18% Validation 16% If you’ve missed out on any of the special features we’ve published throughout 2010 then you can bring yourself up to date at: www.pharmtech.com/ptedigitalarchive
*www.pharmtech.com/polls
1 CONTENTS 6 POST MONITORING
3 REGULATIONS REALISTIC? 8 STERILE PACKAGING
4 PASSING INSPECTIONS 10 CLEANROOM DOORS
5 SELECTING SOLUTIONS 11 TOP TECHNOLOGIES
http://www.pharmtech.com/ptedigital1210http://pharmtech.findpharma.com/pharmtech/issue/issueList.jsp?sort=null&pageNo=1&start=0&id=52http://www.pharmtech.com/polls
Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - December 2010