Pharmaceutical Technology Europe - December 2010 - (Page 5)

Selecting the right cleanroom solutions The cost of cleaning in the cleanroom is always far higher than cleaning outside the cleanroom; hence everything that can be done to keep the dirt out is highly cost effective, such as the use of polymeric flooring. It is widely accepted that around 80% of all contaminants entering a cleanroom do so through entrances and exits at or near floor height (Figure 1). The best managed cleanrooms/critical environments start at the entrance to the building and implement a holistic contamination control programme, starting with basic entrance matting to reduce the ingress of mud, grit, water and gross contamination, and becoming progressively cleaner as you get nearer to the critical area. as germs become more resistant to a specific cleaner. It takes a lot of money and effort to validate a new cleaning detergent/product, but this is accepted as a necessary investment. Time is also a consideration; one must define how long one cleaning system takes versus another. Also, how Mark Dalzie l Figure 1: Concentration of contaminants entering a cleanroom. Red indicates area of highest intensity. Key considerations When selecting detergents for cleanrooms, it is necessary to rotate the solutions used at regular intervals aggressive is the cleaning system? The answer is usually a trade off between killing everything very quickly, and risk ruining other sensitive and even non-sensitive equipment. I have even seen stainless steel eaten away by aggressive cleaning systems so beware! In today’s world, environmental improvement is a also a key goal and there is often a lot of wasted electrical energy from using HEPA or UPLA filters to control the class of cleanroom or mini environment. Also, the use of disposable or consumable products when longer term options are readily available seems a waste of resources. The best way of ensuring a long active life of a cleanroom and its equipment is to slightly over engineer the cleanroom and SOPs so that changes and upgrades can easily be accommodated. If this is not done, then companies will be continuously working hard to meet the standards needed, which is going to be both costly and time consuming. PTE Based on a contribution by Mark Dalziel, Managing Director at Dycem. For the full version of this article, go to www.pharmtech.com/dalziel www.dycem.com 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/dalziel http://www.dycem.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - December 2010

Pharmaceutical Technology Europe - December 2010
Table of Contents
Pharmaceutical Technology Europe Poll Uncovers the Biggest Challenge to Implementing Cleanroom Conditions Amongst Readers
Are Cleanroom Regulations Realistic?
Passing Cleanroom Inspections
Selecting the Right Cleanroom Solutions
Defining the Right Cleanroom Post Monitoring Programme
Should You Implement Modular Cleanrooms?
Developing Sterile Packaging for Aseptic Environments
CMO Cleanroom Challenges
Choosing Your Cleanroom Door
Eight Top Cleanroom Technologies Showcased

Pharmaceutical Technology Europe - December 2010