WCBF Adopts New Approach to Sterile Cleanroom Gowning

• Date: January 27, 2011
• Source: Admin

For the Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin-Madison it is important to maintain strict cleanroom cleanliness and sterility in their Class 7 and 8 cleanrooms.  If contaminated with microorganisms, the products the WCBF manufactures can adversely harm patients.  In addition, the steep price of product rejects and recalls makes it crucial to ensure high product yields.

In the cleanroom, all incoming air, water, chemicals, and materials must be filtered or sterilized to meet high standards of purity and microbiological control.  Also to be “filtered,” in a sense, is the cleanroom operator.
 
So it is critical for cleanroom operators to select cleanroom suits that provide not only the highest levels of inherent sterility, but also the greatest chances of maintaining that sterility through the gowning process.
 
The WCBF turned to a new approach to sterile gowning with Clean-Don technology from Kimberly-Clark Professional. The resulting Clean-Don Technology provides a number of features.  The vacuum packaging makes the garments more compact and easier to store.  When the package is opened, the garment stays in a compact shape, preventing it from unfolding and touching the floor.  It is also packaged inside-out, with a stripe to indicate which side is which.  This helps prevent the cleanroom employees from contaminating the sterile outside of the garment during the gowning process and saves steps and valuable time during the gowning process.
 
Regulations

When validating a new sterile cleanroom gown, the following should be insisted upon, amongst other things:

• Certificates of Conformance  
• Certificates of Irradiation  

All precautions should be taken to ensure that EPA or OSHA regulations or permits are not violated.  It should also be borne in mind that any changes to processes are also concerns for regulatory personnel because they may impact the company’s FDA license.  

Source:

http://www.pharmpro.com/articles/2011/01/cleanroom-equipment-and-supplies-Sterile-Cleanroom-Gowning/