When you work in a cleanroom, you pick up a few tips along the way. Here is some advice shared by one of our readers — Part II is featured in the November/December issue.
Apparel and gowning: The facility should establish a formal visitor training program with video and actual donning exercises. Provide an in-house gowning qualified official to escort and observe technicians at all times. Require dedicated plant shoes; purchase new shoes or provide reimbursements to employees. A formal gowning qualification SOP and program should include periodic re-qualification to verify the gowning technique remains compliant — i.e., initial qualification requires three consecutive donnings with samples taken at 10 specified points on the outside of the sterile coveralls, and double gloved hands to validate that the individual can don the sterile garments without contaminating them. Successful requalification at three consecutive six-month check points leads to reducing the test frequency to once a year.
Entry and exit points: Provide a separate entry point for personnel versus supplies/materials. Limit traffic – viewing windows are a plus for visitors/investors.
Cleaning and disinfection: Review the materials/tools technicians need to take into controlled areas and disinfect thoroughly. Schedule cleaning activities after the product manufacturing activities are completed for the day. Consider cleaning high traffic areas such as the gowning room more than once each day. Differentiate between the “daily” cleaning activities and a more intense “thorough” cleaning activity that takes place at a reduced frequency — i.e., monthly or quarterly.
This cleanroom tip is courtesy of Deborah Hoffer, CQA, CQIA. Hoffer is Manager-Quality Systems with The Rogosin Institute, Xenia Division in Xenia, Ohio. www.rogosin.org
This cleanroom tip appeared in the September/October 2015 issue of Controlled Environments.