Lessons Learned in the Cleanroom – Part II
When you work in a cleanroom, you pick up a few tips along the way. Here is Part II of the advice shared by one of our readers in our last issue (click here for Part I).
Cleanroom components: Install anti-contamination flooring to minimize particulate carry-over, both foot-borne and from cart wheels. Find a qualified third party expert to annually certify the acceptable performance of the air handling systems inside the controlled areas (HEPA filters, BSC, LFH, isolators). Integrate automation/robotics when feasible to limit interventions by personnel.
Training: Use a formal aseptic technique testing program to verify new team members have the proper skills before manipulating sensitive product.
Facility monitoring: Monitor temperature, differential pressure cascade, and % relative humidity in relation to established targets. Monitor total particle counts, viable particulates, water quality, gloved finger tips, materials being transferred, and surface cleanliness, then share the data monthly with all teams that work inside the controlled area as feedback. Don’t forget that seasonal differences in air quality can impact the conditions greatly. Consider including a regional air quality report with the monthly data summary.
Finally: Remember that continuous improvement is your friend — have some fun with it!
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 November/December 2015 issue of Controlled Environments.