— Cleanroom Forum

Phil Allen posted an update in the group Cleanroom Services: 1 year ago · View

I am involved in installing an ISO-8 Cleanroom and I am looking for input on whether to put a ”hands-free” wash stand with a HEPA filtered dryer in the adjoining gown room.

I have been told of two schools of thought on the subject. One school says to install the wash stand and dryer to clean contamination off hands before touching the Cleanroom garments. A second school of thought I found said not to install the wash stand and dryer because it would be a potential source of bacteria that could contaminate the Cleanroom.

I would appreciate any feed back on the subject.

Lauren · 1 year ago
I agree with both the previous posters. A sink and hand dryer are not recommended in the gowning room. 1. It’s a choke point for work flow, and I agree with Roger that operators will skip that step to save time. 2. You don’t want to introduce water in the gowning room. Even if you use ultra-clean water, it can still create humidity and potential contamination, so don’t risk it. 3. Hand dryers create air turbulence, which you don’t want in your clean area. In summary, all gross contamination control should be done outside of the gowning area.
Wipes can be used in the garment room, as well as donning gloves. You can use launder-able gloves for this purpose (as Roger mentioned) or use a low-cost disposable PVC glove.

Phil Allen joined the group Cleanroom Services 1 year ago · View

mike zines joined the group Cleanroom Services 1 year, 1 month ago · View

Lauren posted an update in the group Cleanroom Services: 1 year, 1 month ago · View

Which services (i.e., garment cleaning, calibration, cleanroom certification) do you outsource and why? What do you look for in a service provider?

Lauren · 1 year, 1 month ago
Jeff Becker, owner of Pegasus, a cleanroom cleaning service provider, offered me this great tip: Interview the company the same way you’d interview an employee: How well do they know the standards and the industry?
- mike zines · 1 year, 1 month ago
  Hi Lauren, I am from Controlled Contamination Services. Jeff has a great point. It’s not just the company but more importantly the employees performing the service. At CCS most of our job supervisors have been cleaning cGMP environments for 10 years plus, they have the experience and industry knowledge to lead a crew and get the job done right. They follow your SOP’s and procedures. Beware of a company that does not consider your SOP’s and procedures and just offers a low price, you will spend the savings tenfold following up on failures, excursions and meetings with QA and QC. Not to mention FDA audits and potential 483.