PPE Donning Areas

[Ed Panek]

Do you apply and remove PPE inside the controlled zone or outside it?

 

[Chrisx]

What do you mean by controlled zone? Do you mean like a controlled environment (ie cleanroom)? Those should always have a gowning room.

 

[Ed Panek]

We have a PPE requirement of gloves for production team. I was thinking we could donning inside the production area since the intent is to touch the product in a clean manner. That touching doesn't happen at the donning area.
Enter production area
Don PPE near entry
Walk over to production line
Work

Our production SOP says gloves must be worn when handling product. It doesn't say when the PPE must be applied. Im asserting it is ok as long as its not possible to touch product without PPE.

 

[Nichole F]

The companies I've worked for PPE is usually donned in the uncontrolled cleanliness zone or a gowning room. It really comes down to the intention of your PPE. In your case, the controlled cleanliness zone may be the product line since it doesn't sound like you are aiming to control microbial contamination so as long as the operator has gloves on before approaching the production line, the PPE will be effective.

Some companies have very strict requirements. One supplier that my previous company audited, you were not allowed to wear street clothes in the building at all. Visitors were issued scrubs and crocs. This was even to enter the administrative areas.

 

[FRA 2 FDA]

I used to work as a tech in a cleanroom environment producing a Class III Implantable product (and that is the only criteria I'm basing this response on as I have never looked into cleanroom definitions, guidance, etc). We did "gown up" as we went, before entering any controlled areas... scrubs in the locker room just outside the core--> shoe covers, hair covers in the gowning room before stepping over the magic line and then entering the core --> frocks and knee-high shoe covers in the gowning room adjacent to each manufacturing area. However, gloves were provided IN each manufacturing area and put on only when we were about to do any procedures that required them. But the caveat here is that we were not always required to wear them.