Clothes changing in pharmaceutical factory

[Duyen]

I’m confused about clothes changing procedure for going into Cleanroom class D. If a factory is equipped with a airlock and changing room before going into Cleanroom class D. Where we can change clothes class D? Please give me a recommendation?

 

[Ronen E]

Assuming that Class D is equivalent to ISO 14644 Class 8 (Class 100,000), there's no need to change clothing before entering. Typically over-gowning suffices, and it takes place in the change room you mentioned.

 

[Duyen]

I read in PIC/s guideline. It mentioned that changing room is designed as airlock. So all clothes changing activity will do in airlock. If the factory has air shower. Clothes changing can be done in changing room. Go through the air shower. I have no idea for air lock.

 

[Ronen E]

I think "clothes changing" relates to over-gowning at this level of clean room.

 

[monoj mon]

I also second Ronen's comment, if the confusion in here is all about clothes changing. It is simply putting the protective over-gowning for a class 8 equivalent room.

Clothes changing can be done in changing room. Go through the air shower. I have no idea for air lock.

And for the "Air Lock", if there is confusion about what is it, the basic concept is to maintain the pressure inside it. One simple example I can offer here; suppose, you have a manufacturing facility with clean rooms. The arrangement is such that the airlock changing room will come first followed by the air shower and then your clean room. You first enter through the door of the air-lock room. While you are entering through that door, a second person already in the changing room can not open the door which leads to the adjacent air-shower room. Once you shut the first door, then only the door to the air-shower can be opened. So, in short from my experience, only one door at a time can be opened in the air-lock facilities and from the changing room to the clean room, all are usually air-locked to minimize an abrupt change in the pressure.

 

[Duyen]

I also second Ronen's comment, if the confusion in here is all about clothes changing. It is simply putting the protective over-gowning for a class 8 equivalent room.
And for the "Air Lock", if there is confusion about what is it, the basic concept is to maintain the pressure inside it. One simple example I can offer here; suppose, you have a manufacturing facility with clean rooms. The arrangement is such that the airlock changing room will come first followed by the air shower and then your clean room. You first enter through the door of the air-lock room. While you are entering through that door, a second person already in the changing room can not open the door which leads to the adjacent air-shower room. Once you shut the first door, then only the door to the air-shower can be opened. So, in short from my experience, only one door at a time can be opened in the air-lock facilities and from the changing room to the clean room, all are usually air-locked to minimize an abrupt change in the pressure.

Layout of my facility like this: Changing room (grade D) ==> airlock ==> clean area (grade D). What is the clothes changing procedure? Can u share with me your opinion?

 

[monoj mon]

Layout of my facility like this: Changing room (grade D) ==> airlock ==> clean area (grade D). What is the clothes changing procedure? Can u share with me your opinion?

Usually, we put our protective clothes one after another in a similar fashion as follows and we don't change our normal clothes, but we remove our shoes at shoe rack and enter the non-sterile area of gowning room with socks on. From there we follow the protocol almost similar to the following [to some extent, as it may differ from Class to Class. You may make some changes to the below protocol depending on your convenience keeping compliance in your mind]. ;

1. Before entering gowning room taking at least three small steps with each foot; remove dirty sticky mat layer if needed.
2. Use a shoe brush cleaner
3. Don shoe cover booties [while seating on the gowning bench, don't step on the non-sterile side with the clean-room shoes]
4. Don cleanroom bouffant
5. Wash hands thoroughly (use waterless alcohol solution for USP 797)
6. Put on cleanroom glove liners
7. Apply alcohol solution to outside of liners
8. Put on cleanroom gloves
9. Wash or apply alcohol solution to cleanroom gloves
10. Apply cleanroom bouffant (beard covers for those with facial hair)
11. Apply a freshly laundered cleanroom hood
12. Attach facemask
13. Apply coveralls, only touch the floor on the clean side of a gowning bench
14. Hoods are tucked inside of coveralls
15. Put on cleanroom booties
16. Put on cleanroom gloves
17. Ensure that booties and gloves overlap the coveralls
18. Wipedown the gowning bench with a clean, sterile wiper
19. Use cleanroom mirror for self-check

I found those above steps from this blog, which may be helpful for you.

 

[KerryBrown]

Assuming that Class D is equivalent to ISO 14644 Class 8 (Class 100,000), there's no need to change clothing before entering. Typically over-gowning suffices, and it takes place in the change room you mentioned.

Agreed! My brother is working in a pharmaceutical factory and their company have the similar policy as their clss D is equivalent to 14644 and their staff do not change the clothes at the time of entering

 

[Ninja]

And for the "Air Lock", if there is confusion about what is it, the basic concept is to maintain the pressure inside it.

FWIW, there is often misunderstanding about the word "airlock".
It is NOT important to maintain pressure inside it...and it doesn't matter what the pressure is in it.

What is important is that air flows from the clean room (or not at all), instead of from outside to inside the cleanroom.
It is not always necessary to have a gowning room. We simply had Tyvex coats hanging on hooks outside of the cleanroom door (which did not even latch). What we ensured is that any air change from inside to outside the cleanroom flowed the correct direction (From Inside the cleanroom to outside the cleanroom...this is what keeps outside airborne dust from coming into the room.

If we had skipped the Tyvek coats, we still would have had a Class 100K (ISO8) room with no issue...specifically because the air flowing out from the room was adequate to remove dust from inside the room.

A gowning room (or "airlock" if you will) is one of the many tools you have to accomplish the goal...it is not the only tool, and it is not even a mandatory tool.
That said, it is hard to defend "cleanroom" to a customer without a gowning room in evidence because they are all used to seeing a gowning room...appearance matters with customers, auditors and regulators...

HTH