Clothes changing in pharmaceutical factory

#1
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?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
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.
 
#3
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.
 

monoj mon

Quite Involved in Discussions
#5
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.
 
#6
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

Quite Involved in Discussions
#7
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.
 
Last edited:
#8
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

Looking for Reality
Trusted Information Resource
#9
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
 
Thread starter Similar threads Forum Replies Date
M Is this Quality (Clothes Dryer) Coffee Break and Water Cooler Discussions 4
somashekar Requirements for Patient Gowning & other Hospital Clothes, sheets wrt. static charge? Other Medical Device Related Standards 2
S Where are Work Clothes Mandatory? Occupational Health & Safety Management Standards 29
A Changing Notified Body EU Medical Device Regulations 6
H Traceability after changing the machine IATF 16949 - Automotive Quality Systems Standard 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
Q Changing calibration frequency Calibration and Metrology Software and Hardware 18
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4

Similar threads

Top Bottom