Regulatory Open Forum

Is an anteroom required for an ISO8 cleanroom? This is for a medical device company making diagnostics. 

I understand particle count may be extremely difficult to control without an anteroom. Just trying to figure out if there is an FDA requirement for one. 

Hello Brianna,

For an ISO Class 8 cleanroom, the gowning room is also referred to as an ante-room. In the absence of gowning room (ante-room), where would operators change in and out of street clothes when entering and exiting the cleanroom?  

I am not sure of FDA requirements but the mention of ante-room is mentioned ISO 14644 and USP.

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Ajit Basrur
Worcester MA
United States
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Original Message:
Sent: 16-Feb-2023 19:01
From: Brianna Turcanu
Subject: ISO8 Cleanroom Ante Room Requirement

Is an anteroom required for an ISO8 cleanroom? This is for a medical device company making diagnostics. 

I understand particle count may be extremely difficult to control without an anteroom. Just trying to figure out if there is an FDA requirement for one. 

Hi Brianna,

It's not a FDA requirement to have a gowning anteroom. FDA doesn't even make recommendations or requirements for ISO classification of spaces since all manufacturers will have different requirements. However, it is industry best practice to have some sort of gowning anteroom prior to entering your ISO classified space. This helps maintain your particle count within your cleanroom and improves the overall cleanliness of your operation. 

Ashleigh Rickey

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Ashleigh Rickey, RAC
Regulatory Affairs & Compliance Manager
United States
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Original Message:
Sent: 16-Feb-2023 19:01
From: Brianna Turcanu
Subject: ISO8 Cleanroom Ante Room Requirement

Is an anteroom required for an ISO8 cleanroom? This is for a medical device company making diagnostics. 

I understand particle count may be extremely difficult to control without an anteroom. Just trying to figure out if there is an FDA requirement for one. 

Hello Brianna,

Agree with the other persons posting in this thread there is no specific FDA requirement (or to that matter other regulatory agencies) for an ante-chamber/ante-room or commonly referred to as a gowning room.  Though as Ajit stated it is mentioned in ISO 14644 in order to create the "cross-over" from a dirty environment to the clean environment.  As well, it is Good Manufacturing Practice (GMP) to have an ante-room or gowning room to separate for people and materials coming into a controlled environment.  Also, some people like to "class" their gowning room, but I would not do that personally.  You can measure the ante-room/gowning room to show particulates are at 'x' level, but not classify the room as such - only the controlled environment should be classified.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Feb-2023 19:25
From: Ashleigh Rickey
Subject: ISO8 Cleanroom Ante Room Requirement

Hi Brianna,

It's not a FDA requirement to have a gowning anteroom. FDA doesn't even make recommendations or requirements for ISO classification of spaces since all manufacturers will have different requirements. However, it is industry best practice to have some sort of gowning anteroom prior to entering your ISO classified space. This helps maintain your particle count within your cleanroom and improves the overall cleanliness of your operation. 

Ashleigh Rickey

------------------------------
Ashleigh Rickey, RAC
Regulatory Affairs & Compliance Manager
United States

Original Message:
Sent: 16-Feb-2023 19:01
From: Brianna Turcanu
Subject: ISO8 Cleanroom Ante Room Requirement

Is an anteroom required for an ISO8 cleanroom? This is for a medical device company making diagnostics. 

I understand particle count may be extremely difficult to control without an anteroom. Just trying to figure out if there is an FDA requirement for one.