The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Failure Modes Services and Solutions to ProblemsElsmar Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > Other Medical Device Related Standards
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 14644 Cleanroom Validation - "Operational"

Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links

Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
audit nonconformances and findings, cleanroom validation, iso 14644 - cleanrooms and controlled environments
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 17th October 2013, 11:41 AM
WisdomseekerSC's Avatar

Total Posts: 79
Caution ISO 14644 Cleanroom Validation - "Operational"

During a recent surveillance audit by our certification body we received a nonconformance to ISO 13485 clause Auditor stated "the validation of the clean room "at rest" does not challenge the worst case scenarios of the clean room's intent regarding particle count contamination. The validation for worst case scenario must be done in "Operation". The auditor shared an email from an official at FDA to emphasis his point .

We have performed particle counts in "operation" but not routinely. We do use a contracted service to annually certify the cleanrooms. Their Certificates of Compliance certifies our cleanrooms in compliance to air cleanliness classification for an ISO Class 7 under "at rest" conditions, as outlined in ISO 14644-1:1999. We also measure particle counts to verify continued compliance monthly ourselves, also "at rest". We are now considering changing to particle counts to "operation" instead of "at rest" although my understanding is that most folks in the industry perform this monitoring "at rest". Anybody have some insight regarding this practice?

Sponsored Links
  Post Number #2  
Old 18th October 2013, 08:47 AM
Ajit Basrur's Avatar
Ajit Basrur

Total Posts: 5,859
Re: ISO 14644 Cleanroom Validation - "Operational"

Typically the particulates monitoring is performed under "Operational" situation to challenge the operational integrity and not "at rest".
Thank You to Ajit Basrur for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 18th October 2013, 09:45 AM
somashekar's Avatar

Total Posts: 4,989
Re: ISO 14644 Cleanroom Validation - "Operational"

Your cleanroom class can quickly slip to next lower level by the sheer loading and personnel behavior. The design of cleanroom to a certain class considers operations that are planned to be performed in that room. It so makes sense that you know your operations are indeed happening in your planned environment. This comes form validation in operation condition.
Thank You to somashekar for your informative Post and/or Attachment!
  Post Number #4  
Old 18th October 2013, 09:54 AM

Total Posts: 3,659
Re: ISO 14644 Cleanroom Validation - "Operational"

I have regulatory responsibility for a US facility and a China facility...both claiming conformance to an appropriate level of ISO 14644, and both subject to US FDA regulation. (And also microbiological supervision by our NB.)

At both facilities, we do daily testing under operational conditions.

At both facilities, the respective third party certifier does certification testing under operational conditions, and so states in the certification.

I agree with Somashekar that operational testing should be fundamentally required by the OQ element of the validation process.
Thank You to MIREGMGR for your informative Post and/or Attachment!

Lower Navigation Bar
Go Back   The Elsmar Cove Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > Other Medical Device Related Standards

Do you find this discussion thread helpful and informational?


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
"Testing procedure: TMP", "WMT", "SMT" and "RMT" - IEC 60601-1 TRF nomenclature Jaydub IEC 60601 - Medical Electrical Equipment Safety Standards Series 3 13th June 2012 11:47 AM
What does "Operational Review" mean as tool - Effectiveness of Internal Control Risk selena15 Management Review Meetings and related Processes 3 12th November 2010 05:18 PM
"Value" and "Overhead(s)" of implementation of "CSV - Validation requirements" v9991 Qualification and Validation (including 21 CFR Part 11) 1 22nd November 2009 06:31 PM
ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification JkelleyCDS ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions 29 18th August 2008 11:14 PM
Building a new cleanroom - ISO 14644-3 or ISO 14644-4 ISO MAN ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 4 11th July 2003 12:58 PM

The time now is 07:25 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


Marc Timothy Smith -
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".