The Cove Business Standards Discussion Forums
Establishing alert and action limits for clean room bioburden
UL - Underwriters Laboratories - Health Sciences
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Establishing alert and action limits for clean room bioburden
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Establishing alert and action limits for clean room bioburden - Page 2


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
bioburden, cleanrooms
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 13th March 2009, 12:56 PM
carlosandrosie

 
 
Total Posts: 4
Re: Establishing alert and action limits for clean room bioburden

Gentlemen, thanks a lot for your repsonses to this thread. They are very much appreciated.

Sponsored Links
  Post Number #10  
Old 6th July 2018, 10:35 AM
htcoztrk

 
 
Total Posts: 11
Re: Establishing alert and action limits for clean room bioburden

Quote:
In Reply to Parent Post by Ajit Basrur View Post

Hi carlosandrosie,

In one of my previous organizations, we had set an alert of 50 cfu and action of 70 cfu against a final rejection of the product over 100 cfu.
Hello,
I'm little bir confused about the action limit. So you determined your maximum bioburden limit as 100 cfu/ product but why did you set the action limit as 70 cfu/ product? Should the action to be taken before the value exceed the maximum limit?
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

Bookmarks



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
Emoticons 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
Bioburden testing for Class 10000 (Grade C) clean room mpfizer ISO 13485:2016 - Medical Device Quality Management Systems 1 14th January 2015 07:09 PM
How do I set a limits to cfu in an ISO class 7 Clean Room? Lokus200 ISO 13485:2016 - Medical Device Quality Management Systems 2 4th December 2014 09:10 AM
Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. iaqgal 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 10th March 2012 01:35 AM
Clean Room - Standards or some type of Clean Room Validation - ISO 13485 azaplas ISO 13485:2016 - Medical Device Quality Management Systems 17 15th December 2010 11:53 AM
Monitoring bioburden on clean room gloves LauraGchem Other Medical Device and Orthopedic Related Topics 1 21st June 2009 11:50 PM



The time now is 07:01 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"