The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
Forum Username


Search the Elsmar Cove
Custom Search
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:

Howard's
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
bioburden, cleanrooms, environmental regulatory compliance, iso 13485 - medical device qms, requirements and specifications
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 24th April 2012, 06:59 PM
cranky cranky is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Sep 2008
 
Posts: 3
Thanks Given to Others: 3
Thanked 0 Times in 0 Posts
Karma Power: 25
Karma: 10
cranky has less than 100 Karma points so far.
Please Help! ISO 13485 Class 7 Cleanroom Requirements

Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help!

Sponsored Links
  #2  
Old 24th April 2012, 07:13 PM
Ronen E Ronen E is offline
Glad to help, if I can

 
Registration Date: Mar 2010
Location: Western Australia
 
Posts: 2,016
Thanks Given to Others: 1,760
Thanked 1,178 Times in 826 Posts
Karma Power: 239
Karma: 9730
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
Re: ISO class 7 requirements

Quote:
In Reply to Parent Post by cranky View Post

Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help!
Hello and welcome to the cove

Upgrading your entire cleanroom to class 7 can be challenging and maybe unnecessary. Have you considered creating a limited-space class 7 environment inside your existing class 8 environment (e.g. laminar flow cabinet etc.)?

Have you already consulted ISO 14644 in detail?

Apart from that, humidity and temperature should be dictated by the product/process needs, and maybe addressed as significant process parameters through your new process validation. Begin with a risk assessment to determine the extent and nature of validation required for the new environment.

Bioburden is a factor in the sterilisation process and should be addressed through sterilisation validation / revalidation / monitoring. If the product and process don't change (except the cleanroom class) then I'd say your current bioburden requirements would be a good baseline to start from.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
Sponsored Links

  #3  
Old 25th April 2012, 01:22 AM
somashekar's Avatar
somashekar somashekar is offline
Super Moderator

 
Registration Date: Mar 2008
Location: Bangalore city, INDIA
 
Posts: 4,515
Thanks Given to Others: 1,502
Thanked 2,350 Times in 1,652 Posts
Blog Entries: 2
Karma Power: 508
Karma: 15143
somashekar is appreciated, and has over 1700 Karma points.
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
Send a message via Yahoo to somashekar
Re: ISO 13485 Class 7 Cleanroom Requirements

Quote:
In Reply to Parent Post by cranky View Post

Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help!
ISO class refers to particulate size and count. Rest are work environment related that are directly controlled by the air using a condenser (for temperature) humidifier (for humidity). The CFM of the blower and the volume of your clean room determines the airflow change (number of airchange per hour). Bioburden is more contributed to the cleanroom air by the personnel and practice of working within the enclosed space.

__________________

Best Regards...
Somashekar BV, INDIA
Thanks to somashekar for your informative Post and/or Attachment!
  #4  
Old 25th April 2012, 01:34 PM
cranky cranky is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Sep 2008
 
Posts: 3
Thanks Given to Others: 3
Thanked 0 Times in 0 Posts
Karma Power: 25
Karma: 10
cranky has less than 100 Karma points so far.
Re: ISO 13485 Class 7 Cleanroom Requirements

Ronen, Somashekar

Thanks for your advice, this new customer already knows that we are classified as Class 8, however prior to begin to work with them they have requested to upgrade our clean room environment to class 7. They have not defined yet any other related requirements such as bioburden conditions, air flow changes, temperature and humidity, however in order to gain some time I'm doing some research for any other Class 7 requirements. By the way, devices to be assembled in the Class 7 room will be IV sets.

Forgot to ask, is there any special requirements for the dressing/gowning room for a class 7 room? Will it need to be upgraded also?

Regards.
  #5  
Old 25th April 2012, 02:26 PM
Ninja's Avatar
Ninja Ninja is offline
Looking for Reality

 
Registration Date: Oct 2010
Location: PA, USA
 
Posts: 469
Thanks Given to Others: 88
Thanked 361 Times in 207 Posts
Karma Power: 68
Karma: 3223
Ninja is appreciated, and has over 1700 Karma points.
Ninja is appreciated, and has over 1700 Karma points.Ninja is appreciated, and has over 1700 Karma points.Ninja is appreciated, and has over 1700 Karma points.
Re: ISO 13485 Class 7 Cleanroom Requirements

Howdy cranky,

The requirement is based on partcle count...not how you achieve it.
Some things to note:

- There are various requirements for different particle sizes. Many customers only care about 0.5um and up...but some care about the whole spread. Check out the requirements for 0.1um, 0.2um also...
- Gowning and dress is simply a tool, as are airflow, bioburden (love that term...I'm a Bioburden!...I always thought I was just plain human), # of inlets, location of returns, inlet & return balancing, local process particulate capture, etc.
Use the tools to achieve the particle count requirement...

Make sure to measure the particle count with people actively working in the room, otherwise you just have a meaningless number.

Note also that dress is a multifaceted tool...it can affect employee attitude and expected behavior as well. A minor point to be sure, but get the mileage where you can.

Note lastly that appearance affects not only your employees, but your customer's impression as well. Show me a dingy looking cleanroom with an acceptable particle count, I'll consider having it measured myself or shopping elsewhere.
While you are upgrading the cleanroom, keep your eyes open for the additional low hanging fruit .

__________________

Purpose...Plan...Progress...PEACHES! . . . "To me there is only one form of depravity - the man without a purpose." - Atlas Shrugged by Ayn Rand -
Thank You to Ninja for your informative Post and/or Attachment!
  #6  
Old 25th April 2012, 03:31 PM
cranky cranky is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Sep 2008
 
Posts: 3
Thanks Given to Others: 3
Thanked 0 Times in 0 Posts
Karma Power: 25
Karma: 10
cranky has less than 100 Karma points so far.
Re: ISO 13485 Class 7 Cleanroom Requirements

Thanks for your comments Ninja

Our current gowning/dressing room is environmentally controlled, while I do not perform any particle count nor bioburden (he he he) analysis we keep good practices while personnel stays there, good cleaning practices and a rational dressing procedures so the gowning/dressing room does not become a contamination source for the cleanroom.

I read somewhere else that the tighter the cleanroom class, the tighter the cleaning conditions for the gowning room, well from my point of view it could be logical. I just needed some basis and confirmation from your side regarding this.
  #7  
Old 3rd May 2012, 11:43 AM
Dirt Doctor Dirt Doctor is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: May 2012
Location: Dallas, TX
 
Posts: 1
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 10
Karma: 10
Dirt Doctor has less than 100 Karma points so far.
Re: ISO 13485 Class 7 Cleanroom Requirements

In general, I find that asking for increased cleanroom cleanliness class is what I would refer to as a "pseudo-requirement". That is, the focus should properly be on what cleanliness level that part or assembly has to meet and how, and NOT on the airborne particulate classification, which at best is an INDIRECT measure and therefore only partially relevant at best. However, almost everyone seems to fall into this trap....

Last edited by Marc; 3rd May 2012 at 12:59 PM. Reason: Remove "self promotion" link per section 3 of our ToS.
  #8  
Old 17th June 2013, 08:39 PM
Mel Kimsey's Avatar
Mel Kimsey Mel Kimsey is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Nov 2007
Location: Northern California, USA
 
Posts: 4
Thanks Given to Others: 1
Thanked 0 Times in 0 Posts
Karma Power: 28
Karma: 10
Mel Kimsey has less than 100 Karma points so far.
Re: ISO class 7 requirements

With cleanrooms in mind, do I need to run the hepa filter continuously, even when we're not using it? We have a 10x10 small cleanroom used for medical devices, but it can be 2-3 weeks between production runs when it's not used at all, and no one is in it. Does the filter need to run during that time, or once a week for a day or so? When it's not in use I turn it down low, but we clean it before we use it anyway, so why keep the filter running when no one is in it at all for an extended period?
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

Do you find this discussion thread helpful and informational?


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
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
IC ISO Cleanroom Classification - ISO Class 7 (10k), ISO Class 8 (100K), ISO Class 9 celon Other ISO and International Standards and European Regulations 17 16th October 2012 09:33 PM
Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom MEDQA ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 4 12th September 2008 03:00 PM
Medical Products - Cleanroom Requirements - Plastics injection molding - ISO 13485 edwardkwan ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 28th March 2006 02:47 AM
Are you operating a class 9 cleanroom? Share cleanroom monitoring results? cochranemurray ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 12th November 2005 11:30 AM
ISO 13485 - Cleanroom Operator Training Requirements cochranemurray ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 6 21st March 2005 10:44 AM



The time now is 01:39 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272