The Cove Business Standards Discussion Forums
EO Sterilization of Drugs in Custom Convenience Kits
UL - Underwriters Laboratories - Health Sciences
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
EO Sterilization of Drugs in Custom Convenience Kits
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

EO Sterilization of Drugs in Custom Convenience Kits


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
convenience kits (medical device), eto (ethylene oxide) sterilization, packaging (general), packaging labeling and related requirements, pharmaceuticals and pharmaceutical industry
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 20th September 2012, 04:45 PM
Victoria7

 
 
Total Posts: 7
Please Help! EO Sterilization of Drugs in Custom Convenience Kits

We are a Repackager/Relabeler and I have been ask to search for guidance on putting drugs in our custom packs. One of our sales reps has came across another kit packer who is placing plastic mutidose flip top vials in their kits, then EO sterilizing and I dont think this is acceptable practice. We normally request this information from our suppliers but I was hoping to find documentation somewhere quickly. Can anyone in the forum help me out?
Thanks,
Vicki

Sponsored Links
  Post Number #2  
Old 21st September 2012, 06:49 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,303
Re: EO Sterilization of Drugs in Custom Convenience Kits

A Quick Bump!

Can someone help Vicki?

Thank you very much!!
  Post Number #3  
Old 21st September 2012, 06:55 PM
Scott Catron's Avatar
Scott Catron

 
 
Total Posts: 674
Re: EO Sterilization of Drugs in Custom Convenience Kits

Quote:
In Reply to Parent Post by Victoria7 View Post

We are a Repackager/Relabeler and I have been ask to search for guidance on putting drugs in our custom packs. One of our sales reps has came across another kit packer who is placing plastic mutidose flip top vials in their kits, then EO sterilizing and I dont think this is acceptable practice. We normally request this information from our suppliers but I was hoping to find documentation somewhere quickly. Can anyone in the forum help me out?
Thanks,
Vicki
A little more detail would be helpful. We were producing topical antiseptics in sponge applicators that were being placed into kits that were shipped to Mexico for EO sterilization.

What is it about the process you describe that makes you think it's not acceptable?
  Post Number #4  
Old 24th September 2012, 08:53 AM
Victoria7

 
 
Total Posts: 7
Re: EO Sterilization of Drugs in Custom Convenience Kits

Thanks for the reply Steven. We currently will place sterile glass vials/ampules of Rx in our kits as the EO will not permeate the glass. If we have an Rx that is in a plastic vial or bottle we will piggyback it. The piggybacking process is when you place the sterile Rx in a separate bag that gets attached to the kit after it has been EO sterilized therefore the drug is never exposed. I have worked in the kit packing business for 4 years (previous was pharmaceuticals) and it has always been an understanding the EO will permeate plastic. I am not sure where this information comes from but that is what I have been told since working here. I have searched everywhere for data to support this but have had no luck. We depend on our suppliers through a questionnaire process to allow or not allow us to subject their components to EO.
  Post Number #5  
Old 24th September 2012, 01:37 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: EO Sterilization of Drugs in Custom Convenience Kits

A kit containing both a device and a drug is a combination product, and must be Listed as such (explicitly per the 2013 rules that apply beginning in a week) and coordinated through the Office of Combination Products.

My understanding is that in the case of a kit containing a drug, the CDER side of the clearance process will include a requirement that, if the external packaging has been exposed to EO, either a sufficient technical explanation (i.e. the drug's immediate packaging is of a type that has been shown to be impervious to EO penetration or other effect) or testing data must be provided to show that the drug has not been affected by the EO.

I think the Office of Combination Products would be the place to ask such questions. It's their job to be the information coordinator, and route questions to who will provide FDA's authoritative answer.

I would agree that packaging a drug in most plastics and then EO exposing would be highly undesirable.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #6  
Old 25th September 2012, 02:28 PM
Victoria7

 
 
Total Posts: 7
Re: EO Sterilization of Drugs in Custom Convenience Kits

Well have to admit I am embarrassed that this is the first I have heard of The Office of Combination Products. I am not sure that we fall in that catagory as it has never never been mentioned during a FDA or ISO Audit. Since our kits are convenience kits we do not hold 510K's. Thanks for the info. I am definatly checking it out.
  Post Number #7  
Old 25th September 2012, 02:53 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: EO Sterilization of Drugs in Custom Convenience Kits

http://www.fda.gov/AboutFDA/CentersO...ucm2018184.htm
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
In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Leo Gustaf Damien Other Medical Device Regulations World-Wide 1 11th July 2016 11:31 AM
UDI (Unique Device Identification) for Convenience Kits with several options maggyk Other US Medical Device Regulations 3 9th December 2014 12:25 PM
Convenience Kits - FDA Registration Responsibilities and Requirements AJayC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5 5th March 2014 10:27 PM
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs Gumaer Other Medical Device and Orthopedic Related Topics 2 12th July 2010 04:39 AM
What are Comfort and Convenience Items on a Design FMEA mickng FMEA and Control Plans 4 16th April 2010 01:01 PM



The time now is 09:08 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"
The Elsmar Cove web site and all content is owned by Rabbithash Corp. as of 1 MAY 2018.
Unlike Facebook and other properties such as Linkedin, We don't buy, sell, or "share" visitor information. Never have, Never will...
GDPR Compliant since 1996, keeping Marc's vision alive!