Environmental Control for Storage of Medical Device Packaging Material

P

pangchiaboon

#1
Dear Sirs, what is the environmental control that we should have at packaging material warehouse for medical devices, for example pouch, lid, tray for sterile packaging? We are in Malaysia which is high humidity and temperature contry, how significant is their effect to these packaging materials?

Thank you.
 
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G

George Weiss

#2
Your customer's have requirements, as the product , and product's location develop.
A good plan would be to:
1. Ask your customer(s), (The end-products will have storage guidelines, FDA or other).
2. Do some self process analysis.
.
FDA Basics @
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
21 CFR 820.150 @
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.150
Your product(s) will develop into an end product(s), which should have a storage statement,
Example would be an IN VITRO Diagnostic Product, 21 CFR 809.10 @
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081366.pdf
 
M

MIREGMGR

#3
Obviously higher temperature and higher RH is friendlier to microbiological contamination...but you are going to sterilize. Certainly you do need to protect materials from contamination to such an extent that it's visually distressed, or physically deteriorated, or has toxic properties. But "controlled" doesn't have to mean 25C and 40%RH.

You're required to conduct all operations that potentially affect the quality of sterile-when-marketed devices in a "controlled" environment. Logically that includes storage of sterile-barrier-packaging materials prior to use. You're also required to validate your processes based on the typical-worst-case environmental conditions applicable to them...and you know that worst case from your controls.

So, if you can validate your sterile-barrier-packaging and sterility processes with materials that have been stored in whatever controlled-but-practical conditions you cause to exist at your location, and if those conditions don't cause other problems that sterilization doesn't remediate, you're good to go.
 

Ajit Basrur

Staff member
Admin
#4
In addition you should maintain the "integrity" for all materials ie. the packaging materials should be prevented from external dirt and foreign material.
 
R

Rolande Hall

#5
Dear Sirs, what is the environmental control that we should have at packaging material warehouse for medical devices, for example pouch, lid, tray for sterile packaging? We are in Malaysia which is high humidity and temperature contry, how significant is their effect to these packaging materials?

Thank you.
It is worth noting that some heat seal coatings used on Tyvek lids are adversely effected by storage at "elevated" temperatures. I have had instances where satisfactory heat sealing was not possible after accidental storage at circa 40 celsius for a few weeks.
Good luck with your project.
 
P

pangchiaboon

#6
It is worth noting that some heat seal coatings used on Tyvek lids are adversely effected by storage at "elevated" temperatures. I have had instances where satisfactory heat sealing was not possible after accidental storage at circa 40 celsius for a few weeks.
Good luck with your project.
Thank you Sir.
Is there any technical information / article available from Tyvek supplier or any from the market / internet?
 
A

arios

#7
In addition you should maintain the "integrity" for all materials ie. the packaging materials should be prevented from external dirt and foreign material.
Adding to Ajit's great comment, also please consider the prevention of mix-ups, particularly with printed materials, such as labels, IFU's, preprinted lids, etc... You could achive this by maintaining orderly areas, good identification and inventory control.
 
M

MIREGMGR

#8
Is there any technical information / article available from Tyvek supplier or any from the market / internet?
In regard to the particular materials you use, rather than relying on information obtained here, you should contact your supplier for specifically valid data.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
Hi there Pangciaboon

As has been pointed out the best thing to do is contact your supppliers.

With that in mind: my company prints labels, lidding, and flexible packaging for drug and device companies in the US.
We recommend 70 degrees F at 50% relative humidity for flexible packaging and lidding as well as pressure sensitive labels.
For Thermoplastic Labels we are similar, but with small range: 56-70 deg F, 45%-50% RH.

This is all based on data from our suppliers.

hope that helps some.
 
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