Bioburden and Product Labels - VD Max studies on all the BOMs

D

Denis

#1
Would appreciate any advice on this subject please - although the product is not a medical device, it is labelled sterile and is sterile filled.

The raw materials (bill of materials issue) is pre irradiated by gamma irradiation , and then assembled and filled (typically a biocide).

I am trying to perform VD Max studies on all the BOM,s to prove that the raw materials prior to entry into a Class 2 clean room ; are sterile (10 -6).

The bioburden on the labels is too high to enable an effective VD Max study.

Has anyone any advice or commentary to assist with me getting labels that will pass the VD Max study?

The labels are stored on a cardboard spool and are typically a laminate type.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Can anyone help out with this one? It's way out of my field.
 
M

MIREGMGR

#3
I am trying to perform VD Max studies on all the BOM,s to prove that the raw materials prior to entry into a Class 2 clean room ; are sterile (10 -6).

The bioburden on the labels is too high to enable an effective VD Max study.

Has anyone any advice or commentary to assist with me getting labels that will pass the VD Max study?

The labels are stored on a cardboard spool and are typically a laminate type.
As you already are aware, the cardboard spool isn't working in your favor, and suggests that the labels are coming from a maker that doesn't understand your needs and provide a suitable product.

Google searches on "low particulate labels" and "cleanroom labels" come up with several makers of low-particulate, cleanroom-suitable label systems. My guess is that one of these outfits would have a ready-made solution to the particulars of your situation.
 
O

Outsider

#4
Since the raw materials are irradiated prior movement into the class 2 assembly, can you also irradiate the cardboard/ paper spools before transfer?

I have irradiated SBS trays to lower the bioburden in other device applications.
Outsider
 
D

Denis

#5
The labels come in from the supplier wound on the cardboard spools.

I've been in touch with our current label supplier to explain the situation to them.
They have been very helpful , but don't quite grasp the understanding of bioburden, and the potential effect it is having in trying to prove that the labels are sterile (after 25kGy gamma irradiation).

They have sent me some samples wound on a plastic spool that I'll be having a look at soon.
 
M

MIREGMGR

#6
The label manufacturer is an inappropriate choice for a process to be conducted in an environmentally controlled area, if their production isn't itself conducted in an environmentally controlled area.
 
D

Denis

#7
I agree.

I seem to have discovered through this process that the label manufacturer may not be suitable.

Its a pretty widespread problem, most suppliers are unaware of our product requirements (its a historical problem).

But I'm trying to find some resolution to the issue - maybe a change in the label specification is required / maybe a change of supplier.
 
D

Denis

#8
By way of an update - and seeking a bit more advice.

The label supplier sent us some samples for bioburden assessment.

These labels have been tested, but the bioburden is still far too high to enable a successful VD Max testing.

How do others manage to apply labels to products in a sterile environment?
 
B

brandomenon

#9
Have you done testing on the labels to determine the upper limit of what they can handle for irradiation before there are negative effects on the product?

Too much and the colours can fade or they can even lose adhesive abilities. But if the product can handle a large dose, you have the possibility of dosing in multiple events. This allows you to send labels for irradiation, then perform VD Max study and have a second irradiation event to assure sterility of the labels.

This needs controlled conditions from the time the first irradiation happens so that you are not introducing more bioburden.

Another option would be to consider a second sterilizing method like steam or dry heat or ethylene oxide first, then run the VD Max study (and having irradiation as the second sterilization step in routine manufacturing) all depending on how the product holds up.
 
D

Denis

#10
Thanks brandomenon

You've raised some good points, we have in the past "over" irradiated the labels in error, and the artwork is effected - and the material becomes quite brittle which is obviously something that we can't accept.

I hadn't thought of trying using other sterilizing methods, and this is something that I will look into.

The current supplier doesn't have to firm a grasp on what our requirements are, and I will work with them to ensure that they understand - but it may mean a change of supplier.
 
Thread starter Similar threads Forum Replies Date
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
R Simulated product for bioburden testing Other ISO and International Standards and European Regulations 2
O Bioburden Testing - Non Sterile Product / Tapes - ISO 11737-1 Other ISO and International Standards and European Regulations 9
H Determining a New Product Bioburden Limit ISO 13485:2016 - Medical Device Quality Management Systems 11
M Bioburden Frequency (sterile MD) Other Medical Device Related Standards 2
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
F Bioburden Testing requirements for Non-Sterile Dental Products EU Medical Device Regulations 6
V Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices Other Medical Device Regulations World-Wide 7
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
M Bioburden numbers and ECA gloves 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Bioburden testing for Class 10000 (Grade C) clean room ISO 13485:2016 - Medical Device Quality Management Systems 1
P Serial Testing of Bioburden for Medical Devices Other Medical Device Related Standards 2
M Biological Monitoring Program Environmental Bioburden Test Method Needed ISO 13485:2016 - Medical Device Quality Management Systems 1
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
P Frequency of Bioburden Testing EU Medical Device Regulations 3
B BioBurden and EndoToxin Questions Other Medical Device Related Standards 6
M Sterility Testing vs Bioburden Testing - Differences Qualification and Validation (including 21 CFR Part 11) 7
S Bioburden Monitoring Sample Size Increase ISO 13485:2016 - Medical Device Quality Management Systems 4
I Bioburden and Endotoxin (LAL) Testing proposal help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Bioburden Monitoring - 'Off the Shelf' Bioburden/Microbiological Monitoring Software ISO 13485:2016 - Medical Device Quality Management Systems 4
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
0 Guideline/Method for Raw Material Roll Stock Bioburden Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q Bioburden Requirements on Device used on Unbroken Skin Other Medical Device and Orthopedic Related Topics 4
A Microbial Limit (Bioburden)on dry nonwoven that used for making Hand sanitizing wipes ISO 13485:2016 - Medical Device Quality Management Systems 1
L Validation of transfer materials - Bioburden of items from lab into cleanroom Other Medical Device and Orthopedic Related Topics 2
L Monitoring bioburden on clean room gloves Other Medical Device and Orthopedic Related Topics 1
M Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
C ISO 11737 - Bioburden testing for non-sterile products Other ISO and International Standards and European Regulations 10
E Bioburden tests duration and Monitoring of gloves ISO 13485:2016 - Medical Device Quality Management Systems 6
S What is a reasonable Bioburden limit? ISO 13485:2016 - Medical Device Quality Management Systems 13
I Microbiological Testing - Bioburden and Identification of Micro-Organisms ISO 13485:2016 - Medical Device Quality Management Systems 2
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 1
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 3
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom