ISO 13485 for customer injection molding

H

Heather Vallie

#1
My company is a custom injection molder who customer owns all of the molds, design control, and control which suppliers we use. One of our customers has required us to be ISO 13485. How would be hand risk assessment, shelf life, and lifetime since we have no control over shelf life and lifetime of the device.

Heather
 
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chris1price

Trusted Information Resource
#2
Hi

Product risk assessment and shelf-life should be determined by your customer. Document their shelf life determination as part of the quality agreement so that document retention times can be established.

You should still perform risk assessments and validation of your moulding processes.

Chris
 
H

Heather Vallie

#3
Thank you very much:D. For the Food industry we have a HACCP plan already inplace and used the HACCP plan for all products molded at HQC and hope that it will be acceptable as risk assessment.
 
M

MIREGMGR

#4
13485 of course pertains to medical device manufacturing, which presumably is what the customer in question does.

Presumably your products are not medical devices when you ship them, and become medical devices at your customers' facilties.

If those assumptions are true, you will have only limited responsibility for medical device issues like risk management, mostly extending only to those processes you perform that are required to be validated.

You may however have to participate in your customers' regulatory activities so that they can adequately fulfill their responsibilities to control your production activities on their behalf.
 
H

Heather Vallie

#5
Currently we have 6 molds for this customer 4 of the molds we mold the parts and ship the parts to the customer to package. Two of the molds we put the parts into a assembly machine and send to the customer to packaging. None of the parts we manufacture are for a medical device they are containers for infints and they are use in hospitals. This customer also sells product in Europe and that is the main drive to have my company 13485.

I have updated our HACCP plan to put the medical and the assembly and view any risk on the molding and assembly.:thanks:
 
R

Roland Cooke

#6
There are several threads on this, worth looking around. Your company should do an analysis of its operations and determine where risks can be introduced across all of product realization, and describe what measures you have taken to reduce those risks.

Supplier control (resin purity), equipment control (mold process validation), customer interface (control of customer-initiated change). Those are things that can introduce risks into the system, and which you have direct control over.

Customer knowledge can be a factor her. For medical products, it's a big no-no to use mold release agents, a molding company with no experience in medical devices might not know that.
A risk-based assessment of your process should look at that kind of thing.
 
H

Heather Vallie

#7
Thank you for your help. I will be letting senior management know about the information you gave me. 95% of our business the customer tells us including the medical part of the business what suppliers we should use. Also I had no idea about mold release we have been able to use it for the food industry and assumed it was acceptable for medical.

Heather:thanks:
 
R

Roland Cooke

#8
Well I got that info from several molders that seemed to know what they were talking about, feel free to update us either way!
 
M

MIREGMGR

#9
Three comments on mold releases:

1. Your part-customer may have a subsequent bonding or coating process in mind. Obviously your mold release could affect that subsequent process. This of course is no different from making parts for any other industry.

2. Your customer may intend a part application for which some degree of biocompatibility is required. In that context, if a mold release is used, it will have to meet the same biocompatibility standards as the resin.

Note that "food contact grade" and "USP" are commonly but incorrectly believed to be indicative of medical device safety. Those two rating systems, for food packaging/manufacturing and pharmaceutical packaging/manufacturing respectively, are legally unacceptable and technically inadequate for medical devices. ISO 10993 is the only applicable standard for medical device biocompatibility.

The alternative to biocompatibility for a mold release material is its removal from the part...but in many applications, the completeness of removal will have to be proven by testing, either by biocompatibility testings of the "cleaned" surface or by high-resolution molecular proof of removal completeness.

3. Your customer may intend a part application for which it is fundamentally necessary to the finished device's safety and effectiveness that it not leach/shed/transfer anything into the contacting tissue or fluid. Many types of mold release are inherently designed to be weakly molecularly bonded to themselves. If they are present at all, it is very difficult to prove that they will not leach/shed/transfer.
 
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