Validation Guidance - Plastic Injection Molding Process

QE

Quite Involved in Discussions
#1
Dear all Coves,

I am seeking guidance for the validation of Plastic Injection Molding Process and have searched cove in depth. I have the GHTF and WHO Validation Guidance. Can any one post a document which has details and steps that can lead me to a sucessful validation documentation of a Plastic Injection Molding Process please.

Can some one chime in ?

:thanx:
 
Last edited:
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somashekar

Staff member
Super Moderator
#2
Form a team of production, maintenance and quality primarily.
Study the moulding properties of the raw material that is to be used.
IQ
Set up the injection moulding machine with all service connections in good order.
Ensure all meters on the machine have valid calibration.
OQ
set the zone temperatures of the barrel (material TDS will give you the guidelines)
determine the shot weight and set same
set the injection pressure
ensure that the mold is in order by the tool maintenance and good for use
load mold on machine and set the mold clamping pressure
if the mold needs an MTC (mold temp controller) install same
fix the holding time after injection
try shots and fine tune parameters till you get the parts per requirement
PQ
fix the parameters and run several batches to ensure it works well over time
train people who handle the machine about the parameters and maintenance of tool and machine, about its calibration and record same.
(i am not an expert in plastics, but i have tried answering from my experience with suppliers).
I have a 5 MB .pdf <operator handbook for plastic injection moulding> and it cannot be attached here due to limitations of size. Tell me how I can send it to you as a guidance document in the validation.
 
P

PaulT

#3
I agree with the classical IQ, OQ and PQ approach. :yes:


One item that most Medical Device companies are looking for is how the operating ranges for the process are achieved. This Process Characterization involves hi /low process parameter determination using product measurement (usually critical to functions - CTF) These parameters are the input to the OQ. Somewhere in your documentation is it advisable to identify your important process parameters (It is also helpful to say why they are important.) Hope this helps!
 
H

henryzyh

#5
Thank You to seank for sharing this protocol. It's really useful for someone to learn how to generate the tooling validation. If you can share some templates of the records that you have showed the form number in your attachement, it will be give the great support to others to well learn this.

Thanks.:applause::thanks:
 
#6
Hi mates,

I just notice from this forum there is another guidelines from WHO instead of GHTF documents to develop validation process and documentation.

Shall we share this document as well here?

Tiff...:)
 
J

Juan Dude

#7
Hi mates,

I just notice from this forum there is another guidelines from WHO instead of GHTF documents to develop validation process and documentation.

Shall we share this document as well here?

Tiff...:)
Are you referring to the guidance document for aid vaccine manufacturers validation required by the World Health Organization (WHO)?
 

Roland Cooke

Quite Involved in Discussions
#8
Although I appreciated Somashekar's post, I am interested in talking offline with someone that absolutely is an expert in plastic molding validation and routine control. Does anyone here fit that bill, or have a good contact that would be willing to speak with me on this issue?

Kind Regards,
Roland
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
Form a team of production, maintenance and quality primarily.
Study the moulding properties of the raw material that is to be used.
IQ
Set up the injection moulding machine with all service connections in good order.
Ensure all meters on the machine have valid calibration.
OQ
set the zone temperatures of the barrel (material TDS will give you the guidelines)
determine the shot weight and set same
set the injection pressure
ensure that the mold is in order by the tool maintenance and good for use
load mold on machine and set the mold clamping pressure
if the mold needs an MTC (mold temp controller) install same
fix the holding time after injection
try shots and fine tune parameters till you get the parts per requirement
PQ
fix the parameters and run several batches to ensure it works well over time
train people who handle the machine about the parameters and maintenance of tool and machine, about its calibration and record same.
(i am not an expert in plastics, but i have tried answering from my experience with suppliers).
I have a 5 MB .pdf <operator handbook for plastic injection moulding> and it cannot be attached here due to limitations of size. Tell me how I can send it to you as a guidance document in the validation.
This is what I had done in the past as a QE in injection molding, injection blow molding, extrusion blow molding, and stretch blow molding.

I got the protocol I used back then from Procter & Gamble training and it suited all of our food, cosmetic, and drug customers for qualifying new tooling.
Some customers didn't require several runs for the PQ... it was a single long run - 8 hours with samples taken every hour from each cavity, for example. The reason for that was that they needed the parts in full production and were not willing to wait for several production runs to close the qualification.

We measured all critical dimension of the part as part of the OQ and the PQ.
Also as part of the PQ, capability was caluculated by dimension.
 

BradM

Staff member
Admin
#10
Denice,
I wish you luck. I've requested on multiple occassions to have Somashekar provide this information to the forum or personally and have not received a response.

Dan
With due respect, Dan, I am personally very grateful to Somashekar for all the valuable contributions to this forum. :agree1:

There are complex reasons why someone may not want to post an attachment. There may be confidential stuff in it, there may be a copyright issue, or on a more fundamental level, they simply may choose to do otherwise.

Having said all that, I'm not sure what document you are looking for anyway. What Someshekar has already provided can provide a framework for you to write your oven validation protocol.

It is ill-advised to blanket copy validation documents. They need to be written for the specific application, the specific installation, and needs to address the functional requirements of the process, as identified by management.

So... you should look towards qualifying the injection molding machine, and validating the process using the machine.

I hope that helps.
 
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