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:

Does anyone have some suggestions for Nirlep?

One more bump, just in case someone can help with this.

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.

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!

I came across this document, and am doing a similar validation of an Injection Moulding Process. It has helped me invaluably, hopefully it can help you too......:D

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:

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...:)

yes please !

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...:)

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)?

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.


Hello,
Can you please send this file to me? I am not well versed in molding operations and will be auditing a factory and could use your guidance. You can use yousendit to foward me the file. I look forward to hearing from you.

yousendit.com


Best regards,

Dan