Injection moulding for the medical device industry

look get what you think is a good part OK . now change you mold heats by 10% and run for 8 hrs and take sample ever 20 mins. and measure them. are parts good or bad.. then take pack psi or hold psi up 10% are parts good or bad and do the same with barrel temp. this should give you a range of where your process should be.so you need to make your process stable or so you can repeat it ever time with out any bad parts. that's all.. it is real simple man..

Rendy mold on folks

The process of injection molding must consistently create products that adhere to high quality standards. The performance of parts produced must meet customer specifications.IQ, OQ and PQ play critical roles in the injection molding process validation procedure.Process validation and utilizing IQ,OQ and PQ is part of the incorporated requirements of Crescent Industries quality management system for injection molding

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There are thousands of plastic injection molding companies, that are also FDA registered for the manufacture of medical devices and plastic injection molded components.

Legal Herb

Hi Bill,
I found your post and was wondering if you have any IQ/OQ/PQ protocol examples/forms/templates for running a scientific injection molding validation study that you can share with me. We are a medical device startup company and would like to start with a template and customize it for our operation.
Thank you in advance.
Best regards,
Sudeep
(sudeep@medtoolsinc.com)

Hello all,
I understand this post is pretty old, but I am looking for IQ/OQ/PQ protocol samples for injection molding. Can anyone share with me examples/templates/protocols to run a scientific injection molding validation process (sudeep@medtoolsinc.com)?
Thanks in advance.
Regards

We’ve always been sticking with you around the net all the working week, either that or we have now identical choices since I am been reading many of the incredibly same content. Best wishes!

i did medical devices for 8 years nothing to it get your process set and repeated it and your good you will need a good press to do it i like the Nessie work well. and clean. big thing with medical is your work instruction here in the USA FDA likes to make sure you follow what you say your doing, and prove it.

Mold on!!

Rendy

Making medical devices (FDA approved) is as complex or as simple as you want it to be. Remember: YOU write the procedures - the FDA's only real skill is to see if you are following them.

What the FDA is interested in is that the product you produced and approved, will be consistent.

The big mistake many of my clients make is Over Specifying: They start with the three basic questions:
1. Is the process documented?
2. Are the people trained?
3. Are the trained people (step 2) following the documented process (step 1)?

What follows is a tsunami of documents, vids, pictures, etc. Think about a procedure to put on a long sleeve shirt: It might start with "put your arm fully in one sleeve. Pull the shirt around your back and put your other arm into the other sleeve". That's good enough. But which arm is first? Actually it doesn't matter. If you specify the left arm first and then the right arm and the person doing it puts his right arm in first - you flunked the audit because you didn't follow YOUR OWN procedure!

Train your people - in Molding, certifying the people who are responsible can do de-coupled molding and know how to show the plastic the same thing in any press (and if questioned can document it) is sufficient. Give your people FORMAL TRAINING. Get Diplomas, don't tolerate deviations from the trained procedure.

QA/QC and your documentation should be pointed towards assuring the process is consistent within established limits. NOT whether the part is 'to spec'. Being 'to spec' should have already been established. making acceptable (FDA compliant) parts should only be an exercise in assuring minimal deviation from what was initially established as a good process.

I had a client once that specified a non-functional cap as being 'blue'. QA/QC pitched a snit because the blue concentrate was actually the regrind from a deep blue part mixed into virgin material. Naturally the degree of 'blue' (color intensity) changed. It was quite a fight to convince the inspectors that 'Blue' in all it's variations was acceptable as opposed to 'red'. They had re-interpreted (and spec'd) Blue to actually being a color match. It was an ugly fight to undo the documentation.

As I've previously posted, I have a book that will force you through a series of experiments that will give you the conditions that will consistently produce the same part. I also teach/demonstrate this technique.

It isn't complex, you can do it yourself. Molding is like a dance. Learn the steps, start the music and dance away. It's beautiful. If someone either can't follow the music or doesn't know the steps; it's a mess.

Contact me with questions

Bill Tobin
bill4012@hotmail.com
303 604 9592

Kuyakut,

I would also appreciate it if you could you share some templates and examples for the IQ/OQ/PQ for molding process of molding medical devices.

My email address is bill@magormold.com

Thanks in advance for your help.

Bill Baskind
Process Engineer
Magor Mold

Hi kuyakut,

Could you share some templates and examples for the IQ/OQ/PQ for molding process of molding medical devices.

My email address is henryzyh08@gmail.com

your helps is vey appreciated.

Thanks,
Henry

Hi Cris,

If still need some info regarding IQ, OQ and PQ. Maybe I can help you out in some way. Im also in molding medical devices. Been doing this qualification for quite some time.

Oh, Scottish! I had a Scottish Grandfather. I worked in a place that had a Scottish maintenance man. One Saturday, I asked him to sit down for a "cuppa" in the cafeteria. We talked for about a half hour and I understood about three words of what he said.

Yes, buy my mentor's books, they will help answer your questions. You can do the conversions to metric. They are written in " American" English, but easily understood by all, even though he doesn't use a U in mold.

Do you know a Molder known as "Scottish Jim"? He is President of the Scottish Branch of the IAIM. He wears kilts on festive occasions and eats haggis.

Tell us something about molding (moulding) in Scotland, and we will make you a member of IAIM.

brent

Shameless marketing. Sorry.
Purchase QUALIFICATIONS STARTUPS AND TRYOUTS the e-version is inexpensive and downloadable. The techniques described will get you through your alphabet soup. The site is below. I don't know of any other publication that you can 'plug into' your program

Bill
wjtassociates.com

WEIRD! this thing came up twice.

Hi Brent,

Yes i am Scottish,

IQ - Installation Qualification,
OQ - Operational Qualification,
PQ - Performance Qualification,

I am not ex government i have been in the plastics industry for the part 18 years.

Do you need this PDQ or ASAP? How about SOP, do you want to see some of mine? What QS are you referring to? Since you spell molding with a U, you must be a Canadian, Aussie,Kiwi, Brit Irishman, Scot,European, Asian or some other furner where they don't spell right like we do in the USA. Do you also use that durn metric system?

We have our own acronyms so we can purposely perplex people not part of our peculiar profession.
Please define IQ (mine might be low) and PQ, for that matter OQ for the uninitiated. Are you perhaps a professional in QC or QA, or an ex government worker?

brent
President and Founder of IAIM

Sure, if you want to e-mail me at makayelab@aol.com and tell me specifically what information your looking for I would be more than happy to help you out.