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Catheter Conveyor for Abbot

1. We build the mold first, then produce the part and assembly in class 8 clean room.
2. 23 plastic parts in total, we can outsource for the metal component and inspect to make sure they are in specification.
3. There are some gears mold, overmold, each part has to be assembled with the other components, so the dimension must be controlled very well.

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Product Introduction

Product Description

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Description	Catheter Conveyor
Part Qty.	23 plastic parts
Resin	PC-ABS, POM, PC, TPU, LDPE, TPE, PC+20%GF
Application	Treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD).

Successful Experience

34 years focusing in plastic injection molds

Supera® Stent to Treat People with Peripheral Artery Disease：

1. Treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12 to 20 percent of Americans age 65 or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.

2. There are many gears inside, they have very important transmission function, so the manufacture precision is critical.

Class 8 Clean Room

Promise the quality

Quality Control

Operational process validation that IQ, OQ, PQ for the medical device, which to ensure the stabilized quality in mass production.

Validation overview	IQ	1)Verification of the qualification of the Operator, Injection machine, Measurement equipment, Resin material, Mould(Tools) and Production environment 2) Define which mould will be verified on a specific injection machine 3) Verify Utilities and Environment prior to OQ/PQ testing
	OQ	1) Define acceptance criteria for Operation Qualification 2) Test the lower, upper injection parameter according to Standard trial mould procedure and history experience 3) Run the upper and lower limit for at least 4 hours, measurement of the CTQ dimension and appearance inspection (attributes) 4) If the inspection result is out of spec, investigate and establish a corrective action, re-run the process batches using the lower and upper limit parameter again 5) Setting the nominal parameter according to the result of successful run upper and lower parameter, and Scientific trial mould procedure in T1, T2;
	PQ	1) Define the acceptance criteria of PQ 2) Run three batch (four hours each) at the nominal setting 3) Measure and verify the CTQ dimension and study the CPK for three batches 4) Inspect the appearance of the product in three batches