Seminar Report

Medical Plastics : Materials, Applications And Processing

For Medical Devices And Pharmaceuticals Industries

SUCCESSFUL INJECTION MOLDING FOR MEDICAL COMPONENTS

Lower the category higher the cleanliness requirement

For production of disposable Syringes, Petri-dishes, Infusion/ Transfusion devices

ISO 8 or ISO 7 are applied

ISO 4 to 6 is for contact lenses, saline infusion carriers, human implants, and micro electronic components.

Calls for high cost of clean room

Only Machine's Mold clamping unit is in the clean room

Entire Injection Molding machine is in the clean room

Clean air from the laminar flow box flows through the machine’s mould compartment, articles are transferred through clean air passage to the clean room assembly area

The option where the operating personnel work out side the clean room could be a good choice. This is so called "Grey room" concept 

It’s a good economical solution 

This is preferred as the operation, maintenance and servicing of machine is much easier

Process equipment

The molding equipment should not cause any alterations, even slightly on physical, chemical and mechanical features of the raw materials in use during the processing.

Oil leakage is a concern especially in clamp area

Requirements for Machine surfaces :

• Cleaning of the machines and equipments in the clean room is very important

• Deposition of films on surfaces provides breeding ground for bacteria

The factors influencing are....

• Humidity

• Rough/porous surfaces

• Electrostatic charges

To counter these, machine should have

• A smooth, close grain surface of machine body

• Surface must resistant to all cleaning agents

• Surfaces should not be charged electrostatically

It is preferred to have.....

• Non-lacquered, smooth SS covers 

• Smooth PVC hose jackets

Features of a good Injection Molding machine to meet medical components molding.....

• Closed-loop machine

• Machine with oil leak free hydraulic system

• Low noise pumps

• Adequate hydraulic and electronic controls with finer adjustment controls

• Energy efficient machine (perspective is not only cost saving!!)

• Machine with high up-time

Controls

• Machine with SPC for process monitoring function

• User identification by password protects against unauthorized access and ensures traceability of interventions

• Data logging for production documents

• Alarm history logging