Seminar Report

Medical Plastics : Materials, Applications And Processing

For Medical Devices And Pharmaceuticals Industries

SUCCESSFUL INJECTION MOLDING FOR MEDICAL COMPONENTS

Mr. Jignesh C. Bavishi

Sr. Manager, Technology
Ferromatik Milacron India Ltd., Ahmedabad

Introduction

Application of medical plastics is divided in two main product area.....

1. Relatively "simple" components Like Syringes, Pipettes, Petri-dishes etc.

• Specification / production environment subject to very high demand

• Syringes and pipettes calls for high quality as faras roundness & aperture cross sections are concerned

• In case of Petri-dish the dimensional accuracy is in the focus

2. Medical products / systems Like inhalers/ insulin pens etc.

• Products are combination of complex individual components

• Meant for specific function like storage and metering etc.

• Mechanical plastic parts have decisive importance

From the production/molding point of view both the areas can be treated in the same way

Articles must be molded with maximum accuracy and with the best possible reproducibility

Success of Infection molding means.....

• High quality of molded components meeting stringent norms for medical application

• High rate of components production.....pieces/hr.

• High up-time of machine

• Low energy consumption

High Quality goals.......

• Components completely clean, disinfected and free from any contamination

• Processing defects free moding,

Can be achieved........

• GMP... Good Manufacturing Practices or Processes

Clean Room for molding

Purpose.....

To enable the production steps under conditions, which exclude a harmful influence of contamination, found free in the normal surroundings

Who is a clean room?

• Closed room having clean air with specified level of particle concentration

Special guidelines for clean room technology......

• Room execution

• Process equipment

• Personnel

• Consumables

• Procedures

From where does the contamination come?

Clean room contamination	Source
60-70 %	Human origin
20-25 %	Equipments & Machineries (motor, blower/fans, fluid particles like hydraulic oil etc.)
15 %	Transportation system, packaging boxes etc.

Technical requirement for clean room

American & European standard combined

ISO 14644 with categories from ISO 1 to 9

Example ISO 7 (class 10,000 DIN 2083)