A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
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Cover Story

Medical Device Sterilisation : Key Essentials, Options And Challenges

Dr. V K Tikku
Apar Industries Ltd.
Khatalwada,Taluka Umbergaon-96171. Gujarat

Electron Beam Sterilisation Of Medical Products

The process is environmentally friendly, exceptionally convenient and offers fast turn-around times.

Unlike the other alternatives, Electron Beam processing does not make use of any hazardous or radioactive materials.

Introduction

The sterilisation of Medical Products using Electron Beam Processing is one of the most effective methods available to the Medical Device manufacturing industry and is successfully used commercially for sterilising a wide variety of medical products. The process is environmentally friendly, exceptionally convenient and offers fast turn-around times.

Medical devices can be exposed to the beam after final packaging because the electrons have the ability to penetrate through the packaging to sterilise them. This allows the package to remain intact and guarantees that the product will remain sterile until required for use.

The Electron beam inactivates microorganisms either by causing microbial death as a direct effect of the destruction of a vital molecule or by an indirect chemical reaction, thereby rendering a product sterile. This is the same mechanism as in other methods of radiation sterilisation, and the dose required is the same. For many materials, Electron Beam processing results in less material degradation than with other methods of radiation sterilisation such as Gamma irradiation.

Currently, most disposable medical products are sterilised with EtO gas, or Gamma rays. Various difficulties with these methods have led to increased interest in Electron Beam sterilisation. Much of the interest has been fuelled by environmentally friendliness of Electron Beam processing when compared to these other methods. Unlike the other alternatives, Electron Beam processing does not make use of any hazardous or radioactive materials.

Facility And The Process

The facility includes an Electron Accelerator of energy 3.0 MeV with 100 Kw power, trolley conveyor and shielded room and has been installed by APAR INDUSTRIES LTD, Khatalwada , Taluka Umbergaon, Dist Valsad, Gujarat.

The product to be processed is placed on the Trays of the Trolley conveyor, and then treated as the trolley conveyor passes through the Electron Beam. The speed of the Trolley conveyor, Electron Beam parameters and the height of the beam from the product surface determines the dose delivered to the product. The flexible height of the beam from the trolley conveyor allows many configurations to suit various product types.

Conclusion

There are many considerations when sterilisation is the required outcome: product characteristics, packaging, density, volume and more. It is best to collaborate with sterilisation experts to ensure your unique product goal is achieved. We invite you to Contact Apar Industries Ltd. to learn more about Electron Beam sterilisation.

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