Our 22nd Year of Publication
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Cover Story

Medical Device Sterilisation : Key Essentials, Options And Challenges

Mr. Amit Shrivastava - Facility-Incharge
ISOMED, Board Of Radiation And Isotope Technology
Department Of Atomic Energy, Government Of India

Gamma Radiation Sterilisation: The Indomitable Workhorse For Terminal Sterilisation Of Medical Products

  • This article deals with the packaging requirements for the radiation sterilisation, the product range, limitations of the technology and the future prospects..

  • In India, market share of ETO and Gamma sterilisation is 80 and 15 percentage approximately whereas sterilisation by Autoclaving is limited to 5 percentages.

The cornerstone for demonstration of techno economic viability of the technology of Gamma Radiation Sterilisation in the country was laid nearly four decades ago on January 1, 1974 by commissioning of the ISOMED (Irradiation Sterilisation of Medical Products) facility by the Department of Atomic Energy, Government of India. During the course of over four decades of marathon service to the healthcare industry, the facility has established a niche of it and is popularly recognized as a centre of excellence in the field of radiation sterilisation in the Asia Pacific region. Since its inception, the facility hitherto has processed an astronomical volume admeasuring 0.2 Million Cubic Meters approx of medical products.

The reservoir of technical expertise cherished by the facility that supplemented by the exemplary legacy of customer oriented services to the facility users has ushered into emergence of similar myriad facilities in the private sector from the year 2005 onwards. The growing level of awareness about the radiation sterilisation in the health care industry justifies without an iota of doubt, the mission behind setting up of the ISOMED.

As far as relative apportionment of various industrial methods of sterilisation is concerned, market share of ETO, Gamma and Electron Beam on international scale is approximately 60, 30 and 2 percentage respectively. However in India, market share of ETO and Gamma sterilisation is 80 and 15 percentage approximately whereas sterilisation by Autoclaving is limited to 5 percentages.

Recent studies in the country have indicated that sterilisation techniques such as ETO and autoclaving bear the higher risks with respect to morbidity and mortality in the hospitals due to infection. It is a pressing need to resort to only gamma radiation as far as sterilisation of the gauge, cotton and linen is concerned particularly under Indian circumstances. Accordingly Board of Radiation and Isotope Technology, a constituent industrial unit of Department of Atomic Energy has taken up an initiative, to address the burgeoning issue of morbidity and mortality in the hospitals in India. The work regarding conceptual design of compact gamma irradiators based on Co-60 radioisotope for Central Sterile Supply Departments (CSSDs) of hospitals (100 beds capacity or more) had been taken up early 2012 and currently a prototype 1:2 scaled down model (fully functional) is available with BRIT.

The following paragraphs while highlighting the decade wise performance of the ISOMED facility would attempt to reflect upon the genesis of the technology of radiation sterilisation in the country from a TLC (Technology Life Cycle) perspective.

Decade I (1974-1984): The Era Of Technology Introduction

The core focus during the decade was on sensitizing the health care industry about this relatively novel technology. The prime stake holders of the facility were consulted on several aspects of the radiation sterilisation including the technology knowhow, material compatibility issues, and the validation of radiation sterilisation process. For dissemination of the technology, many technical workshops, with the collaboration of IAEA (International Atomic Energy Agency) were successfully conducted. The CSSDs (Centralized Sterile Services Departments) of the various hospitals across Mumbai were offered novel door to door sterilisation services. The in-house production of the radiation sterilised maternity kits was also undertaken. The radiation dosimetry mainly resorted to the Perspex dosimeters using the spectrophotometric measurement method. The statutory licenses from the Maharashtra state drug control department were obtained for the radiation sterilisation of the products as described in the Drug and Cosmetics Act 1940 and rules there under. The facility had been successful to a larger extent in sensitizing the health care industry till end of this decade.

Decade II (1984-1994): The Era Of Technology Ascent

The decade had been bubbling with the activities primarily concerned with the development of radiation stable polymeric configurations in technical collaboration with BARC , to be used as Single Use Disposable Medical Devices in the state of the art Research and Development labs (Polymer Testing/ Microbiology Lab). It was during this decade major healthcare establishments in the country viz. M/S Johnson and Johnson Ltd., M/S Glaxco Smithkline, M/S Hindustan Unilever Limited , M/S
Hindustan Latex Limited ( now known as HLL Life Care Limited ) etc. included ISOMED facility in their critical supply chain as a contract gamma radiation service provider for terminal sterilisation of their products. The technology was being well accepted by the industry and the facility depicted encouraging performance on the commercial front.

A paradigm shift in the dose measurement system occurred in form of the chemical dosimetry (Cerric Cerrous – Potentiometric Dose Measurement System). By the end of this decade, the facility had acquired a reasonable clientele.

Decade III (1994-2004): The Era Of Technology Ascent (Contd.)

The production and supply of the chemical dosimeters received an impetus. The radiation sterilisation process validation was standardised and the facility had gained a substantial expertise in this crucial aspect of radiation sterilisation technology. The successful operation of newly commissioned facilities by other governmental / non governmental agencies heralded the news of technology making its vital presence amongst the stakeholders from the healthcare industry. R&D trials for the indigenous
development of the qualitative indicators of radiation processing were also undertaken. The facility had been availing itself of the International Dose Assurance Services (IDAS) – IAEA for the quality accreditation of its indigenously produced chemical dosimeters. By end of this decade the facility had depicted a spiral growth both in terms of quantum of the product processed as well as the revenue earned. The technology had also entered into the early phase of its maturity.

Decade IV (2004-2014): The Era With Early Phase Of The Technology Maturity

The era began with a sudden spurt in number of radiation processing facilities in the private sector thus widening the market share of this technology for the healthcare sector. ISOMED shifted its core focus to benchmarking its quality with respect to radiation sterilisation services and adding innovative safety features. The innovative 24x7 automatic consignment processing status enquiry system along with Radio Frequency enabled Access Control features for the irradiation cell won accolades from the stakeholders of the facility. Facility received eu GMP compliance status from the MHRA (Medicine and Healthcare Regulatory Authority) - UK and was recognized as an accredited foreign device manufacturer from the govt. of Japan. Facility also acquired ISO 9001:2008, ISO 13485:2003, ISO 11137:2006, and OHSAS 18001 : 2007 accreditations thus railroading its perpetual unwavering commitment of benchmark radiation sterilisation services to the healthcare industry.

Packaging For Gamma Radiation Sterilisation

The success of the radiation sterilisation has a pivotal bearing on the packaging integrity of the products. It is the regular industry practice that the products are packed firstly using the primary packaging and then a secondary packaging is provided in form of fibreboard cartons for facilitating the smooth shipment of the products from the primary manufacturer’s site to the contract radiation service providers. The primary packaging should provide a complete barrier to the entry of microorganisms and
should be designed to facilitate aseptic removal of contents. The materials to be sterilised are packed in impermeable films for example, polyethylene, cellophane-polyethylene or paper-polyethylene laminates, which can be heat sealed thus ensuring maintenance of sterility. These laminates have good tear and impact strength, have customer appeal and are inexpensive. Other types of laminates can be designed for convenience and to suit the product. Unsupported polyethylene films of 300 gauge thickness are suitable for soft products and of 500 gauge for rigid products. The exhaustive information on the packaging aspects for the products to be radiation sterilised are available in the website of M/S Board of Radiation and Isotope Technology, Department of Atomic Energy, Government of India at www.britatom.gov.in.

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