Sterilization Of Health Care Products By Gamma Radiation

 

DUR/ODR The method of describing the uniformity of dose in a given product is the concept of Dose Uniformity Ratio (DUR), which is the ratio of the maximum dose in a product container to the minimum dose in the container. This ratio increases with increase in the density of the product as well as with the size of the container/tote box Validation of radiation processing • IQ – INSTALLATION QUALIFICATION • OQ – OPERATIONAL QUALIFICATION • PQ – PERFORMANCE QUALIFICATION Installation Qualification Installation qualification is the process of obtaining and documenting evidence that equipment (the irradiator and its associated processing equipment and measurement instruments) has been provided and installed in accordance with its specification Operational Qualification Operational qualification is the process of obtaining and documenting evidence that the installed equipment operates within specified limits when used in accordance with its operational procedures. It is carried out after the commissioning of the facility. Performance Qualification Performance qualification is the process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with specified criteria and thereby yields product meeting its specification Dosimetry Systems used for Radiation dose measurement Dosimeter Measurement instrument Dose range (kGy) Remarks Alanine EPR spectrometer 0.001-100 Various shapes: rods, pellets Dyed PMMA Visible spectrophotometer 1-100 1 × 3 cm 3 mm thick Ceric-cereous sulphate solution Potentiometer, UV spectrophotometer 1-100 Glass ampoules Diameter~12 mm Fricke UV –Vis spectrophotometer 0.04 – 0.4 PP vials Dichromate UV –Vis spectrophotometer 1-100 Glass ampoules Diameter~12 mm Regulatory Bodies/Standards for gamma Sterilization facilities Radiation sterilization process is currently regulated by two standards, ISO 11137 and ISO13485 • In India apart from these standards CDSCO/FDA is regulating the radiation sterilization process for health care products according to MDR 2017 • AERB (Atomic Energy Regulatory Body)-India • Medical Devices Risk Analysis – ISO 14971 • ISO 9001 (QMS) Quality Management System

RECENT DEVELOPMENTS IN SAFETY FEATURES What are current standards for quality/c GMP practised by Irradiators worldwide ? • MHRA/UK • USFDA • TGA –Australia • UNFPA • WHO/Drug and Cosmetic Act , India MDR 2017 / ISO 13485 / ISO 14971 • ANVISA-BRAZIL • MCC- South Africa • PMDA- Japan • NMRA-Srilanka • MDA - Malaysia • ANSM-France • CDSCO –India CURRENT STATUS OF RADIATION STERILISATION TECHNOLOGY • India largest exporter of IUDs to UNFPA • Medical Devices Act 2016 (Impending legislation) • Synergistic growth in medical devices sector • Approximately 0.175 Million Cu. M. medical products sterilized by Gamma currently • With 23 Radiation Processing Facilities operating in the country currently FUTURE IS PROMISING !! Current trend in radiation technology in India • Captive gamma radiation facility • Contract gamma radiation facility • Capacity of each facility 1.5Mci to 5MCi • Total gamma radiation facility in India – 38 • Total Co-60 radiation source – 38Mci as on 2023 • 10MeV 10kW Electron beam facility terminal sterilization is also coming up. Role of BRIT-DAE • Developmental initiatives with changing trends in quality, safety and security of industrial irradiators • Recently developed FOAK (First Of A Kind) - animated training simulator named ISOTRAIN for Radiation Processing Facilities • BRIT also launched ISOCAD (Integrated System of Computer Aided Dosimetry system) – A c GMP Compliant CCPDMS Gamma Lrradiators Worldwide There are now about 200 commercial Co–60 irradiators for radiation sterilization, operating in 47 countries worldwide, containing approximately 240–260 MCi of gamma emitting Co- 60 Sources Merits of gamma Sterilization • Simple Process Only parameter to control is exposure time • Pre-packed in hermetically sealed packages, impermeable to microorganisms, before and after sterilization. • Temperature is not raised much: compatible with temperaturesensitive materials, such as pharmaceuticals and biological samples • Flexibility: can sterilize products of any material, size, or thickness • Leaves no chemical residue • Immediate Availability of product after sterilization • Gamma radiation easily reaches all parts of the object to be sterilized due to its high penetrating ability Limitations of gamma Sterilization • Material Degradation : few material degrade after terminal sterilization radiation dose (brittle, colour change) • Method is costly alternative to heat sterilization