Gamma Irradiation Services
Gamma Radiation Sterilization Services: Safe & Effective Sterilization for Diverse Industries
Cutting-edge sterilization services for a wide array of products. Utilizing highly effective and proven technique of Gamma radiation. We ensure optimal sterilization without compromising the integrity of products.
Shriram Applied Radiation Centre (SARC) of Shriram Institute for Industrial Research is considered to be Centre of Excellence in the field of Gamma Radiation Sterilization of Health care Products. SARC was established in 1990 in collaboration of Board of Radiation and Isotope Technology, Department of Atomic Energy, Govt. of India with the objective to Develop, demonstrate and promote radiation processing technology and its diverse applications by conducting applied research.
Gamma Radiation Processing Plant at SARC is fully automatic Category-IV, Land-Based Panoramic, Wet source storage irradiator. Plant was set up as per the design and norms of BRIT/AERB for round the clock-fail safe operations. Unique plant design of SARC gives very low over dose ratio which is best suitable for radiation sterilization of Health care products including Medical Devices. Products for radiation processing is required to be packed in corrugated box of outer dimension: 59cm (L) x 43cm (W) x 33cm (H). Once loaded on to the loading conveyor at an automatic box transfer station they get transferred in to the next Shelves. These carriers travel at the pre-defined speed on the overhead mono rail enters the irradiation cell and return to the box transfer station. At the completion of each cycle the boxes are progressively transferred to the next shelf.
Gamma Radiation Advantage:
Gamma rays penetrate deep into the stones and gems and enhances its appearance, structure, or luster.
Gamma Sterilization Requirements
To ensure smooth and effective sterilization, we have set certain product requirements for the consignment:
- Packing: Products should be packed in standard 5-ply corrugated cardboard cartons with dimensions: 59cm (L) x 43cm (W) x 33cm (H).
- Documentation: Please submit a covering order specifying product details and irradiation dose requirements.
- Charges: Charges vary based on the product type. For a customized quote, please email us at customercare@shriraminstitute.org.
- Regulatory Approval: For Medical Devices and Drug items, customers must obtain prior regulatory approval from the Central Drugs Standard Control Organisation (CDSCO), Govt. of India and Drugs Control Department, Govt. of NCT of Delhi.
The Gamma Sterilization Advantage
- Non-Heat Based Process: It is a cold process unlike steam or dry heat sterilization, Gamma radiation does not raise the temperature of the products, allowing heat-sensitive materials (like plastics and rubber) to be safely sterilized.
- No Residue: Gamma sterilization does not leave behind any toxic residues, unlike gas sterilization (e.g., Ethylene Oxide), making it ideal for products that will be used in or on the human body.
- High Penetrability: Gamma rays penetrate through dense and complex packaging, ensuring complete sterilization of all products, irrespective of shape or size. Due to high penetration of Gamma (Co-60), sterilization can be done on bigger size of boxes, whereas, due to less penetration as compare to gamma, e-beam has limitation with regard to size of boxes for sterilization.
- Environmental Benefits: Gamma sterilization is a clean, non-polluting process, making it an eco-friendly option compared to other methods like autoclaving or gas sterilization.
- Uniform & Reliable Results: As a continuous process, Gamma sterilization delivers consistent results every time.
Sterility Assurance Level (SAL):
Gamma radiation is found to be most effective technique to achieve desire SAL of irradiated product.
SARC also undertake the following activities:
- Using irradiation services Studies with regard to optimization of radiation dose for various types of Healthcare products.
- Validation studies on medical devices as per ISO 11137 and ISO 13485.
- Testing and certification of residual radiation to detect alpha, beta and gamma emitters in various commodities.
- Studies for development and modification of polymeric material for various industrial application.
- Shelf life enhancement of Food & Food products, Fruits and Dehydrated Vegetables, Spices, Herbal / Ayurvedic products.
- Studies for radiation dose optimization for desired colour enhancement of various types of gem & gem stones.
Accreditations/Approvals:
SARC irradiator licensed for operation by Atomic Energy Regulatory Board (AERB), Govt. of India. SARC is approved by Central Drugs Standard Control Organization (CDSCO), Govt. of India and Drugs Control Department Govt. of Delhi with regard to radiation sterilization of Medical Devices covered under MDR 2017. SARC is also approved by Drugs Control Department, Govt. of Delhi for sterilization of pharmaceuticals products. SARC is accredited for ISO 11137 and ISO 13485- Medical Devices- Quality management Systems – Requirements for Regulatory Purposes, with regard to radiation sterilization and validation of Healthcare Products using Co-60 source.
SARC is also accredited for ISO 9001 for QMS, ISO 45001 for OH&SM and ISO 14001 for EMS. SARC is also registered with USFDA for sterilization of Medical Devices
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To learn more about our Gamma Radiation Sterilization Lab services or to get a customized quote for your products, please reach out to us.
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