Standardization News

Standards Form the Foundation of Sterility Assurance

The majority of healthcare products manufactured today are labeled as sterile and sold globally. The claim to sterility must be supported by scientific data and meet strict regulatory requirements. One way to achieve sterility is through a process known as radiation sterilization.

Johnson & Johnson, headquartered in New Brunswick, N.J., is a leading global manufacturer of sterile consumer products, pharmaceuticals and medical devices. Johnson & Johnson has a community of experts throughout its more than 150 operating companies who are responsible for ensuring that the products are sterilized using validated processes and reach doctors, nurses, patients, mothers, fathers, children and all other consumers in a sterile condition. We use standards developed by ASTM International Committee E61 on Radiation Processing to help ensure that the products we sterilize using ionizing radiation meet international regulatory requirements.

The use of internationally recognized standards to define, validate and identify routine control mechanisms for radiation sterilization allow for the consistent application of those processes. The International Organization for Standardization's ISO 11137-1, Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices, and ISO 11137-2, Sterilization of Healthcare Products – Radiation – Part 2: Establishing the Sterilization Dose, are two industry standards that most regulatory bodies around the world recognize as the requirements for radiation sterilization processing. The standards developed by ASTM International Committee E61 play a critical role for Johnson & Johnson as they provide valuable practices and guidance for meeting the requirements outlined in the ISO 11137 standards. In fact, 14 of these ASTM standards, many of which are also ISO/ASTM standards, are directly referenced and recommended in ISO 11137-3, Sterilization of Healthcare Products – Radiation – Part 3: Guidance on Dosimetric Aspects. Additionally, nine of those 14 ASTM and ISO/ASTM standards are also on the U.S. Food and Drug Administration list of recommended standards, which identifies them to industry as preferred practices or guides for FDA regulated products.

A critical part of the radiation sterilization process is the dosimetry system employed to measure absorbed dose in a product. ASTM standards E2628, Practice for Dosimetry in Radiation Processing, and E2701, Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing, provide Johnson & Johnson with a way to ensure that the radiation sterilization of our products is monitored with the appropriate dosimeters. ISO/ASTM 51261, Practice for Calibration of Routine Dosimeters for Radiation Processing, and ISO/ASTM 51707, Guide for Estimating Uncertainties in Dosimetry for Radiation Processing, provide additional guidance in establishing procedures for the measurement and traceability of absorbed dose, including estimating measurement uncertainty. The ability to measure absorbed dose accurately and have it traceable to a national standard is a critical component of the process used to release products sold by Johnson & Johnson as sterile.

According to ISO 11137-1, all radiation sterilization processes must be validated, therefore it is critical to understand the dose magnitude and distribution of absorbed doses throughout our products. ISO/ASTM 51702, Practice for Dosimetry in a Gamma Facility for Radiation Processing, and ASTM E2303, Guide for Absorbed-Dose Mapping in Radiation Processing Facilities, provide the necessary guidance to help ensure our gamma sterilization processes are robust and validated in compliance with regulatory requirements.

Johnson & Johnson also utilizes ASTM Committee E61 standards in research and development. Many studies conducted during the development of a new product require the same level of validation and traceability as routinely manufactured products. The data obtained during the studies help form the basis for the routine sterilization process; this information must be submitted for regulatory review and approval. The use of ASTM E61 standards provides Johnson & Johnson companies with industry-approved guidance in establishing that the studies used to ensure our radiation sterilization validations are acceptable for regulatory approval.

Johnson & Johnson employees have been active in the development of radiation processing standards within ASTM for decades. Our company recognizes the strategic value of being part of the continuing growth of ASTM Committee E61. The ability to collaborate with industry colleagues from around the world in establishing and promoting best practices in radiation processing through ASTM ensures that Johnson & Johnson is meeting and helping to define industry and regulatory requirements for their radiation sterilized products.

Johnson & Johnson Sterility Assurance

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