Our 22nd Year of Publication
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Cover Story

Advances In Sterile Medical Device Manufacturing

Prof. Sujoy K. Guha
School Of Medical Science And Technology
Indian Institute Of Technology Kharagpur

Sterile Medical Devices Manufacturing is a domain of rapid advancements and changes in all respects. Design complexities are increasing and that calls for new materials; new processes; better quality control; and consideration of ultimate risk in the planning and implementation of the of the entire chain from the design desk; to the industry; to the distribution and delivery; the clinical use; and follow-up. ISO 13485 for Quality Management and its updates and ISO 14971 for Risk Management are essentials but only a part of the whole. At the IIT Kharagpur in respect of the Contraceptive Implant and Artificial Heart new sterile manufacturing barrier methods; sterilization technology; robotic processing; and sterile packaging are being explored. These methodologies will in future have widespread impact on sterile medical device manufacturing.

Advances In Asepsis

On-linemonitoring of microbial volatile metabolites by proton reaction mass spectrometry

Risk Management

Integrate risk management processes across entire quality management system. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk using standards such as ISO 14971

ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

What are the benefits of ISO 14971?

  • Implement ideal methods of reducing risk for all stakeholders

  • Develop devices and therapies that are proven effective in the industry

  • Manage speed and cost to market

  • Optimize speed of iteration

  • Streamline the regulatory process that will enable entry to selected markets

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

A sterile barrier system is an essential part of a sterile medical device. (A sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”

This is distinct from protective packaging which is defined as the “packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use”.)

Quality Management System

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

As a result, it includes some particular requirements for medical devices

Excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Biomedical production of implants by additive electro-chemical and physical processes


From: Bartolo P, Kruth Jean-Pierre, Silva J, Levy G, Malshe A, Rajurkar K, Mitsuishi M , Ciurana J , Leu M. Biomedical production of implants by additive electro-chemical and physical processes, CIRP Annals - Manufacturing Technology 61 (2012) 635–655

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