Tech Talk

Managing Cleanrooms and Sterile Medical Device Products: The Importance of Training in Maintaining High Standards

Whether you are new to the business of manufacturing sterile medical devices or a 20-year veteran of the industry, continuous education and training are essential in this ever-changing field. Not only are the standards and regulations related to managing cleanrooms and sterile medical devices changing, the way regulators are applying standards and regulations is constantly evolving as well. Manufacturers of sterile medical devices must actively work to keep up with these ever-changing standards and interpretations while also looking down the road to see how they are likely to change in the future.

While it’s difficult to quantify the return on investment of training, it’s easy to see the cost of failure to comply with relevant regulations. Take a moment and Google the words “sterile medical device lawsuits” or “hip replacement recalls” and you’ll immediately recognise what’s at stake. Failure to effectively manage cleanrooms and controlled environments used in the manufacture of sterile medical devices can result in serious consumer safety issues, massive recalls and costly lawsuits.

Between the numerous European and U.S. standards and regulations related to the manufacture of sterile medical devices, it’s challenging for anyone in the industry to stay up to date in this changing environment. From quality assurance, regulatory and operational personnel to manufacturing and design engineers, almost anyone involved in the manufacture of sterile medical devices needs frequent training and continuous education. Not sure you need additional training? Consider these questions:

• How well do you understand sterilisation kinetics and the concept of sterility assurance level (SAL)?
• Are you well versed in the regulatory requirements under Directive 93/42/EEC?
• Do you fully understand the EN ISO 14644 series of standards for cleanrooms and controlled environments together with the allied EN ISO 14698 standards for bio-contamination control?
• When and how should you use various sterilisation processes?
• What are the roles and responsibilities of the manufacturer vs. a sterilisation subcontractor?
• Are you familiar with EN ISO 11607 and what it requires?
• How can you assure your packaging design maintains the sterility of the device and provides physical protection up to the point of use over its intended lifetime?
• Do you know how to satisfy current regulatory expectations related to the validation and routine control of your cleaning processes?

These are just a few of the questions leaders in the sterile medical device industry must be able to address to ensure regulatory compliance and consumer safety. NSF-DBA offers a modular training programme designed for professionals in various roles and levels of the sterile medical device industry. The training programme consists of four modules ¡X three one-day classes and one two-day class. The classes can be taken individually or together as a fully comprehensive five-day programme.

Module 1: Microbiological and Environmental Control of Cleanrooms and Controlled Environments for Medical Devices.

This one-day course provides an introduction to the management of cleanrooms and controlled environments used in the manufacture of sterile medical device products. It presents an introduction to the design, construction and start-up of cleanrooms and controlled environments and describes practices for the routine monitoring and control of these facilities. The course also offers a brief introduction to microbiology, sterilisation and the concept of sterility assurance, but at a level principally intended for the non-microbiologist. Find out more about and/or book this course

Module 2: Validation and Routine Control of Sterilisation Processes in the Manufacture of Sterile Medical Devices.

This two-day course provides an introduction to the validation and routine control of the common sterilisation processes that may be used in the manufacture of sterile medical devices, including how to satisfy current regulatory expectations. The course covers the basics of sterilisation kinetics and the concept of sterility assurance level (SAL); general principles related to validation and routine control of irradiation, ethylene oxide, steam and dry heat sterilisation processes; how current standards are applied to the validation and routine control of sterilization processes; when and how to use biological and chemical indicators correctly; the use of risk management processes; factors to consider when selecting a sterilization process; and the role and responsibilities of the manufacturer and a sterilisation subcontractor. Find out more about and/or book this course

Module 3: Packaging Processes for Sterile Medical Devices.

This one-day course provides an introduction to the design, validation and routine controls applied to sterile barrier systems and packaging systems, as described in the harmonised standard EN ISO 11607. The aim of a terminally sterilised medical device packaging system is to allow sterilisation of the medical device and to provide physical protection and maintain sterility up to the point of use. The specific nature of the medical device, the intended sterilisation methods, the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials. Find out more about and/or book this course

Module 4: Validation of Cleaning Processes for Sterile Medical Devices.

This one-day course provides an introduction to validation of cleaning processes applied during the design and manufacture of sterile medical devices. This course presents participants with practical advice on what they can do to satisfy current regulatory expectations in relation to the validation and routine control of cleaning processes. The course covers principles of product cleanliness and definitions of cleanliness; how to manage a cleaning validation, including what to look for and how to measure cleanliness; the risks associated with poor cleanliness and the potential consequences; and the current work standards associated with cleanliness. Find out more about and/or book this course

Simon Richards, Ph.D. is an Associate at NSF-DBA Medical Devices, part of NSF International, NSF Health Sciences Division. NSF-DBA has more than 30 years of experience in consulting, training and auditing services for the pharmaceutical and medical device industries. He can be reached at [email protected].

The complete four-module training program will be offered at the AMP Technology Centre in Sheffield, UK in October. For more information or to reserve your place in one or more of the classes, go to our course section. Each of the modules can also be offered at your location as a convenient, in-house training program.