Packaging Processes for Sterile Medical Devices

About this course

This one-day course is intended to provide an introduction to the design, validation and routine controls applied to sterile barrier systems and packaging systems, as described within the harmonised standard EN ISO 11607.

The aim of a terminally sterilized medical device packaging system is to allow sterilization of the medical device and then to provide physical protection and maintain sterility up to the point of use. The specific nature of the medical device, the intended sterilization methods, the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials.

This course is designed to provide you with practical advice on what to do to satisfy current regulatory expectations in relation to packaging processes for sterile medical devices.

What You Will Learn

• Factors to consider in packaging design
• How to validate the packaging design so that the characteristics and performances of the device will not be adversely affected during transport and storage
• How to validate the packaging design so that the characteristics and performances of the device will not be adversely affected during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use
• Consideration of user requirements (customer needs) when designing packaging for a medical device
• Validation of packaging processes
• Routine control of packaging processes

Who Should Attend

The course is designed for Development Engineers, Packaging Engineers, Quality Assurance, Regulatory and Operational personnel involved in the design, validation and routine control of sterile medical device product packaging processes.

This course forms part of the ‘Managing Cleanrooms & Sterile Medical Device Products’ suite

Enjoy a discount by attending more than one course in this suite. Please speak to our team at NSF-DBA for further information

Course outline

• The basic attributes required of packaging materials and packaging systems intended for use in packaging terminally sterilized medical devices
• Packaging requirements including human factors, market requirements and device requirements
• Packaging design including design options for various sterilization processes
• Material evaluation including requirements and testing protocols
• Packaging design validation including sterilization studies, shelf-life studies and shipping tests
• Standards associated with packaging materials for sterile medical devices including general requirements and test methods
• Labelling processes and compatibility with labels
• Process validation, including the use of statistics to determine sample sizes in packaging validation
• Quality assurance procedures associated with packaging processes
• Packaging failures, why they have occurred and possible corrective actions

This course forms part of the ‘Managing Cleanrooms & Sterile Medical Device Products’ suite

Venue

AMP Technology Centre, Sheffield, UK & 'In House' company course available

We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.

The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.

Hotel Accommodation

We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.

Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.

Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.

Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.

Venue Address and Contact Details

AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England

Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Simon Richards
  NSF-DBA Medical Devices Consultant
  

  • [email protected]
  • +44 (0) 1143 600868

What you've said

This is a new course for NSF-DBA in 2013 and we will soon be able to provide you with feedback from our Medical Device program