About this course
This one-day course is intended to provide an introduction to the management of cleanrooms and controlled environments used in the manufacture of sterile medical device products. It will provide an introduction to the design, construction and start-up of cleanrooms and controlled environments and describe practices for the routine monitoring and control of these facilities.
The course will provide a brief introduction to microbiology, sterilization and the concept of sterility assurance, but at a level principally intended for the non-microbiologist.
The course will describe general principles for bio-contamination control and describe the potential influences that poor microbiological and environmental controls may have on the production of a sterile product.
What You Will Learn
The course will provide a brief introduction to microbiology, sterilization and the concept of SAL as applied to the manufacture of sterile medical devices.
The course will describe the EN ISO 14644 series of standards for cleanrooms and controlled environments together with the allied EN ISO 14698 standards for bio-contamination control. Pending changes to these standards, and the implications of these changes to manufacturers, will also be discussed.
The course will discuss potential sources of microbiological and environmental contamination, how they may be controlled and what action could be taken should limits be exceeded.
You will gain an insight into the influences that microbiological controls may have on the routine control and validation of these processes.
Who Should Attend
The course is designed for Quality Assurance, Regulatory and Operational personnel involved in the design, validation and routine control of cleanrooms and controlled environments, for Medical Device products.
It will also be of use to Manufacturing and Development Engineers engaged in the design of sterile medical device products or the establishment of manufacturing processes where microbiological control may be crucial.
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: Speak to our team at NSF-DBA for further details
Course outline
- Microbiology – understanding the basics
- Sterilization – how microorganisms are inactivated and the concept of Sterility Assurance Level (SAL)
- Regulatory requirements under Directive 93/42/EEC – what are the relevant essential requirements and how do we meet them through current standards for cleanrooms and controlled environments and bio-contamination control
- Routine controls within cleanrooms and controlled environments, including hygiene and gowning practices, cleaning and suitable equipment for use within the cleanroom
- How microbiological controls may influence the sterilization processes
Workshops will involve you reviewing the suitability of practices within cleanrooms and identifying possible risks that may lead to contamination. Further workshops will look at situations involving breaches of microbiological limits, investigation of potential root causes and the identification of 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:
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
An NSF International Company 
