ICEB Accredited Cleanroom Technology (basic course)
This Cleanroom Technology course has been delivered to over 400 attendees from the Pharma and Medical Device sectors.
The objectives of this course are to create a core and thorough understanding of the impacts of contamination within the cleanroom; create a fundamental awareness and understanding among personnel as to how they and their processes, behaviours, methods and practices, can contribute to contamination within the cleanroom and how these contamination levels can be prevented or minimised.
Clients have attended this training program for various reasons, including issues within the cleanroom, seeking an external opinion & independent feedback, ensuring a high standard of GMP is adhered to, improving current standards, supporting a corrective action process, preparing staff for regulatory body audits, or rolling out changes in policies & procedures where necessary.
There is an assessment on completion of the program and accreditation lasts up to 3 years.
Who should attend?
Any person in the organisation/service sector who is involved in working with Cleanroom environments including Management, Operations, Quality, Engineering, Purchasing, Warehouse, Facilities, Maintenance, Cleaning, Security Staff and Construction workers.
The programme offers the participants, from different backgrounds, an opportunity to work together in exploring challenges, solving problems and finding solutions to issues that are relevant to all businesses working with Cleanroom environments.
- Introduction into Cleanrooms & Contamination
- Controls put in place to minimise contamination during the Cleanroom set-up
- Cleanroom Clothing & Gowning Practices
- Personal Behaviour & Hygiene
- Transfer of Materials into the Cleanroom
- Effective Cleaning of surfaces and equipment
- Monitoring and Measuring the Performance of the Cleanroom
The training programme is very interactive, constantly encourages feedback from the participants and applies various different training methods and styles to deliver the key messages e.g. discussions, group activities, demonstrations and practical exercises. There is an assessment on completion of the programme in which a pass mark of 50% must be achieved in order to receive accreditation. The accreditation lasts up to 3 years.
Training support for In-house Programmes
Prior to organising an in-house training programme, a cleanroom audit can be performed in order to examine specific problems / issues within the Cleanroom Environment, e.g. environmental monitoring trends, current Cleanroom processes, methods and behaviours. This allows the tutor to further tailor the training programme to suit the specific client's requirements.
A Cleanroom audit looks at:
- Current relevant procedures,
- The current level of GMP within the cleanroom and supporting areas,
- The Cleanliness and Housekeeping of the cleanroom environment,
- Effective Contamination Control Practices and Methods and
- Personal Behaviour.
A detailed report featuring observations, suggestions and recommendations will be submitted to the client as to how the standard of GMP can be improved. Any suggestions or changes taken on board by the client can then be rolled out as part of the training programme. A follow up audit can be performed after the training has been completed in order to review improvements in Contamination Control practices that have been put in place by the client and to offer further guidance and support as required.
All attendees will be provided with course manual including a full set of powerpoint slides and accompanying notes, which proves to be an excellent source of reference after the course.
The course is accredited by the International Cleanroom Educational Board (ICEB) and approved by the Irish Cleanroom Society. Certificates are issued by the ICEB with the approval of the Irish Cleanroom Society.