Course Title: Contamination Control in the Cleanroom Environment

  • ICEB Accredited Cleanroom Technology  – ‘Contamination Control in the Cleanroom Environment’ 

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Contamination Control practices are an essential element of working within Cleanroom Environments and have never before been so vitally important to so many industries. This Cleanroom Technology course has been delivered to over 800 individuals from the Pharma and Medical Device sectors in recent years.

The interactive programme offers participants, from a variety of different backgrounds, the opportunity to work together in exploring challenges, solving problems and finding solutions to issues that are relevant to all businesses working with Cleanroom Environments.

The objectives of the 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 and independent feedback.
  • Ensuring a high standard of GMP is adhered to.
  • Improving current standards.
  • Implementing a preventative action process.
  • Preparing staff for Regulatory Body Audits.
  • Rolling out changes in policies and procedures where necessary.
  • Supporting root cause analysis and corrective actions. 

This Course requires participants to complete a post course assessment. A pass mark of 50% must be achieved in order to receive accreditation. The accreditation serves for three years.

The programme will review in detail:

  • Controls put in place to minimise contamination during the Cleanroom set-up.
  • Cleanroom clothing and gowning practices.
  • Personal behaviour and hygiene.
  • Transfer of materials into the Cleanroom.
  • Effective cleaning of surfaces and equipment.
  • Monitoring and measuring the performance of the Cleanroom.

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
  • Packing
  • Security Staff
  • Construction Workers

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. For example, Environmental Monitoring Trends, current Cleanroom Processes, Methods and Behaviours.

This allows the tutor to further tailor the training programme to suit specific client 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.

Cleanroom Audit

Course materials

All attendees will be provided with a course manual including a full set of PowerPoint slides and accompanying notes. Each serves as an excellent source of reference following the programme.

Accreditation

The course is accredited by the International Cleanroom Educational Board (ICEB) and approved by the Irish Cleanroom Society (ICS). Certificates are issued by the ICEB to those that obtain a pass result.

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