3rd Annual Conference: Cleanrooms 2010

Understanding regulation and energy management
9 June 2010, CBI Conference Centre London

Do you use the ISO 14644 or ISO 14698 series of standards? Are you aware of potential changes to regulation? Do need to improve the energy management of your cleanrooms?


BSI's 3rd Annual Cleanrooms Conference will describe how changes to the ISO 14644 and ISO 14698 series of cleanroom and biocontamination standards are likely to affect your cleanroom operations. The event will also examine how these changes will impact on requirements for complying with GMP and medical device regulation.

There will be a particular focus on effective energy management in cleanrooms, including an introduction to BS EN 16001 Energy management systems and case studies from those organizations that have already optimized their energy performance. The programme provides guidance from the UK’s authority on standards and offers delegates the opportunity to benchmark processes and results against key thought leaders and operators to reduce contamination and drive the quality and efficiency of operation and processes.

Download the conference brochure


Three easy ways to book:


You should attend this conference for:

  • Updates on the revision to the BS EN ISO 14644 and BS EN ISO 14698 series of standards
  • Advanced information on how changes to cleanrooms standards may impact on regulation
  • Best practice examples of how you can improve energy management in your cleanrooms from those that are already ahead
  • Discussion and networking opportunities with some of the leading cleanroom experts in the UK and Ireland
  • Solutions to the latest issues and problems in validation and particle counting in cleanrooms.

Bronze sponsors:

  Schulke

 

Heipha

 

   Shield Medicare


Supporting organizations:

 


Media partners:

Clean Air & Containment Review

 

 

Agenda - Wednesday 9 June



Chair’s Introduction

Tony Harrison
UK Technical Expert, ISO TC209 WG 01 - Non-viable Contamination
Convenor, ISO TC209 WG 02 - Biocontamination
Technical Expert, BSI LBI/030 - Cleanrooms
Vice Chairman, UK Pharmaceutical Healthcare Sciences Society


Standards and updates to regulation

Changes affecting EU GMP and the FDA’s CGMP – progress of revisions to the BS EN ISO 14644 and ISO 14698 series - Non-viable and viable particle cleanliness in cleanrooms

  • What are the potential revisions?
  • Timeline
  • Impact of changes to ISO 14644 on EU GMP and the FDA’s CGMP
  • The need in GMP for the instrument standardization procedures and tests in ISO 21501-4
  • Managing the particle counting data
  • Future impact of ISO 14698 on EU GMP
Tony Harrison
UK Technical Expert, ISO TC209 WG 01 - Non-viable Contamination
Convenor, ISO TC209 WG 02 - Biocontamination
Technical Expert, BSI LBI/030 - Cleanrooms
Vice Chairman, UK Pharmaceutical Healthcare Sciences Society


Reducing emissions and improving energy management

Cleanroom HVAC and Contamination Control – A Green Challenge to the Regulatory Guidelines

  • Principles and origins of unidirectional airflow and non-unidirectional airflow cleanrooms
  • Regulatory authority cleanroom cleanliness levels recommendations and their origins
  • Comparison of in operation cleanroom performance vs. regulatory authority guidelines
  • Scenarios for energy savings whilst maintaining adequate contamination control
  • Realistic and achievable cleanroom energy reductions
Tim Eaton
Sterile Manufacturing Specialist, AstraZeneca


Case Study: Designing cleanrooms for more efficient energy consumption and reduced emissions

  • Implications of the Carbon Reduction Commitment on operating costs
  • Design Consideration – Life cycle cost optimisation
  • Cleanroom MOT / Energy Audit to identify component energy consumption and wastage
  • Identifying optimal balance between regulatory compliance and energy consumption
  • Satisfying the stakeholders: - Production, Quality, Procurement and Engineering
  • Cleanroom re-classification (costs v benefits)
  • Examples of energy efficient cleanrooms designs:-
    i) New build
    ii) Modifications to existing facility
Brendon McManus
Managing Director, Clean Air Technologies


BS EN 16001 - The new European energy management standard

  • What is it?
  • How does it work?
  • What are the benefits?
  • How does it differ from ISO 14001?
  • How easy is it to implement?
  • Will it fit all sizes of organization?
  • The practices, purpose and principles
Trevor Floyd
Principal Consultant, TENBY Consultancy Group


BS EN 16001 – Is it appropriate for cleanrooms?

  • Could BS EN 16001 be applicable to cleanrooms
  • Potential benefits/difficulties
  • Other options
Tim Triggs
Director, DOP Solutions


Discussion session: Cleanroom energy management solutions

  • What are your needs? What issues are you facing?
  • How have they been tackled?
  • Advice and suggestions

Case Studies

Case Study: Particulate and chemical contamination control in microelectronic and medical device manufacture

  • Varied case studies into particulate and chemical contamination (SPC& SMC)
  • Detection and measurement of surface product particulate and film
  • The corrosive and destructive effect on product life due to outgassing material
  • Compliance with new standards for SPC and SCC within the BS EN ISO 14644 standards
Dick Gibbons
Working group convenor, BS EN ISO 14644 surface chemical contamination
UK expert, BS EN ISO 14644 surface particle contamination group
Member, LBI 30


Case study: Validation of cleanroom disinfectants

  • EN microbiological tests available Other factors to consider
  • Common issues when validating disinfectants
  • New techniques for the validation of disinfectant packaging
Karen Rossington
Marketing & Development Manager, Shield Medicare


Case Study: Validating cleanrooms for pharmaceuticals manufacture

  • Overall approach to cleanroom validation
  • Harnessing cleanroom technology to protect product from particulate and bioburden challenge during open operations
  • Importance of additional airflow visualisation (smoke) and particulate studies to support cleanroom qualification
Richard Swift
MS&T Microbiologist, Lilly UK


Sponsorship & exhibition opportunities


Through BSI conferences and events your company will be able to reach your target market and showcase your products and services.

If you are interested in promoting your company, its products and services at the 3rd Annual Cleanrooms Conference, please contact Courtney McGrath on
+44 (0)20 8996 7371 or email conferences@bsigroup.com.

Who should attend?

All those working with cleanrooms in healthcare, pharmaceuticals and medical devices, including:
  • Quality assurance and quality control managers
  • Cleanroom managers
  • Operations managers
  • Pharmacists
  • Technical Quality Managers
  • Validation managers
  • Validation consultants
  • Manufacturing managers
  • Facilities managers

Please check back for updates as the date, venue and conference agenda is confirmed

Standards & Publications:

BS EN ISO 14644-1:1999
Cleanrooms and associated controlled environments. Classification of air cleanliness

BS EN ISO 14698-1:2003
Cleanrooms and associated controlled environments. Biocontamination control. General principles and methods

BS EN ISO 14698-2:2003
Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data

PD 6609:2007
Environmental cleanliness in enclosed spaces. Guide to in situ high efficiency filter leak testing

BS EN 14175-1:2003
Fume Cupboards. Vocabulary

BS EN 14175-2:2003
Fume cupboards. Safety and performance requirements

BS ISO 48:2007
Rubber, vulcanized or thermoplastic. Determination of hardness (hardness between 10 IRHD and 100 IRHD)

BS EN 16001:2009
Energy management systems. Requirements with guidance for use

Useful links:

BSI cleanrooms and controlled environments homepage
A comprehensive online overview of cleanrooms standards

BSI 2nd Annual Cleanrooms Conference 2009
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