S2C2 Annual Technical Meeting

NEC, Birmingham

2-3 June 1999

 

Synopsis of Course Content

Registration

Registration will be from 08:00 on Wednesday. For those not attending the first session, registration for the other sessions will be available throughout the day. Note that the start times of the morning sessions are staggered. Each session will break for coffee/tea at a suitable point.

Cleanroom Technology - Bill Whyte Wednesday 09:15-12:30

With the rapid expansion of cleanrooms, many people coming recently into the subject find it difficult to obtain good hard information on cleanroom technology. This half-day course on Cleanroom Technology is a basic general course for those new in the field or those who wish to "brush up" their knowledge. The course has been developed over the last 10 years and has been attended by about 3000 people. Course includes 90 page course manual. Topics include:

Basic Design Principles · Necessity for cleanrooms · Types of cleanrooms
Specifications and Validation · Cleanroom standards · Pharmaceutical requirements · HEPA and ULPA filters · Validation of cleanrooms
Cleanroom Clothing · Use of changing areas · Correct attire · How clothing works · Gloves and masks
Cleanroom Practices · Cleanroom Disciplines · Cleaning materials · Cleaning practices · Types of wipes

Fundamentals of Cleanroom Design - Ken Goldstein Wednesday 14:00-17:00

This course will examine the fundamentals of cleanroom design at the basic level. It will address the subject material from a general perspective that is meant to be non-specific to any single using industry. The emphasis will be on the common approaches and design aspects that all cleanrooms share. It is intended for managers, planners, novice designers, and cleanroom users who require a good overall understanding of this increasingly important enabling technology. Topics include:

Cleanrooms · Definitions · Users, Costs, Concerns · Room Environmental Conditions · Plan and Section Views · Airborne Cleanliness Standards · ISO 14644-1, USFS 209E · Cleanroom PlanningLayouts, Utility Matrix · Cleanroom Mechanical Systems · HVAC (Heating, Ventilation, Air Conditioning) · Effluents · Non-Process Utility Systems · Cleanroom Process Utility Systems · Gases, Liquids · Other Topics · Protocols, Start Up Issues

Isolators - a practical course - Tim Coles Wednesday 09:30-16:30

The course will be of interest to anyone concerned with isolators of any type, but is primarily aimed at those with a fairly limited knowledge of the subject. Topics include:

Introduction · Isolators v Cleanrooms · Materials of Construction · Air Filtration · Regimes - Air Flow & Pressure · Control & Instrumentation · Handling Devices · Transfer Methods · Sanitisation/Sterilisation · Validation · Maintenance · MCA - The PHIGOO concept

The afternoon will be devoted to three workshop sessions on · Validation and Environmental Monitoring · Sanitisation & Sterilisation · Design and Mechanics of Isolators

Paper Session 1 should include

G F Barrett
Control of Foot and Wheel-borne Contamination in Clean Environments - The Application of Polymeric Flooring Technology
Douglas Cansfield
Airflow modelling applications in the semiconductor industry
J Comerford & Conor Murray
Architectural Product Selection in Fast Track Clean Build Cleanrooms
Udo Gommel
Qualification of products for equipping cleanrooms
Jeff Granger
Validating an Automated Airborne Particle Monitoring System
Micky Hesse
Helmke Drum Test for Polyester Overalls Particles 0.3 Microns
Norman Hurst
Reduction of electrostatic contamination from cleanroom operators to zero volts by the application of new methods of construction for cleanroom garments

Paper Session 2 should include

Philip Addison
The move to sterile ready-to-use disinfectants
Philippe Bonfield
Application of vaporised hydrogen peroxide for the sterilisation of various enclosure systems
Trevor Downey
The validation and start up of a Bacterial Seed Production Facility in Siena, Italy
Mike Foster & Tim Coles
Isolator/Containment Pressure Testing
James Lyda
Recent Technical and Regulatory Developments in Clean Environments for Pharmaceutical Production
Didier Meyer
Safe liquid transfer systems for preventing cross contamination product-people in aseptic and toxic processes
David Watling
A new method of cleanroom sanitisation using hydrogen peroxide

Cleanroom Garment Application and Use - Bob Spector Thursday 09:15-12:30

This course is intended to present a practical and day-to-day real world understanding of cleanroom garment systems that are used in a variety of industries. The course will review human-sourced contamination along with appropriate counter measures for control as well as garment system guidelines. Other relevant factors reviewed will include recommended maintenance and processing practices, relevant testing and cost factors. This course is recommended for anyone who uses or is in any way associated with the procurement, management and evaluation of cleanroom garment systems and laundries.

Running a Cleanroom - Gary Knoth Thursday 14:00-17:00

This course presents a comprehensive overview of the considerations for staffing and operation of cleanrooms and controlled environments for micro electronics and precision assembly. Many of the subjects covered can be equally applied to pharmaceutical and biomedical controlled environments, but aseptic concerns are not specifically addressed. The course covers hiring procedures, hygiene and health, training and compliance, gowning, change rooms, entry procedures, behavior, monitoring and auditing, gowning system management, and exiting protocol.

Validating a Cleanroom - Bill Whyte Thursday 09:30-16:00

A new cleanroom must be tested to ensure that it has been built to the standard specified in the design. During the life of a cleanroom it must be monitored to ensure that the standard to which it is built is maintained. This course will present information in two sessions as to how this should be done. During the first session details will be given of the standards required in cleanrooms and how cleanrooms can be checked to ensure that they are up to these standards by describing:

In the afternoon a "Hands-on" demonstration will be given of equipment used in validating and monitoring a cleanroom. Groups of participants will receive tuition on the following:

Course includes 45 page course manual.

Airflow Modelling - Andy Parker, George Pollock & Mark Seymour Thursday 09:45-16:00

Airflow modelling is a computer technique that investigates strategies at the design stage as well as troubleshooting existing installations. Aimed at consultants, designers and operators of cleanrooms, this seminar is designed to show some of the practical ways in which airflow modelling has been and can be used by engineers to improve ventilation effectiveness, reduce costs, etc. In addition to explaining some of the background and evolution of the techniques, speakers from AMEC Design, M+W Pearce and Construction and Flomerics will present case studies from both the pharmaceutical and semi-conductor industries. A software demonstration will illustrate how different ventilation concepts can be built into an airflow model and, within a matter of minutes, an assessment made of their relative effectiveness in controlling contamination sources. Three-dimensional visualisation techniques will also be shown which enable smoke testing to be carried out in the computer model before a mock-up has even been considered.

THE S2C2 ANNUAL TECHNICAL MEETING 1999

 

Why you should be there!

   

The Programme, Course Fees & Application Form

     

Synopsis of Courses

       

The Presenters

       

How to get there - travel, access and accommodation

 

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