The following report details activities and events which took place during the last financial year.

1. ICCCS CONFERENCE - Copenhagen, Denmark May 2000

Every two years one of the member societies of the International Confederation of Contamination Control Societies hosts an international conference to which the members of each Contamination Control group are invited.

This year our hosts were R3 Nordic and the conference was held in Copenhagen.

A wide range of subjects were covered via paper presentations, workshops and formal lectures,but the focus of the conference centred around the new series of ISO standards.

During the conference the ICCCS Board, which comprises delegates from each of the Contamination Control Societies around the world, meets to discuss future developments in the field of contamination control and the best ways of allowing the dissemination of the relevant information. Bill Whyte and myself represented S2C2.

2. CONFERENCES AND COURSES

(a) BS EN ISO 14644 - 1 - Glasgow , October 1999

Speakers

Mr Gordon Farquharson (UK) on Classification Method and Test Requirements

Mr Martin Reeves (UK) on Testing and Test Intervals to Demonstrate Continued Compliance with BS EN IS014644-1

Mr A1 Lieberman (USA) on Test Methods to be used in Association with BS EN ISO 14644 - 1

(b) Exhibition Roadshow and Conference - Accrington December 1999

Speakers

Mr William Whyte on Cleanroom Technology

Mr Martin Reeves on ISO 14644 - 1- Background and Implementation. Proposed content of Part 2.

Publicity & Services to members

WEBSITE The website is now routinely receiving over 6000 hits per week. The information found on this site is constantly updated and developed through the addition of new sections e.g. anyone looking for a product or service for the cleanroom will be able to find a company able to supply, anyone looking for a new job or any company wishing to hire new employees can use the employment section.

The Cleanroom Forum allows our members to pose and answer questions on all aspects of Cleanroom Technology. It alone receives over 1000 hits per week. To extend its use we are now running it in CO-operation with the International Confederation of Contamination Control Societies and access to it is also through their website or through any of the societies around the world.

MEMBERS LIST AND SOURCE DIRECTORY 2000 edition was published and sent out to all members.

THE CLEANROOM MONITOR The Monitor has a new editor -Barbara MacLeod - who has implemented a number of changes in the format and content.

SITE VISITS The site visits are organised to allow our members to view cleanroom facilities of other groups or companies. This year we have been able to restart this activity and have three future visits already in the pipeline to take place over the next 12 months.

MEMBERSHIP

The total number now approaches 1300.

CONCLUSION

I would like to thank Bill Whyte, Harry Marshall, Kay Johnston and the Executive Committee for their hard work, enthusiasm and continued support throughout the last 12 months. Thanks must also go to Union Chemical Company for continuing to support us by allowing us to use their premises at Carronshore to hold our committee meetings and to Glasgow University Printing department.

Thank you also to all the speakers who have given presentations at our various courses and lastly but by no means least to you, our membership, for your continued support.

Bill Whyte

This year at the Society's AGM in November Bill Whyte was awarded an Honorary Life Membership. He has been in the field of cleanroom technology for 35 years and is the person who started the Society in 1986. He was Chairman, then Secretary and is presently helping in an ex-officio capacity.

Last year Bill was awarded the Cleanrooms Hall of Fame Award by the Cleanrooms world-wide magazine of Contamination Control Technology. It was supposed to be presented at the Cleanrooms West Show in USA last November but because he couldn't manage to attend the presentation it was made this July at the Cleanroom Europe show in Germany.

It was presented by Mike Levans, Chief Editor of Cleanrooms magazine. One person is awarded every year for outstanding work done in the field of cleanroom technology. Bill is the only person who has received this award in the UK.

Bill runs courses relating to cleanroom technology and writes books, academic papers and course notes on the subject. From the time he first started giving courses he noticed that the help they needed or the questions they asked could be obtained by a person who was just around the corner from them.

The Scottish Development Agency was keen to do something to assist in both training and helping firms to network. Through Mr Bob Begg, they provided the necessary pumppriming money and underwrote the university courses, as well as the inaugural S2C2 meeting in 1986.

There already existed (and continues to exist) the Society of Environmental Engineers based in England. The establishment of a Scottish Society for Contamination Control aimed to help those in the north of the UK who found it difficult and time-consuming to travel south.

These days Bill spends a lot of his time working with S2C2, various International Standards Committees as well as writing. He is presently working on his next book which is to be called Cleanroom Technology - The Fundamentals of Design, Testing and Operation. It is aimed at people who have to teach in a factory or laboratory, as well as those coming into the field. It will be published by John Wiley & Sons, the same publisher who published the Cleanroom Design book he produced in 1991.

CLEANROOM & ISOLATOR DESIGN
Isolator Leaks- A Moveable Feast? Mike Foster

Leak testing of isolators/containments will be eventually incorporated in the new clean room standard BS EN ISO 14644. Effectively the document will incorporate the test and reporting methods currently used in the ISO standard 10648 part 2. (A very good concise document well worth the read) along with the Parjo leak test.

These tests are scientifically based, well proven procedures and are undertaken at 1000 pascals. The test pressure reflects the pressures that may be experienced during transient operations such as glove entry or exit. The test pressure also ensures sufficient capacity to sustain one hour test duration by providing latitude for ambient and temperature changes.

There are four levels of pressure integrity and from a simplistic view the maximum (temperature and pressure corrected) pressure drop that the unit under test should experience during a 1-hour- 1000 Pa test is as follows:

Tests 3 and 4 are normally a constant pressure test, i.e. maintained by additional (accurately measured) flow although there is an oxygen test suitable for low integrity.

The oxygen test method is extremely good and it allows an exact leakage to be determined on flexible, or none rigid isolators, or half suit systems!

This is an ideal test for initial installations and validations. Intermediate tests could be via pressure decay comparisons of an original pressure decay test following the oxygen system commissioning.

This is a low cost very accurate test. This oxygen test can also be used on high and medium integrity units.

Hospital Isolators

It is generally realised that a significant number of hospital isolators may not achieve either the 1000 pascal test pressure or indeed perhaps the low leakage rates at the 1000 pascal test pressure.

However, "leakage" or flow through an orifice varies as the square root of the test pressure. For example the flow through a fixed orifice at 250 pascals will double at 1000 pascals. Similarly it will halve at 62.5 pascals. (Note: a leak in a seal or glove system is unlikely to be a fixed orifice, hence the need to test in the worst condition to establish the actual leak rate.)

Whatever the test pressure knowing the exact leakage allows an accurate risk and/or hazard analysis to be undertaken.

To achieve an accurate leakage one requires a test pressure that can be "sustained" long enough during the temperature and ambient changes that may be experienced during the test period. For example one Celsius degree change could completely destroy a test undertaken at 250 pascals in a very short time.

However, it may be worthwhile to undertake a risk analysis in reverse, i.e. determine the leakage that the risk may sustain, remembering that leak rate is the only protection during a system failure such as loss of power, or indeed during gaseous sterilisation process.

During operation "leakage" is only one of several considerations that affect the internal air quality. Transfer systems and procedures, operator actions and possibly even the product under process may affect the internal air quality conditions.

With the advent of affordable gas sterilisation systems, perhaps we may see the beginning of the end of "open isolator" technology with "closed isolator" system taking over. Leakage then becomes important for third party protection, or indeed product being produced under negative pressure conditions.

As with most developing technologies standards and expectations become higher and more achievable. One only has to examine the developments and improvements of HEPA and ULPA filters over the past 20 years to understand improvements in what is now considered "everyday accepted technology". Similarly risk assessment will also get more stringent as detection becomes more sensitive and health and safety issues quite correctly lower acceptable exposure limits.

A good repeatable accurate leak test is therefore important in its own right for the reasons explained and deserves its place as a separate entity in the validation process.

* Mike Foster is one of S2C2's members on the LBI 30 [the technical committee to do with cleanrooms] , the BSI [British Standards Institute] committee and one of the UK experts on the ISO TC [International Standards Organisation Technical Committee] 209 Working Group 7 which is responsible for producing the committee draft standard. He also serves on the UK Pharmaceutical Isolator Group. Contact: Telephone (business) 01489 885 111