Welcome to the new look Monitor! We hope you enjoy this edition and approve of the new format. We have a new editor, Mrs Barbara MacLeod, whose enthusiasm for this position has already resulted in a few changes as you will see as you browse through the following pages.
We have retained our scientific approach in that technical articles will still be printed and obviously we hope that you will keep sending us papers on innovative aspects of cleanroom technology and contamination control. However we hope also to focus on issues pertinent to the people actually working within the cleanroom situation and to this end will select questions and answers from our Cleanroom Forum to reinforce points raised.
Chairman's Corner will also be a permanent feature of the new format where I hope to address areas of importance within Cleanroom Technology and also within the Society. The first of these topics is the 15th ICCCS (International Confederation of Contamination Control Societies) International Symposium on Cleanroom Technology held in Copenhagen from 14th to 18th May 2000.
For those of you who do not know anything about ICCCS, it is an international organisation comprising all countries with Cleanroom and Contamination Control Societies like ourselves. It is operated by a Board of Delegates which comprises representatives from each society ‑ Bill Whyte and myself are S2C2's representatives ‑ who decide on the activities and direction ICCCS will take with regard to the dissemination of information and the development and implementation of standards.
Every two years one Society hosts an international symposium to which all members of each Society are invited. This year it was the turn of R3 Nordic, our colleagues in Scandinavia. Papers are presented by delegates from all over the world on a wide variety of topics.
This year the focus was placed on current and forthcoming standards ‑ISO 14644 Cleanrooms and Associated Environments and ISO 14698 Biocontamination Control with a full day being assigned to these topics allowing delegates time for questions to be raised.
The Symposium was well attended and along with the Exhibition was a very successful event. On behalf of S2C2 I would like to thank R3 Nordic for their hospitality and congratulate them on their excellent organisation.
Moredun Research Institute is a small ruminant disease research establishment at the Pentlands Science Park south of Edinburgh. Research is focused on infectious diseases of livestock, mainly sheep. Surrounded by fields of sheep MRI is part of the complex of buildings all related to work on animal health and welfare.
The Institute has 3 cleanrooms in the 11,500 m2 of lab and animal accommodation. They are all Class 100 and are used for the production of liquid, semi and solid state media for growth of microbes.
Dr Frank Scott, a virologist, is one of the S2C2 Committee and organised the visit for members. Moredun has a staff of 150 covering 5 divisions: Bacteriology, Parisitology, Virology, Clinical and Scientific/Information Services. Frank is head of the Scientific/Information section.
The work of the Institute is driven by farmers' needs to solve the problems related to infections in their animals. For example the diseases of sheep scab and foot rot had no cure so this lead to research programs to develop treatments or prophylactic remedies. Recognition of diseases which can be transmitted from animals to man and the ecological impact of some chemotherapeutics used in the sheep industry have lead to increased work.
A separate company within the Moredun Group is Moredun Isolators Ltd. They build and export purpose built isolators for use in a variety of industries to provide controlled environmental conditions. They have also developed a range of soft tissue veterinary simulators. These are models of animals or parts of animals that are used by trainees to practice procedures, for example, learning to do injections thereby reducing the necessity of using real animals. Development of new ideas such as this happened because of proximity of other firms within the Science Park.
Members were impressed with the brand new lecture theatre and meetings' facilities. The building is suitable for conferences. Contact: Dr Frank Scott, Moredun Research Institute, Pentland Science Park, Bush Loan, Penicuik, EH26 0PZ. Tel 0131 445 5111. Email: scotf@mri.sari.ac.uk
For 13 years Sally has been Cleanroom Supervisor at Aortech, a biomedical manufacturer based in Strathclyde Business Park, Bellshill, near Glasgow, Scotland. She is a local girl, from Uddingston who started her working life as a seamstress in the local Levi factory. When it closed she declined the offer of a move to another facility, and chose to re‑evaluate her skills, and after researching a local company, successfully applied to join Biomedical Systems Ltd. (BMS) in Bothwell. Recalling her interview, Sally tells of meeting an impressive and commanding gentleman clearing snow from the Welcome Mat in reception, who asked if he could help her. Soon after joining BMS, she again met the man in reception, this time, introducing herself she said, “Good morning my name is Sally, and I now work here.” The smiling man replied “I’m Gordon Wright, I work here too” ‑ a typically polite understatement from the man who has now been her boss for 13 years.
Working from the bottom Sally was trained by Linda Cathcart at BMS in the manufacture of heart valves. Keen to learn and, drawing on her hand skills gained in specialist sample production at Levi’s, she found the detailed, intricate work stimulating. The difference, however, between manufacturing clothing “to save someone’s embarrassment” and manufacturing heart valves “to save someone’s life” was, for Sally, profound. A day’s work could involve the quality of someone’s life, not only the look of a fashion item. Backed by expert training and a commitment to quality at all levels in the company, you could, through your work, make a positive contribution to your fellow man/woman.
External training and study helped to nurture the essential skills required, to produce the hand crafted precision heart valves, implanted and still operating today.
Whilst at Biomedical Systems, Sally worked on tissue heart valves, then on to mechanical heart valves in the late 80’s. When she became Supervisor she moved from being involved with several labs, to managing a Cleanroom. The biggest task in moving to a Supervisor’s role was letting go of the hands‑on work, in favour of the increasing legislation and operational aspects of running an efficient Cleanroom.
The industry at that time was growing rapidly, as was Biomedical Systems, who were soon acquired by 3M. Sally and a select team decided to stay with Gordon Wright and join his new venture AorTech Ltd. in 1990. With her came other Cleanroom specialists: Annette MacDonald, Patricia Berry (nee Donnolly), and 3 others who worked for Sally: Nan Campbell, Jackie Mooney and Karina (nee Smith) Hutchison.
The rapid growth of AorTech, evolving into a PLC., and operating worldwide, now covers manufacture of mechanical heart valves, mitral and aortic, and a mitral repair system, and sterile subcontract assembly work. Operating with 2 Cleanroom at Class 100,000 and 1 Cleanroom at Class 10,000, there are also areas earmarked for new facilities and products, Sally is currently in charge of 2 Cleanrooms.
AorTech’s expansion also involves research into the manufacture of a new generation of valves and to this end have recently acquired in March 2000. “Elastomedic”, an Australian company which manufactures a specialized polyurethane material, the tissue valve business of Tissuemed Ltd. Leeds, who bring a range of Porcine tissue valves and in July 99, seen the addition of the T r u C O M M S Monitoring System, all new additions to the AorTech International PLC., product range.
Sally’s typical day involves a staff briefing at the beginning of the day, covering production planning, and the constant monitoring of staff and operating procedures to conform with Class 100,000 directives and Quality Assurance issues. “the company is as proud of our QA and CE Mark awards, as we are of the Business Awards, which line the building walls.” says Sally.
To produce a mechanical heart valve one of the stages involves securing a fabric onto the valve housing (a pure titanium ring) using a needle and thread. The fabric is stitched in place by hand. This is all done in a Class 10,000 Cleanroom. As Sally says: “The Levi factory was never like this!”
Early in her career when she told friends she worked in a Cleanroom, they thought she worked in a “cleaning room” with a mop! Her time is now spent co‑ordinating production in her work areas, which also involves some time being spent assisting the Research & Development side of the business.
In her early 20’s, Sally realized the human dimension to biomedical skills, when her long term boyfriend Danny Anderson was diagnosed with leukemia, and treated at Glasgow Royal Infirmary, a place she had previously visited to see cardiac surgeons, and to witness her own work being implanted.
She had been going out with Danny, a Director in the family Oil & Gas business, and their respective families had known each other for generations. Thankfully, after some setbacks over the last 15 years, Danny is well and they have been married for 9 years. Danny and Sally have no family, although Danny says he feels like godfather to half of Scotland, “When you have no children of your own, you tend to inherit everyone else’s kids, especially at weekends, Christmas and Easter.” The kids parties at the Anderson’s are something of a local legend now, and they have trouble keeping the older parents away.
“At the end of the day, I know my team have made a small contribution to other peoples lives, we don’t know them, and they don’t know us, we take home much more than a pay slip from our work. That’s why we treat every valve that leaves this building as if it could end up in our own father’s or mother’s body.”
