WHO控制区洁净服管理english

Garment management for controlled environments: an introduction getting started test ing typica l c leanroom laundry funct ion garment management systems c leanroom garments contaminat ion contro l1 2 3 4 6 5 the micronclean organisation c o n t e n t Micronclean International was established in the 1980’s to meet the growing need for professional cleanroom clothing management services. Now Micronclean is present throughout the world and has a portfolio of customers in diverse industrial and service organisations. The organisation operates to the highest standards of professionalism, working within the very latest international codes of practice. It is recognised as an innovator, having contributed significantly to modern cleanroom garment design and management techniques. All Micronclean centres operate from modern premises and with a workforce committed to a ‘right first time’ philosophy. Objectives and philosophy We aim to be the best! We are prepared to meet the ever increasing technical demands on fabrics, clothing style production and the disciplines required within our processing plants. Only by being the best do we expect to command the respect and future business from our customers. The International dimension Micronclean has but one standard - the highest possible quality. Our procedures are common to all processing plants and our policy of closed loop garment management is designed to ensure efficient tracking and optimised asset management irrespective of geographical location. One policy, one standard! Communication with customers All Micronclean companies have a commitment to communicate with their customers. The results for garment performance and the processing are both communicated. We help you with the training of your personnel. We keep you informed on international standards and developments and we help you to find any specific information you might need. Micronclean is putting a lot of effort into the continuous improvement of our communications by using technology (e.g. the internet). Global guarantee When you are served by a Micronclean company, you have the assurance of dealing with a quality global cleanroom solution partner. Uninterrupted service Every Micronclean company has a fully detailed contingency plan with another Micronclean plant to ensure your cleanroom garment needs are always met. Leading edge technology Micronclean companies undergo a formal technology audit every six months. Then, against a peer group of advanced cleanroom operations from around the globe, quality of output, equipment capabilities and quality systems are analysed, compared and refined. Research and development Micronclean International has permanent R&D projects. These projects include all elements of the cleanroom services we offer, be it specific decontamination processes for a certain industry, garment and fabric development. We have our own testing facilities and co-operate with specialised research laboratories where needed. Most of the time we include some of our customers in our R&D projects to combine our know-how with practical experience. Cleanroom solution partner All twenty-plus Micronclean companies around the globe share informaton. They are truly partnering with customers to find solutions for all their cleanroom needs. Micronclean International has unparalleled depth to call upon to help find those optimal solutions. We have resources around the globe, with experience in every cleanroom application, classification and service aspect. Micronclean companies lead the industry and can rapidly bring the experience and knowledge to help solve your toughest problem. the micronclean organisation Garment management for controlled environments: an introduction 3 Low cost provider Micronclean companies benchmark all leading indicators of efficiency and performance on a continuous basis. Copy exactly Micronclean International understands international customer’s need for identical cleanroom processes across multiple locations. We are uniquely positioned to accommodate “copy exactly” requirements. We speak a common language around the globe and have a support team charged with facilitating cross-site communication. We operate international working groups and an aggressive schedule of cross training and visitation programmes. International standards Micronclean International has representatives at the standards bodies which impact your business and quality requirements. Micronclean International has the manpower and international reach to stay abreast of developments communicating them promptly around the globe. Micronclean companies meet all recognised standards. Market coverage Principle areas of operation include: Microelectronics - Pharmaceuticals - Opticals - Biotechnology - Telecommunications - Aerospace & Defence - Medical devices - Static Sensitive Areas - Hospital Pharmacies - Cosmetics - Food Processing - ... With this brochure Micronclean International provides you a basic knowledge of contamination control and garment management for cleanrooms. We will be pleased to assist with any information you might request. the micronclean organisation Garment management for controlled environments: an introduction 4 Headquarters: Micronclean International Diedenweg 94 6717 KV Ede the Netherlands phone: +31 318 622 484 fax: +31 318 630 444 info@micronclean-international.com www.micronclean.com Members Europe: AUSTRIA Micronclean Austria Wozabal Sterilgut-Systeme Atterseestraße 97 4860 Lenzing phone: +43 7672 913 0 fax: +43 7672 913 85 www.wozabal.com BELGIUM Micronclean Belgium Scaldis St.Martin 36, rue de la Hurtrie 7600 Peruwelz phone: +32 69 77 16 25 fax: +32 69 77 57 70 www.micronclean.com DENMARK Micronclean Denmark Berendsen Textil Service Vølundsvej 12 4300 Holbæk phone: +45 59 43 22 22 fax: +45 59 43 53 72 www.berendsen.com FRANCE Micronclean France Initial Services Textiles Parc d’activités de Villejust 6, rue Lionel Terray 91971 Courtaboeuf phone: +33 1 69 31 76 80 fax: +33 1 69 31 76 89 www.initial-btb.fr GERMANY Micronclean Germany Bilger-Schwenk Stollweg 6 72760 Reutlingen phone: +49 7121 3121 57 fax: +49 7121 3121 21 www.micronclean.de HOLLAND Micronclean Holland Micronclean Koopman Heeresweg 10 8701 PR Bolsward phone: +31 515 578 990 fax: +31 515 578 981 www.micronclean.nl IRELAND Micronclean Ireland Micron Clean (Ireland) Spiddal Industrial Estate Spiddal, Co. Galway phone: +353 91 553 066 fax: +353 91 553 068 www.micronclean.ie ITALY Micronclean – ICS Italy Linen Supply Italiana Via Cesare da Sesto 15 20123 Milano MI phone: +39 02 89 40 05 23 fax: +39 02 89 40 14 93 www.intlcleanroom.com SWEDEN Micronclean Sweden Berendsen Textil Service Rättarvägen 4 611 35 Nyköping phone: +46 155 20 96 00 fax: +43 155 28 49 40 www.berendsen.com Micronclean Sweden Berendsen Textil Service Axel Danielssons väg 195 215 92 Malmö phone: +46 40 36 80 00 fax: +46 40 36 80 60 www.berendsen.com UNITED KINGDOM Micronclean Newbury Micronclean C1 Faraday Road Newbury, Berkshire RG14 2AD phone: +44 1635 37901 fax: +44 1635 31528 www.micronclean-newbury.co.uk Micronclean Skegness Micronclean Roman Bank Skegness, Lincolnshire PE25 1SQ phone: +44 1754 767377 fax: +44 1754 610344 www.micronclean.co.uk Members America: BRAZIL Micronclean – ICS Brazil ALSCO Toalheiro Brasil Rua Conde de Itú, 875 04741-001 São Paulo phone: +55 11 5523 8722 fax: +55 11 5523 6961 www.intlcleanroom.com USA Micronclean – ICS USA American Cleanroom Garments P.O. Box 82269 Portland, OR 97282-0269 phone: +1 503 233 5445 fax: +1 503 235 0509 www.intlcleanroom.com Micronclean – ICS USA American Cleanroom Garments 971 Northpoint Boulevard Waukegan, IL 60085-8214 phone: +1 847 473 1200 fax: +1 847 473 4595 www.intlcleanroom.com Micronclean – ICS USA American Cleanroom Garments Servitex Cleanroom Services 3 Yadkin Street Durham, NC 27703 phone: +1 919 957 9800 fax: +1 919 957 0403 www.intlcleanroom.com Members Australia: Micronclean – ICS Australia Clean Room Products 1 Carlotta Street Artamon NSW 2064 Sydney phone: +61 2 9439 3622 fax: +61 2 9437 4351 www.intcleanroom.com the micronclean organisation Garment management for controlled environments: an introduction 5 Micronclean International Contamination control is a key element in the concept of the zero defect philosophy employed by an increasing number of modern production and service organisations. Few productive entities escape the need for close attention to contamination control. Gone are the days when cleanroom concepts were confined to ‘leading edge’ space and biological developments. The cleanroom philosophy can now be found in production environments as diverse as vehicle finishing and food processing where all important added value factors are reliant on quality and performance. 1.1. The nature of contamination Contamination can be considered as anything which has an effect on the quality or performance of something being created. Contaminates can take the form of particulate, biopollutants, chemical cross-contamination or electrical charges (ESD), which individually or collectively can have a deleterious effect on product or process performance. That such contaminates can be of infinitesimally small or of surprisingly large proportion - as small as 0,1 micrometers in the case of particulate or as high as 0,1 Amp in ESD terms - makes the task all the more challenging. Furthermore, no single element can be considered in isolation. The integrity of any process is only as strong as its weakest link, be that in the operating environment, the logistics including style, composition and comfort of clothing or in the inherent disciplines which must be maintained throughout the cycle. By working within a controlled area like a cleanroom, some pollutants can be filtered out, others eliminated by improvements in the production environment. Airborne particles - skin, fibres, bacteria - pose the greatest challenge. 1.2. Different contaminants Whilst there are many different potential contaminants, these four pose the greatest threat: 1.2.1. Dust In this context this can be considered as skin shed by operatives or particulate matter brought into the production area from outside either by operatives or through poorly filtered purging air. (fig. 01) 1.2.2. Bacteria In the broadest sense this embraces not only particulate and chemical pollutants likely to affect the quality of production but also the health of operators. Thus production chemicals and incoming air must be strictly controlled. This is mainly a problem for pharmaceutical and food processing industries. (fig. 02) 1 contamination control Garment management for controlled environments: an introduction 6 fig. 01 fig. 02 1.2.3. Chemicals Potential cross-contamination from process-to-process or from bodies, garments or equipment entering the controlled environment. 1.2.4. Electrical charge Static electricity is a contaminant causing possible problems in all areas of cleanroom activity. Polyester cleanroom garments produce static electrical charge as fabric is in contact with fabric or with garments worn under the cleanroom garments. Electrical charges of many thousands of volts may be present on the garments during use. The charge may be discharged at any time to the cleanroom structure, articles or products in the cleanroom. Discharges of static electricity may cause problems in the following ways: - Microelectronics: the discharge of static electricity may damage sensitive products such as microchips and disc drives. Discharges of static electricity occur so rapidly that current flow for a short duration may be high enough to damage products. Damage may weaken components causing premature failure. - Pharmaceuticals: these cleanrooms are not normally associated with products that are damaged by electrostatic discharge, however many pharmaceutical cleanrooms require protection: - Protection against explosion caused by spark discharges - Protection against damage to sensitive microelectronic measuring equipment - Protection against attraction or repulsion of micro-organisms by electrically charged cleanroom garment fabrics. 1.3. Cleanrooms The history of cleanrooms starts during World War II. Indeed during the assembly of the first atomic weapons, it was found that some of the problems were related to dust. The idea of the HEPA (High Efficiency Particulate Air Filter) was introduced in an air-conditioned environment. A next step in the development of cleanroom techniques was the space race. Dust particles caused problems in the liquid oxygen release valves in the rockets. This introduced a research programme to develop precision component assembly methods. This programme led to the laminar flow cleanroom. Microelectronics and the pharmaceutical industries started using cleanrooms in the 60’s and 70’s. Since the 80’s other industries became interested in the advantages of cleanrooms for their critical production processes. Now we find cleanrooms in such diverse industries as: opticals; biotechnology; tele- communications; aerospace & defence; medical devices; static sensitive areas; hospital pharmacies; cosmetics; food processing; ... Cleanroom concepts also found their way into the modern operating theatres. A cleanroom is an enclosed space served by HEPA filtered air at positive pressure. In view of the major threat to the ‘clean’ environment posed by humans, the area should preferably be unpopulated by operators - obviously not always possible. Modern cleanrooms are extremely efficient in reducing contamination but there are no standard solutions. Each industry and location has its own priorities. To a micro- electronics specialist the problem of static electricity is probably as critical as particulate contamination; to a micro-biological company the attendant risk might well come from the danger from toxins or explosion. Each project must be the subject of individual risk assessment. Logically, the current trend is towards compact, localised cleanrooms or compartmentalised workstations for essential clean working rather than large volume coverage. This approach is most flexible, controllable and economical. Whilst much has been achieved in the design of production benches and equipment, such elements now contribute about half the pollution, the balance being from incoming air, gases, chemicals and people. 1 contamination control Garment management for controlled environments: an introduction 7 RA RA Turbulent SA Displacement RA RA Turbulent SA Displacement 1.4. Basic cleanroom concepts Modern cleanrooms fall into two principal categories: - Unidirectional cleanrooms (fig. 03). The airflow in this type of cleanroom is often vertical. The air flows downwards through HEPA or ULPA (Ultra Low Penetration Air) filters located in the ceiling and is extracted through perforated flooring or grilles mounted in the walls at floor level. Airflow in unidirectional cleanrooms may also be horizontal when the air flows through a full wall of filters and is extracted through returns in the opposite wall. Horizontal airflow is used in applications where operations with stringent cleanliness requirements take place close to the wall of filters and operations with decreasing cleanliness requirements take place “downstream” (meaning further away from the filter wall). - Non-unidirectional cleanrooms (fig. 04). In this type of cleanrooms the air flows from HEPA or ULPA filters located in various positions and is returned through opposite locations. Filters may be distributed at equal intervals throughout the cleanroom or grouped over critical areas. Because of the distribution of the filters and returns, the airflow may be turbulent in nature. In several cleanrooms a combination of both types can be found. 1 contamination control Garment management for controlled environments: an introduction 8 Horizontal SA RA Vertical SA RA Horizontal SA RA Vertical SA RA fig. 04 fig. 03 The classification of the cleanroom environment is determined by the number of particles of a given size in a cube of air at any moment. Fig. 05 illustrates the established standard classifications for controlled environments. These form part of internationally accepted working practices detailed elsewhere in this publication. Class limits (particles/m3) ISO 14644-1 Fed Std. 209E 0,1 µm 0,2 µm 0,3 µm 0,5 µm 1 µm 5 µm ISO Class 1 101= 10 2 ISO Class 2 102= 100 24 10 4 ISO Class 3 Class 1 103= 1.000 237 102 35 8 ISO Class 4 Class 10 104= 10.000 2.370 1.020 352 83 ISO Class 5 Class 100 105= 100.000 23.700 10.200 3.520 832 29 ISO Class 6 Class 1.000 106=1.000.000 237.000 102.000 35.200 8.320 293 ISO Class 7 Class 10.000 352.000 83.200 2.930 ISO Class 8 Class 100.000 3.520.000 832.000 29.300 ISO Class 9 35.200.000 8.320.000 293.000 fig. 05: Airborne particulate cleanliness classes 1 contamination control Garment management for controlled environments: an introduction 9 1.5. Cleanroom standards The construction and operation of cleanrooms is subject to a number of international standards and recommended practices. The first standard on cleanrooms was the American Federal Standard 209, which has been revised several times. The role of this Federal Standard will be taken over by the international standard ISO 14644. For the operation of cleanrooms several standards and recommended practices have been developed by standardisation bodies such as ISO and CEN or controlled environment organisations such as IEST, FDA, ... In most cases these organisations are related to a specific industry, e.g. HACCP for the food processing industry, GMP for the pharmaceuticals, ... 1.6. The human element Between 40 % and 80 % of contamination can be traced to human operatives working in cleanrooms. The threat posed by human intrusion into cleanrooms is obvious - each of us sheds our outer layer of skin approximately every week in the form of loose particles (about 4/5 micrometers) or groups of cells typically 25/30 micrometers or larger. Abrasion can grind these into a fine powder, using convection to issue these particles - some of which contain chemical or bio residues - into the atmosphere. Fig. 06 shows the particulate shed by humans during a range of activities. Sex, age, temperature differentials and patterns of activity all have a bearing on the rate of issue, as do contaminants from clothing, cosmetics and personal hygiene. Garment management for controlled environments: an introduction 10 100.000 500.000 1.000.000 2.500.000 5.000.000 10.000.000 15.000.000 30.000.000 fig. 06 1 contamination control 1.7. Use of specialist clothing The human body creates its own micro-environment of potentially damaging particulate contamination (fig. 07). Since humans are essential to production situations, damage limitation through the use of purpose-designed cleanroom clothing has proved to be the most practical solution to the problem. The use of specialist clothing is now commonplace. To be effective it must: - form a particulate barrier for the human micro-environment - allow freedom of movement and be comfortable - address any specialist requirement, e.g. static dissipation - avoid being a significant particulate contributor itself Details of parameters for garments including those for the head, torso and feet are included in section 2 of this publication. 1 contamination control Garment management for controlled environments: an introduction 11 fig. 07 2.1. Garment materials As mentioned in the previous section, people are one of the greatest contaminants in a controlled environment. Therefore we need specialised garments to protect the environment and the workplace from the human contaminant. Cleanroom garments are unique as they must me