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EP0994031B1 - Verfahren zum Herstellen eines Produkts für eine sterile Umgebung - Google Patents

Verfahren zum Herstellen eines Produkts für eine sterile Umgebung Download PDF

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Publication number
EP0994031B1
EP0994031B1 EP98650068A EP98650068A EP0994031B1 EP 0994031 B1 EP0994031 B1 EP 0994031B1 EP 98650068 A EP98650068 A EP 98650068A EP 98650068 A EP98650068 A EP 98650068A EP 0994031 B1 EP0994031 B1 EP 0994031B1
Authority
EP
European Patent Office
Prior art keywords
item
air
cleanroom
filter
packing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP98650068A
Other languages
English (en)
French (fr)
Other versions
EP0994031A1 (de
Inventor
Thomas Comerford
Patrick Joseph O'mahony
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Comerford O'mahony developments c/o OMC Engineering
Original Assignee
Comerford O'mahony developments c/o OMC Engineering
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Comerford O'mahony developments c/o OMC Engineering filed Critical Comerford O'mahony developments c/o OMC Engineering
Priority to DE69822831T priority Critical patent/DE69822831D1/de
Priority to EP98650068A priority patent/EP0994031B1/de
Publication of EP0994031A1 publication Critical patent/EP0994031A1/de
Application granted granted Critical
Publication of EP0994031B1 publication Critical patent/EP0994031B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/027—Packaging in aseptic chambers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
    • F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
    • F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
    • F24F3/167—Clean rooms, i.e. enclosed spaces in which a uniform flow of filtered air is distributed

Definitions

  • the invention relates to a process for producing items of equipment for use in a sterile environments such as semiconductor wafer or health care product production facilities.
  • the invention in a very simple manner provides for modular production of an item because all fabrication and sterility operations are dealt with at the one location and the item may be shipped directly to any destination facility. Installation work at the facility is greatly reduced and the producer has control of the sterility standard achieved.
  • the process comprises the further step of packing the item with a third packaging layer in the controlled packing room. This provides an additional level of protection to ensure sterility.
  • the cleanroom air is pumped through a pre-filter and subsequently through a HEPA filter.
  • input air to the pre-filter is a combination of external air and re-circulated air, and the pre-filter includes chemical adsorption filtration media.
  • the proportion of external air is approximately 10% by volume. It has been found that this provides a particularly consistent sterile environment.
  • the re-circulated air is pumped through low vents into air walls, upwardly through the air walls and overhead into the pre-filter.
  • the polishing step comprises the sub-steps of pre-cleaning descaling, electropolishing, passivation, sodium bicarbonate flushing and deionised water rinsing.
  • the electropolishing is performed with phosphoric, sulphuric, and organic solutions.
  • Fig. 1 there is shown a plan view of a production facility in which single lines indicate the production areas and double lines indicate process flow.
  • the process of the invention produces stainless steel fabricated items for use in a sterile environment.
  • step 2 the item is fabricated.
  • An important aspects of fabrication is that consistent and accurate workplace fabrication is ensured by use of jigs. All tubes are bent using a mandril tube bender to minimise the number of welded joints. Welding is 100% and is free from pinholes to avoid electrolytes becoming trapped in joints.
  • step 3 the item is treated in a pickling area in which nitric hydrofluoric acid is used at varying strengths according to time and oxide thickness.
  • This area has negative pressure by action of an extraction unit.
  • polishing involves the sub-steps of electropolishing, passivation, sodium bicarbonate flushing and dionised water rinsing.
  • Polishing ensures that minute particles introduced during the fabrication step 2 are eliminated. This is particularly important because these impurities may be fused during welding. Also, the fabrication step 2 may introduce contamination by:-
  • step 20 the item is precleaned with an alkaline spray to remove any organic matter.
  • step 21 the item is rinsed with deionised water.
  • step 22 the item is descaled with nitric HF at a concentration of 6 to 25%.
  • a particularly preferred concentration within this range is 15% Nitric Acid in 10% hydrofluoric acid.
  • the item is rinsed in step 23 with high pressure dionised water pumped as a power jet at 1400 kPa.
  • the electropolishing tank preferably includes 53% H 2 SO 4 , 22% H 3 PO, 23% H 2 O, 2% aniline.
  • the temperature is maintained at 55°C.
  • There is a low voltage DC supply providing a current of 10 to 50 A/dm 2 .
  • step 25 the item is rinsed with a power spray.
  • the item is passivated with 10 to 50% nitric solution in step 26.
  • the preferred solution concentration is 20%.
  • the passivation neutralises carbon elements which may have adhered to the tubes by dissolution in nitric acid.
  • step 27 there is sodium bicarbonate treatment in which items are immersed in a 4% solution of this chemical and agitated so that the chemical passes through all the internal cavities.
  • the item is rinsed with deionised water in step 28 using a power jet delivering 1400 kPa.
  • step 7 The item is then dried in step 7 in a drying area maintained at a positive pressure.
  • Drying involves blowing hot air which has been treated to sub-micron filtration by use of HEPA filters.
  • step 8 the item is transferred into a buffer area, which is also at a positive pressure relative to the previous area.
  • the buffer area separates the drying area from a cleanroom, in which the item is cleaned and packed.
  • the cleanroom is described in more detail below.
  • the drying step 7 is very important as it ensures that internal surfaces of the item such as the internal surfaces of tubes are thoroughly cleaned to the extent that they do not include residues arising from the polishing step 4. Transfer to the buffer area helps to ensure that the cleanroom is maintained according to a particular sterility specification
  • the item is cleaned using laboratory grade isopropyl alcohol manually applied using cleanroom wipes selected to avoid particulate or outgassing residues.
  • the cleanroom is indicated by the numeral 40 and it comprises an air inlet 41 which passes air through a pre-filter 42.
  • the air is then distributed in a manifold which pumps it through HEPA filters 43 before it is directed downwardly into the space.
  • the flow rate is 0.7 m/s. However, the flow rate may be in the region of 0.3 to 0.9 m/s.
  • the air is directed through vents 44 and into vertical air walls 45 at each of the four sides of the cleanroom.
  • the air is then directed back into the pre-filter 42. Approximately 90% of the air is re-circulated in this manner, the remaining 10% being introduced from the external environment.
  • the cleanroom environment is at least as sterile as that of the facility to which the item is to be shipped, in this case Class 1000 sterility.
  • Chemical filtration media are used in the pre-filter to prevent ingress of trace ionic or organic airborne film into the cleanroom.
  • Solvent vapours are separately extracted by fans connected to adsorption filters.
  • An important aspect of the cleanroom operations is that after cleaning the item is immediately packed in non-outgassing polymeric material within a Class 1000 environment. Complex assemblies are also vacuum pack to ensure integrity.
  • Packaging material is selected to be free of plasticiser and polysilicates. Sealing tapes are also free of solvents and volatile chemicals. Examples of packaging materials and tapes are cleanroom quality polypropylene and acrylic adhesive.
  • the item After transfer from the buffer area the item is packed with a second layer of packaging in step 10. While in the same area, the item is finally packed with a third packaging layer in step 11.
  • the material for the second and third packaging layers is impervious to airborne ingress or adsorption of organic or ionic matter. Suitable high density polypropylene film satisfies these requirements.
  • the item After final inspection in step 12, the item is shipped to the destination.
  • the procedure is to remove the third packaging layer and the second packaging layer in an area adjacent to the sterile environment.
  • the first packaging layer In the sterile environment, the first packaging layer is removed and there is no need to clean the item and it may be installed directly.
  • the invention in a very simple manner allows sterility control at a central production location at which all of the fabrication, surface treating and sterility aspects are dealt with. This provides significantly improved control as there is no reliance on personnel or the environment at the destination.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Combustion & Propulsion (AREA)
  • General Engineering & Computer Science (AREA)
  • Cleaning By Liquid Or Steam (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)

Claims (9)

  1. Verfahren zur Herstellung eines Artikels für eine sterile Umgebung, wobei das Verfahren folgende Schritte umfasst:
    Herstellen des Artikels aus rostfreiem Stahl;
    Polieren des Artikels;
    Trocknen des Artikels mit gefilterter heißer Luft;
    Befördern des Artikels in einen Reinraum, in dem die Umgebung gemäß einer Spezifikation geregelt ist, die der der sterilen Umgebung, in die der Artikel gesendet werden soll, entspricht oder diese übertrifft; Reinigen des Artikels mit einer Reinigungslösung und nachfolgend Verpacken des Artikels mit einer ersten Verpackungsschicht aus einem nicht ausgasenden Polymermaterial, das frei von Weichmachern und Polysilikaten ist; und
    Befördern des verpackten Artikels in einen geregelten Verpackungsraum und Verpacken des Artikels mit einer zweiten Verpackungsschicht.
  2. Verfahren nach Anspruch 1, das des Weiteren den Schritt des Verpackens des Artikels mit einer dritten Verpackungsschicht in dem geregelten Verpackungsraum umfasst.
  3. Verfahren nach Anspruch 1 oder 2, wobei die Reinraumluft durch ein Vorfilter und nachfolgend durch ein HEPA-Filter gepumpt wird und der Artikel durch eine Luftschleuse in den Reinraum befördert wird.
  4. Verfahren nach Anspruch 3, wobei die Eingangsluft in das Vorfilter eine Kombination aus Außenluft und umgewälzter Luft ist und das Vorfilter ein chemisches Adsorptionsfiltermedium umfasst.
  5. Verfahren nach Anspruch 4, wobei der Anteil an Außenluft etwa 10 Vol.-% beträgt.
  6. Verfahren nach einem der Ansprüche 3 bis 6 [sic], wobei die Luftströmungsgeschwindigkeit im Bereich von 0,3 bis 0,9 m/s liegt.
  7. Verfahren nach einem der Ansprüche 4 bis 6, wobei die umgewälzte Luft durch niedrige Entlüftungsöffnungen in Luftwände, aufwärts durch die Luftwände und über Kopf in das Vorfilter gepumpt wird.
  8. Verfahren nach einem der vorhergehenden Ansprüche, wobei der Polierschritt folgende Unterschritte umfasst: Vorreinigen, Abbeizen, elektrolytisches Polieren, Passivierung, Spülen mit Natriumbikarbonat und Spülen mit deionisiertem Wasser.
  9. Verfahren nach Anspruch 8, wobei das elektrolytische Polieren mit Phosphorlösungen, Schwefellösungen und organischen Lösungen durchgeführt wird.
EP98650068A 1998-10-14 1998-10-14 Verfahren zum Herstellen eines Produkts für eine sterile Umgebung Expired - Lifetime EP0994031B1 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE69822831T DE69822831D1 (de) 1998-10-14 1998-10-14 Verfahren zum Herstellen eines Produkts für eine sterile Umgebung
EP98650068A EP0994031B1 (de) 1998-10-14 1998-10-14 Verfahren zum Herstellen eines Produkts für eine sterile Umgebung

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP98650068A EP0994031B1 (de) 1998-10-14 1998-10-14 Verfahren zum Herstellen eines Produkts für eine sterile Umgebung

Publications (2)

Publication Number Publication Date
EP0994031A1 EP0994031A1 (de) 2000-04-19
EP0994031B1 true EP0994031B1 (de) 2004-03-31

Family

ID=8235873

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98650068A Expired - Lifetime EP0994031B1 (de) 1998-10-14 1998-10-14 Verfahren zum Herstellen eines Produkts für eine sterile Umgebung

Country Status (2)

Country Link
EP (1) EP0994031B1 (de)
DE (1) DE69822831D1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108735634A (zh) * 2018-05-29 2018-11-02 陈欣洁 一种半导体二极管酸洗系统

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112185852B (zh) * 2020-09-21 2023-08-18 武汉光谷航天三江激光产业技术研究院有限公司 用于半导体器件封装的可搬运级联式百级洁净装置及方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4065816A (en) * 1975-05-22 1978-01-03 Philip Nicholas Sawyer Surgical method of using a sterile packaged prosthesis
US4171740A (en) * 1976-09-07 1979-10-23 Monsanto Company Wafer packaging system
US4880581A (en) * 1986-12-24 1989-11-14 Alcon Laboratories, Inc. Means and method for aseptic particle-free production of articles
US4987673A (en) * 1987-06-18 1991-01-29 Mitsubishi Denki Kabushiki Kaisha Apparatus for packaging semiconductor devices
DE4121327C1 (en) * 1991-06-28 1992-09-17 Fraunhofer-Gesellschaft Zur Foerderung Der Angewandten Forschung Ev, 8000 Muenchen, De Local clean space module e.g. for exposure in semiconductor mfr. or packing sterile product - has inlets providing clean air of various qualities at predetermined areas of internal space limited by socket module with hood above

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108735634A (zh) * 2018-05-29 2018-11-02 陈欣洁 一种半导体二极管酸洗系统
CN108735634B (zh) * 2018-05-29 2020-11-27 朝阳微电子科技股份有限公司 一种半导体二极管酸洗系统

Also Published As

Publication number Publication date
EP0994031A1 (de) 2000-04-19
DE69822831D1 (de) 2004-05-06

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