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Update on ISO Cleanroom Standards – 14644 & 14698

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Update on ISO Cleanroom Standards – 14644 & 14698

15 ISO 14644 & 14698-Overview ISO 14644 & 14698 Standards ISO Document Title ISO-14644-1 Classification of Air Cleanliness - 1999 ISO-14644-2 Testing for Continued Compliance to -1 -1999

http://www.oerrg.at/ueber-uns/aktuelles/ISO%20Cleanroom%20Standards%20ORRG%20July%202012%20-%20Conor%20Murray.pdf

Date added: October 15, 2012 - Views: 251

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The ISO contamination control standards - ICCCS

ISO 14698-2 Biocontamination control: Evaluation and interpretation of biocontamination data FDIS 04.03 ... control standards is compiled. ISO/DIS 14698-1.213 is devoted to the general principles of the measurement of biocontamination.

http://www.icccs.net/news/ContamCtrlStdsSchicht.pdf

Date added: February 13, 2012 - Views: 369

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INTERNATIONAL STANDARD 14698-2 - Esileht - Eesti Standardikeskus

ISO 14698-2:2003(E) © ISO 2003 — All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical

http://www.evs.ee/eelvaade/iso-14698-2-2003-en.pdf

Date added: May 21, 2013 - Views: 100

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FS209E and ISO Cleanroom Standards - Terra Universal

ISO 14644-2 describes the type and frequency of testing required to conform to certain standards. ... ISO 14644-8 Molecular Contamination ISO 14698-1 Biocontamination: Control General Principles ISO 14698-2 Biocontamination: Evaluation and Interpretation of Data

http://www.terrauniversal.com/file_library/federalcleanroomstandards_010412164241.pdf

Date added: September 20, 2012 - Views: 373

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INTERNATIONAL STANDARD 14698-1 - Esileht - Eesti Standardikeskus

ISO 14698-1:2003(E) © ISO 2003 INTERNATIONAL STANDARD ISO 14698-1 First edition 2003-09-01 Cleanrooms and associated controlled ... ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: ...

http://www.evs.ee/eelvaade/iso-14698-1-2003-en.pdf

Date added: April 29, 2012 - Views: 747

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iso 14698 - SAI Global

EN ISO 14698-1:2003 (E) 2 Foreword This document (EN ISO 14698-1:2003) has been prepared by Technical Committee ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with Technical Committee

http://www.saiglobal.com/PDFTemp/Previews/OSH/IS/EN/2003/I.S.ENISO14698-1-2003.pdf

Date added: April 29, 2012 - Views: 118

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international standard 14698 2

en iso 14698-2 oprava 1 12 5370 listopad 2006 ?eskÁ technickÁ norma ... international standard iso 14698-2:2003 technical corrigendum 1 published 2004-11-01. Update on ISO Cleanroom Standards – 14644 & 14698.

http://www.pdfspath.com/download/international%20standard%2014698%202.pdf

Date added: August 4, 2014 - Views: 1

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iso 14698 filetype - Bing - Free PDF Downloads Blog ...

ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. Title: iso 14698 filetype - Bing Created Date:

http://pdfsdir.com/download/iso-14698-filetype.pdf

Date added: April 16, 2014 - Views: 6

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international standard 14698 1

International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. iso 14698 - SAI Global. http://www.saiglobal.com/PDFTemp/Previews/OSH/IS/EN/2003/I.S.ENISO14698-1-2003.pdf

http://www.pdfspath.com/download/international%20standard%2014698%201.pdf

Date added: August 4, 2014 - Views: 1

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ISO/FDIS 14644 – 9 CLEANROOMS AND ASSOCIATED CONTROLLED ...

1 ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. ISO/FDIS 14644-9 provides a classification for the determination and designation of surface

http://www.swissccs.org/d/docs_db/srrt_20120419_105926_02%20Abstract_ISO%20FDIS%2014644-9_e_Straub.pdf

Date added: September 27, 2012 - Views: 227

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Cleanroom Design Basics - ASHRAE chapters

ISO-14644-2 Cleanroom Testing for Compliance ISO-14644-3 Methods for Evaluating & Measuring Cleanrooms & Associated Controlled ... ISO-14698-1 Biocontamination: Control General Principles ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data

http://pakistan.ashraechapters.org/web2/pdf/Seminar%201%20-%20Cleanroom%20&%20HVAC%20Design%20-%20Karachi.pdf

Date added: June 3, 2012 - Views: 119

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ČSN EN ISO 14698-2 OPRAVA 1 - ČSN online pro firmy s více ...

ICS 13.040.35 ČSN EN ISO 14698-2 OPRAVA 1 12 5370 Listopad 2006 ČESKÁ TECHNICKÁ NORMA Čisté prostory a příslušné řízené prostředí –

http://pdfonline.cni.cz/wwwcsni/opravy/12/69438/Zmeny/76212.pdf

Date added: April 29, 2012 - Views: 13

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ISO TC209 Standards Overview - PharmOut

ISO 14644-2 First edition 2000-09-15, Cleanrooms and associated controlled environments — Part 2: Specifications for monitoring and periodic testing to prove continued ... ISO 14698-2 First edition 2004-11-01, Cleanrooms and

http://www.pharmout.net/downloads/pres-01-ISO-TC209-overview-13jun12.pdf

Date added: November 17, 2012 - Views: 16

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Cleanrooms and associated controlled environments ...

BS EN ISO 14698-2:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 24 October 2003

http://files.instrument.com.cn/bbs/upfile/files/20100416/2010416114011.pdf

Date added: June 26, 2013 - Views: 7

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POPRAWKA do POLSKIEJ NORMY

Technical Corrigendum 1 to ISO 14698-2:2003 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. Page 1 3.1. Delete the word “microbiological” from the definition “microbiological level ...

https://sklep.pkn.pl/fileuploader/download/download/?d=0&fileId=5758

Date added: April 16, 2014 - Views: 3

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New Support for ISO14644-1 - MET ONE and HIAC Particle Counters

The International Standards Organization Technical Committee ISO TC 209 has decided that, ... revision of ISO 14698-1 and -2 for the classification of the cleanroom environment by ... Particle Counter: Changes in ISO 14644-1 to improve confidence in quality for critical life-science ...

http://www.particle.com/wp-content/uploads/downloads/2012/05/Particle-Counting-ISO-21501-Application-Note-New-Support-for-ISO-14644-1.pdf

Date added: January 13, 2013 - Views: 134

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Voorbeeld - NEN

Nederlandse norm NEN-EN-ISO 14698-2 (en) Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of

http://www.nen.nl/pdfpreview/preview_87938.pdf

Date added: August 6, 2013 - Views: 1

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Environmental Monitoring methods for Decontamination Units

ISO 14698: Part 1:2003 and EN ISO 14698 Part 2:2003) Joy Markey HSE 2012 Environmental control ... Entry to the decontamination unit should be restricted to authorised personnel only. ...

http://www.wfhss.com/html/conf/wfhss-conference-2012/lectures/wfhss_conf20121121_lecture_sp_s301_en.pdf

Date added: January 30, 2013 - Views: 2

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Clean Room Particulate Count - Portland State University

Clean Room Particulate Count . Date - 2/28/2012 . Device - Met One Particulate Counter . Mdl. A2408-1-115-1 . Cal. Date: 4/12/11 by Hach Ultra (Cal#000200172) ... ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data

http://www.pdx.edu/pnna/sites/www.pdx.edu.pnna/files/Clean_Room_Particulate_Count.pdf

Date added: October 21, 2012 - Views: 31

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Biological Air Sampling Product Line Overview

PMS Proprietary and Confidential Information Objectives of ISO 14698 – 1 Establishes definition of a Formal System for what is to be included in ‘any’ biological

http://www.pmeasuring.com/wrap/files/BiologicalSamplers/ver_1271038094/microbial.pdf

Date added: March 2, 2012 - Views: 25

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Physical Efficiency Testing of the bioMérieux air IDEAL 3P ...

Physical Efficiency Testing of the bioMérieux air IDEAL 3P ® air sampler following the ISO 14698-1 standard bioMérieux Industry Culture Media Group, Chemin de l’Orme, 69280 Marcy L’etoile, France

http://www.biomerieux-usa.com/upload/airIDEAL-Physical-Efficiency-Testing-1.pdf

Date added: April 29, 2012 - Views: 19

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AS/NZS ISO 14644.5:2006 Australian/New Zealand Standard

ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing ... ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=495632

Date added: May 10, 2012 - Views: 69

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Irish Cleanroom Society Open Day, Workshop & Podcast 25 June 2014

Background Technical Committee TC 209 is responsible for ISO 14644 & 14698 standards dealing with airborne and surface contamination in cleanrooms and controlled environments.

http://www.wfhss.com/html/conf/assets/ie_ics_conf20140625_en.pdf

Date added: June 26, 2014 - Views: 1

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Deutsche Akkreditierungsstelle GmbH Annex to the ...

DIN EN ISO 14698-1 DIN EN ISO 14698-2 Supplement guidance on sterile products . Annex to the accreditation certificate D-PL-18488-03-00 Period of validity: 09.12.2013 to 05.06.2018 - Translation 11/19 Date of issue: 09.12.2013 Corpus of legislation4

http://www.ul-mdt.com/fileadmin/user/Resource_Center/Certificates/Accreditation_Scope.pdf

Date added: February 23, 2014 - Views: 2

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SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 NORTH AMERICAN ...

USP <71>, ISO 11737-2, ISO 11135, ISO 11137 Sterility ISO 14698-1 Gram Stain & Colony Morphology ISO 10993:5, USP <87> Cytotoxicity Assay – Elution Method (48-hour Exposure): L929 Cells

http://www.namsa.com/Portals/0/Documents/ISO17025_Biological_CA_2419-02.pdf

Date added: September 26, 2012 - Views: 26

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Cleanroom Air Systems Design - High-Performance Buildings for ...

ISO 14698-2 Evaluation and interpretation of ... ISO class 5 LBNL Cleanroom Benchmark Data ISO Class 5 (Class 100) Cleanrooms 0 100 200 300 400 500 600 Facility A Facility B Facility C Facility D Facility E Facility F Facility G Facility H M e a s ur e d A i r C h a n g e R a te (A C /

http://hightech.lbl.gov/presentations/cleanroom_air_design.pdf

Date added: March 15, 2012 - Views: 50

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CLEANROOM ENVIRONMENTAL MONITORING - Kenelec

4 Microbiological Air Sampling & ISO 14698 Selecting the right Air Sampler According to ISO 14698-1 2003 Annex A.3.2 there are many factors to consider when choosing an Air Sampler.

http://www.kenelec.com.au/sb/modules/news/attachments/21/CEM052010.pdf

Date added: October 29, 2012 - Views: 5

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Rebecca is an Irish Subject Matter Expert (SME) Irish ...

ISO 14698 -1 & -2:2003 deal with airborne and surface Biocontamination. WG 02 has been meeting since 2009 to explore the value and application of Microbiological Classification Tables in line with ISO 14644 and carry out a systematic revision.

http://www.cleanrooms-ireland.ie/index.cfm/fuseaction/common.files/id/AE2D7328198E47E88F019AE6833F31AB

Date added: May 27, 2013 - Views: 7

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ISO Std. 14644 Clean Rooms

ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces . Title ISO Std. 14644_Clean Rooms Author: Raimondo.Moroni Created Date: 12/11/2013 2:33:00 PM

http://emits.sso.esa.int/emits-doc/ALENIA/Exomars/ExoMars_Mission_2018/ALD_MGSE/ISO_Std.14644_CleanRooms.pdf

Date added: May 19, 2014 - Views: 5

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Standards for classification and testing of cleanrooms - ICCCS

2 ISO Standards A range of cleanroom standards is being produced by the International Organization for ... 2.2 ISO 14698 This consists of the ... During the clean room qualification it should

http://www.icccs.net/news/ClassificationOfCleanrooms2005.pdf

Date added: February 9, 2012 - Views: 165

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Pairing ISO standard series with new IEST Recommended Practices

ISO/DTR 14698-3 Biocontamination CC013.2: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Control–Methodology for Measuring the Cleanrooms and Other Controlled Environments (2006)

http://www.researchgate.net/profile/Tengfang_Xu/publication/241959939_Keeping_up_with_New_Challenges_in_Contamination_Control_AcrossIndustries_Pairing_ISO_Standard_Series_with_New_Set_of_IEST_RecommendedPractices/file/50463526073e6e7629.pdf

Date added: June 4, 2014 - Views: 1

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INTERNATIONAL STANDARD 14644-7 - SAI Global

In applications with biological contamination requirements, ISO 14698-1 and 14698-2 will apply. However, some applications can have special requirements for monitoring because of ... ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: ...

http://www.saiglobal.com/PDFTemp/Previews/OSH/iso/updates2004/wk41/ISO_14644-7_2004%28E%29-Character.pdf

Date added: June 3, 2013 - Views: 4

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SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 NORTH AMERICAN ...

ISO 14698-1 Incubation and Enumeration of Fallout Plates, RODAC® Plates, or Air Sampler Media ... USP <71>, ISO 11737-2, ISO 11135, ISO 11137 Sterility ISO 14698-1 Gram Stain & Colony Morphology ISO 10993:5, USP <87> Cytotoxicity Assay ...

http://www.namsa.com/Portals/0/Documents/Biological%20Irvine.pdf

Date added: June 5, 2013 - Views: 13

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ISO Update - April 2014 - ISO - International Organization ...

2 ISO Update, Supplement to ISO Focus -- April 2014 TC 146 Air quality ISO/CD 18466 Determination of the biogenic fraction in CO2 ... ISO/CD 14698 Cleanrooms and associated controlled environ-ments — Biocontamination control — Microbial

http://www.iso.org/iso/isoupdate_april2014.pdf

Date added: April 17, 2014 - Views: 12

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Detection of Micro-organisms in Compressed Gases

The International Standard ISO 14698-1/2 1 demands the monitoring of bio-contamination in compressed gas systems which are used in pharmaceutical production processes. The norm describes the detection of bio-

http://www.swissccs.org/d/docs_db/swissccs_20131031_000319_SwissCCS_Microorganismen_Druckgase_Paper_01e.pdf

Date added: December 4, 2013 - Views: 3

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ISO 14698 & MICROBIOLOGICAL AIR SAMPLERS - Kenelec

ISO 14698 & MICROBIOLOGICAL AIR SAMPLERS Jason Kelly Kenelec Scientific This Article has been previously published in Cleanroom Technology Environments magazine USA (Nov 2005).

http://www.kenelec.com.au/sitebuilder/products/files/833/14698airsampler.pdf

Date added: July 9, 2012 - Views: 168

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Microbiological Monitoring in Aseptic Environments - IESMAT

UNI-EN-ISO 14698/1-2 for biocontamination control in cleanrooms Applicable regulations for Sterile Manufacturing •ISO Standards:

http://www.iesmat.com/iesmat/upload/5.%20Microbial%20Monitoring%20Technology.pdf

Date added: April 6, 2014 - Views: 1

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Irish Biocontamination Mirror Group

Meet Your Speakers Tony Harrison, Life Sciences Manager Pharmagraph, Convenor WG02 Tony is the Convenor of Working Group, WG02 of ISO TC 209 revising ISO 14698 -1 & -2:2003.

http://www.nsai.ie/NSAI/files/29/29f01306-76d7-4016-ba09-2e9e91fc375e.pdf

Date added: May 13, 2013 - Views: 9

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Reference Document Title Subject Matter Source

ISO 14698-1,2 Biocontamination Control General Principles AS 2252.1 Biological Safety Cabinets (Class1) Australian Std AS 2252.2 Biological Safety Cabinets (Class 2) “ AS 2647 Biological safety cabinets – Installation and use “ ASTM F ...

http://www.cleanroommanagement.com/image/data/ReferenceSource.pdf

Date added: August 2, 2014 - Views: 1

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Control your microbiological environment - Inici | servei

C o n v e n i e n t f e s bioMérieux also has a range of culture media suitable for samples in protected environments. i r air IDEAL® 3PTM Collection efficiency as per the ISO 14698 standard: High collection level

http://jornades.uab.cat/workshopmrama/sites/jornades.uab.cat.workshopmrama/files/Control_ambiental.pdf

Date added: May 13, 2013 - Views: 5

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ISO Technical Committee 209 Status Report

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data 2004 2007 - SG6 2004 2007 2003-WG2 2003-WG2. ISO TC 209 ... ISO-14644-2 Specification of Testing for Continued Compliance to -1 ISO-14644-3 Test Methods & Metrology ISO -14644 -4 Design, ...

http://www.racc.com.ro/standarde%20europene%20camere%20curate.pdf

Date added: January 8, 2014 - Views: 7

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British European and ISO Decontaminated Related Standards 27 ...

BS EN 556-2:2003 Sterilization of medical devices. Requirements for medical devices to be ... BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data

http://www.idsc-uk.co.uk/documents/British-European-and-ISO-Decontaminated-Related-Standards.pdf

Date added: August 27, 2013 - Views: 47

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Contamination Control for Pharmaceutical Industry

Pharmaceutical Industry. 2 The World Leader In Particle Counting www.particle.com Manufacture of sterile medical product ... ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency

http://drug.fda.moph.go.th/drug/zone_gmp/files/GMP2549/May1006/P1/Charn.pdf

Date added: November 24, 2012 - Views: 17

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Biological Efficiency Testing of the bioMérieux air IDEAL 3P ...

Biological Efficiency Testing of the bioMérieux air IDEAL 3P ® air sampler following the ISO 14698-1 standard versus the main commercially-available air samplers

http://www.biomerieux-usa.com/upload/airIDEAL-Biological-Efficiency-Poster-2.pdf

Date added: June 29, 2012 - Views: 1

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FAQ – Microbial - Particle Measuring Systems - Particle ...

FAQ – Microbial Submit a New Question - What is microbial air sampling? ... Guidelines, 2004, or ISO 14698-1 or -2. The ISO 14698-1 document specifically requires all air samplers to be validated for both physical and biological collection efficiency because both recovery

http://www.pmeasuring.com/wrap/files/microbialFAQ/FAQmicrobial.pdf

Date added: April 29, 2012 - Views: 4

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Focus on ISO Standards & Research

ISO Standards 14698 –1 & 2 – An Introduction Enrico Bompadre, Asco Tec CTCB, (Cleanroom Testing & Certification Board) Peter Fernie & Conor Murray, Irish Cleanroom Society Automatic Microbiolgical Air Sampling to ISO 14698 Enrico Bompadre, Asco Tec

http://www.cleanrooms-ireland.ie/index.cfm/fuseaction/common.files/id/FF0EADE9D2C740BF8B386351D2C5B957

Date added: May 27, 2013 - Views: 3

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SAS SUPER ISO - Adelab Scientific | Suppliers of quality ...

of the new “SAS SUPER ISO 100” and “SAS SUPER ISO 180”. SAS (Surface Air System) IN SPACE YOUR PARTNER IN ENVIRONMENTAL MICROBIOLOGY SAS SUPER ISO ... • Performance in compliance with ISO 14698-1 • Large LCD with illuminated touch panel • All operator commands via touch keypad for

http://adelab.com.au/wp-content/uploads/PBI-SAS-Super-ISO-Sampler.pdf

Date added: December 18, 2013 - Views: 1

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Corporate Q. A. Manager, Cintas Cleanroom Resources President ...

All food processing industries are concerned with controlling the microbial population in production areas. ISO 14698 - 1 and 2, “Cleanrooms and

http://www.cintas.com/PDF/CleanroomResources/Enhance_your_HACCP_Program.pdf

Date added: November 22, 2011 - Views: 17

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Fundamentals of Aseptic Pharmaceutical/Biotech Engineering

Aseptic Pharmaceutical Engineering is perhaps the most interesting to an engineer compared to other pharma/biotech projects. ... 14644-1, ISO 14644-3, ISO 14698-1, ISO 14698-2;” or, “The maximum number of particles greater than or equal to

http://www.pdhonline.org/courses/k112/k112content.pdf

Date added: March 22, 2012 - Views: 5

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CETA Certification Guide for USP <797> Environmental ...

CETA Application Guide for USP <797> Viable Environmental Sampling & Gowning Evaluation CAG-009-00 Page 2 of 27 1/31/2012 1.0 Revision History 1.1 Revision 00 ... refer to ISO 14698-1:2003(E) Annex B Guidance on Validating Air Samplers.

http://www.cetainternational.org/reference/CAG-009v3.pdf?sid=1267

Date added: October 7, 2013 - Views: 13