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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 ISO 14698-3 Biocontamination control: Measuring the efficiency of cleaning and disinfection processes for inert surfaces DIS 02.99

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

International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled

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

Date added: May 21, 2013 - Views: 84

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FS209E and ISO Cleanroom Standards - Terra Universal

ISO 14698-2 Biocontamination: Evaluation and Interpretation of Data ISO 14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces The USA source for ISO documents is: Institute of Environmental Sciences & Technology (IEST)

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

Date added: September 20, 2012 - Views: 370

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INTERNATIONAL STANDARD 14698-1 - Esileht - Eesti Standardikeskus

ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled environments — Biocontamination control: — Part 1: General principles and methods — Part 2: Evaluation and interpretation of biocontamination data

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

Date added: April 29, 2012 - Views: 745

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ČSN EN ISO 14698 -2 OPRAVA 1

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://seznamcsn.unmz.cz/soubory/opravy/12/69438/Zmeny/76212.pdf

Date added: July 27, 2013 - Views: 12

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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: 117

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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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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-14698-2 Biocontamination: Evaluation & Interpretation of Data ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces Classifications Air Cleanliness Class Definition Comparison Between FS 209 and ISO 14644

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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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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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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POPRAWKA do POLSKIEJ NORMY

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 14698-2:2003/AC April 2006 Avril 2006 April 2006 ICS 13.040.30 English version Version Française

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

Date added: April 16, 2014 - Views: 3

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Ardmac Cleanroom Tutorial - Cleanroom Standards

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data Status 1999 2000 FDIS 2001 2004 CD 2004 FDIS 2003 2004 ISO CLEANROOM STANDARDS – (SEP ’05) 2 BASIC GUIDE TO CLEANROOM DESIGN EU GMP "A/B" at rest "C" at rest "D" at rest

http://www.dohc.ie/working_groups/Concluded/tissues_cells/cleanroom_standards.pdf?direct=1

Date added: August 8, 2013 - Views: 141

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Voorbeeld

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

http://www.nen.nl/web/preview.pdf?recordNumber=87938

Date added: July 11, 2014 - Views: 1

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Cyclonic Coriolis®technology qualification according to ISO ...

Context Cyclonic Coriolis®technology qualification according to ISO 14698-1 Protocol Physical efficiency theoretical determination depending on the equipment design characteristics

http://bioamerica-inc.com/files/pdf/Coriolis%20Brochure%202.pdf

Date added: October 18, 2013 - Views: 4

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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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Environmental Monitoring methods for Decontamination Units

ISO 14698: Part 1:2003 and EN ISO 14698 Part 2:2003) Joy Markey HSE 2012 Environmental control

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

ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces By EJS . Title: Clean Room Particulate Count Author: Erik Created Date:

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

The International Standards Organization Technical Committee ISO TC 209 has decided that, in order to improve clarity, ... revision of ISO 14698-1 and -2 for the classification of the cleanroom environment by microbiological cleanliness.

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: 131

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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: 17

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Deutsche Akkreditierungsstelle GmbH Annex to the ...

DIN EN ISO 14698-2 : 2004-02 Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data DIN EN ISO 14730 : 2001-08 Ophthalmic optics – Contact lens care products – Antimicrobial preservative ...

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: 24

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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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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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Standards for classification and testing of cleanrooms - ICCCS

2.2 ISO 14698 This consists of the following parts under the general title ‘Cleanrooms and Associated Controlled Environments–Biocontamination Control’: Part 1: General principles and methods This gives information on how to establish a risk system and methods for measuring

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

Date added: February 9, 2012 - Views: 164

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Pairing ISO standard series with new IEST Recommended Practices

ISO 14698-2 Biocontamination Control– CC013.2: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Evaluation and Interpretation of Cleanrooms and Other Controlled Environments (2006) Biocontamination Data (2003) ...

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

ISO 14698-3 Technical Report. Cleanliness classes ISO 14644-1 cleanliness classes. ISO 14644-1 formula for maximum allowable particles. Which class do I choose?

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

Date added: March 15, 2012 - Views: 50

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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: 9

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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 extreme conditions that may be encountered.

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

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

Date added: May 27, 2013 - Views: 7

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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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HACCP MAS-100 Eco® ISO - Merck Millipore

• Convenient 2-buttons operation • Low running costs by using Standard Petridishes • 100 l/min acc. to ISO 14698 • Isokinetic: no turbulence in laminar flow areas ... ISO Microbial airsampler based on the wellknown MAS-100® principle, ...

http://www.merckmillipore.com/chemicals/en_US/Merck-International-Site/USD/ViewProductDocuments-File?ProductSKU=MDA_CHEM-109227&DocumentType=TI&DocumentId=200508.047.ProNet&DocumentSource=PRONET

Date added: August 2, 2013 - Views: 5

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Contamination Control for Pharmaceutical Industry

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces Status Active Active Draft Active Draft Draft Draft Draft Active Active Active. 14

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

Date added: May 16, 2014 - Views: 1

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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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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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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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ISO Technical Committee 209 Status Report

ISO-14698-1 Biocontamination: General Principles ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data 2004 2007 - SG6 2004 2007 2003-WG2 2003-WG2. ISO TC 209 Cleanrooms and associated controlled environments Australia Belgium Brazil China Denmark Kenya

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

Date added: January 8, 2014 - Views: 5

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

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 percentages are air flow rate and inlet geometry-dependent.

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

Date added: April 29, 2012 - Views: 4

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Open Day, Workshop & Podcast May 22 - Irish Cleanroom Society

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.cleanrooms-ireland.ie/index.cfm/fuseaction/common.files/id/3866B85FFB6149FBBC00377F4F74B06D

Date added: May 11, 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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CETA Certification Guide for USP <797> Environmental ...

refer to ISO 14698-1:2003(E) Annex B Guidance on Validating Air Samplers. You can be assured that your air sampler is compliant with this standard by requesting a copy of the ISO compliance validation document from the manufacturer of the air sampler.

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

Date added: October 7, 2013 - Views: 11

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GMP MAS-100® airsampler ISO cleanrooms, to count the ...

• 100 l/min acc. to ISO 14698 • Only 2.5 % deviation • Isokinetic: no turbulence in laminar flow • Sample volume programmable up to 2000 liters • Runs 7.5 hours with built-in NiMH battery • Built-in memory, PC-port • Automatic calibration reminder

http://www.merckmillipore.com/chemicals/de_DE/Merck-DE-Site/EUR/ViewProductDocuments-File?ProductSKU=MDA_CHEM-109227&DocumentType=TI&DocumentId=18389.ProNet&DocumentSource=PRONET

Date added: June 13, 2014 - Views: 1

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

ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data 1) To be published. This is a free 7 page sample. Access the full version online.

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

Date added: May 10, 2012 - Views: 67

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CONTAMINATION CONTROL REQUIREMENTS MANUAL

ISO 14698-2, “Cleanrooms and associated controlled environments – Biocontamination control Part 2: Evaluation and Interpretation of biocontamination data” t. SAE AS 9100, SAE Aerospace Standard u.

http://www.aeropackaging.com/specs/JPR5322.1G.pdf

Date added: October 12, 2012 - Views: 18

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British European and ISO Decontaminated Related Standards 27 ...

BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices

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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Fundamentals of Aseptic Pharmaceutical/Biotech Engineering

14644-1, ISO 14644-3, ISO 14698-1, ISO 14698-2;” or, “The maximum number of particles greater than or equal to 0.5µm in diameter that may be present in a cubic foot of room air.” (ISPE’s online glossary,

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

Date added: March 22, 2012 - Views: 5

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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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CLEANROOM ENVIRONMENTAL MONITORING - Kenelec Scientific

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