THE COMPLETE GUIDE ISO 14644 - Kleanlabs

THE COMPLETE GUIDEISO14644CLEAN ROOM STANDARDFree DownloadThis document has been created by Kleanlabs, a European manufacturer of clean room products.

The Revised Cleanroom ISO 14644ForewordISO (the International Organization for Standardization) is aworldwide federation of national standards bodies (ISO memberbodies). The work of preparing International Standards is normallycarried out through ISO technical committees.Each member body interested in a subject for which a technicalcommittee has been established has the right to be representedon that committee. International organizations, governmentaland non-governmental organizations, in liaison with ISO,also take part in the work. ISO collaborates closely with theInternational Electrotechnical Commission (IEC) on all matters ofelectrotechnical standardization.What exactly do I get for free?We need to stress the importance that all ISO standards are theintellectual property of the ISO organization, therefore, spreadingthese across the internet free of charge would be illegal. Not tomention that the detailed specifications of these standards usuallycost several thousand euros/dollars and giving them away forfree would cause a competitive disadvantage for the companieswho buy it. This is why you’re unlikely to find the package on theinternet. However, we have created an informative guide that willlead you to the exact place on the official ISO website where youcan purchase what you need. Our goal was to provide informationon the various parts of the standard so that you will know whichparts you need and which parts to purchase.This document has been created by Kleanlabs, a European manufacturer of clean room products.1

For reference, the full set ofISO 14644 parts is listed belowISO 14644-1:2015 – PART 1Classification of air cleanlinessISO 14644-2:2015 – PART 2Specifications for testing and monitoring to prove continued compliancewith ISO 14644ISO 14644-3:2005 – PART 3Test methodsISO 14644-4:2001 – PART 4Design, construction and start-upISO 14644-5:2004 – PART 5OperationsISO 14644-6:2004 – PART 6VocabularyISO 14644-7:2004 – PART 7Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)ISO 14644-8:2013 – PART 8Classification of air cleanliness by chemical concentration (ACC)ISO 14644-9:2012 – PART 9Classification of surface cleanliness by particle concentrationISO 14644-10:2013 – PART 10Classification of surface cleanliness by chemical concentrationNO PART 11in draftISO 14644-12: DRAFT – PART 12Classification of air cleanliness by nanoscale particle concentrationISO 14644-13: DRAFT – PART 13Cleaning of surfaces to achieve defined levels of cleanliness in terms ofparticle and chemical classificationsISO 14644-14: DRAFT – PART 14Assessment of suitability for use of equipment by airborne particleconcentrationThis document has been created by Kleanlabs, a European manufacturer of clean room products.2

ISO 14644 Series Cleanroom StandardsImportantly, ISO 14644 is NOT a GMP standard. Parts of the standardhave been adopted by GMP systems, such as the reference toISO classes in the 2004 FDA Guidance on Aseptic Processing andthe requirement to use the standard to classify cleanrooms inAnnex 1 of EU GMP. Not all parts of the standard are applicableto GMP environments, for example, Part 12 is intended for thenanotechnology industry. Revisions to ISO 14644 In December 2015,of ISO 14644 were revised. The more substantial changes relateto Part 1. As part of the change process, the title of the secondpart of the standard was altered to “Specifications for testing andmonitoring to prove continued compliance by ACP” (with ACPrepresenting ‘airborne particulate contamination’).This main part ofthe article considers the key changes, beginning with Part 1.LIST OFISO14644CLEANROOM STANDARDS PUBLISHEDThis document has been created by Kleanlabs, a European manufacturer of clean room products.3

DocumentTitleStatusDescriptionISO 14644-1Classification of aircleanliness by particleconcentrationANSI Standard2015Covers the classification of air cleanliness incleanrooms and associated controlled environments.ISO 14644-2Monitoring to provideevidence of cleanroomperformance relatedto air cleanliness byparticle concentrationANSI Standard2015Specifies requirements for monitoring and periodictesting of a cleanroom or clean zone to prove itscontinued compliance with ISO 14644-1.ISO/ANS14644-3Test methodsANSI Standard2005Specifies test methods for designated classificationof airborne particle cleanliness for characterizing theperformance of cleanrooms and clean zones.ISO 14644-3Test methodsISO Standard2019This ISO Standard has not been approved as anAmerican National Standard, and does not replaceANSI/IEST/ISO 14644-3:2005.ISO 14644-4Design, construction,and start-upANSI Standard2001Specifies requirements for the design and constructionof cleanroom installations.ISO 14644-5OperationsANSI StandardAug. 2004Specifies basic requirements for cleanroomoperations.ISO 14644-7Separative devices(clean air hoods,gloveboxes, isolators,minienvironments)ANSI StandardNov. 2004Specifies the minimum requirements for the design,construction, installation, testing and approval ofseparative devices.ISO 14644-8Classification of aircleanliness by chemicalconcentration (ACC)ANSI Standard2013Covers the classification of airborne molecularcontamination (AMC) in cleanrooms and associatedcontrolled environments.ISO 14644-9Classification of surfaceparticle cleanlinessANSI Standard2012Establishes the classification of cleanliness levels onsolid surfaces by particle concentration in cleanroomsand associated controlled environments.ISO 14644-10Classification of surfacecleanliness by chemicalconcentrationsISO Standard2013Defines the classification system for cleanliness ofsurfaces in cleanrooms with regard to the presence ofchemical compounds or elements.ISO 14644-12SpecificationsANSIfor monitoring airStandard 2018cleanliness by nanoscaleparticle concentrationCovers the monitoring of air cleanliness by particles interms of concentration of airborne nanoscale particles.ISO 14644-13Cleaning of surfaces toachieve defined levelsof cleanliness in termsof particle and chemicalclassificationsAddresses the cleaning to a specified degree oncleanroom surfaces, surfaces of equipment in acleanroom and surfaces of materials in a cleanroom.ISO 14644-14Assessment of suitability ISOfor use of equipmentStandard 2016by airborne particleconcentrationSpecifies a methodology to assess the suitability ofequipment for use in cleanrooms and associatedcontrolled environments.ISO 14644-15Assessment of suitability ISOfor use of equipmentStandard 2017and materials byairborne chemicalconcentrationProvides requirements and guidance for assessingthe chemical airborne cleanliness of equipmentand materials, which are foreseen to be used incleanrooms and associated controlled environments.ISO 14644-16Code of practice forimproving energyefficiency in cleanroomsand clean air devicesANSI Standard2019Provides guidance and recommendations foroptimizing energy usage and maintaining energyefficiency in new and existing cleanrooms, clean zonesand separative devices.ISO/DIS14644-17Particle deposition rateapplicationsDISOctober 2019Provides guidance on the interpretation andapplication of the results of the measurement ofParticle Deposition Rate (PDR) on one, or morevulnerable surfaces in a cleanroom as part of acontamination control program.ISOStandard 2017This document has been created by Kleanlabs, a European manufacturer of clean room products.4

How is ISO 14644-1:2015 differentfrom ISO 14644-1:1999What makes it substantially different? Let us guide you through itin the following table.ISO 14644-1:2015ISO 14644-1:1999UCL 95%If the number of sampling locations wasbetween 1 and 10, standard deviation andUCL 95% was calculated. It is this figurethat must be within a certain range for thespecific class of clean room.Completely removed the standarddeviation and UCL 95%. The clean roomhas met its classification requirementsif the average particle concentrationsat each sample location are withinspecification.EquipmentCalibrationThe instrument shall have a validcalibration certificate, the frequency andmethod of calibration should be based oncurrent accepted practice.The particle counter shall have a validcalibration certificate: the frequencyand method of calibration should bebased upon current accepted practice asspecified in ISO 21501-4Ultra andMicro(u, M)DescriptorsSmaller than 0.1 microns defined as u,larger than 0.5 microns defined as M.Smaller than 0.1-micron particles will nolonger exist in ISO 14644-1. This issue willaddress in ISO 14644-12This document has been created by Kleanlabs, a European manufacturer of clean room products.5

What do you need to knowabout Kleanlabs?Kleanlabs is the subsidiary of an established clean roommanufacturer on the Central European market with quarter of acentury history. Although the Kleanlabs brand might be young, ourexperience in the industry has helped us to be able to manufactureproducts with an outstanding quality. Today we manufacture 5000items a year that are used all over the world.Our unique selling point has always been a competitive price. Webelieve that cost efficiency should never be related to low quality.Kleanlabs systems meet all clean room requirements such asISO14644-1 and GMP and feature a user-friendly design, meaningeasy installation and maintenance. We offer world-leading qualityat much more affordable prices that you might be familiar with.Get to know our product lineCapitalizing on our several decades of experience in the industry,we have designed a product line that withstands extrememechanical stress, yet is pleasing to the eye. Our product familyfocuses on clean room doors and pass boxes that can be installedinto any already-existing clean room.This document has been created by Kleanlabs, a European manufacturer of clean room products.6

Kleanlabs clean room doorsAll our clean room doors are independent systems and easyto mount. We offer both hinged and sliding models. The 60mmthick, completely flat aluminum door panels are outstandinglyresilient to bending and are extremely long lasting. They featurea high level of airtightness that will comply with any standard.We market our doors with safety glazing, antistatic surfaces andpremium hardware.Kleanlabs pass boxesWe offer static, semi-active and active pass boxes, depending onthe application. All our products are easy to clean thanks to their flatsurfaces and easy to integrate into any wall structure. Similarly toour clean room door product line, Kleanlabs clean room pass boxesfeature robust, 60 mm thick door panels that are extremely durable.Also equipped with safety glazing, antistatic surfaces and premiumhardware, our clean room pass boxes will be an ideal addition toany clean room.Kleanlabs clean room cabinetsAs a version of Kleanlabs pass boxes, we have designed theKleanlabs clean room cabinet especially for operating rooms.These cabinets are equipped with the same features as the abovementioned products but are completely see-through and can becustomized to fit a hospital environment perfectly.Kleanlabs mobile clean roomcontainerShould you need a certified clean room on the move, the Kleanlabsmobile clean room container might be the right solution for you.These portable clean rooms that are built into standard 20’ and40’ containers can be taken to any remote location. Given itsstandardized measurements, easy shipping is guaranteed andcan be done by boat or on the road. Only an adequate source ofpower is required to work the mobile clean room.This document has been created by Kleanlabs, a European manufacturer of clean room products.7

Kleanlabs clean room doorsThis document has been created by Kleanlabs, a European manufacturer of clean room products.8

Kleanlabs pass boxesThis document has been created by Kleanlabs, a European manufacturer of clean room products.9