ASTM E2614-2015 Standard Guide for Evaluation of Cleanroom Disinfectants《洁净室消毒剂评估的标准指南》.pdf

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1、Designation: E2614 15Standard Guide forEvaluation of Cleanroom Disinfectants1This standard is issued under the fixed designation E2614; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parenthe

2、ses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide identifies important factors to consider whenselecting a disinfectant for use in a cleanroom or similarcontrolled environment and recommends t

3、est methods suitablefor evaluating disinfectants. The proper selection of disinfect-ing agent combined with qualification testing is a key elementof a successful disinfection program. Regulatory guidance suchas United States Pharmacopoeia Chapter , “Disinfec-tants and Antiseptics” and the FDA Guidan

4、ce for Industry,“Sterile Drug Products Produced by Aseptic ProcessingCur-rent Good Manufacturing Practice” address the necessity ofdisinfectant effectiveness testing but do not clearly defineacceptable test methods.1.2 An understanding of microbiology and microbiologicaltechniques is essential. Know

5、ledge in the following areas isrecommended: microorganisms, antimicrobial products(disinfectants, sporicides, and decontamination agents), thechemistry of disinfection, mechanism of activity of disinfec-tants on cells, application procedures, cleanroom surfaces, andenvironmental conditions within a

6、cleanroom. This informa-tion is available in several published texts listed in thebibliography.1.3 The theoretical basis for disinfectant activity is notaddressed in this guide. An understanding of the effect ofdisinfectant concentration on microbial reduction (concentra-tion exponent) and kinetics

7、is desirable in determining theuse-dilution of different disinfectants and in using dilution toneutralize a disinfectant for efficacy testing. USP chapterprovides further information on this topic.1.4 This guide is written for the cleanroom environment,although many of the principles outlined in thi

8、s standard areapplicable to manufacturing and processing environmentsoutside of the cleanroom.1.5 Evaluation of disinfectants for biofilm control is outsidethe scope of this document.2. Referenced Documents2.1 ASTM Standards:2E2111 Quantitative Carrier Test Method to Evaluate theBactericidal, Fungic

9、idal, Mycobactericidal, and SporicidalPotencies of Liquid ChemicalsE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,and Sporicidal Activities of ChemicalsE2315 Guide for Assessment of Antimicrobial Activity Us-ing a Time-Kill Procedur

10、e2.2 BSI Standards:3BS EN 1040 Chemical disinfectants and antiseptics. Quan-titative suspension test for the evaluation of basic bacte-ricidal activity of chemical disinfectants and antiseptics.Test method and requirements (phase 1)BS EN 1276 Chemical disinfectants and antiseptics. Quan-titative sus

11、pension test for the evaluation of bactericidalactivity of chemical disinfectants and antiseptics used infood, industrial, domestic and institutional areas. Testmethod and requirements (phase 2, step 1)BS EN 1650 Chemical disinfectants and antiseptics. Quan-titative suspension test for the evaluatio

12、n of fungicidal oryeasticidal activity of chemical disinfectants and antisep-tics used in food, industrial, domestic and institutionalareas. Test method and requirements (phase 2, step 1)BS EN 13704 Chemical disinfectants. Quantitative suspen-sion test for the evaluation of sporicidal activity ofche

13、mical disinfectants used in food, industrial, domesticand institutional areas. Test method and requirements(phase 2, step 1)BS EN 13697 Chemical disinfectants and antiseptics. Quan-titative non-porous surface test for the evaluation ofbactericidal and/or fungicidal activity of chemical disin-fectant

14、s used in food, industrial, domestic and institutionalareas. Test method and requirements without mechanicalaction (phase 2, step 2)1This specification is under the jurisdiction of ASTM Committee E35 onPesticides, Antimicrobials, and Alternative Control Agents and is under the directresponsibility o

15、f Subcommittee E35.15 on Antimicrobial Agents.Current edition approved May 1, 2015. Published July 2015. Originally approvedin 2008. Last previous edition approved in 2008 as E261408. DOI: 10.1520/E2614-15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer

16、Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from British Standards Institute (BSI), 389 Chiswick High Rd.,London W4 4AL, U.K., http:/www.bsi-.Copyright ASTM International, 100 Barr Harbor

17、Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.3 Other Standards:AOAC International, Official Methods of Analysis, Chapter6Disinfectants, 18th Edition, 20054ISO 14644-1 Cleanrooms and associated controlled environ-ments - Part 1: Classification of air cleanliness5United States

18、 Pharmacopeia 38, Chapter Disinfec-tants and Antiseptics, May 1, 201563. Terminology3.1 Definitions:3.1.1 antimicrobial, ndescribes an agent that kills bacteriaor suppresses their growth or reproduction.3.1.2 bioburden, nthe number and type of viable micro-organisms that can be estimated using presc

19、ribed recoveryprocedures.3.1.3 biocide, na physical or chemical agent that killsorganisms.3.1.4 carrier, na surrogate surface or matrix that facili-tates the interaction of test microorganisms and treatment.3.1.5 cleanroom, nan area that establishes and maintainsthe level of microbial control necess

20、ary for the intendedmanipulations.3.1.6 contact time, npredetermined time that a test micro-organism is exposed to the activity of a test material.3.1.7 disinfectant, na physical or chemical agent or pro-cess that destroys pathogenic or potentially pathogenic micro-organisms on inanimate surfaces or

21、 objects.3.1.8 effcacy, nthe proven performance of a productestablished under defined conditions.3.1.9 effectiveness, na measure of the performance of aproduct.3.1.10 inoculum, nthe viable microorganisms used tocontaminate a sample, device, or surface, often expressed as tonumber and type.3.1.11 neu

22、tralization, nthe process for inactivating orquenching the activity of a microbiocide, often achievedthrough physical (for example, filtration or dilution) or chemi-cal means.3.1.12 qualification, nto determine effectiveness in thecontext of a given process.3.1.13 sanitizer, nchemical or physical ag

23、ent(s) used toreduce the number of microorganisms to a level judged to beappropriate for a defined purpose and/or claim.3.1.14 soil load, na chemical or physical material(s)included in a test procedure to simulate conditions or use.3.1.15 sporicide, na chemical or physical agent(s) that killspores.3

24、.1.16 substrate, nsurface on which an organism cangrow.3.1.17 surfactant, nan agent that reduces the surfacetension of water or the tension at a water-liquid interface3.2 Acronyms:SDS = Safety Data SheetGMP = Good Manufacturing PracticeIPA = Isopropyl AlcoholUSP = United States Pharmacopeia4. Summar

25、y of Guide4.1 Selecting and qualifying the appropriate disinfectionagents is an integral factor in developing a compliant cleaningand disinfection program for a cleanroom. Significant factorsto consider when selecting disinfectant for use in cleanroomsand controlled environments are discussed in thi

26、s guide. Asummary of the most common test methods used to determinedisinfectant effectiveness is also presented.5. Significance and Use5.1 Requirements for aseptic processing areas include read-ily cleanable floors, walls, and ceilings that have smooth,non-porous surfaces; particle, temperature, and

27、 humidity con-trols; and cleaning and disinfecting procedures to produce andmaintain aseptic conditions. These controls, combined withcareful and thorough evaluation of the chemical agents used forthe cleaning and disinfection program, should lead to achievingthe specified cleanliness standards and

28、control of microbialcontamination of products. Qualification of disinfectants inpharmaceutical, biotechnology, medical device facilities, andassociated controlled environments, along with validation ofthe cleaning and disinfection process, is subject to scrutiny byregulatory agencies.5.2 An effectiv

29、e cleaning and disinfection program in asep-tic processing areas of a Good Manufacturing Practice (GMP)- regulated facility is critical to assure product quality. Manu-facturers are held to a high standard when it comes to productsterility, and regulatory agencies increasingly request valida-tion da

30、ta to support sanitization and disinfection procedures.Regulatory authorities expect evidence of the effectiveness ofdisinfection agents against environmental microorganisms iso-lated from the facility. The FDA Guideline for Aseptic Pro-cessing states, “The suitability, efficacy, and limitations ofd

31、isinfecting agents and procedures should be assessed. Theeffectiveness of these disinfectants and procedures should bemeasured by their ability to ensure that potential contaminantsare adequately removed from surfaces.”75.3 Basic knowledge regarding the effectiveness of differentchemical agents agai

32、nst vegetative bacteria, fungi, and sporeswill aid in selecting chemical agents.5.4 An understanding of test methods used to assess disin-fectant effectiveness is important. Most methods are adaptable,allowing the user to customize the methods to their specificrequirements.4Available from AOAC Inter

33、national, 481 North Frederick Ave., Suite 500,Gaithersburg, Maryland 20877-2417, http:/www.aoac.org.5Available from International Organization for Standardization (ISO), Cheminde Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, http:/www.iso.org.6Available from U.S. Pharmacopeia (USP), 12601

34、 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.7FDA Guideline for Industry: Sterile Drug Products Produced by AsepticProcessingCurrent Good Manufacturing Process, September 2004. Available athttp:/www.fda.gov/cder/guidance/index.htmE2614 1526. Procedure6.1 Selection Procedure:6.1.1 In

35、the pharmaceutical, biotechnology, and associatedindustries, the selection of one sanitizer, one or twodisinfectants, and one sporicide is typical. More than one typeof chemical agent may be needed to obtain the proper balanceof effective microbial control and minimal surface damagebecause products

36、vary in spectrum of activity and formulation.Most facilities select one or two disinfecting agents to use ona routine basis and supplement them with a sporicide which isused on a less frequent routine basis to address spores that maynot be killed by the routine disinfectant.All three product typessh

37、ould be evaluated for effectiveness with appropriate testmethods. Typical agents used in cleanrooms are:Sanitizers: 70 % v/v Isopropyl Alcohol (IPA)70 % v/v EthanolDisinfectants: Phenolic Detergent CompoundsQuaternary Ammonium CompoundsHydrogen Peroxide 3%Sodium Hypochlorite 0.3 %Hydrogen Peroxide 6

38、 %Peracetic AcidChlorine DioxideVaporized Hydrogen Peroxide6.1.2 Sanitizers such as 70% solutions of IPA or ethanol arenot intended for use as primary microbial control agent incleanrooms. Their use should be limited to specific purposessuch as glove decontamination, cleaning processes, and residuer

39、emoval.6.1.3 It is important to choose a disinfectant that incorpo-rates a surfactant in its formulation to help clean surfaces.Occasionally, the choice will be made to rotate differentdisinfectants. These agents are designed for frequent use.6.1.4 Sporicidal formulations typically contain highly re

40、ac-tive chemicals (for example, sodium hypochlorite or hydrogenperoxide) and may cause damage to surfaces, even stainlesssteel, if used too frequently. However, they are a necessity inthe cleanroom since routine disinfectants are not effectiveagainst bacterial endospores or resistant mold spores.Typ

41、ically, they are not used on a daily basis to avoid damageto substrates and reduce the potential irritation to cleaningpersonnel.6.1.5 Critical Factors in Selection of Chemical Agents:6.1.5.1 Product InformationOne of the first steps in selec-tion of a chemical agent is to collect all pertinent and

42、availableinformation from the potential supplier. This would includeEPA registration information, technical data sheets, SDS,recommended directions for use as well as data on substratecompatibility, stability, and microbiocidal efficacy performedaccording to acceptable standards.6.1.5.2 Cleanroom Bi

43、oburdenA review of environmentalmonitoring data is necessary to determine the number andtypes of microorganisms to be controlled. Not all chemicalagents are effective against all microorganisms and not all aresporicidal. Knowing the types of microbial flora in the area tobe disinfected aids in selec

44、ting an appropriate disinfectant withthe desired spectrum of activity. From this information, afacility can determine what efficacy is needed and identifypotential product candidates.6.1.5.3 Contact TimeFor a biocide to be effective, asurface must remain in contact with the agent for a definedperiod

45、 of time. The contact time may vary depending on thetarget microbial contamination, air temperature, as well as thetype of surface being treated.6.1.5.4 PreparationProducts can be purchased in concen-trate form or a ready-to-use form. If a concentrated product isselected, dilution will be necessary.

46、 Accurate preparation of ause-dilution is critical for optimal performance. Regulatorystandards require that disinfectants used in ISO Class 5environments are sterile; therefore, it may be necessary topurchase the agent sterile or to sterilize it in-house. The qualityof water used for dilution is al

47、so important. Water hardness orsoftness can interfere with the action of some disinfectants. Itis recommended that purified water or better be used to dilutethe concentrate.6.1.5.5 Safety and ToxicityThe product SDS should bereviewed to determine special storage and handling require-ments and to ide

48、ntify any potential hazards to personnelworking with the agent. Appropriate regulations should bereviewed regarding disposal.6.1.5.6 CompatibilitySome disinfectants are incompatiblewith others and can cause problematic residues. Performanceof disinfectants can be decreased if they are incompatible w

49、ithcleaning agents used in the area. Additionally, compatibilitywith surface types in the cleanroom should be evaluated.7. Disinfectant Challenge Testing7.1 Once the chemical agents to be used in the cleanroomhave been selected, they must be qualified for use throughefficacy testing. This testing provides a means of assessing thata disinfectant will render a surface microbiologically safe forthe intended purpose. A combination of several test methods isnecessary to qualify a disinfectant for use.7.1.1 Data from in vitro testing contributes t