ASTM E2614-2008 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: E 2614 08Standard Guide forEvaluation of Cleanroom Disinfectants1This standard is issued under the fixed designation E 2614; 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 parent

2、heses indicates the year of last reapproval. Asuperscript epsilon (e) 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 recommend

3、s test methods suitablefor evaluating disinfectants. The proper selection of disinfect-ing agents combined with in-house qualification testing is a keyelement to a successful disinfection program. Recent publica-tions of regulatory guidance/standards such as Chapter, “Disinfectants and Antiseptics”

4、in the United StatesPharmacopoeia address the issue of disinfectant testing butthere is very little published guidance on what criteria and testmethods should be used for selection and efficacy testing ofdisinfectants that will be used in cleanrooms and controlledenvironments.1.2 An understanding of

5、 microbiology and microbiologicaltechniques is essential. Knowledge in the following areas isrecommended: microorganisms, antimicrobial products (disin-fectants, sporicides, and decontamination agents), and thechemistry of disinfection, mechanism of activity of disinfec-tants on cells, application p

6、rocedures, cleanroom surfaces, andenvironmental conditions within a 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 concentr

7、ation on microbial reduction (concentra-tion exponent) and kinetics 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 Although the information in thi

8、s guide is written for thecleanroom environment, many of the principles outlined in thisstandard are applicable to manufacturing/processing environ-ments outside of the cleanroom.1.5 Evaluation of disinfectants for biofilm control is outsidethe scope of this document. The reader is referred to Guide

9、E 1427.1.6 The values state in inch-pound units are to be regardedas standard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2E 1427 Guide for Selecting Test Methods to Determine theEffectiveness of Antimicrobial Agents and Other Chemi-cals for

10、the Prevention, Inactivation and Removal ofBiofilmE 2111 Quantitative Carrier Test Method to Evaluate theBactericidal, Fungicidal, Mycobactericidal, and SporicidalPotencies of Liquid Chemical MicrobicidesE 2197 Quantitative Disk Carrier Test Method for Deter-mining the Bactericidal, Virucidal, Fungi

11、cidal, Mycobac-tericidal and Sporicidal Activities of Liquid ChemicalGermicidesE 2315 Guide for Assessment of Antimicrobial ActivityUsing a Time-Kill Procedure2.2 Other Standard:United States Pharmacopeia 30, Chapter Disinfec-tants and Antiseptics, May 1, 20073AOAC, Chapter 6, 15th Edition Official

12、Methods of Analy-sis of AOAC International, Chapter 6: Disinfectants, 15thed, 19904AOAC Chapter 6, 17th Edition Official Methods of Analy-sis of AOAC International, Chapter 6: Disinfectants, 17thed., 20004BS EN 1040 Chemical Disinfectants and AntisepticsBasic Bactericidal Activity5BS EN 1276 Chemica

13、l disinfectants and antisepticsQuantitative Suspension Test for the Evaluation of Bacte-ricidal Activity of Chemical Disinfectants and Antiseptics1This specification is under the jurisdiction of ASTM Committee E35 onPesticides and Alternative Control Agents and is under the direct responsibility ofS

14、ubcommittee E35.15 Antimicrobial Agents.Current edition approved April 1, 2008. Published May 2008.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Doc

15、ument Summary page onthe ASTM website.3Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.4Available from AOAC International, 481 North Frederick Ave., Suite 500,Gaithersburg, Maryland 20877-2417, http:/www.aoac.org.5Available from British Stand

16、ards Institute (BSI), 389 Chiswick High Rd.,London W4 4AL, U.K., http:/www.bsi-.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.used in Food, Industrial, Domestic, and InstitutionalAreas5BS EN 13697 Chemical Disinfectants and Antisep

17、ticsQuantitative Non-Porous Surface Test for the Evaluationof Bactericidal and/or Fungicidal Activity of ChemicalDisinfectants used in Food, Industrial, Domestic andInstitutional Areas53. Terminology3.1 Definitions:3.1.1 antimicrobial, ndescribes an agent that kills bacteriaor suppresses their growt

18、h or reproduction.3.1.2 bioburden, nthe number and type of viable micro-organisms that can be estimated using prescribed 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 microor

19、ganisms and treatment.3.1.5 cleanroom, nan area equipped with HEPA filteredair and used for aseptic processing.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

20、pathogenic or potentially pathogenic micro-organisms on inanimate surfaces or 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

21、a sample, device, or surface, often expressed as tonumber and type.3.1.11 neutralization, 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 effectivenes

22、s in thecontext of a given process.3.1.13 sanitizer, nchemical or physical agent(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, nchemical or physical material(s) in-cluded in a test procedure to simulate condition

23、s or use.3.1.15 sporicide, nchemical or physical agent(s) that killspores.3.1.16 substrate, nsurface on which an organism cangrow3.1.17 surfactant, nsynthetic detergent3.2 Acronyms:3.2.1 MSDSMaterial Safety Data Sheet4. Summary of Guide4.1 Selecting and qualifying the appropriate disinfectionagents

24、is an integral factor in developing a compliant cleaningand disinfection program for a cleanroom. Significant factorsto consider when selecting disinfectants for use in cleanroomsand controlled environments are discussed in this guide. Asummary of the most common test methods used to determinedisinf

25、ectant effectiveness is also presented.5. Significance and Use5.1 Requirements for aseptic processing areas includereadily cleanable floors, walls, and ceilings that have smooth,non-porous surfaces; particulate, temperature, and humiditycontrols; and cleaning and disinfecting procedures to producean

26、d maintain aseptic conditions. These conditions combinedwith careful and thorough evaluation of the chemical agentsused for the cleaning and disinfection program should lead toachieving the specified cleanliness standards and control ofmicrobial contamination of products. In recent years, the use of

27、disinfectants in pharmaceutical, biotechnology, medical devicefacilities, and associated controlled environments has been thesubject of scrutiny by regulatory agencies.5.2 An effective cleaning and disinfection program in asep-tic processing areas of a Good Manufacturing Practice (GMP)facility is cr

28、itical to assure the quality of the products.Manufacturers are being held to a high standard when it comesto product sterility and regulatory agencies are increasinglyasking for validation data to support sanitization and disinfec-tion procedures. Regulatory authorities now expect evidence ofthe eff

29、icacy of disinfection agents against environmental iso-lates. The FDA Guideline for Aseptic Processing states, “thesuitability, efficacy, and limitations of disinfecting agents andprocedures should be assessed. The effectiveness of thesedisinfectants and procedures should be measured by theirability

30、 to ensure that potential contaminants are adequatelyremoved from surfaces.”65.3 Basic knowledge regarding the effectiveness of differentchemical agents against vegetative bacteria, fungi, and sporeswill aid in selecting chemical agents.5.4 A good understanding of test methods used to assessdisinfec

31、tant effectiveness is important. Most methods areadaptable allowing the user to customize the methods to theirspecific requirements.6. Procedure6.1 Selection Procedure:6.1.1 In pharmaceutical, biotechnology, and associated in-dustries, the selection of one sanitizer, one or two disinfectants,and one

32、 sporicide is typical. More than one type of chemicalagent is needed to obtain the proper balance of effectivemicrobial control and minimal surface damage because prod-ucts vary in spectrum of activity and formulation Currently,most facilities select one or two disinfecting agents to use on aroutine

33、 basis and supplement with a sporicide which is used ona less frequent routine basis to address spores that may not bedestroyed by the routine disinfectant. All three product typesshould be evaluated for effectiveness with appropriate testmethods. Typical agents used in cleanrooms are:6FDA Guideline

34、 for Industry: Sterile Drug Products Produced by AsepticProcessingCurrent Good Manufacturing Process, September 2004. Available athttp:/www.fda.gov/cder/guidance/index.htmE2614082Sanitizers: 70 % v/v Isopropyl Alcohol (IPA)70 % v/v EthanolDisinfectants: PhenolsQuaternary Ammonium CompoundsHydrogen P

35、eroxide 3 % SodiumHypochlorite 0.3 %Hydrogen Peroxide 6 %Peracetic Acid ChlorineDioxide Vaporized HydrogenPeroxide6.1.2 Sanitizers play a role in a cleanroom disinfectionprogram. Isopropyl alcohol has good broad-spectrum efficacy,but in the manner which it is used routinely, minimal productcontact t

36、ime and flammability are of concern. Classifying 70 %IPA as a decontamination or residue control agent is moreappropriate since it is often used during cleaning operations, asa sanitizer during manufacturing, and for removal of residuesleft from other antimicrobial agents.6.1.3 It is important to ch

37、oose a disinfectant that incorpo-rates a surfactant in its formulation to help clean surfaces.Occasionally, the choice will be made to rotate two differentdisinfectants. These agents are designed for frequent use.6.1.4 Sporicidal formulations typically contain highly reac-tive chemicals (for example

38、, sodium hypochlorite or oxidizers)and may cause damage to surfaces, even stainless steel, if usedtoo frequently. However, they are a necessity in the cleanroomsince routine disinfectants are not effective against bacterialendospores or resistant mold spores such as Aspergillus niger.Typically, they

39、 are not used on a daily basis to avoid damageto substrates and reduce the potential for irritation to cleaningpersonnel.6.1.5 Critical Factors in Selection of Chemical Agents:6.1.5.1 Product InformationOne of the first steps inselection of a chemical agent is to collect all pertinent andavailable i

40、nformation from the potential supplier. This wouldinclude EPA registration, technical data sheets, MSDS, recom-mended directions for use as well as data on substratecompatibility, stability, and microbiocidal efficacy performedaccording to acceptable standards.6.1.5.2 Cleanroom BioburdenA review of

41、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 selecting an appropriate

42、 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 disinfectant to be effective, asurface must remain wet for a defined period of time. Thecontact time may vary

43、depending on the target microbialcontamination, air temperature, as well as the type of surfacebeing 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. The accuracy of prepara-tion of a u

44、se-dilution is critical for optimal performance.Regulatory standards require that disinfectants used in clean-rooms are sterile, therefore it may be necessary to purchase theagent sterile or sterilize it in-house. The kind of water availablefor dilution is also important. Water hardness or softness

45、caninterfere with the action of some disinfectants. It is recom-mended that purified water or better be used to dilute theconcentrate.6.1.5.5 Safety and ToxicityThe product MSDS should bereviewed to determine special storage and handling require-ments and to identify any potential hazards to personn

46、elworking 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 withcleaning agents used in the area. A

47、dditionally, 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 with efficacytesting. This testing provides a means of assessing that adisinfe

48、ctant will render a surface microbiologically safe for theintended purpose. A combination of several test methods isnecessary to qualify a disinfectant for use.7.1.1 Data from in vitro testing contributes to the overallpicture of how a disinfectant will potentially perform inpractice. In vitro testi

49、ng includes suspension tests and carriertests.7.1.2 In situ testing demonstrates that the disinfectant, asused, will kill the target organisms.7.1.3 Trend analysis of environmental monitoring data pro-vides an on-going analysis on the effectiveness of the disin-fectant.7.2 Laboratory tests for the evaluation of disinfectants mustbe scientifically based and ensure that the agent is safe andeffective for its intended use.7.3 Following the same basic methods when evaluatingseveral potential disinfectants for use is a good idea as it allowsdirect c