ASTM G121-2018 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents.pdf

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1、Designation: G121 98 (Reapproved 2015)1G121 18Standard Practice forPreparation of Contaminated Test Coupons for theEvaluation of Cleaning Agents1This standard is issued under the fixed designation G121; the number immediately following the designation indicates the year oforiginal adoption or, in th

2、e case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1 NOTEEditorial changes were made throughout in October 2015.1. Scope1.1 This practice describes t

3、he procedure for the preparation of single- and double-sided contaminated metallic test coupons forthe evaluation of cleaning agents. It is applicable for the evaluation of cleaning agents proposed for the cleaning ofoxygen-enriched systems and components. oxygen equipment, pharmaceutical manufactur

4、ing equipment, and medical devices (seeTest Method G122 and Guide G127). It also is applicable to other systems where contamination is a concern.1.2 Several classes of contaminantscontaminants/residues most likely to be found in oxygen-enriched systems and componentsoxygen equipment, pharmaceutical

5、manufacturing equipment, and medical devices are identified. However, if the user of thispractice has identified contaminants not included in these classes, such identified contaminants may be substituted for thepreparation of the test coupons.coupons if appropriate for this test method.1.3 Preparat

6、ion of nonmetallic substrates is not addressed, although similar methodology may be used. Solvent and cleaningagent compatibility with the nonmetallic substratesubstrates should be verified prior to the preparation of the test coupons. Typicalnonmetallic materials utilized in oxygen systems are cont

7、ained in Guide G63.1.4 This practice may involve hazardous materials, operations, and equipment. This practice does not purport to address allof the safety concerns associated with its use. It is the responsibility of whomever uses this practice to consult and establishappropriate safety safety, hea

8、lth, and healthenvironmental practices and determine the applicability of regulatory limitations priorto use.1.5 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of Inter

9、national Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1235 Test Method for Gravimetric Determination of Nonvolatile Residue (NVR) in Environment

10、ally Controlled Areas forSpacecraftE3106 Guide for Science-Based and Risk-Based Cleaning Process Development and ValidationF303 Practices for Sampling for Particles in Aerospace Fluids and ComponentsF312 Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane F

11、iltersF324 Test Method for Nonvolatile Residue of Volatile Cleaning Solvents Using the Solvent Purity Meter (Withdrawn 1987)3F331 Test Method for Nonvolatile Residue of Solvent Extract from Aerospace Components (Using Flash Evaporator)F3127 Guide for Validating Cleaning Processes Used During the Man

12、ufacture of Medical DevicesG63 Guide for Evaluating Nonmetallic Materials for Oxygen ServiceG94 Guide for Evaluating Metals for Oxygen ServiceG122 Test Method for Evaluating the Effectiveness of Cleaning Agents1 This practice is under the jurisdiction of ASTM Committee G04 on Compatibility and Sensi

13、tivity of Materials in Oxygen Enriched Atmospheres and is the directresponsibility of Subcommittee G04.02 on Recommended Practices.Current edition approved Sept. 1, 2004Dec. 1, 2018. Published October 2015January 2019. Originally approved in 1993. Last previous edition approved in 20102015 asG121 98

14、 (2010)(2015)1. DOI: 10.1520/G0121-98R15E01.10.1520/G0121-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.

15、3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to

16、adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consh

17、ohocken, PA 19428-2959. United States1G127 Guide for the Selection of Cleaning Agents for Oxygen-Enriched Systems2.2 ANSI:ANSI Standard:4B 46.1B46.1 Surface Texture (Surface Roughness, Waviness, and Lay)3. Terminology3.1 Definitions:3.1.1 blank, nthe contamination level of the fluid when the test co

18、upon is omitted.3.1.1.1 DiscussionSometimes referred to as “background” level.3.1.2 cleaning agent, nan agent used to support the removal of contaminant from equipment surfaces or other critical objects(such as a medical device).3.1.3 contaminant, contaminant (contamination), nunwanted molecular and

19、 molecular, non-volatile residue (NVR), and/orparticulate matter that could adversely affect or degrade the performance operation, life, or reliability of the systems or componentsupon which they reside.3.1.3.1 DiscussionThe contaminant could be a drug substance, an intermediate, a formulated produc

20、t, a lubricant, a machining oil, a solvent, acleaning agent, etc. The contaminant may migrate to other surfaces or users may become exposed to the contaminant during theuse of equipment.3.1.4 contamination,contaminate, nva process of contaminating.applying contaminant (non-volatile residue (NVR) and

21、/orparticulate matter).3.1.3 surface roughness, Ra, nthe arithmetic average deviation of the surface profile from the centerline, normally reportedin micrometres.3.1.4 nonvolatile residue (NVR), nresidual molecular and particulate matter remaining following the filtration of a solventcontaining cont

22、aminants and evaporation of the solvent at a specified temperature.3.1.5 particle (particulate contaminant), control coupon (witness coupon), na piece of matter in a solid state with observablelength, width, and thickness.coupon made from the same material as the test coupons, but in this test metho

23、d is not coated withthe contaminant.3.1.5.1 DiscussionThe size of a particle is usually defined by its great dimension and is specified in micrometres.3.1.6 dirty hold time (DHT), nthe maximum time interval between equipment use and cleaning.3.1.7 molecular contaminant (nonparticulate(non-particulat

24、e contamination), nthe molecular contaminant contaminants thatmay beexist in a gaseous, liquid, or solid state.state and may be uniformly or non-uniformly distributed.3.1.7.1 DiscussionIt may be uniformly or nonuniformly distributed, or be Molecular contaminants may be found as a solution, an emulsi

25、on, or inthe form of droplets. Molecular contaminants account for most of the what constitutes NVR.3.1.8 blank, nonvolatile residue (NVR), nthe contamination level of the fluid when the test coupon is omitted.a molecular andparticulate matter remaining following the filtration and controlled evapora

26、tion of a solvent containing contaminants.3.1.7.1 DiscussionSometimes referred to as “background” level.3.1.9 control coupon (witness coupon), particle (particulate contaminant), na coupon made from the same material as the testcoupons, but in this test method is not coated with the contaminant.gene

27、ral term used to describe a finely divided solid of organicor inorganic matter with observable length, width, and thickness.4 Dusts of varying particle sizes are available from the AC Spark Plug Division of General Motors, 1300-T N. Dort Hwy., Flint, MI 48556.Available from AmericanNational Standard

28、s Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.G121 1823.1.9.1 DiscussionParticulates are usually reported as the amount of contaminant by the population of a specific micrometer size, usually defined byits greatest dimension. See methods described in Test Meth

29、ods F312, Practices F303, or ARP 598 for particle size and populationdetermination.3.1.10 surface roughness, Ra, nthe arithmetic average deviation of the surface profile from the centerline, normally reportedin micrometres.3.1.11 test coupon, nrepresentative surface that is typically a rectangular p

30、iece of a material of construction on which a knownamount of a compound is deposited to simulate a process residue.4. Summary of Practice4.1 A solution of the contaminant The contaminant under study is applied to either one side or both sides of the precleaned testcoupons and dried under standard co

31、nditions. in a defined area. The amount of contaminant on the test coupons is determined.determined by weighing the test coupons before and after application. The amount of contaminant applied should be controlledand the variation in weight between test coupons minimized. Test coupons should be test

32、ed in a manner that simulates the actualcleaning conditions for the product, equipment, or system. Coupons may be tested immediately to simulate actual cleaningconditions or dried under specified conditions (for example, ambient overnight, 8 h at 104 C, etc.) prior to testing (for example,for Dirty

33、Hold Time studies). Nonmetallic material test coupons used as inserts, seats, seals, gaskets, etc. may also be preparedby this procedure and are evaluated in the as-used condition.under actual cleaning conditions.4.2 Three methods of test coupon preparation are used:Method A,A: NVR sample, single si

34、de,Method B,B: NVR sample, double side side, andMethod C,C: NVR and particulate samplesample.5. Significance and Use5.1 This practice will be suitable to direct the preparation of test coupons with a known amount of contaminant on the surface.A standard test coupon is described and a list of contami

35、nants that have typically been found in oxygen-enriched systems andcomponents is provided.5.2 These test coupons shall be used in the evaluation of cleaning agents for oxygen-enriched systems and components. Thiswill permit direct comparison within and between test facilities.5.3 Materials used in o

36、ther fluid handling systems such as nitrogen, helium, hydrogen, gasoline, etc. may also be prepared forevaluation by this practice.6. Apparatus6.1 Test CouponMetal panels Panels of the same material as the component part of construction and finish as the equipment,product, or system to be cleaned. O

37、ther alloys that may be used if the specific alloy is unknown are included in Guide G94. Thecoupon Test coupons should be numbered and in a manner that prevents removal during testing.Aspecified area of the test couponmay be designated as the test area where the test material is applied. Test coupon

38、s may be of different test area dimensions (forexample, 5 cm x 5 cm, 10 cm x 10 cm) depending on the test procedure they are used in. An example test coupon configurationis shown in Fig. 1.NOTE 1The surface finish of the test coupon should be the same as the part to be cleaned.6.2 Balance-Range Bala

39、nceRange to a minimum of 50 g with an 0.1-mg accuracy capable of weighing to 60.1 mg.6.3 Oven-Convection, Convection OvencapableCapable of maintaining 50C 6 5C.50 C 6 5 C.6.4 Spray ApplicatorCapable of applying an even coat of contaminant; that is, an artists airbrush, perfume atomizer, or aspray de

40、vice such as that used with window or tile cleaners has been found to apply an even coating of the contaminant in acontrolled manner.6.5 Other standard equipment such as a vacuum filtration system, solvent resistant filters, gloves, laboratory glassware, syringes,pipettes, desiccator, laboratory ton

41、gs, tweezers, and wire.7. Reagents7.1 Contaminant MaterialsContaminant materials-general General classes of materials that have typically been found inoxygen-enriched systems and components as a result of the manufacturing, assembly, fabrication, and construction processesinclude:silicone oils and g

42、reases,fluorinated aerospace fluids and greases,G121 183petroleum based oils and greases,oils,ester based oils and greases,oils,phosphate esters,waxes,chlorotrifluoroethylene based oils and greases,oils,inks,cutting oils, anddye penetrants.7.1.1 Solvent-reagent-grade used to prepare standard solutio

43、ns of contaminants which may include the following: 2-propanol,2-butanone, hexane, Type II reagent water, or better, in accordance with Specification D1193, and perfluorinated carbon fluids.(WarningSolvents such as 2-propanol hexane and 2-butanone are highly flammable. Appropriate safe handling proc

44、eduresshould be used.)7.2 Contaminant materialsSolvent-reagent-grade used to prepare standard solutions of contaminants which may include thefollowing: 2-propanol, 2-butanone, hexane, Type II reagent water, or better, in accordance with SpecificationClasses of materialsthat are typically evaluated i

45、n health care industry products, equipment, and processes include but are not limited to D1193, andperfluorinated carbon fluids. (the following:WarningSolvents such as 2-propanol hexane and 2-butanone are highly flammable.The reader should refer to appropriate safe handling procedures.)Active Pharma

46、ceutical Ingredients,Intermediates of Active Pharmaceutical Ingredients,Finished Pharmaceutical Products,Biological products (proteins, fermentation broth, etc.),Cosmetic products,Degradants,Excipients,Etc.7.2.1 Solvent-reagent-grade used to prepare standard solutions of contaminants may include USP

47、 Purified Water and Water forInjection, and solvents such as Methanol, Ethanol, Isopropyl Alcohol, etc.7.3 DesiccantDesiccantforfor example, silica gel.FIG. 1 StandardExample Test CouponG121 1847.4 Particulate ContaminantParticulate contaminantfine fine (0- to 80-m), or coarse (0- to 200-m) dustspow

48、ders/particles.5 available commercially.8. Procedure8.1 Test Coupon Preparation:8.1.1 Test coupons should be prepared from the same Material of Construction (MOC) and with the same material grade (forexample, SS 316L/#4) that will be used in the equipment, product, or system under study. The test co

49、upons shall be numbered andprecleaned prior to use; record the number. Determine the surface use and the number recorded. If surface roughness is a variablein the application, selecting the roughest surface finish for the test coupons is advisable to represent worst-case conditions. Thesurface roughness, Ra, of representative test coupons of each alloy being can be evaluated perANSI B 46.1 and record. Determinethe B46.1 and recorded. The surface area to be contaminated (S) of each of the test coupons and record. Attach should bepre