Developments in Surface Contamination and Cleaning Developments in Surface Contamination and Cleaning Series SeriesEditors RajivKohliandK.L.Mittal Volume1:FundamentalsandAppliedAspects(2008)ISBN:978-0-8155-1555-5 Volume2:ParticleDeposition,ControlandRemoval(2010)ISBN:978-1-4377-7830-4 Volume3:MethodsforRemovalofParticleContaminants(2011)ISBN:978-1-4377- 7885-4 Volume4:Detection,Characterization,andAnalysisofContaminants(2012)ISBN: 978-1-4377-7883-0 Volume5:ContaminantRemovalandMonitoring(2013)ISBN:978-1-4377-7881-6 Volume6:MethodsofCleaningandCleanlinessVerification(2013)ISBN:978-1-4377- 7879-3 Volume7:CleanlinessValidationandVerification(2015)ISBN:978-0-3233-1303-2 Volume8:CleaningTechniques(2015)ISBN:978-0-3232-9961-9 Developments in Surface Contamination and Cleaning Cleanliness Validation and Verification Volume 7 Edited by Rajiv Kohli and K.L. Mittal AMSTERDAM (cid:129) BOSTON (cid:129) HEIDELBERG (cid:129) LONDON (cid:129) NEW YORK (cid:129) OXFORD PARIS (cid:129) SAN DIEGO (cid:129) SAN FRANCISCO (cid:129) SINGAPORE (cid:129) SYDNEY (cid:129) TOKYO William Andrew is an imprint of Elsevier WilliamAndrewisanimprintofElsevier TheBoulevard,LangfordLane,Kidlington,Oxford,OX51GB,UK 225WymanStreet,Waltham,MA02451,USA Firstedition2015 Copyright©2015ElsevierInc.Allrightsreserved Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronic ormechanical,includingphotocopying,recording,oranyinformationstorageandretrievalsystem, withoutpermissioninwritingfromthepublisher.Detailsonhowtoseekpermission,further informationaboutthePublisher’spermissionspoliciesandourarrangementswithorganizations suchastheCopyrightClearanceCenterandtheCopyrightLicensingAgency,canbefoundatour website:www.elsevier.com/permissions. Thisbookandtheindividualcontributionscontainedinitareprotectedundercopyrightbythe Publisher(otherthanasmaybenotedherein). Notices Knowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchandexperience broadenourunderstanding,changesinresearchmethods,professionalpractices,ormedical treatmentmaybecomenecessary. Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgeinevaluating andusinganyinformation,methods,compounds,orexperimentsdescribedherein.Inusingsuch informationormethodstheyshouldbemindfuloftheirownsafetyandthesafetyofothers,including partiesforwhomtheyhaveaprofessionalresponsibility. Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,oreditors,assume anyliabilityforanyinjuryand/ordamagetopersonsorpropertyasamatterofproductsliability, negligenceorotherwise,orfromanyuseoroperationofanymethods,products,instructions,or ideascontainedinthematerialherein. LibraryofCongressCataloging-in-PublicationData AcatalogrecordforthisbookisavailablefromtheLibraryofCongress BritishLibraryCataloguinginPublicationData AcataloguerecordforthisbookisavailablefromtheBritishLibrary ISBN:978-0-3233-1303-2 ForinformationonallElsevierpublications visitourwebsiteatstore.elsevier.com PrintedandboundintheUSA 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Contributors DavidE.Albert,NAMSA,Walbridge,Ohio,USA MantoshK.Chawla,PhotoEmissionTech.,Inc.,Camarillo,California,USA RajivKohli,TheAerospaceCorporation,NASAJohnsonSpaceCenter,Houston, Texas,USA S.LakshmanaPrabu,DepartmentofPharmaceuticalTechnology,Bharathidasan InstituteofTechnology,AnnaUniversity,Tiruchirappalli,TamilNadu,India T.N.K.SuriyaPrakash,DepartmentofPharmaceutics,AlShifaCollegeofPharmacy, Malappuram,Kerala,India R.Thirumurugan,DepartmentofPharmaceuticalChemistry,SchoolofPharmacy, InternationalMedicalUniversity,KualaLumpur,Malaysia MaryA.Thomson,RemspecCorporation,Sturbridge,Massachusetts,USA ix Preface The purpose of the book series Developments in Surface Contamination and Cleaningistoprovideacontinuousstate-of-the-artcriticallookatthecurrent knowledge of the behavior of both film-type and particulate surface contami- nants. The first six volumes, published in 2008, 2010, 2011, 2012, and 2013 (Volumes 5 and 6),respectively, covered various topics dealingwith the fun- damental nature of contaminants, their measurement and characterization, anddifferenttechniquesfortheirremoval.Thepresentbookistheseventhvol- ume inthe series. Theindividualcontributionsinthisbookprovidestate-of-the-artreviewsby subject matter experts on contamination sourcesand cleanlinessvalidation. Contaminantsare ubiquitous.Themostcommon typesof surface contam- inants are particles; thin film or molecular contamination that can be organic orinorganic;ioniccontamination;andmicrobialcontamination.Surfaceclean- linesslevelsaredefinedforeachofthesecontaminantcategoriesbyconsensus standards that aim to help control and mitigate the deleterious effects of con- taminants.Inhiscontribution,RajivKohliprovidesanoverviewofthesources ofthesecontaminantsandmechanismsoftheirgenerationanddiscussessome of the impacts of the contaminants. Thiscan assist indeveloping remediation solutions for these types ofcontaminants. Mid-IRspectroscopy,performedatgrazingangleandindirectreflectance mode, provides a convenient tool for surface analysis and cleanliness valida- tion.MaryThomsondescribesthemethodindetailanddiscussesawiderange of qualitative, semiquantitative, and fully quantitative applications in surface concentration ranges that are relevant to pharmaceutical cleaning validation inparticular.Thismethodcanbeusedtoidentifyandmeasureorganiccontam- inants down to submicrogram levels, and it provides a direct, near-real-time result without the need for subsequent laboratory analysis. The chapter by Mantosh Chawla presents a thorough treatise of optically stimulated electron emission (OSEE), also known as photoelectric effect. The OSEE technique is very well suited to thin film contamination detection andmonitoring.Thechapterdiscussesthetheoryofthetechnique,thefactors affectingthetechnique,andthemostcommonapplicationsofthetechniquefor the study, measurement, and evaluation of the changes in the surface state of almostanysubstrate.Specificexamplesofthevastarrayofapplicationsarealso presentedspanningalltypesofindustries.Thischapterisintendedasapractical xi xii Preface anda useful reference tool for anybody involved insurface cleanliness moni- toring/measuring ordetection, control,and/orelimination ofsurface contami- nation in various industries. Successfulcleaningofmedicaldevicesandinstrumentsrequiresbothcare- ful selection of materials and consistent monitoring of the procedures used to processthem.Chemicalcharacterizationofresiduesthatmaybeadsorbedonto surfaces and mechanical testing to ensure functionality should provide suffi- cient information to evaluate the potential success of cleaned and disin- fected/sterilized medical devices. By using a combination of chemical and mechanicalanalysistechniques,bothmanufacturinganddecontaminationpro- cesses can be optimized to ensure a safe and effective product. Choosing the optimal testingprotocols,interpreting results, selecting theappropriate chem- istries,andimplementingrugged,reliableprocessesrequireexperiencedadvice andinput.Itisimportanttonotethatnotest,howeverfoolproofitsdesign,can everbeconsideredadefinitivepredictorofclinicalperformance.Thechapter byDavidAlbertexaminesvariouskindsofcontaminantsassociatedwithmed- icaldevicesandexploresvariousanalyticaltechniquestodetecttheirpresence or absence. The use of toxicological risk assessment as a way to set residue limitsandasamethodtoevaluatetheoverallbiologicalsafetyofanyremaining ordetectedcontaminantsleft on medicaldevices isdiscussed. Pharmaceuticalproductsandactivepharmaceuticalingredients(APIs)can becontaminatedbyotherpharmaceuticalproductsorAPIs,bycleaningagents, bymicroorganisms,orbyothermaterials,suchasairborneparticles,dust,lubri- cants,rawmaterials,intermediates,andauxiliaries.Toavoidcontaminationof the product, adequate cleaning procedures are essential. In their chapter, S. Lakshmana Prabu, T. N. K. Suriya Prakash, andR. Thirumurugan discuss cleaningvalidationanditsregulatoryaspectsinpharmaceuticalmanufacturing. The purpose of cleaning validation is to prevent contamination and cross- contamination in pharmaceutical dosage forms. Cleaning validation describes properapplicationofcleaningproceduresfortheremovalofcontaminantsasso- ciated with the previous products, residues of cleaning agents, as well as the controlofpotentialmicrobialcontaminantsandsignificantlyreducestheamount of actives, excipients, and cleaning agents to a concentration within defined acceptancelimits. Thecontributionsinthisbookprovideavaluablesourceofinformationon the current status and recent developments in the respective topics on the impact, characterization,andremovalofsurface contaminants. Thebook will be of value to government, academic, and industry personnel involved in researchanddevelopment,manufacturing,processandqualitycontrol,andpro- curement specifications in microelectronics, aerospace, optics, xerography, joining (adhesivebonding), andotherindustries. Wewouldliketoexpressourheartfeltthankstoalltheauthorsinthisbook for their contributions, enthusiasm, and cooperation. Our sincere appreciation goes to our publishers Peter Gane and Matthew Deans, who have strongly Preface xiii supportedthepublicationofthisvolume,inparticular,andthisseries,ingen- eral.MelissaReadandtheeditorialstaffatElsevierhavebeeninstrumentalin seeingthebooktopublication.RajivKohliwouldalsoliketothankthestaffof theSTIlibraryattheJohnsonSpaceCenterfortheireffortsinlocatingobscure and difficult-to-accessreference materials. Rajiv Kohli Houston,TX Kash Mittal HopewellJunction,NY About the Editors Dr.RajivKohliisaleadingexpertwithTheAero- spaceCorporationincontaminantparticlebehavior, surface cleaning,and contaminationcontrol. Atthe NASAJohnsonSpaceCenterinHouston,Texas,he providestechnicalsupportforcontaminationcontrol related to ground-based and manned spaceflight hardware, as well as for unmanned spacecraft. His technicalinterestsareinparticlebehavior,precision cleaning, solution and surface chemistry, advanced materials,andchemicalthermodynamics.Dr.Kohli was involved indevelopingsolvent-basedcleaningapplications for useinthe nuclearindustry,andhealsodevelopedaninnovativemicroabrasivesystemfor a wide variety of precision cleaning and microprocessing applications in the commercialindustry.HeistheprincipaleditorofthisbookseriesDevelopments inSurfaceContaminationandCleaning;thefirstsixvolumesintheserieswere publishedin2008,2010,2011,2012,and2013(Volumes5and6),respectively, andthepresentbookistheseventhvolumeintheseries.Previously,Dr.Kohli coauthoredthebookCommercialUtilizationofSpace:AnInternationalCom- parisonofFrameworkConditions,andhehaspublishedmorethan250techni- cal papers, articles, and reports on precision cleaning, advanced materials, chemicalthermodynamics,environmentaldegradationofmaterials,andtechni- calandeconomicassessmentofemergingtechnologies.Dr.Kohliwasrecently recognized for his contributions to NASA’s Space Shuttle Return to Flight effort with the Public Service Medal, oneof the agency’shighest awards. Dr. Kashmiri Lal “Kash” Mittal was associated withIBMfrom1972to1994.Currently,heisteaching andconsultingin theareasofsurface contamination andcleaningandinadhesionscienceandtechnology. HeisthefoundingeditorofthenewjournalReviews of Adhesion and Adhesives which made its debut in 2013.HecofoundedtheJournalofAdhesionScience and Technology and was its editor-in-chief until April 2012. Dr. Mittal is the editor of more than xv xvi AbouttheEditors 120 published books, many of them dealing with surface contamination and cleaning. He was recognized for his contributions and accomplishments by the worldwideadhesioncommunitywhichorganizedinhishonoronhis50thbirth- day the 1st International Congress on Adhesion Science and Technology in Amsterdam in 1995. The Kash Mittal Award was inaugurated in his honor for hisextensiveeffortsandsignificantcontributionsinthefieldofcolloidandinter- facechemistry.Amonghisnumerousawards,Dr.Mittalwasawardedthetitleof doctor honoris causa by the Maria Curie-Sklodowska University in Lublin, Poland,in2003.In2014twobooksentitledRecentAdvancesinAdhesionScience andTechnologyandSurfactantsScienceandTechnology:RetrospectsandPros- pectswerepublishedinhishonor.