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Extractables and Leachables Testing Services - Vimta Labs Ltd

Packaging materials & manufacturing components coming in contact with drug products, active ingredients or medical devices are a potential source for chemical contamination, posing a risk to product safety and quality. A detailed study of container closure system, manufacturing components and drug product is becoming increasingly necessary to evaluate the impact of such interactions.<br><br>Extractable and Leachable study is a critical regulatory requirement which requires thorough understanding of the subject, extensive experience, high end instrumentation and qualified resource.<br><br>VIMTA provides customized protocol driven extractables and leachables testing services to help ensure that your product is safe for the patient. Our scientific team is well versed with applicable regulatory requirements, standards and guidelines such as PQRI, FDA, ISO, EMEA, ICH, EP and USP, in addition to its decades of experience in analytical and physical chemistry. <br><br>Our cGMP facilities offer a proven track record in carrying out studies of extractables and leachables to detect ultra-trace levels of contaminants from materials in contact with drug products or medical devices.<br><br>VIMTA has successfully faced over 70 regulatory audits including 16 US FDA inspections and has an excellent track record of delivering high quality services to its global customers.<br><br>Visit our website https://www.vimta.com for more details

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Extractables and Leachables Testing Services - Vimta Labs Ltd

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  1. LargestNetworkofLabs *DelhiNCR Ahmedabad Indore Kolkata Vishakhapatnam EXTRACTABLES& LEACHABLES Pune Bhimavaram Hyderabad (HeadQuarters) Nellore Bengaluru Cochin SERVICE THROUGH UNCOMPROMISING COMMITMENT TOQUALITY! Life SciencesCampus PlotNo.5,MNPark,GenomeValley,ShameerpetMedchal -500101,Hyderabad,Telangana,India. Tel: +91 40 6740 4040 | Email: bd@vimta.com| Website:www.vimta.com /VimtaLL /vimta-labs-ltd www.vimta.com

  2. ABOUTVIMTA LEGACY 34Years Foundedin1984withheadquartersinHyderabad,India,VIMTALABSLTD.,isaleadingcontractresearch and testing organization, providing bio/pharmaceutical companies an integrated scientific, technical andregulatoryexpertisetosupportallstagesofdrugdevelopmentandmanufacturingprocess. VIMTA has been supporting many national and overseas companies for more than 3 decades, for their third party testing, research and outsourcing needs. Along with the growth in pharma, food and other manufacturingsectors,wehavebeenabletogrowandalsoexpandourservicestointernationalmarkets. INFRA 350,000 Sqft.oflabspace GROWTH Single benchto Wold classlaboratory 72% Growth in5 years PEOPLE 700+ 1100+ Scientists withwide, variedandstrongtechnicalexpertise strongteam QUALITYSYSTEMS cGMP, GLP,GCP Compliant ISO17075 ISO15189 ISO9001 1 2

  3. QUALITY SERVICEPORTFOLIO VIMTAhassuccessfullyfacedover70regulatoryauditsincluding16USFDAinspectionsandhasan excellenttrackrecordofdeliveringhighqualityservicestoitsglobalcustomers. CLINICAL RESEARCH PRECLINICAL RESEARCH cGMP ANALYTICAL SERVICES ANALYTICAL FOOD &WATER BIOSIMILAR SERVICES ENVIRONMENTAL ASSESSMENT 3 4

  4. EXPERIENCE EXTRACTABLES ANDLEACHABLES Packagingmaterials&manufacturingcomponentscomingincontactwithadrugproduct,activeingredient or medical device are a potential source for chemical contamination, posing a risk to product safety and quality. A detailed study of container closure system, manufacturing components and drug product is becomingincreasinglynecessarytoevaluatetheimpactofsuchinteractions. ExtractableandLeachablestudyisa criticalregulatoryrequirementwhichrequiresthoroughunderstand- ingofthesubject,extensiveexperience,highendinstrumentationandqualifiedresource. Data submitted andaccepted byglobal regulatory authorities Over500 studies conducted Pioneer in India tooffer E/LStudies. • ServicesOffered • Extractables • Leachables • Ink & GumMigration • GlassDelamination • Elemental Analysis(ICH Q3D) • ToxicologicalEvaluation • GenotoxicImpurities VIMTA provides customized protocol driven extractables and leachables testing services to help ensure that your product is safe for the patient. Our scientific team is well versed with applicable regulatory requirements, standards and guidelines such as PQRI, FDA, ISO, EMEA, ICH,EPand USP, inadditiontoitsdecadesofexperienceinanalyticalandphysicalchemistry. Our cGMP facilities offer a proven track record in carrying out studies of extractables and leachables to detect ultra-trace levels of contaminants from materials in contact with drug products or medicaldevices. 5 6

  5. EXTRACTABLES LEACHABLES • Evaluationofpackagingmaterialsincluding‘Primary&Secondary’components&manufacturingcomponents. • Customized studydesign. • Controlledextractionstudyusingdifferentextractiontechniques&solvents. • Qualitativeandquantitativeanalysisofpotentialextractables. Organic impurities - Non-volatiles, Semi volatiles, Volatiles Inorganicimpurities–Anions&Elements • Optimizationandvalidationofcontrolextractablestudyforroutinecontrolofpackagingmaterialquality. • Methoddevelopmentandvalidationforthequantificationofleachablesinthedrugproduct. • Monitoringoftheunkownsusingscreeningtechniques. • Leachablemonitoringthroughoutproductshelflife. • Correlationestablishmentofpotentialleachables&actualleachables. • Toxicologicalevaluation. Packaging MaterialExperience PRODUCTEXPERIENCE • Inhalations/Aerosols • Ophthalmics • Injectables • Large volumeparenterals • Suppository • Oralvaccines • Topicals • Transdermal • Oralsuspensions • OralSolids • Rubberstoppers • EPDMpackaging • Gaskets &O-rings • Inhalationdevices • PrefilledSyringes • Patches • Films /Blister packs • Disposables (Bioprocess–singleuse) • Laminatedtubes • HDPE/LDPE/PP/Plasticbags&containers • Large volumecontainers • Implants • Resins • Injectable bags /vials • Tubing &Filters • In-process manufacturingcomponents • Glass vials, SyringesEtc., • Labels &Inks 7 8

  6. GLASS DELAMINATIONSTUDY VALIDATIONS Delamination is the process whereby thin layers of glass, described as either flakes or lamellae, are detached from the inner surface of a glass container. The appearance of glass lamellae is the mostobviousvisualindicatorofstructuralinstabilitywhichrepresentsthefinalstageofaseriously weakenedglasssurface.Thisisaseriousqualityissueandcanresultinaproductrecall. ThepotentialleachablesfromtheextractablestudyofCCSaremonitoredinthedrugproductsampleto assessthesuitabilityoftheCCSforitsintendedpurposeusingvalidatedmethods. ThemethodsaredevelopedandvalidatedbasedontheICHQ2(R1)andareusedtomonitorthepotential leachablesthroughouttheshelflifeoftheproduct. • Degreeofvialsurfacepitting • pH andConductivity • Particlemorphology • ElementalAnalysis The Validationcovers: SystemPrecision Linearity Accuracy Specificity Solution Stability MethodPrecision IntermediatePrecision Robustness LOD&LOQdetermination LODPrecision LOQPrecision Range 9 10

  7. IDENTIFICATIONDATABASE INSTRUMENTATION Vimtahascreatedadatabaseofcompounds.Thesecompoundshavebeencategorizedbroadlyas: • LC-MS/MS • GC-MS/MS • GC-MSHeadSpaceandPurge&Trap • HPLCwithUV,Flame,RI,PDAdetectors • HR-GC-MS (AutoSpec) • GC-FID – ECD &FPD • Atomic AbsorptionSpectrometry • C,H,N,SAnalyser • FTIR • Particle SizeAnalyser • Plasticsadditives • Tubingcompounds • ResidualSolvents • PolymerAdditives&Degradationcompounds • FilterResidues • Inkmigration • Gum &Adhesive • Rubber ingredients &Impurities • ICP-MS • ICP-OES • IonChromatographwithTCD&UVD • Automated ExtractionSystems • SEM • CE Thedatabaseisgeneratedusingauthenticstandards,retentiontimeandmassspectrumandused fortheidentification&confirmationofunknownpeaksgeneratedduringthestudies. 11 12

  8. TOXICOLOGICALEVALUATIONS BIOCOMPATIBILITYTESTING • VIMTAs in-house board certified toxicologists offers toxicological and safety evaluation of the potentialleachatesidentifiedduringthecontrolledextractionstudytoaidintheselectionofthe potentialonesforleachablestudydesign.Thisisatedioustaskduetonon-availabilityofthecom- poundprofiles. • The toxicological evaluation is performed as per relevant ICH guidelines and strict complianceto OECD GLPprinciples. • Vimtaoffersfirstpassscreeningusing: • TOPKAT Toxtree • In-vitromutagenicity • In-vivo acute oraltoxicity • Cytotoxicity VIMTAhasover2decadesofexperienceperformingbiocompatibilitystudiesfortheglobalmedical deviceindustriesasperISO–10993standards. Insomespecificcases,biocompatibilitydataneedstobegeneratedoncontainerclosuresystems. Among the risks to be considered are those arising from exposure to leachable substancesfrom container closuresystems. • ISO 10993-Part3 • ISO 10993-Part4 • ISO 10993-Part5 • ISO 10993-Part6 • ISO 10993-Part10 • ISO 10993-Part11 • ISO 10993-Part12 • ISO 10993-Part18 • OECD 471: AMES testing(Mutagenicity)... 13 14

  9. STABILITYPROGRAM TECHNICALCONSULTATION VIMTAisoneofIndia’slargestprovidersofstabilitytestingandstorageservices. • VIMTA'sscientificteamofferstechnicalconsultationatallphasesoftheproject(pre&post) • The pre-project phase involves one-on-one discussion with the customer to understand the project requirements.Thestudiesaredesignedtomeettheregulatoryrequirementsandfinalizedinconsultation with thecustomer. • WesupportcustomersindatainterpretationandevaluationforsuitabilityofCCSwithDrugproducts. Thestudyreportsincludedetailedconclusionwhichaidinsubmissionandacceptanceofthedata. • Dedicated customerservice • Wegreatlyvaluetheimportanceofopenandtimelycommunications • Dedicated project managementteam MultinationalcorporationsinOTC,Rx,andAnimalHealtharoundtheworldtrustourservices. We offer substantial cost-savings compared to investing in your own storage chambers, related space, manpower andtestingequipmenttherebyfreeingupyourresourcesforyourcoreactivities. WeconductstabilitystudiesasperICHguidelinesandalsooffercustomizedstabilityprograms. Our state-of-the-art stability chambers, with close to ~4,50,000 Liters capacity, are equipped with advanced chiller basedtechnologies,backupsystems,redundantpowerbackup,alarmssystem,andautomatedtemp/RHexcursion mobilephonenotifications.Allstabilitychambersaremonitored24x7. StudiesConducted • Clinicalstability • Developmentalstability • Follow-upstability • Registrationstability • Transportstability • Freeze thaw cyclingstability • Photostabilitystudies • Customized stabilityprograms 15 16

  10. EXPERTISE • 24/7Operations • Optimizedprocesses • CostEffective • Speedtomeetyourinternalorregulatorytimelines • Provenefficiencyofastrongtechnicalteamthatcancustomizestudy design,developprotocolsandconductE&Lstudies. • Scalablecapacities. • Accesstofullcapabilitiesofourcompany • OurexpertiseextendsbeyondE&Lstudies.Wehaveverticallyand horizontally integrated CROservices. • Toxicologyassessments • Stabilitystudies • Genotoxic impuritystudies • Method development andvalidations • LCPMS,IC,LCMS/MS,GCMS/MS,HPLC,GC,UPLC,LCMS-TOF,HRGCMS • PhysicalCharacterication • Compliant&reliabledeliverablesyoucantrust • Excellentcompliancetrackrecordwithsuccessfulregulatoryaudits. • MultidisciplinefullserviceCROwithinterdeployableresources (peopleandequipment)andefficientoperations • Purposebuiltlaboratorydesignedtominimizetheriskofanycross contamination. 17 18

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