Eee | Validating Medical Ronald Pilchikrary of Congress Cxalogngn uation Data "iim page / Re ii Vis the CRC Press Web seat ww wrepresicom Table of Contents What Validation’ Package Design Vlcaion Media Packager Package Process Vaid ‘dato! Reacing Chapter one Package Design Validation - Hlemens of Phage Dees Package Design Validation, uncon ofthe Package Properties of the Beste Pakage Sha Lie Considerations Package Design lrues ‘Pachage Testing Protocols “est Sequences ‘atidaon Flowchart ‘aldaton Ness Package Materials "Porous Packaging Materials 2 Nenporous Packaging Mates (uated Supple ‘additonal Reading Se (Chapter two Package Process Validation - "roses Vaan What "The Sealing Process. Froces Copa Sod (Other Variables Acsocnted ih Packaging ‘Seling Proce [Abit t Conte) Cia Parameters ‘Ay of Catal Persmeter Manauring DevicesSe Plates Unorm, Level Suppor Gaskess Contamination {Changes in Envizoneial Canons Sumacy and Conclusions Aasinal Renin ‘Capit Ping It A Topether— The Validation rote FDA Form 43 Table of Cantens Tees! baitin Production Inormaton ches. Product Don Sheet A220, (Quay Audi Repet - (ener infnnation Validation rool FroessCapabily Say ValdtonFrotorol: Process Capel Stay Vaidstion Protcol: Proves Capa Study Subject Clencem "Low Pelt” Cewung inns Chapter four Regulatory AcE ooo "okcted Cases = Pectaging Nondorplances. Industy Generated Support Documents CASE STUDY #1 Case STUDY #2 CASE STUDY #3 = IN THE UNITED Sii#S DiStRICT Cotler FOR ‘THE WESTERN DISTRICT OF NOKTH CAROLINA (CHARLOTTE DIVISION, Appendin2, - Indes: us Introduction Dac anc alee ta devi pug nd sipping ‘nists designed and constructed fo protect the dete rom aemtan ‘mage during te customary condos of prowesing. tose, hands ‘nd dlsubuton, dan Drag Aina Quy Spin Repulation 820360 1a hs simple paragraph the Food and Drug Administration (FDA) estab Inhe the manafactoer's responsi for mesial device packaging Dat prides ao dectios on how to adeve compliance. “Fis pacgeaph gar withthe veal Ga! Manning Pats fr Mail Denes pubes 197% and ae rained thot revo he FDA QSR of 197. 1rhas witstood thet of ne ‘Wo can aly the reuirerents exe Ensure = guarnte without servations DDesignad=pactage design mest be proven Corto = prcage proceatng inst be proven ‘Aeron ox damage = what canine represent aeration, damn see? Cooma conditions = “routine” handing — nat dropping ff 210 soy soo ov slang the package anit brik wal or arin, ori hough 2a Peceatng = usually inclades terization, he device obese ‘Storge “when and how and fr bow lng? “handling towing of he back of» tsek? Ditton ~ bon cas tough Als in winter and hough Arion inlay? Medical devie packagers developed an inition book cals 150 _1607 Pacing or ery Stans Mil Deve 180 1107 proves 1 mew dr fs plasenting the Qualty Sytem Regulations (SR) peck