Advancing Pharmaceutical Packaging：An Introduction to USP 662 and 1662 for Metal Containers-Desmond G. Hunt, Ph.D.pdf

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1、1 2021 USPNew:662 and Metallic Packaging Systems and Their Materials and Components of ConstructionDesmond G.Hunt,Ph.D.Sr.Principal ScientistSuzhou,ChinaAugust 20242 2021 USP2 2021 USPEarly UsageEarly 1900s Stip Tube:Introduced as the first ophthalmic or eye-tip tube Syrette:An early device with two

2、 collapsible tubes for injecting liquids.It evolved into a metal tube with a hypodermic needle,widely used during WWII(over 70 million manufactured)1940s-1950s Metal Tubes:Used for various ointments.Metal tubes impermeability to light and air preserved product potency and prevented contamination1960

3、s Foil Strip Packs:Introduced,followed by aerosols,squeeze packs,and blisters.Blisters were designed to improve patient compliance1980s GrowthBlister Packs:Rapid growth,driven by advocacy for original packed dispensing(OPD).OPD reduced tampering,contamination,and dispensing errorsHistorical:Metal Pa

4、ckaging in PharmaceuticalsModern UsageMetal packaging systems are now widely used for:Primary and secondary packagingAuxiliary packaging componentsKey BenefitsBarrier Properties:Blocks light,oxygen,moisture,and gasesDurability:Withstands mechanical stressTamper Evidence:Features to detect tamperingS

5、ustainability:Easy to recycle and environmentally friendlyCustomization:Various shapes,sizes,and finishes for branding.3 2021 USP3 2021 USPUSP Standards Gap:Metal PackagingUSP Packaging Material Standards Elastomeric Materials:-Elastomeric Components in Injectable Pharmaceutical Product Packaging/De

6、livery Systems Glass Packaging:-Containers Glass Plastic Packaging -Plastic Packaging Systems and Their Materials of Construction -Plastic Materials of Construction -Plastic Packaging Systems for Pharmaceutical UseUSP Metal Packaging Standards Gaps in Existing Standards:Unlike elastomer,glass and pl