WHEATON COMPLETEPAK

The WHEATON® COMPLETEPAK™ product line is a range of crimp top vials, rubber stoppers and seals that are ready-to-use and are off-the-shelf, which can be customized for any application. This reduces our customer’s supply chain due to our one source solution capability. Each kit comes with a specific United States Pharmacopeia (USP) & European Pharmacopiea (EP) certificate showing that the product meets or exceeds critical USP / EP standards that are enforced by the Federal Drug Administration (FDA) & European Directorate for the Quality of Medicines and Healthcare (EDQM). This kind of solution allows for our customers to focus on their core competency which is manufacturing, compounding and developing drug products.

KEY BENEFITS

• Sterilized, off-the-shelf, ready-to-use (RtU) products

• Variety of Kitted and stand-alone sterile components — a solution for any application

• Kitted solutions feature equal amounts of RtU components for reduced scrap rates

• Complete manufacturing & certificate of analysis traceability

• USP <788>/EP 2.9.19 Particulate Matter in Injections, USP <85>/EP 2.6.1, The Bacterial Endotoxins Test and lot certified to SAL ≤ 10-6, USP <660>/EP 3.2.1 Glass Containers for Pharmaceutical Use, and USP <381>/EP 3.2.9 Elastomeric Closures used in Parenteral Preparations • COMPLETEPAK™ Amber for light sensitive content packaging

• COMPLETEPAK™ ModPAK Bulk configurations

• Ready-to-Use, Just-in-Time, minimum 180 day shelf life from time of shipment

• Container Closure Integrity (CCI) certification available upon request

MATERIALS

• Vials are designed for parenteral applications and manufactured from low extractable borosilicate glass

• All stoppers are manufactured from an ultrapure bromobutyl latex free formulation with extremely high chemical purity and low gas permeability

• Omniflex stoppers offer low levels of residual binding to maximize extraction of active pharmaceutical ingredients

• Omniflex stopper elasticity delivers a more effective barrier to optimize container closure integrity and content protection

• Igloo lyopholized stoppers are suited for biologics and content with sensitivities to silicone