DWK Life Sciences WHEATON™ CompletePAK Sterile ModPAK Sterile Vial Kit

Descripción

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.

Each kit comes with specific United States Pharmacopeia (USP) certificates showing that the product meets or exceeds critical USP standards that are enforced by the Federal Drug Administration (FDA).

Key Benefits:

• Sterilized, off-the-shelf, ready-to-use (RtU) products
• Variety of Kitted and stand-alone sterile components
• Kitted solutions feature equal amounts of RtU components for reduced scrap rates
• Complete manufacturing and certificate of analysis traceability
• CompletePAK Amber for light sensitive content packaging
• CompletePAK ModPAK Bulk configurations
• 18 month shelf life from date of processing
• 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 ultra pure 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 silicon

Certifications

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