Diagnostic Vials Ideal for Applications such as Vaccine Production Trials

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Diagnostic Vials Ideal for Applications such as Vaccine Production Trials
WHEATON now provides a range of kits, COMPLETEPAK, consisting of a selection of tubular glass serum vials, rubber stoppers, and seals supplied ready-to-use in one complete kit, certified to European Pharmacopoeia and US Pharmacopoeia, these kits are available off the shelf and can be customised for any application. Key benefits include:
  • Ready-to-use clear tubular glass serum vials, rubber stoppers, and seals
  • 18 month shelf life from date of processing
  • Comes with critical USP and EP certifications, and product conforms to requirements outlined in the current versions EP 3.2.1 and EP 3.2.9
  • PARTICULATE - lot certified to current versions of USP <788> using Method 2, and EP 2.9.19 Microscopic Particle Count Test
  • STERILITY - lot certified to current versions of USP <71> and EP 2.6.1
  • ENDOTOXINS - Lot certified to current versions of USP <85> and EP 2.6.14, lots are tested and is certified to <0.25 EU/mL, Kinetic Turbidimetric LAL Method, FDA Guideline
  • Container Closure Integrity (CCI) certification available upon request
  • Complete manufacturing traceability
The WHEATON COMPLETEPAK product line allows focusing on the core competency such as manufacturing, compounding, and developing drug products.   Target Applications
  • Compounding pharmaceuticals
  • Aseptic filling of injectable drug products
  • Drug discovery
  • Drug research
  • Freeze-drying / lyophilized drug products
  • Large and small molecule drug packaging
  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 lyophilised stoppers are suited for biologics and content with sensitivities to silicon
  For further information please contact support@camlab.co.uk.
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