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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:
The WHEATONÂ COMPLETEPAK product line allows focusing on the core competency such as manufacturing, compounding, and developing drug products.
Target Applications
- 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
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
- 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
