New plastic parenteral vials
Improved barrier properties for sensitive drugs
1. vials have a unique triple-layer structure consisting of a layer of polyamide sandwiched between two COP (cyclic olefin polymer)layers. They have unique barrier properties which en- hance the drug's stability over its shelf life.
2. All materials used fufill the stringent biocompatibilit and pharma-copoeia requirements for pharmaceutical plastic packaging mate-rials Pharm.Eur./USP/JP.
3. The absence of metal ions in the vials and their inertness against acidic or alkaline conditions make them the ideal choice for heavy metal-sensitive drugs or parenterals with a high pH-value.
4. The multilayer design offers additional integrity assurance, even under force impact, The combined crack resistance and integrity performance are a unique packaging safety feature for manufac-turers of toxic or high potency drug solutions.
5. ROTECH vials are available in the sizesof 2, 5, 10, 15, 50 and 100 ml and manufactured under clean room conditions. A mul-tifunctional automated packaging line makes it possible to supply vials both as bulk products and in ready-to-use format.
6. The vials are manufactured at our plant in Boleslawiec, Poland.
7. The Boleslawiec faclity is certified as compliant with IsO 9001,ISO 14001 and ISO 15378. This site has registered a DMF with the FDA(USA).
Product characteristics
1. Unique barrier properties.
2. Superior break resistance.
3. Inert against high and low pH.
4. No metal ions.
5. Low absorption.
Product offering
1. Standard.
2. Ready-to-sterilize(includes certified Bioburden, Endotoxin and particle level).
3. Ready-to-use(includes validated gamma sterilization).
