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.
Fill out the form
Waiting for review
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).
1. Unique barrier properties.
2. Superior break resistance.
3. Inert against high and low pH.
4. No metal ions.
5. Low absorption.
2. Ready-to-sterilize(includes certified Bioburden, Endotoxin and particle level).
3. Ready-to-use(includes validated gamma sterilization).
|2R||EN ISO 8362-1||2||3.5||16||35||3.6||13||7||2.7|
|6R||EN ISO 8362-1||5||9.1||22||40||3.6||20||12.6||4.9|
|10R||EN ISO 8362-1||10||12.5||24||45||3.6||20||12.6||6.1|
|15R||EN ISO 8362-1||15||17||24||60||3.6||20||12.6||16|
|50H||EN ISO 8362-4||50||67||42.5||73||3.8||20||12.6||16|
|100H||EN ISO 8362-4||100||132.2||51.6||94.5||3.8||20||12.6||26.5|
PRODUCT PACKAGING AND FINISH DESCRIPTION
|Production environment||ISO 7||√||√||√|
|Packaging processing||Fully automated||√||√||√|
|Packaging environment||ISO 7||√||√||√|
|Packaging materials in direct contact with vials||Produced in ISO 7||√||√||√|
|Dimensions||Accord. to standard specification||√||√||√|
|Defects||Accord. to standard specification||√||√||√|
|Cleanliness||Accord. to standard specification||√||√||√|
|Endotoxin||Certified per batch; limit: 0.06 EU/mI||√|
|Particles||Certified per batch||√||√|
|Bioburden||Certified per batch; limit:10 CFU/mI||√||√|
|Gamma radiation||Validated sterilisation dose||√|
|Sterilisation||Certified per batch/parametric release||√|
|Endotoxin test post sterilisation Certified per batch||√|