A New PE Film for Bio-Pharma with Purity & Performance. HiPure™ ULP7 is a new pharma ready LLDPE film developed by ChargePoint Technology to meet the demands of even the most critical aseptic processing environments
HiPure™ ULP7 Film is a high purity polyethylene liner for use in pharmaceutical and biotech applications. The film is primarily used within ChargeBag® flexible packaging for the contained and sterile transfer of powder ingredients and as primary packaging for drug product transport between facilities.
The film is a single layer Polyethylene extrusion with excellent mechanical strength characteristics to withstand the rigours of industrial use giving operators and production teams a high level of protection from failures often associated with poor quality films.
The material is compliant to pharma standards and manufactured in controlled clean-room conditions to provide the basis for a consistent and ultimately sterile end product suitable for critical pharma application.
The Film has been tested to all the major regulatory standards and has achieved a well-rounded data profile for both chemical and biological tests that prove its suitability for a wide range of pharmaceutical products and uses minimal additives (purity) to ensure suitability for, and compatibility with, many pharmaceutical powder based products and production processes.
A permanent, non-migrating anti-static additive gives the film excellent surface resistivity properties to enhance performance with powders and qualifies as being Electrically Dissipative.
As part of the development of the film, ChargePoint have carried out rigorous and extensive testing of the HiPure™ ULP7. The following qualification testing has been carried out and a pass rate has been confirmed:
|Biological Reactivity -In Vitro / In Vivo||USP 87, 88|
|Bacterial Endotoxins||USP 85|
|Biological evaluation of medical devices||ISO10993 Parts 1, 4, 5|
|Polyolefin materials for pharmaceutical use||EP 3.1.3|
|Physicochemical Container Test with and without Alternative Extract||USP 661.1|
|EU Food Contact||EU 10/2011|
|FDA Food Contact||21 CFR 177|
|Free from Animal Derivatives|