HiPure™ ULP7 film is a new PE film for biopharma with purity and performance & performance. This secure pharmaceutical LLDPE film was 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 secure pharmaceutical 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 HiPure™ ULP7 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 HiPure™ ULP7 film, ChargePoint carried out rigorous and extensive testing. 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|