HiPure ULP7 film

A New PE Film for Bio-Pharma with Purity & PerformanceHiPure® ULP7 is a new pharma ready LLDPE film developed by ChargePoint Technology to meet the demands of even the most critical aseptic processing environments 

About HiPure® ULP7

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 cleanroom 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. 

Regulatory Compliance – Testing

As part of the development of the film, ChargePoint have carried out rigorous and extensive testing of the HiPure ULP7 prior to launch in the industry. The following qualification testing has been carried out and a pass rate has been confirmed: 

Biological Testing
Biological Reactivity -In Vitro / In Vivo USP 87, 88
Bacterial Endotoxins USP 85
Biological evaluation of medical devices ISO10993 Parts 1, 4, 5
Chemical Testing
Polyolefin materials for pharmaceutical use EP 3.1.3
Physicochemical Container Test with and without Alternative Extract USP 661.1
Regulatory
EU Food Contact EU 10/2011
FDA Food Contact 21 CFR 177
REACH Compliance
Free from Animal Derivatives