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ChargeBag® PE-S

Aseptic Single Use Powder Transfer Bag

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ChargePoint Technology’s single use ChargeBag® PE-S is a high Integrity powder transfer bag.

Reducing the risks associated with cross contamination and eliminating the time and expense associated with cleaning and validation.

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Product information

ChargePoint’s ChargeBag® PE-S is a single use bag for pharmaceutical ingredients that acts as a cost-effective and convenient container for the handling, storage and transfer of bio-pharmaceutical powders. The ChargeBag® PE-S reduces the risks associated with cross contamination and eliminate the time and expense associated with cleaning and validation.

Each ChargeBag® PE-S is manufactured with high levels of quality control within an ISO6 cleanroom environment. Each ChargeBag® PE-S is 100% pressure decay tested to ensure integrity and supplied gamma sterilised ready to use in aseptic and many other cGMP manufacturing facilities. The bag has been comprehensively qualified according to the most rigorous standards for chemical, biological and physical compliance and delivers a well-rounded data profile characteristic of a wide range of products and process conditions.

The single use ChargeBag® PE-S is made with HiPureTM ULP7, ChargePoint’s pharma ready LLDPE film. HiPureTM ULP7 is manufactured with extremely high levels of integrity related to regulatory qualification, as well as robustness with excellent mechanical strength and anti-static properties providing both performance and purity for the safety of products and personnel.

The ChargeBag® PE-S is also available as part of a complete single use transfer solution, with a ChargePoint single use passive split butterfly valve directly welded to the ChargeBag® PE-S assembly, offering high levels of containment and sterility assurance performance.

A permanent, non-migrating, anti-static additive ensures that even cohesive powders can be recovered effectively from each transfer with minimal hold up. The pliable, transparent characteristics allow for physical manipulation of difficult powders and visual confirmation whilst maintaining the physical integrity of the bag.

A simple HDPE reinforced handle ensures the ChargeBag® PE-S can be adopted safely for any ergonomic manual lifting operation or larger volume transfers with an automatic lifting hoist via specific lifting points located in the handle.

The ChargeBag® PE-S can be easily adapted to new and existing processes via an industry standard hygienic tri-clamp ferrule, making it quick, convenient and safe to connect to a ChargePoint SBV, alternative transfer device or even direct to the process vessel/machine.

Chemical synthesis: Seed, intermediates, actives, API
Solid dose formulation: API, excipients, formulations, tablets, capsules
Aseptic processing / filling: API, closure components (vial stoppers)
Bioprocessing:   Buffer / media powders
ChargeBag® PE-SSingle Port / Double Port
MaterialsFilmHiPure™ ULP7, 250 micron (10mil) single layer LLDPE with a permanent antistatic additive (Translucent) – product contact
ConnectionHDPE (White) - product contact
HandlePolypropylene (Green
ManufactureChargeBag® is manufactured in ISO6 cleanroom as per ISO14644 under certified ISO9001 Quality Management System
SterilisationAvailable Non-Sterile or Gamma Irradiated at 25kGy (min)
Connection BS4825 Tri-clamp ferrule welded directly to bag liner
Available in three sizes: 50mm (2”), 100mm (4”), 150mm (6”)
Maximum loading1L-5L – 5kg (11lbs)
10L-25L – 15kg (33lb)
40L-55L - 30kg (66lb)
Temperature rangeLong term static storage: -20 to 40 °C (-4 °F to 104 °F)
Operating: 0 to 40 °C (32 °F to 104 °F)
Pressure ratingNone
Hazardous areasElectrically dissipative and therefore suitable for use in Zones 1 & 2 with gasses of explosion groups IIA and IIB provided it is suitably earthed during gravity filling and discharging. Suitable for Zones 21 & 22, with dusts of explosion group IIIA, IIIB, IIIC that have a MIE > 1mJ.
Testing / Inspection100% visual inspection
Pressure tested to verify integrity
PackagingEach ChargeBag® is individually packed within a sealed secondary PE sleeve. Bags are packed in additional protective liner per carton. The amount of the bags per box depends on the size.
LabellingEach ChargeBag® and shipping carton labelled with: • Lot number • manufacturing date • part number
Regulatory complianceHiPure™ ULP7 Film: • FDA 21 CFR 177 • USP Class VI • EP 3.1.3 Polyolefins • EU 10/2011 • REACH • Free from animal derivatives
Tested in accordance to: • USP <85> Bacterial endotoxins • USP <87> Biological reactivity, In Vitro • USP <88> Biological reactivity tests, in Vivo • ISO10993 Biological evaluation of medical devices Part 1, 4 and 5 • USP 661.1 Plastic Materials of Construction Contact us for comprehensive material data book
Tri-clamp Ferrule Material: • FDA 21 CFR 177 • USP Class VI
Shelf life5 years non-sterile; 2 years gamma sterile (excluding liquid rinse option – to be advised on order)
Optional addition – rinse portMPX non-valved coupling insert (male), polycarbonate
Tubing: platinum cured silicone
Length: 200 mm
ID x OD: 12.7 x 19.1 mm (1/2” x ¾” in.)
  • Overview

    ChargePoint’s ChargeBag® PE-S is a single use bag for pharmaceutical ingredients that acts as a cost-effective and convenient container for the handling, storage and transfer of bio-pharmaceutical powders. The ChargeBag® PE-S reduces the risks associated with cross contamination and eliminate the time and expense associated with cleaning and validation.

    Each ChargeBag® PE-S is manufactured with high levels of quality control within an ISO6 cleanroom environment. Each ChargeBag® PE-S is 100% pressure decay tested to ensure integrity and supplied gamma sterilised ready to use in aseptic and many other cGMP manufacturing facilities. The bag has been comprehensively qualified according to the most rigorous standards for chemical, biological and physical compliance and delivers a well-rounded data profile characteristic of a wide range of products and process conditions.

    The single use ChargeBag® PE-S is made with HiPureTM ULP7, ChargePoint’s pharma ready LLDPE film. HiPureTM ULP7 is manufactured with extremely high levels of integrity related to regulatory qualification, as well as robustness with excellent mechanical strength and anti-static properties providing both performance and purity for the safety of products and personnel.

    The ChargeBag® PE-S is also available as part of a complete single use transfer solution, with a ChargePoint single use passive split butterfly valve directly welded to the ChargeBag® PE-S assembly, offering high levels of containment and sterility assurance performance.

  • How it works

    A permanent, non-migrating, anti-static additive ensures that even cohesive powders can be recovered effectively from each transfer with minimal hold up. The pliable, transparent characteristics allow for physical manipulation of difficult powders and visual confirmation whilst maintaining the physical integrity of the bag.

    A simple HDPE reinforced handle ensures the ChargeBag® PE-S can be adopted safely for any ergonomic manual lifting operation or larger volume transfers with an automatic lifting hoist via specific lifting points located in the handle.

    The ChargeBag® PE-S can be easily adapted to new and existing processes via an industry standard hygienic tri-clamp ferrule, making it quick, convenient and safe to connect to a ChargePoint SBV, alternative transfer device or even direct to the process vessel/machine.

  • Specifications
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