ChargePoint’s ChargeBag® PE-SBV 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-SBV reduces the risks associated with cross contamination and eliminate the time and expense associated with cleaning and validation.
Each ChargeBag® PE-SBV 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-SBV 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-SBV comes with a ChargePoint single use passive split butterfly valve directly welded to the assembly, offering high levels of containment and sterility assurance performance.
Available in single bottom port and also in a double port configuration.
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.
| Chemical Synthesis | Solid Dose Formulation | Biotech Processing | Aseptic Processing | |
|---|---|---|---|---|
| Solutions | • Dispensing of raw materials from Isolator/Booth | • Dispensing of API and excipients | • Transfer of buffer and media powders into preparation vessel | • Dispensing of AP |
| Processes | • Charging of materials into Reactor | • Charging & Offloading processes: Granulation; Fluid Bed Drying; Milling; Compactor; Tablet Compression & Coating; Capsule Filling | • Loading of materials into bioreactor | • Offloading Spray Dryer |
| • Offload from Filter Dryer / centrifuge | • IBC docking stations and direct IBC to IBC transfers | • Transfer of API into formulation vessel | ||
| • Milling / Sizing and pack-off | • IBC washing | • Loading of API in to Filling line Isolator / RABS | ||
| • Seed, Intermediates, API | • Offloading of stoppers from autoclave to IBC | |||
| • Loading of stoppers into the filling line Isolator / RABS |
| ChargeBag® PE-SBV | Single Port / Double Port | |
|---|---|---|
| Materials | Film | HiPure™ ULP7, 250 micron (10mil) single layer LLDPE with a permanent antistatic additive |
| Connection | HDPE | |
| Handle | Polypropylene (Green Colour) | |
| Manufacture | ChargeBag® is manufactured in ISO6 cleanroom as per ISO14644 under certified ISO9001 Quality Management System | |
| Sterilisation | Available Non-Sterile or Gamma Irradiated at 25kGy (min) | |
| Connection | BS4825 Tri-clamp ferrule welded directly to bag liner | |
| Available in three sizes: DN50 (2”), DN100 (4”), DN150 (6”) | ||
| ChargePoint Single Use Passive welded directly to bag liner Available in two sizes: DN100 (4”), DN150 (6”) | ||
| Maximum loading | 1L-5L – 5kg (11lbs) | |
| 10L-25L – 15kg (33lb) | ||
| 40L-55L - 30kg (66lb) | ||
| Temperature range | Long term static storage: -20 to 40 °C (-4 °F to 104 °F) | |
| Operating: 0 to 40 °C (32 °F to 104 °F) | ||
| Pressure rating | None | |
| Hazardous areas | Suitable for use in Dust Zones 20, 21, 22, explosion group III | |
| Testing / Inspection | 100% visual inspection | |
| Pressure tested to verify integrity | ||
| Packaging | Each 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. | |
| Labelling | Each ChargeBag® and shipping carton labelled with: • Lot number • manufacturing date • part number | |
| Regulatory compliance | HiPure™ 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 life | 5 years non-sterile; 2 years gamma sterile |
ChargePoint’s ChargeBag® PE-SBV 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-SBV reduces the risks associated with cross contamination and eliminate the time and expense associated with cleaning and validation.
Each ChargeBag® PE-SBV 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-SBV 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-SBV comes with a ChargePoint single use passive split butterfly valve directly welded to the assembly, offering high levels of containment and sterility assurance performance.
Available in single bottom port and also in a double port configuration.
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.
