ChargePoint Technology Ltd

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 HiPure^TM ULP7, ChargePoint’s pharma ready LLDPE film. HiPure^TM 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.

ChargePoint PharmaSafe® Containment Valves

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ChargePoint PharmaSafe® transfer valve range offers the highest levels of operator protection through validated containment performance.

High containment powder transfer valves provide safe handling of non-sterile API and formulation ingredients with nanogram levels of containment performance.

ChargePoint’s aseptic split butterfly valves (SBVs) offer increased sterility assurance when handling sensitive ingredients and small components in fill/finish, aseptic transfer and biotech sterile API production.

The ChargePoint AseptiSafe® SBV range provides multiple benefits to the user and the product process including

• Maintaining critical area integrity
• Removing the need for high air class control areas and cumbersome PPE
• Toxic powder processing whilst ensuring the safety of your personnel and a dust free environment
• Maximising yield transfer for poorly flowing and high value product

Several alternative methods of sterilising the ChargePoint AseptiSafe® split butterfly valves contact and sealing faces are available to meet the critical area and process set-up requirements of our customers.

ChargePoint AseptiSafe®

• Sterilisation method: autoclave or/and SIP (steam in place)
• Offers a simple upgrade to GMP requirements in existing or new facilities
• SIP prior to material transfer
• Ideal for installation in higher grade cleanrooms with Isolator/RABS or existing LAF or other higher air class control systems

ChargePoint AseptiSafe® pro

Sterilisation method: SIP/ISO5 HEPA LAF

• In-board ports direct clean Grade A air directly across the valve interface
• Remote filter/fan unit supplies air to the terminal HEPA filter positioned next to the valve interface
• Can be used for high containment dust control with dust particulate collected from the second port and returned to air filtration in a closed loop system