ChargePoint® SUP (Single Use Passive)
The ChargePoint® SUP (Single Use Passive) is a contained powder transfer interface for pharmaceutical manufacturers that need to economically transfer powder ingredients between process steps or even facilities. As the Passive mating half of the ChargePoint Split Butterfly Valve system it delivers outstanding containment and sterility assurance performance whilst eliminating the time and cost associated with cleaning, maintenance and validation.
Features & Benefits
Reduce costs and control risks
- Reduces the risks associated with cross contamination and the time and expense associated with cleaning and validation is eliminated.
- Pre-validated, ready to use interface available off the shelf.
Ready for aseptic processing
- The ChargePoint® SUP is manufactured within an ISO6 cleanroom environment and can be supplied gamma sterilised.
Easy to integrate and handle
- The all plastic design is lightweight for easy manual handling with the ChargeBag® or other single use containers
Safety for personnel and product
- Offers high levels of dust containment and sterility assurance performance as part of the ChargePoint SBV system.
Security for products
- A lockable GMP cover is provided as standard to ensure integrity of the connection and contents whilst in storage or transit.
|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|
|ChargePoint® SUP – Non-Sterile||ChargePoint® SUP – Sterile|
|Size||100mm (4”) NB|
|Passive||PA (GFR), TPE, HDPE (All White)||PA (GFR), TPE, HDPE (All White)|
|Cover||HDPE (Green)||HDPE (Green)|
|Connection Interface||100mm (4”) BS4825 Tri-Clamp|
Or direct weld to ChargeBag PE-SBV (see separate datasheet).
|Operation Temp Range||0 to 40°C (32 to 104°F)||0 to 40°C (32 to 104°F)|
|Hazardous Areas||Suitable for Dust Zones 20,21,22, Explosion Group III|
|Sterilisation||Gamma Irradiation at 25-50 kGy|
|Regulatory Compliance||All Materials:|
FDA 21 CFR 177; USP Class VI
|Manufacturing||Assembled in ISO6 cleanroom as per ISO14644 under certified ISO9001 Quality Management System.|
|Packaging||Each SU Passive individually packed within a sealed secondary PE sleeve. 20 units packed in additional protective liner per carton.|
|Labelling||Each ChargePoint® SUP and shipping carton labelled with Lot number, manufacturing date, part number.|
|Verification Testing/ Inspection||100% visual inspection|
|Shelf Life||5 years|