Aseptic transfer valve for sterility assurance
Ensure sterility and safety in your critical production processes with advanced aseptic transfer solutions for handling sensitive ingredients and potent materials, optimizing containment and reducing contamination risks.
Ensures Sterile and Safe Powder Transfers
The ChargePoint AseptiSafe® Aseptic Split Butterfly Valve is engineered for the secure and sterile transfer of pharmaceutical powders. This valve integrates seamlessly into aseptic processing lines, providing a high level of sterility assurance for handling sensitive APIs and biopharmaceutical products. Its design eliminates the need for high air class control areas, maximizing containment and yield during transfer operations. Utilizing either autoclave or steam-in-place sterilization, it suits GMP-compliant environments and supports high containment applications with effective dust control. Compatible with bulk powders, intermediates, and toxic materials, it ensures sterility is maintained throughout the process, from transfer and filling to sampling and discharge. Constructed for use in ISO5 and higher-grade cleanrooms, this valve can be tailored to meet specific process requirements, offering flexibility for pharmaceutical manufacturers and biotech companies.
Benefits
- Enhances process safety by maintaining sterility and minimizing contamination risks.
- Reduces operational costs by eliminating high air class control requirements.
- Protects personnel with effective containment for toxic and potent materials.
- Increases product yield through optimized transfer of poorly flowing powders.
- Simplifies compliance with GMP standards through flexible sterilization methods.
- Applications
- Toxic/potent materials,Fine chemicals,Active pharmaceutical ingredients (apis),Bulk powders,Biopharmaceuticals,Intermediates,Pharmaceutical powders
- End products
- Cytotoxic drugs,Polymer additives,Monoclonal antibodies,Ibuprofen api,Vitamin precursors,Milk protein concentrate,Paracetamol powder
- Steps before
- Bulk powder preparation,Active ingredient formulation,Component load preparation,Buffer preparation
- Steps after
- Sterilization,Material dispensing,Transfer to filling line,Component unloading
- Input ingredients
- sensitive ingredients,small components,bulk powders,intermediates,toxic/potent materials,active ingredients,components (e.g. stoppers)
- Output ingredients
- finished product,sterile API,dispensed materials,processed powders,clean transferred materials
- Market info
- Chargepoint Technology is known for its expertise in designing and manufacturing high containment and sterile transfer solutions for pharmaceutical and biopharmaceutical industries, particularly in powder containment and aseptic transfer systems.
- Sterilisation method
- Autoclave / SIP (steam in place)
- Air class control
- ISO5 HEPA LAF
- Containment performance
- High
- Installation environment
- Higher grade cleanrooms
- Clean air supply
- In-board ports with Grade A air
- Air filtration
- Terminal HEPA filter
- Material transfer control
- Active and passive unit docking
- Sterility Assurance
- High
- Handling Type
- Aseptic transfer
- Containment Level
- High
- Sterilization Methods
- Autoclave,SIP (steam in place)
- Installation Environment
- High-grade cleanrooms
- Clean Air Supply
- ISO5 HEPA LAF
- Air Class Control
- Not required
- Interface Sealing
- Ensured to prevent contamination
- Automation Level
- Manual / SIP
- Operation Type
- Batch
- Biological compatibility
- Yes,compatible with sterile API production and sensitive ingredients
- Cleanability
- Sterilisation in place (SIP) and autoclave methods
- Corrosive resistance (e.g. acids)
- Suitable for toxic/potent material handling
- Density/particle size
- Various powders and small components
- High containment capability
- Yes/No
- Sterility Assurance
- FDA standards
- Valve size options
- Multiple sizes available for specific applications
- Material
- Stainless Steel
- Sealing faces
- Specialised contact and sealing faces for sterility
- Design
- Split Butterfly Valve with aseptic and containment features
- Footprint
- Compact to fit within existing cleanroom setups
- Port configuration
- In-board ports for clean air deployment
- Sterilisation Method
- Autoclave / SIP (steam in place)
- Cleanroom Integration
- Isolator/RABS / LAF
- Containment Level
- High containment dust control
- Port Configuration
- In-board ports / Remote filter/fan unit