ChargePoint AseptiSafe®

AS Valve Key Brand
AS Valve Key Brand
Aseptisafe Stoppers
Asepti Active Passive
Aseptisafe Drain
Aseptisafe Disc Open
Verifi Valve

Contained Aseptic Transfer Valves

ChargePoint AseptiSafe® aseptic transfer valves offer increased sterility assurance when handling sensitive ingredients and small components in fill/finish aseptic processing and biotech sterile API production.

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Benefits

Arrow Web 01 Perform aseptic transfers that maintain critical area integrity with an SAL of up to 10-6.

Arrow Web 01 Reduce risk of cross contamination with closed transfers that limit manual intervention.

Arrow Web 01 Meet GMP and product quality requirements.

Arrow Web 01 Remove high air class control areas and cumbersome PPE.

Arrow Web 01 Process toxic powders, ensuring the safety of your personnel and a dust free environment.

Arrow Web 01 Maximise yield transferring poorly flowing and high value product.

 

Several alternative methods of sterilising the product contact and sealing faces of the valve are available to meet the critical area and process set-up.

In all cases, patented split-valve technology will ensure a closed environment at the point of transfer and throughout the handling and storage process.

 ChargePoint AseptiSafe®

Sterilisation method: Autoclave or/and Steam in Place (SIP)

  • Offers a simple upgrade to GMP requirements in existing or new facilities
  • Simple steam in place (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 with HEPA LAF

 Sterilisation method: Steam in Place (SIP)/ISO5 HEPA LAF 

  •  Ideal for installation in Grade B cleanrooms, providing a Grade A environment around the valve transfer interface
  • Remote filter/fan unit supplies air to the terminal HEPA filter positioned next to the valve interface
  • Offers a simple upgrade to GMP requirements in existing or new facilities

 ChargePoint AseptiSafe pro

 Sterilisation method: Steam in Place (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

 ChargePoint AseptiSafe® bio

Sterilisation method: Steam in place (SIP) & H2O2 Biodecontamination

  • Can eliminate the need to construct large high air class control areas in new facilities
  • Optimised biodecontamination cycle
  • Ideal for lower grade cleanrooms to reduce the costs associated with the construction, validation and management of large clean areas

 Asepti SIP 02

  The Active unit is sterilised in place (SIP) with the use of a SIP Passive unit.
AS Op Sequence 01    The two valve halves are docked together.
 AS Op Sequence 02   The disc faces are exposed to decontamination gases within a sealed chamber prior to the product transfer to ensure decontamination of critical areas. AseptiSafe bio only
 AS Op Sequence 03   The Active unit is the driving half of the valve. Once operated the disc will open to allow the transfer of material through the valve. The Active and Passive interface is sealed to ensure no material can penetrate the critical area. Once the transfer has taken place the valve is closed.
 AS Op Sequence 04   The Active and Passive units are then unlocked and undocked revealing the previously closed interfaces ensuring a clean transfer.

Contained filling and dispensing for all production processes

Processes

Products

Vessel Charging
Isolator / RABS filling and dispensing
Dryer discharge
Autoclave – component load/unloading
Transfer to filling line
Buffer Prep
Sampling

Bulk Powders
Intermediates
Active Ingredients
Components (e.g. stoppers)
Toxic/potent materials

Download the AseptiSafe Specifications

 PDF 710 01AseptiSafe Specifications

The ability to effectively clean or wash the product contact and sealing areas of a ChargePoint® valve is assured with the use of our specifically designed Steam In Place or Wash in Place (SIP/WIP) devices

 

Steam Sterilisation (SIP)

The inner ‘Ring of Concern’ surfaces of the valve, disc and disc edges can be sterilised with the use of an SIP Passive accessory prior to any material transfer.

With a ChargePoint AseptiSafe® valve it is also possible to SIP through a coupled, open Active and Passive assembly. 

Both of these methods can be achieved in conjunction with the SIP of the process machine.

 

Bio-decontamination

The ChargePoint AspetiSafe® bio eliminates the ‘Area’ of Concern by first creating a sealed chamber as the two faces are partially docked, once in this position H2Ogas is introduced to the space which bio decontaminates all exposed surfaces. This provides a validated 6 log reduction (SAL 10-6) of the area.

Still within the sealed chamber the two surfaces then fully dock allowing the aseptic transfer to take place. Employing both the SIP process (penetrative sterilisation) and Bio-decontamination (surface decontamination) ensure the highest and most repeatable level of aseptic transfer possible and one which is unique to Chargepoint Technology split butterfly valves.

 

Autoclave

It is possible to autoclave the Active or Passive units. Dedicated opening devices can be utilised to ensure the Passive remains open and exposed to sterilisation during the autoclave cycle.

It is also possible to place a special Active within the Autoclave for automatic docking and opening of the Passive and attached container. This set up ensures that the Passive and Container can be removed from the autoclave as a single, closed, clean assembly.

 

Washing

Offering elementary local gross decontamination, the WIP Passive mimics a standard Passive unit by locking into an Active unit to allow washing of the Active unit inner product contact and sealing surfaces. 

 

To learn more about cleaning & washing accessories

Cleaning & Washing

Valve Automation

Two optional levels of automation can be provided to operate ChargePoint® valves in hazardous or inaccessible areas, or when the production scale does not permit manual handling.

 

Sensors

Pneumatic or electric proximity detection sensors, combined with existing mechanical safety interlock features ensure the safe function of the ChargePoint®.