Biopharmaceutical

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ChargePoint® patented split valve technology offers improved sterility assurance in the aseptic processing of small components and powder product in fill/finish processes and during sterile API manufacturing.

The requirements for minimising the risk of bioburden and achieving a validated SAL (Sterility Assurance Level) of 10-6 reduction in the probability of viable microorganisms, are critical considerations in GMP fill/finish production of sterile products such as vaccines.

ChargePoint AseptiSafe® aseptic transfer valve technology meets these demands as a common interface or the aseptic transfer of powder and components from process to process.

  • Biotech API's
  • Sterile and Highly Potent  API's
  • ADC's (Antobody Drug Condugates)
  • Small Components (e.g. stoppers)
  • Buffer Media
  • Intermediates

 

Product & operator protection against potent ingredients

ChargePoint AseptiSafe® valves will not only provide improved sterility assurance but also a validated containment level for operator protection when handling highly potent powder ingredients.

Improved Sterility Assurance

ChargePoint AseptiSafe® aseptic transfer valves

Two alternative methods of sterilization are available to meet the critical area and process set up. In both cases, patented split valve technology will ensure a closed environment at the point of transfer and throughout the handling and storage process.

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Component (e.g. Stopper) Processing

  • Dispensing from supplier
  • Discharge from autoclave
  • Discharge from stopper processing vessel
  • Transfer to filling line

 

Powder Processing

  • Charge bio-reactor
  • Dispensing powder from supplier
  • Charge formulation vessel
  • Discharge from dryer
  • Charge into powder filling line

ChargePoint AseptiSafe®

ChargePoint® AseptiSafe™ aseptic transfer valves offer increased sterility assurance when handling sensitive ingredients and small components in aseptic processing.

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ChargeBag®

The contained and sterile transfer of powder and small process components from process to process is now easier than ever with the cost effective ChargeBag®.

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Arrow Web 01  Perform aseptic transfers that maintain critical area integrity.

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  Maximize yield transferring poorly flowing and high value products.