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 (Antibody-drug conjugates)
- Small Components (e.g. stoppers)
- Buffer Media
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.
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.
Component (e.g. Stopper) Processing
- Dispensing from supplier
- Discharge from autoclave
- Discharge from stopper processing vessel
- Transfer to filling line
- Charge bio-reactor
- Dispensing powder from supplier
- Charge formulation vessel
- Discharge from dryer
- Charge into powder filling line
Perform aseptic transfers that maintain critical area integrity.
Reduce risk of cross contamination with closed transfers that limit manual intervention.
Meet GMP and product quality requirements.
Remove high air class control areas and cumbersome PPE.
Process toxic powders, ensuring the safety of your personnel and a dust free environment.
Maximise yield transferring poorly flowing and high value products.