We can support our clients through the drug development journey from early phase process development to commercial manufacturing.
Gallus offers early clinical drug product filling in glass or polymer vials with a variety of stopper types and sizes to meet customer needs. The system uses a single use, pre-sterilized, disposable filling flow path. This format is designed as a closed system to avoid contamination and for product protection. Based on peristaltic transfer, this filling method has been proven to be ideal for protein products due to its low shear characteristics, providing gentle transfer of protein therapeutics into the vials.
Performed in a GMP environment (EU Class A/ Class 100), the filling system is fully automatic, capable of filling free standing vials from 2 to 100mL within qualified GMP conditions. The system provides in-line filling, stoppering and capping. Manual fill volume checks are performed throughout the filling process at timeframes agreed upon with the customer.
All vials are 100% manually inspected by trained and qualified personnel.
Extensive environmental monitoring and controls are in place to ensure the appropriate level of cleanliness.
- Both systems described above are established within a RABs enclosure for added control and sterility assurance.
- The aseptic processing area is continuously monitored for temperature, humidity and differential pressure.
- Continuous in-process monitoring for non-viable particulate and passive viable air is performed. Active viable air monitoring is performed at intervals during any filling operation.
- Upon process completion environmental monitoring is performed on personnel, surface viable (rodac) and non-viable particulates.
- Personnel undergo stringent Gowning qualification and annual recertification.