For stopper loading, the process vessel is docked at a cleanroom-lift (Atec Lifting Device). The lift rotates the vessel to bring it into an ergonomic loading position. A funnel is placed on the vessel and stoppers are loaded from bags into the vessel. If loading stoppers through a clean room wall, a port system is used. The loading station is an integral part of the stopper processing system. Batch data can be entered at the loading station.
To achieve sterile filling requirements, stoppers must undergo the following process steps at the Process Station:
- Washing – Minimises endotoxins & particles
- Siliconisation – Applies homogeneous silicone layer
- Sterilisation – Reduces bioburden
- Drying – Ensures low moisture content
- Cooling – Eliminates clumping and sticking
Pressure and vacuum tests can be carried out before and after the process.
Stopper processing systems are characterized by:
- Variable process volume up to 340 litres
- High degree of drying by pulse drying
- Effective endotoxin and particle reduction
- Process reliability via batch tracking of process vessel
- Treatment of a variety of components
For the transfer of stoppers, the process vessel can be docked directly to the RABS or Isolator of the filling line. Atec manufactures both floor- and ceiling-mounted cleanroom lifts for positioning the process vessel.
At the RABS or Isolator a Rapid Transfer Port (RTP) is used to connect the process vessel. A transfer chute inside the RABS / Isolator is installed to guide the stopper or caps from the process vessel into the bunker from the filling line.
Alpha ports ensure a secure, sterile transfer and are typically hand-operated by a line worker. However, when the transfer point is difficult to access or poses safety risks to staff, manual operation is no longer an option. Atec therefore offers a fully-automated RTP solution which allows an automatic transfer connection of the process vessel to the filling line without intervention from a worker.
The Atec stopper and cap bag filling systems are used for sterile transfer of pharmaceutical components into bags. Fully-automated cleanroom lift systems are used to position the vessels filled with sterile components over a VHP transfer isolator or RABS for sterile stopper or cap distribution into bags.
Alternatively, Atec’s vessels can be fitted with Biosteam ports for transferring stoppers or caps into beta-ported bags.The ported bags can then be connected to a RABS/Isolator just like an RTU or RTS supply.
Atec integrated an automated bag filling system into an interchangeable PSI L-Isolator flange to minimise contamination and ensure higher process security.