Active vs passive charging
PTS reactor charging
Reactor Charging - PTS vs Isolator
In the pharmaceutical industry it is still standard practice to pre-dispense powder inside an isolator in the dedicated dispensing area and then charge the pre-dispensed material into the vessel in the production area, through another isolator. This usually requires to contain two areas implying higher risks of product and containment loss as well as an increase in manpower and cleaning efforts.
In standard operation, an isolator will be installed directly on top of the inerted reactor into which pre-dispensed powder will be charged. The isolator needs to be flushed with nitrogen in order to avoid air introduction into the vessel.
One of the issues with this method is that the isolator is not pressure rated. It must be strictly guaranteed that no pressure from the vessel enters into the solator.
When the isolation valve of the vessel is opened, there will be a gas exchange between the vessel and the isolator due to the negative pressure present inside the isolator which is guaranteeing the containment.
Therefore, the isolator needs to be made of corrosion resistant materials due to the risk of the presence of corrosive vapors in the vessel. Furthermore, the isolator must also be fully inerted to avoid any air introduction in the vessel.
In order to solve such issues, PTS Powder Transfer System® can be used as an interface bewteen the isolator and the reactor and can be installed directly onto the vessel. PTS fully isolates the reactor and allows a safe atmosphere even in presence of highly flammable solvents, high temperature or pressure.
The powder can be handled on the ground floor for instance by using Isotube which won't be exposed to the vapors of the vessel and doesn’t need to be inerted as PTS will remove the oxygen of the powder before charging it into the vessel. Alternatively to the Isotube system, the DCS® Drum Containment System for drums can be used.
DCS® can be installed on load cells and the powder can be sucked directly from the drums removing the requirement of pre-dispensing the materials. With such a solution, a containment level of OEB 5 can be achieved.
Reactor Charging - PTS vs Split Valve
In standard operation, an isolator will be used to dispense powder from drums or bags into an intermediate container equipped with split valve. The container with the pre-dispensed powder will be then moved to the production area and docked unto the vessel which is equipped with a split valve, i.e. discharge by gravity.
The connection needs to be flushed with nitrogen in order to avoid air introduction into the vessel. This intermediate container can be made with rigid walls or as a single use bag.
In both cases, a complex CIP system for the canister and/or the split valve should be provided.
One of the issue when installing a container directly on top of a reactor is that usually such containers are not pressure rated. It must be strictly guaranteed that the vessel is not under pressure when the bottle is connected or disconnected as there is a risk of containment loss or even worse, a risk of breakage of the intermediate container (rigid or flexible).
It is therefore recommended to install an isolation valve under the split valve to guarantee full tightness. The container and the valve need to be made of corrosion resistant materials in case of the presence of corrosive vapors in the vessel.
PTS Powder Transfer System®, directly installed onto the vessel, provides a simple and effective solution to charge vessels and remove the need to use split valve technology.
In this case as well, the powder can be handled on the ground floor for instance by using DCS® Drum Containment System.
DCS® will not be exposed to the vapors of the vessel and doesn’t need to be inerted as PTS will remove the oxygen of the powder before charging it into the vessel.
The system can be installed on load cells and the powder can be sucked directly from the drums. With this arrangement, a containment level of OEB 4-5 can be achieved and therefore, it is not required to have a dispensing area.
Intermediate products can be discharged directly from dryers or centrifuges and charged either directly back into the reactor or into an intermediate packaging like a drum or a mini-bag and re-discharged back into the vessel by means of the PTS.