Tablet production module and method for continuous production of tablets
The contained module ( 1 ) comprises inlets for an active pharmaceutical ingredient (API) and for an excipient. The inlets are in fluid communication with at least one mixing unit ( 41,46 ), and the outlet of the tablet press ( 6 ) is in fluid communication with the releasable outlet port for tablets. The material stream comprising the API and the excipient is mixed in the mixing units. During operation parameters of the contents of the material stream are measured with one or more analytical sensors upstream of the tablet press. The speed of the tablet press is controlled in response to the parameters measured upstream of the tablet press. The finished tablets are discharged at an outlet of the tablet press ( 6 ).
1. A module for production of tablets, the module comprising:
at least one inlet for an active pharmaceutical ingredient (API);
at least one inlet for an excipient;
at least one mixing unit;
a tablet press;
at least one outlet for tablets; and
a control unit configured to receive data from the at least one analytical sensor and send commands to the tablet press to control the speed of the tablet press to maintain a continuous process;
said inlets being in fluid communication with an inlet of the at least one mixing unit, an outlet of the at least one mixing unit is in fluid communication with an inlet of the tablet press, and an outlet of the tablet press is in fluid communication with the outlet for tablets;
wherein
the module is contained to have a level of containment below 100 mcg/m 3 ;
at least one analytical sensor is provided, said at least one analytical sensor being positioned to analyze the contents or properties upstream of the tablet press, and
said inlets comprise a releasable inlet conduit for an active pharmaceutical ingredient (API) and a releasable inlet conduit for an excipient, and said outlet a releasable outlet port for tablets, the releasable inlet conduits being in fluid communication with the inlet of the mixing unit, and the outlet of the tablet press is in fluid communication with the releasable outlet port for tablets,
a fully continuous process is provided,
the control unit is configured to send commands to the at least one inlet for API, the at least one inlet for the excipient, the mixing unit and the tablet press, and
the at least one inlet for the API, the at least one inlet for the excipient, the at least one mixing unit, and the tablet press are directly connected to each other by a conduit without an intermediate containment vessel provided therebetween.
2. A contained module according to claim 1 , wherein the module has a level of containment below 10 mcg/m 3 .
3. A contained module according to claim 1 , wherein the analytical sensor is a spectroscopic analytical sensor.
4. A contained module according to claim 1 , further comprising an additional mixing unit.
5. A contained module according to claim 1 , further comprising a drying unit.
6. A contained module according to claim 1 , wherein said at least one analytical sensor is positioned at the at least one of the inlets to the contained module, the inlet of the mixing unit, the outlet of the mixing unit, and at the inlet of the tablet press.
7. A contained module according to claim 1 , wherein the contained module is designed as a single piece of equipment including a physical confinement of the interfaces of the contained module.
8. A contained module according to claim 3 , wherein the spectroscopic analytical sensor is an ultraviolet sensor.
9. A module for production of tablets, the module comprising:
at least one inlet for an active pharmaceutical ingredient (API);
at least one inlet for an excipient;
at least one mixing unit;
a tablet press;
at least one outlet for tablets; and
a control unit configured to receive data from the at least one analytical sensor and send commands to the tablet press to control the speed of the tablet press to maintain a continuous process;
said inlets being in fluid communication with an inlet of the at least one mixing unit, an outlet of the at least one mixing unit is in fluid communication with an inlet of the tablet press, and an outlet of the tablet press is in fluid communication with the outlet for tablets;
wherein
the module is contained, defined by its level of containment as at least dust-tight below 100 mcg/m 3 ;
at least one analytical sensor is provided, said at least one analytical sensor being positioned to analyze the contents or properties upstream of the tablet press, and
said inlets comprise a releasable inlet conduit for an active pharmaceutical ingredient (API) and a releasable inlet conduit for an excipient, and said outlet a releasable outlet port for tablets, the releasable inlet conduits being in fluid communication with the inlet of the mixing unit, and the outlet of the tablet press is in fluid communication with the releasable outlet port for tablets,
a fully continuous process is provided,
the control unit is configured to send commands to the at least one inlet for API, the at least one inlet for the excipient, the mixing unit and the tablet press,
the at least one inlet for the API, the at least one inlet for the excipient, the at least one mixing unit, and the tablet press are directly connected to each other by a conduit without an intermediate containment vessel provided therebetween, and
the contained module is designed as a single piece of equipment including a physical confinement of the interfaces of the contained module.
10. A contained module according to claim 1 , wherein the at least one analytical sensor is positioned to analyze the contents or properties of a material stream from the mixing unit upstream of the tablet press.
11. A contained module according to claim 10 , wherein at least one further analytical sensor is provided and said at least one further analytical sensor is positioned at the at least one of the inlets to the contained module, the inlet of the mixing unit, and at the inlet of the tablet press.