Containment System for Mixing Dry Powders with Solvents During Drug Production or Processing

A containment system for mixing a solvent with a dry powder without exposing the dry powder to surrounding atmosphere, wherein the dry powder is supplied to the containment system in a dry powder container having a sealed connection, the containment system comprising:

• a) a dual compartment flexible isolator for safely removing the dry powder from the dry powder container, the dual compartment flexible isolator including
• a top portion and a bottom portion, the top portion and the bottom portion being linked together by one or more side walls, forming an interior portion, the interior portion comprising an internal wall that is sealingly connected to the side walls and that separates the interior portion into a first compartment and a second compartment;
• at least one glove formed in at least one of the side walls, said at least one glove extending into the interior portion of the dual compartment flexible isolator;
• and
• a first sealable opening formed in one of the side walls for permitting a dry powder material container to be placed inside the first compartment;
• a second sealable opening formed in the internal wall for permitting the dry powder container to be moved from the first compartment into the second compartment without exposing the dry powder to surrounding atmosphere;
• a containment valve, located inside the second compartment, the containment valve having a fitting suitably configured to mate with the sealed connection on the dry powder container, and
• a negative cascading pressure controller for generating negative pressure within the first compartment and second compartment;
• and
• b) a mixing vessel for mixing the dry powder with the solvent, the mixing vessel including
• a mixing chamber;
• a solids charging port, fluidly connecting the mixing chamber to the containment valve in the second compartment of the dual compartment flexible isolator to permit the dry powder to pass out of the dry powder container through the containment valve and into the mixing chamber without exposing the dry powder to surrounding atmosphere,
• a solvent inlet for admitting the solvent into the mixing chamber;
• an agitator for mixing the solvent and the dry powder together in the mixing chamber to produce a solvent and dry powder mixture;
• and
• an outlet valve for discharging the solvent and dry powder mixture from the mixing chamber.

A dual compartment flexible isolator comprising:

• a top portion and a bottom portion, the top portion and the bottom portion being linked together by one or more side walls, forming an interior portion, the interior portion, comprising an internal wall that is sealingly connected to the side walls and that separates the interior portion into a first compartment and a second compartment;
• at least one glove formed in at least one of the side walls, said at least one glove extending into the interior portion of the dual compartment flexible isolator;
• and
• a first sealable opening formed in one of the side walls for permitting a dry powder material container to be placed inside the first compartment;
• a second sealable opening formed in the internal wall for permitting the dry powder material container to be moved from the first compartment into the second compartment without exposing dry powder material in said dry powder material container to surrounding atmosphere;
• a containment valve, located inside the second compartment, the containment valve having a fitting suitably configured to mate with a sealed connection on the dry powder material container;
• and
• a negative cascading pressure controller for generating negative pressure within the first compartment and second compartment.

A containment system for mixing a solvent with a dry powder without exposing the dry powder to a surrounding atmosphere, comprising:

• a) a primary containment subsystem comprising a containment valve with a fitting configured to accept a sealed connection on a dry powder container, and a connection to solids charging port of a mixing vessel;
• and
• b) a secondary containment subsystem comprising the mixing vessel,
• a dual compartment flexible isolator, and
• a negative cascading pressure controller.

A method of producing a slurry or solution from a dry powder and a solvent, comprising:

• providing a dual compartment isolator, the dual compartment isolator comprising a staging compartment, a raw material entry port connected to the staging compartment, a charging compartment, a containment valve located in the charging compartment, and a partition between the staging compartment and the charging compartment,
• connecting a negative cascading pressure controller to the dual compartment isolator;
• providing a mixing vessel comprising a solvent inlet, a mixing chamber and a solids charging port fluidly connected to the mixing chamber;
• receiving a dry powder container containing the dry powder, the dry powder container having a sealed connection;
• activating the negative cascading pressure controller to produce negative pressure in both the staging compartment and the charging compartment of the dual compartment isolator;
• admitting the dry powder container into the staging compartment via the raw material entry port;
• transferring the dry powder container from the staging compartment to the charging compartment by passing the dry powder container through a resealable opening in the partition;
• closing the resealable opening in the partition;
• connecting the sealed connection on the dry powder container to a fitting on one end of the containment valve in the charging compartment of the dual compartment isolator;
• connecting the solids charging port on the mixing vessel to an opposite end of the containment valve;
• opening the sealed connection on the dry powder container and the fitting on the containment valve to permit the dry powder to pass out of the dry powder container in the charging compartment of the dual compartment isolator, through the sealed connection and the fitting and the solids charging port, and into the mixing chamber of the mixing vessel;
• introducing the solvent into the mixing chamber of the mixing vessel via the solvent inlet;
• and
• agitating the dry powder and the solvent in the mixing chamber to produce the slurry or solution.