Method of mixing a pharmaceutical solution and mixing system

A bubble agitation system for mixing a pharmaceutical solution, the system comprising:

• a mix bag including one or more walls defining an interior chamber having a top portion and a bottom portion opposite the top portion;
• a top gas recirculation port extending into the top portion of the interior chamber through the one or more walls of the mix bag;
• a bottom gas recirculation port extending into the bottom portion of the interior chamber through the one or more walls of the mix bag;
• a solvent pathway coupled to the interior chamber of the mix bag and configured to deliver a solvent into the mix bag:
• a solute pathway coupled to the interior chamber of the mix bag and configured to deliver a solute into the mix bag;
• and
• a recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway, the connecting pathway having a first end coupled to the top gas recirculation port and a second end coupled to the bottom gas recirculation port;
• wherein the recirculation pump engages the connecting pathway to pull gas from a headspace disposed adjacent to the top portion of the mix bag and deliver gas through the connecting pathway and into the bottom portion of the mix bag via the bottom gas recirculation port
• an excipient pathway coupled to the solvent pathway and configured to deliver an excipient into the solvent pathway;
• and
• a pump operably coupled to at least one of the excipient pathway and the solvent pathway;
• wherein the pump is configured to deliver the excipient and the solvent into the mix bag through the solvent pathway;
• a valve operably coupled to the bottom gas recirculation port to control fluid flow through the bottom gas recirculation port, the valve operably coupled to the solvent pathway and the connecting pathway of the recirculation assembly;
• wherein the pump is configured to deliver the excipient and the solvent into the mix bag through the bottom gas recirculation port.

A bubble agitation system for mixing a pharmaceutical solution, the system comprising:

• a mix bag including one or more walls defining an interior chamber having a top portion and a bottom portion opposite the top portion;
• a top gas recirculation port extending into the top portion of the interior chamber through the one or more walls of the mix bag;
• a bottom gas recirculation port extending into the bottom portion of the interior chamber through the one or more walls of the mix bag;
• a solvent pathway coupled to the interior chamber of the mix bag and configured to deliver a solvent into the mix bag;
• a solute pathway coupled to the interior chamber of the mix bag and configured to deliver a solute into the mix bag;
• and
• a recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway, the connecting pathway having a first end coupled to the top gas recirculation port and a second end coupled to the bottom gas recirculation port;
• wherein the recirculation pump engages the connecting pathway to pull gas from a headspace disposed adjacent to the top portion of the mix bag and deliver gas through the connecting pathway and into the bottom portion of the mix bag via the bottom gas recirculation port;
• and
• a solute pump operably coupled to the solute pathway to deliver the solute to the top portion of the interior chamber of the mix bag;
• wherein the solute pathway is coupled to the connecting pathway, the connecting pathway configured to deliver the solute into the mix bag via the top gas recirculation port.