Abstract: The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

Abstract: The system of the invention involves a gloveless aseptic processing system. The automated system is for filling nested pharmaceutical containers with a pharmaceutical fluid substance. A closed sterilizable gloveless isolator chamber is capable of maintaining an aseptic condition, having a sterilization system. The container filling system has a dispensing head for filling the containers, and a container closing system disposed within the gloveless isolator chamber with rams for pushing closures into openings of the nested containers. The container manipulation mechanism is disposed within the gloveless isolator chamber and is capable of positioning the nested pharmaceutical containers within the gloveless isolator chamber including operably disposing the nested pharmaceutical containers with the container filling system and the container closing system. Container tubs sealed by removable covers and contain a container nest bearing a plurality of pre-sterilized pharmaceutical containers.

Abstract: The present invention involves a rotary peristaltic pump and associated method employing the relaxation of pressure on flexible tubing between the rotor and stator of the pump to restore the rotor to a start angle while a valve on the output of the pump is closed to avoid progress of fluid through the system. Three different implementations of the pump and method are presented including reciprocating the stator, reciprocating the rotor, and retracting the idler rollers of the rotor into the rotor to relieve the pressure on the flexible tubing. A controller ensures the appropriate switching and timing of the valve and rotor of the pump. The pump and associated method are directed to the precision dispensing of pharmaceutical fluids into containers, including containers held in container nests.

Abstract: A system is presented for monitoring and controlling in a sterilizable environment the peeling of a cover from a tub sealed by the cover. The system employs a platform having a fiducial source locating structure for holding the tub, a cover removal station disposed to engage with the cover and to peel the cover from the tub, a light source disposed to illuminate a portion of the platform proximate the cover removal station, a light sensor sensitive to light from the light source and disposed to preferentially collect and measure light diffusely reflected from the illuminated portion of the platform, and a controller with software to operate the system. An associated method for monitoring and controlling the peeling of the cover involves moving a peeled portion of the cover into a predetermined peeling monitor zone within the illuminated portion of the platform, and measuring an intensity of light from the light source diffusely reflected specifically from the peeling monitor zone.

Abstract: The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

Abstract: The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

Abstract: The present invention involves a rotary peristaltic pump and associated method employing the relaxation of pressure on flexible tubing between the rotor and stator of the pump to restore the rotor to a start angle while a valve on the output of the pump is closed to avoid progress of fluid through the system. Three different implementations of the pump and method are presented including reciprocating the stator, reciprocating the rotor, and retracting the idler rollers of the rotor into the rotor to relieve the pressure on the flexible tubing. A controller ensures the appropriate switching and timing of the valve and rotor of the pump. The pump and associated method are directed to the precision dispensing of pharmaceutical fluids into containers, including containers held in container nests.

Abstract: The present invention involves both an apparatus and an associated method for confirming the presence or absence of closures in a closure nest inside an aseptic chamber. The apparatus comprises a topographical profiler disposed to monitor the closure nests. Vertical displacements in topographical maps obtained by the profiler are compared with information from a database about the nest and closure combinations. Vertical displacements falling outside predetermined upper and lower bounds are deemed absences of closures. The topographical profiler may be disposed outside the aseptic chamber. The system may be automated via a controller and suitable software. In some embodiments the nests and disposed in the monitored area by robotic articulated arms. In other embodiments the closure nests are moved by vacuum pickup systems. The system and method may also be employed to assess the suitability of a closure nest for closing in an aseptic chamber containers in a container nest.

Abstract: The present invention involves both an apparatus and an associated method for confirming the presence or absence of closures in a closure nest inside an aseptic chamber. The apparatus comprises a topographical profiler disposed to monitor the closure nests. Vertical displacements in topographical maps obtained by the profiler are compared with information from a database about the nest and closure combinations. Vertical displacements falling outside predetermined upper and lower bounds are deemed absences of closures. The topographical profiler may be disposed outside the aseptic chamber. The system may be automated via a controller and suitable software. In some embodiments the nests and disposed in the monitored area by robotic articulated arms. In other embodiments the closure nests are moved by vacuum pickup systems. The system and method may also be employed to assess the suitability of a closure nest for closing in an aseptic chamber containers in a container nest.

Abstract: The present invention involves a rotary peristaltic pump and associated method employing the relaxation of pressure on flexible tubing between the rotor and stator of the pump to restore the rotor to a start angle while a valve on the output of the pump is closed to avoid progress of fluid through the system. Three different implementations of the pump and method are presented including reciprocating the stator, reciprocating the rotor, and retracting the idler rollers of the rotor into the rotor to relieve the pressure on the flexible tubing. A controller ensures the appropriate switching and timing of the valve and rotor of the pump. The pump and associated method are directed to the precision dispensing of pharmaceutical fluids into containers, including containers held in container nests.

Abstract: The present invention involves a rotary peristaltic pump and associated method employing the relaxation of pressure on flexible tubing between the rotor and stator of the pump to restore the rotor to a start angle while a valve on the output of the pump is closed to avoid progress of fluid through the system. Three different implementations of the pump and method are presented including reciprocating the stator, reciprocating the rotor, and retracting the idler rollers of the rotor into the rotor to relieve the pressure on the flexible tubing. A controller ensures the appropriate switching and timing of the valve and rotor of the pump. The pump and associated method are directed to the precision dispensing of pharmaceutical fluids into containers, including containers held in container nests.

Abstract: A purgeable fill needle for dispensing pharmaceutical fluid into a pharmaceutical container comprises a fill needle hub, a fill needle tubing extending through the fill needle hub; a fill needle dispensing tip; a fill needle sheath removably mated with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a terminal fluid ejector for removing fluid retained by the tip after halting dispensing of pharmaceutical fluid. The terminal fluid ejector may be based on automatic injection of an aseptic gas into the fill needle tubing, automated action of a gas bladder at the dispensing tip, or the automated operation of a compression actuator at the dispensing tip. The removal of terminal fluid retained at the tip after halting dispensing of the fluid may also be effected by automatically blowing attached droplets off the tip and automatically shaking the fill needle tubing.

Abstract: A system is presented for monitoring and controlling in a sterilizable environment the peeling of a cover from a tub sealed by the cover. The system employs a platform having a fiducial source locating structure for holding the tub, a cover removal station disposed to engage with the cover and to peel the cover from the tub, a light source disposed to illuminate a portion of the platform proximate the cover removal station, a light sensor sensitive to light from the light source and disposed to preferentially collect and measure light diffusely reflected from the illuminated portion of the platform, and a controller with software to operate the system. An associated method for monitoring and controlling the peeling of the cover involves moving a peeled portion of the cover into a predetermined peeling monitor zone within the illuminated portion of the platform, and measuring an intensity of light from the light source diffusely reflected specifically from the peeling monitor zone.

Abstract: The present invention involves a rotary peristaltic pump and associated method employing the relaxation of pressure on flexible tubing between the rotor and stator of the pump to restore the rotor to a start angle while a valve on the output of the pump is closed to avoid progress of fluid through the system. Three different implementations of the pump and method are presented including reciprocating the stator, reciprocating the rotor, and retracting the idler rollers of the rotor into the rotor to relieve the pressure on the flexible tubing. A controller ensures the appropriate switching and timing of the valve and rotor of the pump. The pump and associated method are directed to the precision dispensing of pharmaceutical fluids into containers, including containers held in container nests.

Abstract: The present invention involves a system and method for monitoring and controlling the aseptic dispensing of a pharmaceutical fluid into containers. The system employs a pharmaceutical fluid dispensing head to dispense droplets of the pharmaceutical fluid along a droplet path into the container and a droplet monitoring system to monitor the droplets produced and dispensed. The volume of at least one droplet is determined based on images of the droplet falling along the droplet path. The volume of pharmaceutical fluid dispensed is determined from the volume of the droplets. The pharmaceutical fluid dispensing head and the droplet monitoring system may be mutually integrated and may be used in systems using different mechanisms for moving containers, including rotary stage systems and robotic arms.

Abstract: The present invention involves both an apparatus and an associated method for confirming the presence or absence of closures in a closure nest inside an aseptic chamber. The apparatus comprises a topographical profiler disposed to monitor the closure nests. Vertical displacements in topographical maps obtained by the profiler are compared with information from a database about the nest and closure combinations. Vertical displacements falling outside predetermined upper and lower bounds are deemed absences of closures. The topographical profiler may be disposed outside the aseptic chamber. The system may be automated via a controller and suitable software. In some embodiments the nests and disposed in the monitored area by robotic articulated arms. In other embodiments the closure nests are moved by vacuum pickup systems. The system and method may also be employed to assess the suitability of a closure nest for closing in an aseptic chamber containers in a container nest.

Abstract: In one general aspect, a system for aseptically filling a tray of pharmaceutical containers with a pharmaceutical product is disclosed, which consists of an aseptic chamber, one or more articulated arms within the chamber, a sensor aseptically disposed with respect to the chamber, and a controller. The controller determines the locations of openings of the containers based on the image information from the sensor, and automatically guides one of the arms to fill the containers with the product. In order to obtain suitable contrast for accurately identifying the openings, an illuminator illuminates the tray with substantially collimated light. The sensor images the tray and containers using collimated light reflected from a reflective surface such as a retroreflector under the tray. To this end, the sensor may be disposed at a large enough distance from the retroreflector to collect largely the retroreflected light, or the sensor may employ a telecentric lens or a Fresnel lens.

Abstract: A purgeable fill needle for dispensing pharmaceutical fluid into a pharmaceutical container comprises a fill needle hub, a fill needle tubing extending through the fill needle hub; a fill needle dispensing tip; a fill needle sheath removably mated with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a terminal fluid ejector for removing fluid retained by the tip after halting dispensing of pharmaceutical fluid. The terminal fluid ejector may be based on automatic injection of an aseptic gas into the fill needle tubing, automated action of a gas bladder at the dispensing tip, or the automated operation of a compression actuator at the dispensing tip. The removal of terminal fluid retained at the tip after halting dispensing of the fluid may also be effected by automatically blowing attached droplets off the tip and automatically shaking the fill needle tubing.

Abstract: A system is presented for monitoring and controlling in a sterilizable environment the peeling of a cover from a tub sealed by the cover. The system employs a platform having a fiducial source locating structure for holding the tub, a cover removal station disposed to engage with the cover and to peel the cover from the tub, a light source disposed to illuminate a portion of the platform proximate the cover removal station, a light sensor sensitive to light from the light source and disposed to preferentially collect and measure light diffusely reflected from the illuminated portion of the platform, and a controller with software to operate the system. An associated method for monitoring and controlling the peeling of the cover involves moving a peeled portion of the cover into a predetermined peeling monitor zone within the illuminated portion of the platform, and measuring an intensity of light from the light source diffusely reflected specifically from the peeling monitor zone.

Abstract: The present invention involves a system and method for monitoring and controlling the aseptic dispensing of a pharmaceutical fluid into containers. The system employs a pharmaceutical fluid dispensing head to dispense droplets of the pharmaceutical fluid along a droplet path into the container and a droplet monitoring system to monitor the droplets produced and dispensed. The volume of at least one droplet is determined based on images of the droplet falling along the droplet path. The volume of pharmaceutical fluid dispensed is determined from the volume of the droplets. The pharmaceutical fluid dispensing head and the droplet monitoring system may be mutually integrated and may be used in systems using different mechanisms for moving containers, including rotary stage systems and robotic arms.