Curium US LLC

Mallinckrodt Nuclear Medicine LLC

Mallinckrodt, Inc.

Mallinckrodkt Nuclear Medicine LLC

Bryan Scott Petrofsky

Kevin Bartlett Graves

Sumit Verma

Kevin B Graves

Michael J D'Hooge

John Schmitz

Michael J D'hooge

Donald W Reese

Andrew D Speth

Andrew M Schadt

Matthew S Muraczewski

Rafael A Martinez

Stephen C Iverson

Lars Lindskog

Brian J Morton

James Richard Spieker, Jr

Jesse Gurley, Iv

Greg Bushman

Gregory P Wehmer

Mark A Spinelli, Sr

Ryan W Lenger

Martin R Walker

Gregory Bengard

Paul Hibbeln

Michael J D'HOOGE

James Richard Spieker Jr

James Richard Spieker

Production systems for producing a radioactive drug product include a hot cell having a radiation isolating shielding and a dispensing unit positioned within the hot cell. The dispensing unit includes a manipulator arm for manipulating a closure component of a vial. The system further includes a pneumatic line extending from the manipulator arm and through the radiation isolating shielding to a location outside of the hot cell and a pressure sensor connected to the pneumatic line and positioned outside of the radiation isolating shielding. The pressure sensor is operable to detect air pressure within the pneumatic line.

Systems and methods for producing a radioactive drug product using a dispensing unit

A system includes a radiation containment chamber, an isolator connected to the radiation containment chamber, a rotating transfer door positioned between the radiation containment chamber and the isolator, and an antimicrobial vapor generator connected to the isolator. The rotating transfer door includes a cavity for receiving a radionuclide generator column assembly, and is rotatable between a first position, in which the cavity is open to the radiation containment chamber, and a second position, in which the cavity is open to the isolator. The transfer door is adapted to rotate while antimicrobial vapor is introduced into the isolator by the antimicrobial vapor generator.

Column assembly transfer mechanism and systems and methods for sanitizing same

A system for manufacturing radionuclide generators includes an enclosure defining a radioactive environment. The enclosure includes radiation shielding to prevent radiation within the radioactive environment from moving to an exterior of the enclosure. The system also includes a conveyance system having a forward track and first carriages positioned on and movable along the forward track for conveying racks in a first direction. The conveyance system also includes a first walking beam mechanism magnetically coupled to the first carriages to move the first carriages. The conveyance system further includes a return track and second carriages positioned on and movable along the return track for conveying racks in a second direction opposite the first direction. The forward track and the return track form a loop.

Conveyance system for operation in radioactive environment

A system for manufacturing radionuclide generators includes an enclosure defining a radioactive environment. The enclosure includes radiation shielding to prevent radiation within the radioactive environment from moving to an exterior of the enclosure. The system also includes a pump within the enclosure for transferring fluid through tubing. The pump includes a pump head including a casing, a rotor that rotates in relation to the casing, and a clamp. The tubing extends through the pump head. The clamp compresses the tubing against the rotor and directs radioactive fluid through the tubing as the rotor rotates. The pump also includes a servomotor that controls the rotation of the rotor and a coupling connecting the pump head to the servomotor. The coupling prevents backlash between the servomotor and the rotor during rotation.

Pump for operation in radioactive environment

Systems and methods for sterilizing a column assembly including a column having an interior containing a retaining media and a parent radionuclide retained by the retaining media, an inlet port in fluid communication with the interior of the column, and an outlet port in fluid communication with the interior of the column. The method includes sealing at least one of the inlet port and the outlet port to form a sealed column assembly such that fluid communication with the column interior though both the inlet port and the outlet port is prevented, and sterilizing the sealed column assembly to form a terminally-sterilized column assembly.

Systems and methods for sterilizing sealed radionuclide generator column assemblies

Systems and methods for formulating a radioactive liquid using a disposable container are described. The disposable container includes a flexible sidewall defining an interior space for containing the radioactive liquid during formulation. The flexible sidewall is constructed of sterile, pyrogen-free material to prevent contamination of the radioactive liquid. The flexible sidewall includes a first portion and a second portion. The disposable container also includes an access port and a dispense port. The access port is defined by the first portion of the flexible sidewall to provide access to the interior space. The dispense port is defined by the second portion of the flexible sidewall for the radioactive liquid within the interior space to be dispensed through.

Systems and methods for formulating radioactive liquids

A system for manufacturing radionuclide generators including an enclosure defining a radioactive environment, at least one autoclave sterilizer within the enclosure, and at least two loading and unloading elevators. The enclosure includes radiation shielding to prevent radiation within the radioactive environment from moving to an exterior of the enclosure. Each autoclave sterilizer includes a plurality of sterilization stations arranged vertically and at least two autoclave rails. One loading and unloading elevator is configured to load a cart into the autoclave sterilizer and one loading and unloading elevator is configured to unload the cart from the autoclave sterilizer. Each loading and unloading elevator includes at least two cart rails configured to support the cart and a plurality of loading elevator rails coupled to the cart rails. The loading elevator rails are configured to adjust the height of the cart rails.

Systems and methods for autoclave cart loading and unloading system

An air distribution system for supplying filtered air to isolator working volumes includes an inlet including a HEPA filter and an outlet including a slidably mounted sintered panel. Methods for supplying filtered air to an isolator working volume are also disclosed.

HEPA filter airflow distribution systems

A method includes sterilizing a column assembly including a column having a parent radionuclide contained therein with a sterilizer. The method further includes transferring the column assembly from the sterilizer to a first clean room environment, transferring the column assembly from the first clean room environment to a second clean room environment, and collecting a sterility test sample from the column assembly within the second clean room environment.

Systems and methods for sterility testing of radionuclide generator column assemblies

HEPA filter integrity testing apparatus including an automated mover, a scan module connected to the automated mover, and scan probes disposed along the length of the scan module. Assemblies also include HEPA filters and the filter integrity testing apparatus. A method of determining the integrity of HEPA filters with the filter integrity apparatus is disclosed.

Automated HEPA filter integrity testing

Systems and methods for dispensing radioactive liquids using a liquid dispensing apparatus are described. The apparatus includes a support arm rotatable about a rotation axis, an actuator operatively connected to the support arm and configured to at least one of rotate the support arm about the rotation axis and displace the support arm in a direction parallel to the rotation axis, and a pipette assembly mounted to the support arm. The pipette assembly includes a pipette tip defining an opening through which liquids are aspirated and dispensed, a piston, and a stepper motor operatively connected to the piston to control linear displacement of the piston.

Systems and methods for dispensing radioactive liquids

A system for manufacturing radionuclide generators includes an enclosure defining a radioactive environment. The enclosure includes radiation shielding to prevent radiation within the radioactive environment from moving to an exterior of the enclosure. The system also includes a barcode positioned on an object within the enclosure and a scanning system for scanning the barcode. The scanning system includes a camera on the exterior of the enclosure, a mirror, and a conduit extending through a wall of the enclosure for light to travel between the camera and the mirror.

Scanning system for scanning objects in radioactive environment

A system for assaying a sample for Molybdenum-99 content includes an inner ionization chamber including a well configured to receive the sample, an outer ionization chamber concentric with the inner ionization chamber, attenuating material positioned in the well, and a computing device. The computing device is configured to determine a first Molybdenum-99 content value of the sample based on a first current measured in the inner ionization chamber, determine a second Molybdenum-99 content value of the sample based on a second current measured in the outer ionization chamber, and determine a final Molybdenum-99 content value based on the first and second Molybdenum-99 content values.

Growing community of inventors

St. Louis, MO, United States of America

Bryan Scott Petrofsky