Purgeable pharmaceutical fill needle

Patent metadata

Field	Value
Publication number	US-2019016484-A1
Application number	US-201715818986-A
Country	US
Kind code	A1
Filing date	Nov 21, 2017
Priority date	Jul 12, 2017
Publication date	Jan 17, 2019
Grant date	—

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.

First claim

What is claimed is:

1 . A method for aseptically filling a pharmaceutical container with a pharmaceutical fluid, the method comprising:
in a chamber capable of maintaining an aseptic condition, providing a fill needle comprising a fill needle tubing having a dispensing tip; establishing in the chamber an aseptic condition; providing in the chamber at least one aseptic pharmaceutical container comprising a container opening; moving at least one of the fill needle and the at least one container to dispose the fill needle over the container opening; dispensing the pharmaceutical fluid through the dispensing tip and the container opening into the at least one container; halting the dispensing to retain within the fill needle a terminal pharmaceutical fluid portion; and automatically removing the terminal pharmaceutical fluid portion from the fill needle into the container after halting the dispensing.

2 . The method of claim 1 , wherein automatically removing the terminal pharmaceutical fluid portion comprises injecting an aseptic gas into the fill needle tubing.

3 . The method of claim 2 , wherein
providing the fill needle comprises providing a fill needle having a gas inlet orifice in the fill needle tubing proximate the dispensing tip; and wherein injecting the aseptic gas into the fill needle tubing comprises injecting the aseptic gas via the orifice.

4 . The method of claim 2 , further comprising maintaining a flow of the gas until no more pharmaceutical fluid is removed from the fill needle.

5 . The method of claim 2 , wherein injecting an aseptic gas into the fill needle tubing comprises injecting aseptic nitrogen gas.

6 . The method of claim 2 , wherein injecting an aseptic gas into the fill needle tubing comprises injecting aseptic air.

7 . The method of claim 2 , wherein injecting an aseptic gas into the fill needle tubing comprises injecting aseptic helium gas.

8 . The method of claim 2 , wherein injecting an aseptic gas into the fill needle tubing comprises filtering a gas to render the gas aseptic.

9 . The method of claim 1 , wherein automatically removing the terminal pharmaceutical fluid portion comprises inflating a bladder within the dispensing tip.

10 . The method of claim 1 , wherein:
providing the fill needle comprises providing a flexible terminal tube disposed within the dispensing tip and a compression actuator disposed to compress the flexible terminal tube; and automatically removing the terminal pharmaceutical fluid portion comprises automatically operating the compression actuator to compress the flexible terminal tube.

11 . The method of claim 10 , wherein operating the actuator comprises piezoelectrically actuating the actuator.

12 . The method of claim 10 , wherein operating the actuator comprises electromechanically actuating the actuator.

13 . The method of claim 1 , wherein:
providing the fill needle comprises providing the fill needle tubing with a vibration actuator disposed on the fill needle tubing for shaking the dispensing tip; and automatically removing the terminal pharmaceutical fluid portion comprises automatically operating the vibration actuator to shake the dispensing tip.

14 . The method of claim 1 , wherein:
providing the fill needle comprises providing a fill needle having a gas channel, the gas channel having an opening proximate to the dispensing tip; and wherein automatically removing the terminal pharmaceutical fluid portion comprises blowing an aseptic gas at the terminal pharmaceutical fluid portion.

15 . The method of claim 14 , wherein
providing the fill needle comprises providing a fill needle having a gas channel, the gas channel having an annular opening with respect to and proximate the dispensing tip; and wherein automatically removing the terminal pharmaceutical fluid portion comprises blowing an aseptic gas at the terminal pharmaceutical fluid portion through the annular opening.

16 . The method of claim 1 , further comprising providing a controller operably coupled to the chamber to control fluid dispensing.

17 . The method of claim 16 , wherein the removing is automatically initiated and terminated by the controller.

18 . The method of claim 1 , wherein:
providing a fill needle comprises providing a first robotic arm having a first end effector; and wherein moving the fill needle comprises engaging the fill needle with the first end effector and operating the robotic arm.

19 . The method of claim 18 , wherein providing a first robotic arm comprises providing a first articulated robotic arm.

20 . The method of claim 1 , wherein providing the at least one container comprises providing a container nest bearing the at least one container.

21 . The method of claim 20 , wherein:
providing the container nest further comprises providing a second robotic arm having a second end effector; and wherein moving the at least one container comprises engaging the container nest with the second end effector and operating the second robotic arm.

22 . The method of claim 21 , wherein providing a second robotic arm comprises providing a second articulated robotic arm.

23 . The method of claim 20 , wherein:
providing the container nest comprises providing the container nest held in a locating structure of a rotary stage, and wherein moving the at least one container comprises rotating the rotary stage.

24 . The method of claim 1 , wherein providing the fill needle comprises:
providing the fill needle closed with a fill needle sheath; sterilizing the chamber to establish within the chamber an aseptic condition; and disengaging and removing the fill needle from the fill needle sheath.

25 . The method of claim 24 , further comprising engaging the fill needle with the fill needle sheath after removing the terminal pharmaceutical fluid portion from the fill needle.

26 . A fill needle system for aseptically dispensing a pharmaceutical fluid in a chamber capable of maintaining an aseptic condition, the system comprising:
a fill needle hub, a fill needle tubing in fluid communication with a pharmaceutical fluid source and extending through the 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 terminal fluid ejector disposed and configured for removing a terminal pharmaceutical fluid portion from the dispensing tip.

27 . The system of claim 26 , wherein the terminal fluid ejector comprises a gas channel in fluid communication with the dispensing tip via an orifice located in the fill needle tubing fluidwise immediately upstream from the dispensing tip.

28 . The system of claim 27 , further comprising a gas source for supplying aseptic gas to the gas channel.

29 . The system of claim 28 , further comprising a gas filter disposed to filter gas from the gas source in order to supply aseptic gas to the gas channel.

30 . The system of claim 26 , wherein the terminal fluid ejector comprises a bladder disposed and arranged to remove the terminal pharmaceutical fluid portion from the dispensing tip when expanded under action of gas pressure.

Assignees

• Vanrx Pharmasystems Inc

Inventors

• Diaz Guerrero Carlos Alberto

Classifications

• B65B43/50

  using rotary tables or turrets {(B65B43/46 takes precedence)} · CPC title

• B65B7/28

  by applying separate preformed closures, e.g. lids, covers · CPC title

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• B65B55/027

  Packaging in aseptic chambers · CPC title

• B65B55/10 Primary

  by liquids or gases · CPC title