Aseptic assembling of pharmaceutical containers

• US 10,207,046 B2
• Filed: 08/30/2016
• Issued: 02/19/2019
• Est. Priority Date: 09/29/2015
• Status: Active Grant

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG), Siemens Medical Solutions USA Incorporated (Siemens AG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG), Siemens Medical Solutions USA Incorporated (Siemens AG)
• Inventors: Webster, Eric, Zigler, Steven, Simmons, Gregory James
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/250,961
• Publication Number:
  US 20170088325A1
• Time in Patent Office: 903 Days
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/0094 Gaseous substances
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/027 Packaging in aseptic chambers
• CPC Class Codes: B65D 73/0014 by means of separate fixing elements, e.g. clips, clamps, bands
• CPC Class Codes: B65D 77/22 Details

Abstract

A template frame for holding a container and one or more additional components in a predetermined first arrangement is disclosed. The template frame has a first pair of stanchions for engaging the container; and additional pairs of stanchions provided for engaging the one or more additional components, wherein each of the additional pairs of stanchions is for engaging one of the one or more additional components, wherein the stanchions are arranged on the template frame for holding the container and the one or more additional components out of direct physical contact from one another in the predetermined first arrangement to be subsequently assembled into a second arrangement.

Claims

1. A template frame for holding a container and one or more additional components in a predetermined first arrangement, the template frame comprising:

a first pair of stanchions configured for engaging and holding the container, wherein the first pair of stanchions have cutout portions along their top portions that are configured and shaped to hold the container in the predetermined first arrangement; and

additional pairs of stanchions provided for engaging and holding the one or more additional components in the predetermined first arrangement, wherein the one or more additional components comprises a vented spike/needle for puncturing a sealed closure on the container, and a membrane filter for sterilizing a pharmaceutical liquid as the liquid flows through the filter;

wherein one of the additional pairs of stanchions is configured for engaging and holding the vented spike/needle and have cutout portions along their top portions that are configured and shaped to hold the vented spike/needle;

wherein another one of the additional pairs of stanchions is configured for engaging and holding the membrane filter and have cutout portions along their top portions that are configured and shaped to hold the membrane filter;

wherein the stanchions are arranged on the template frame for holding the container and the one or more additional components out of direct physical contact from one another in the predetermined first arrangement to be subsequently assembled into a second arrangement; and

wherein the stanchions are positioned on the template frame so that in the predetermined first arrangement, the container and the one or more additional components are in a linear alignment.

2. The template frame of claim 1, wherein the stanchions are separate pieces attached to the template frame.

3. The template frame of claim 1, wherein the stanchions are integrally formed from the template frame.

4. The template frame of claim 3, wherein each of the stanchions have a top portion for engaging the container or the one or more additional components, and a base portion, wherein the template frame is formed from a sheet of rigid cardboard material and the integrally formed stanchions are created by cutting an outline of the top portions of the stanchions in the template frame then standing the stanchions up by folding the stanchions up along the base portions.

5. The template frame of claim 1, wherein the template frame can be made from a material that is sufficiently rigid such that when the container and the one or more additional components are affixed to the template frame into the predetermined first arrangement, the template frame can maintain the container and the one or more components in the first arrangement.