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CA-3079689-C - METHOD AND DEVICE FOR A POLYESTER STERILIZATION PROCESS

CA3079689CCA 3079689 CCA3079689 CCA 3079689CCA-3079689-C

Abstract

Described herein are packages for orienting and cooling polyesters during a sterilization process, and containers for storing, transporting, and cooling the package. Also described herein are methods of sterilizing polyesters.

Inventors

  • Edward Parent
  • Boris Obermeier
  • Jie Lu

Assignees

  • EVONIK CORPORATION

Dates

Publication Date
20260505
Application Date
20181023
Priority Date
20171023

Claims (14)

  1. CLAIMS What is claimed is: I. A package for orienting and cooling a polyester during a polyester sterilization process, the package comprising: a plurality of packets each containing polyester granules; and a housing defining a receptacle for receiving the plurality of packets and further defining a top region disposed above the receptacle, a bottom region disposed below the receptacle generally opposite the top region, and a plurality of sides disposed around the receptacle between the top region and the bottom region, the housing including: at least one divider disposed between adjacent packets for separating the packets, and a compartment disposed in at least one of the plurality of sides, the compartment receiving a coolant, wherein the coolant is not disposed directly above the receptacle and is not disposed directly below the receptacle such that the receptacle can be irradiated from top to bottom or bottom to top without radiation passing through the coolant.
  2. 2. The package of claim I, wherein the housing further includes a plurality of vents in fluid communication with the compartment for venting the coolant.
  3. 3. The package of claim I or 2, wherein the packets are substantially free of oxygen.
  4. 4. The package of any one of claims I to 3, wherein the at least one divider includes a plurality of generally planar dividers arranged in parallel, one packet being disposed between adjacent dividers.
  5. 5. The package of claim 4, wherein the dividers and the packets are arranged face-toface in a row extending in a direction from one of the plurality of sides to another of the plurality of sides.
  6. 6. A method of sterilizing a polyester, the method comprising: a) adding a polyester to a package; and 19 Date Re9ue/Date Received 2024-03-04 b) irradiating the polyester, the polyester having a glass transition temperature with an electron beam, wherein the polyester is maintained at a temperature below the glass transition temperature by a coolant, and wherein the electron beam does not pass though the coolant; wherein the package comprises: a housing defining a receptacle for receiving a plurality of packets comprising the polyester and further defining a top region disposed above the receptacle, a bottom region disposed below the receptacle generally opposite the top region, and a plurality of sides disposed around the receptacle between the top region and the bottom region, the housing including: at least one divider disposed between adjacent packets for separating the packets, and a compartment disposed in at least one of the plurality of sides, the compartment receiving the coolant, wherein the coolant is not disposed directly above the receptacle and is not disposed directly below the receptacle such that the receptacle can be irradiated from top to bottom or bottom to top without radiation passing through the coolant.
  7. 7. The method of claim 6, wherein the polyester is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, copolymers of poly lactic acid, polyglycolic acid and/or polycaprolactone, copolymers of poly(lactic-co-glycolic acid) (PLGA) and polyethylene glycol (PEG), copolymers of PLGA and poly(dioxanone), copolymers of PLGA and poly(trimethylene carbonate) and combinations thereof.
  8. 8. The method of claim 6 or 7, wherein the coolant is dry ice, gel ice packs, ice blankets, or combinations thereof.
  9. 9. The method of any one of claims 6 to 8, wherein the polyester is irradiated at about 10 kGy to about 300 kGy.
  10. I 0. The method of any one of claims 6 to 9, wherein the polyester is in the form of granules, powder, pellets, bulk or combinations thereof. Date Re9ue/Date Received 2024-03-04
  11. 11. The method of any one of claims 6 to 10, wherein the polyester is packaged in a packet substantially free of oxygen.
  12. 12. The method of claim 11, wherein the packet is vacuum sealed or vacuum sealed and then purged with nitrogen.
  13. 13. The method of claim 11 or 12, wherein the packet comprises an inner pouch and an outer pouch.
  14. 14. The method of claim 13, wherein the inner pouch comprises polyethylene, nylon or a combination thereof, and the outer pouch comprises foil. 21 Date Re9ue/Date Received 2024-03-04

Description

METHOD AND DEVICE FOR A POLYESTER STERILIZATION PROCESS BACKGROUND [0001] Biomaterials that are intended for medical applications are in need of sterilization prior to use. One sterilization technique is through the use of electron beam (E-beam) radiation. However, E-beam sterilization of biomaterials, such as biodegradable polyesters, may cause deleterious side-effects that can hinder their use. SUMMARY [0002] In one aspect, the invention provides a package for orienting and cooling a polyester during a polyester sterilization process. The package includes a plurality of packets each containing polyester granules, and a housing defining a receptacle for receiving the plurality of packets. The housing defines a top region disposed above the receptacle, a bottom region disposed below the receptacle generally opposite the top region, and a plurality of sides disposed around the receptacle between the top region and the bottom region. The housing includes at least one divider disposed between adjacent packets for separating the packets, and a compartment disposed in at least one of the plurality of sides. The compartment receives a coolant. The coolant is not disposed directly above the receptacle and is not disposed directly below the receptacle such that the receptacle can be irradiated from top to bottom or bottom to top without radiation passing through the coolant. [0003] In another aspect, the invention provides methods of sterilizing a polyester, the method comprising irradiating a polyester having a glass transition temperature (T g) with an electron beam, wherein the polyester is maintained at a temperature below its T g by a coolant, and wherein the electron beam does not pass though the coolant. [0004] In another aspect, the invention provides methods of sterilizing a polyester, the method comprising irradiating a polyester with an electron beam, wherein the polyester is packaged in a packet substantially free of oxygen. BRIEF DESCRIPTION OF THE DRAWINGS [0005] Fig. 1 is an exploded view of a packaging system having a package for orienting and cooling a polyester during a sterilization process and a container for storing and transporting the package. 1 [0006] [0007] [0008] [0009] [0010] [0011] Fig. 2 is a side view of the package of Fig. L Fig. 3 is a cross-section view of the package taken along line 3-3 in Fig. 2. Fig. 4 is a cross-section view of the package taken along line 4-4 in Fig. 2. Fig. 5 is a plan view of a first divider for the package of Fig. 2. Fig. 6 is a plan view of a second divider for the package of Fig. 2. Fig. 7 is a plot showing the effect of E-beam dose on inherent viscosity (IV) of different polyesters. [0012] Fig. 8 is a series of images showing A: untreated polyester; B: 25 kGy treated polyester; and C: 25 kGy treated polyester with dry ice as a coolant. DETAILED DESCRIPTION [0013] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. 1. Definitions [0014] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present invention. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting. [0015] The terms "comprise(s)," "include(s)," "having," "has," "can," "contain(s)," and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. The singular forms 2 Date Re9ue/Date Received 2024-03-04 WO 2019/083985 PCT/0S2018/057080 "a," "an" and "the" include plural references unless the context clearly dictates otherwise. The present disclosure also contemplates other embodiments "comprising," "consisting of" and "consisting essentially of," the embodiments or elements presented herein, whether explicitly set forth or not. [0016] The conjunctive term "or" includes any and all combinations of one or more listed elements associated by the conjunctive term. For example, the phrase "an apparatus comprising A or B" may refer to an apparatus including A where B is not present, an apparatus including B where A is not present, or an apparatus where both A and Bare present. The phrases "at least one of A, B, ... and N" or "at least one of A, B, ... N, or combinations thereof' are defined in the broadest sense to mean one or more elements selected fr