WO2022073085A1 - Équipement de lyophilisation de lait humain dans un environnement stérile - Google Patents

Équipement de lyophilisation de lait humain dans un environnement stérile Download PDF

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Publication number
WO2022073085A1
WO2022073085A1 PCT/BR2021/050199 BR2021050199W WO2022073085A1 WO 2022073085 A1 WO2022073085 A1 WO 2022073085A1 BR 2021050199 W BR2021050199 W BR 2021050199W WO 2022073085 A1 WO2022073085 A1 WO 2022073085A1
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WO
WIPO (PCT)
Prior art keywords
human milk
equipment
lyophilization
sterile
sterile environment
Prior art date
Application number
PCT/BR2021/050199
Other languages
English (en)
Portuguese (pt)
Inventor
Mario Lizenor Da COSTA
Original Assignee
Costa Mario Lizenor Da
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Costa Mario Lizenor Da filed Critical Costa Mario Lizenor Da
Publication of WO2022073085A1 publication Critical patent/WO2022073085A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/14—Milk preparations; Milk powder or milk powder preparations in which the chemical composition of the milk is modified by non-chemical treatment
    • A23C9/142—Milk preparations; Milk powder or milk powder preparations in which the chemical composition of the milk is modified by non-chemical treatment by dialysis, reverse osmosis or ultrafiltration

Definitions

  • the present invention patent deals with an unprecedented equipment for lyophilization, of small and medium production volume, of human milk in a sterile chamber, with slightly positive pressure, equipped with a condenser connected to a remote refrigeration unit, as well as such as a vacuum pump and nitrogen gas piping, which together promote all the steps necessary for the lyophilization to be carried out, including the packaging of the final product.
  • HMBs human milk banks
  • CN 203885861 entitled “Fully-automatic freeze-drying pharmaceutical equipment” comprises a washing machine, a tunnel-type baking oven connected to the bottle washing machine, a filling machine connected to the tunnel-baking oven, an alignment machine connected to the filling machine, a conveyor belt connected to the alignment machine, and a freeze drying machine connected to the conveyor belt.
  • the system comprises a small lyophilization unit having an upper half and a lower half.
  • the upper half of the unit includes a chamber where the lyophilization process is carried out.
  • the lower half of the freeze drying unit comprises a vacuum pump and a freezing unit.
  • an inert gas preferably nitrogen
  • the invention deals with a human milk lyophilization equipment consisting of a sterile chamber, accessed by a door, subjected to a positive pressure thanks to a blower that directs an air flow from top to bottom, which air is captured in the rear wall of said sterile chamber and purified/sterilized by mechanical filters, horizontal and vertical, and UVC lamps 2.
  • the positive pressure makes it possible to open the chamber door without risk of contamination from the outside to the inside.
  • the sterile chamber is complemented by a condenser with manifolds for fixing the vials with frozen human milk to be lyophilized.
  • the condenser has three inlet holes in which the central hole is followed by a concentric tube, which receives the conductive duct from the cooling unit, while the upper hole, external to the concentric tube, receives the conductive duct from the vacuum pump. and, finally, the orifice with the smallest diameter, the conduit carrying the inert gas, preferably nitrogen.
  • FIGURE 1 Perspective view of the human milk lyophilization equipment in a sterile environment
  • FIGURE 2 Inverted perspective view of the human milk lyophilization equipment in a sterile environment
  • FIGURE 3 Exploded perspective view of the human milk lyophilization equipment in a sterile environment
  • FIGURE 4 Exploded perspective view of the sterile chamber of the human milk lyophilization equipment in a sterile environment
  • FIGURE 5 Perspective detail of the inputs of the operational components in the condensation tube of the human milk lyophilization equipment in a sterile environment
  • FIGURE 6 Sectional view of the condensation tube of the human milk lyophilization equipment in a sterile environment
  • FIGURE 7 Perspective view of the human milk lyophilization equipment manifold in a sterile environment
  • FIGURE 8 Perspective view of the manifold with the vials of the human milk lyophilization equipment in a sterile environment
  • FIGURE 9 Exploded perspective view of the vial in relation to the manifold of the human milk lyophilization equipment in a sterile environment
  • FIGURE 10 Exploded perspective view of the human milk lyophilization equipment bottle in a sterile environment.
  • HUMAN MILK LYOPHYLIZATION EQUIPMENT IN STERILE ENVIRONMENT comprises a sterile chamber (3) equipped with a condenser (12), connected to a remote cooling unit (13) and vacuum pump (19), which enable sublimation of frozen human milk contained in vials (10) fixed to the taps (11) (manifolds), in addition to a resistive plate (23) that carries out the second part of the freeze-drying process by heating the internal environment, so that once the milk human lyophilized, called desorption, is already packaged in a vacuum sealer (24) as the sterile chamber (3) operates at positive pressure, which prevents contamination from the outside to the inside.
  • the invention deals with an equipment (1) for lyophilization of human milk, on a small and medium scale, which on a base (2) comprises a sterile chamber (3) divided into two parts, separated by mechanical filters (4), and in its upper part (3S) there is a blower (5) which generates a flow, from top to bottom, of the air captured through the rear cover (6) that passes through a vertical mechanical filter ( 7), by at least one UVC lamp 2 (8) and by horizontal mechanical filters (4), delimiters of the lower part (3I) of the sterile chamber (3), thus generating an aseptic environment with slightly positive pressure, which allows handling, without risk of contamination, of the vials (10), containing the frozen human milk, in the taps (1 1 ) (manifolds) of the condenser (12) where the first part of the lyophilization process takes place, by the action of components remote to the sterile chamber (3), in which there is a cooling unit (13) whose duct is The inductor (14) enters a central hole (15
  • An eccentric hole (17) in the condenser (12) receives the conduction duct (18) of the vacuum pump (19), while a second eccentric hole (20), of smaller diameter, receives the hose (21) of a gas inert, preferably nitrogen, contained in a cylinder (22) that keeps the internal environment of the flasks inert at the end of lyophilization, when the vacuum pump (19) is turned off.
  • the second part of the freeze-drying process, desorption, that is, desorption takes place with the activation of a resistive plate (23), which heats the interior of the sterile chamber (3) to a temperature sufficient to remove the remaining moisture from the first part of the process.
  • the flasks (10) have a lid (T) for fixing to the tap (11) (manifold), a reservoir (R) for containing human milk, screwed to said lid (T), and a tube (X) that serves as a template to form a cylindrical space when freezing human milk, since the best performance of lyophilization occurs when the thickness of the product is less than 25 mm.
  • the equipment (1) is complemented by a vacuum sealer (24) located at the bottom (3I) of the sterile chamber and a control panel (25) for monitoring the entire process.
  • the sterile chamber (3) is turned off. After the lyophilization time has elapsed, the sterile chamber (3) is reconnected, now with the resistive plate (23) to start the second part of the lyophilization process, the desorption, which, once completed, the taps (1 1 ) (manifolds) must be closed. Then the vacuum sealer (24) must be turned on, the valve and the vacuum pump (19) closed, and then open the cylinder's inert gas valve (22) until the pressure is equalized. Subsequently, the cooling unit (13) is turned off and the taps (1 1 ) (manifolds) are opened to remove the vials (10). Finally, the human milk, already in powder form, is packed in the vacuum sealer (24).
  • the sterile chamber (3) is mounted on a chassis (26) with a perforated base (27) to receive the lower tray (28) and an intermediate base (29) where the blower (5) takes place.
  • the sterile chamber (3), a back cover (6) with holes (30) for capturing ambient air by the blower (5), a top cover (31), front door (32) and a hold (33) for the filters complement horizontal mechanics (4).
  • the entire system is built in AISI 304 Stainless Steel, in order to guarantee total asepsis in accordance with current sanitary and hospital regulations.

Landscapes

  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Preparation (AREA)
  • Drying Of Solid Materials (AREA)
  • Dairy Products (AREA)

Abstract

Un équipement de lyophilisation de lait humain dans un environnement stérile comprend une chambre (3) stérile pourvue d'un condensateur (12) relié à une unité de refroidissement (13) et une pompe à vide (19) distantes, qui permettent la sublimation du lait humain congelé contenu dans des flacons (10) fixés à des collecteurs (11), ainsi qu'une plaque résistive (23) qui permet à la seconde partie du processus de lyophilisation pour chauffer le milieu interne, de sorte qu'une fois, le lait humain lyophilisé, il est déjà emballé dans une scelleuse (24) à vide, étant donné que la chambre (3) stérile fonctionne à pression positive, ce qui empêche la contamination de l'extérieur vers l'intérieur.
PCT/BR2021/050199 2020-10-09 2021-05-12 Équipement de lyophilisation de lait humain dans un environnement stérile WO2022073085A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BR102020020839-0A BR102020020839A2 (pt) 2020-10-09 2020-10-09 equipamento de liofilização de leite humano em ambiente estéril
BRBR1020200208390 2020-10-09

Publications (1)

Publication Number Publication Date
WO2022073085A1 true WO2022073085A1 (fr) 2022-04-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2021/050199 WO2022073085A1 (fr) 2020-10-09 2021-05-12 Équipement de lyophilisation de lait humain dans un environnement stérile

Country Status (2)

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BR (1) BR102020020839A2 (fr)
WO (1) WO2022073085A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202915656U (zh) * 2012-07-11 2013-05-01 游金铭 无尘无菌式冷冻干燥机
CN207797518U (zh) * 2017-12-01 2018-08-31 曾向东 一种新型的真空冷冻干燥装置
US20200205430A1 (en) * 2018-12-31 2020-07-02 Madeline Owens Freeze-drying, storing, rehydrating and feeding using breast milk
CN211316756U (zh) * 2019-10-31 2020-08-21 南京瑞碧斯生物科技有限公司 一种食品冻干机离心式干燥装置
CN211601342U (zh) * 2020-01-09 2020-09-29 上海奕杉生物科技有限公司 一种新型冻干机
CN212081806U (zh) * 2020-04-21 2020-12-04 润盈生物工程（上海）有限公司 一种无菌的冷冻干燥机

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202915656U (zh) * 2012-07-11 2013-05-01 游金铭 无尘无菌式冷冻干燥机
CN207797518U (zh) * 2017-12-01 2018-08-31 曾向东 一种新型的真空冷冻干燥装置
US20200205430A1 (en) * 2018-12-31 2020-07-02 Madeline Owens Freeze-drying, storing, rehydrating and feeding using breast milk
CN211316756U (zh) * 2019-10-31 2020-08-21 南京瑞碧斯生物科技有限公司 一种食品冻干机离心式干燥装置
CN211601342U (zh) * 2020-01-09 2020-09-29 上海奕杉生物科技有限公司 一种新型冻干机
CN212081806U (zh) * 2020-04-21 2020-12-04 润盈生物工程（上海）有限公司 一种无菌的冷冻干燥机

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TERRONI EQUIPAMENTOS CIENTIFICOS, LIOFILIZADOR SERIE LT, 9 May 2014 (2014-05-09), Retrieved from the Internet <URL:https://www.terroni.com.br/produto/liofilizadores-de-bancada/liofilizador-serie-lt> [retrieved on 20210707] *

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