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Package system and method for inhibiting moisture entry

a technology of moisture entry and packaging system, applied in the field of packaging system, can solve the problems of cake tendency, i.e., joining together, caking of solids, etc., and achieve the effect of low moisture transmission ra

Inactive Publication Date: 2017-04-27
AVANTOR PERFORMANCE MATERIALS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a package system that prevents moisture entry and continuous removal of free moisture from the package contents. The package system includes an inner bag, an outer bag, a discharge port, a pressure equalizing port, and at least one desiccant or gas scavenging material. The inner bag is made from a gas and / or moisture permeable material and has an interior, a first end, and a second end. The outer bag is made from a gas and / or moisture impermeable polymeric material and has a first end and a second end. The discharge port has an interior passage that provides access to the interior of the outer bag and allows filtered or inert gas to enter the interior, while the pressure equalizing port vents air from the interior of the inner bag. The desiccant(s) or gas scavenging material can be safely used with pharmaceutical products. The package system also includes an inner bag sealed closed at the bottom and an outer bag sealed closed at the bottom, forming an intermediate space between them. The function of the seals is to keep the inner bag from falling to the bottom and impeding the flow of material through the discharge port. The package system also includes a handle for easy handling and a removable cap for sealing the discharge port. The pressure equalizing port allows for the introduction of dry inert gas to blanket the material in the inner bag.

Problems solved by technology

A common problem with delivering granular solids is that they have a tendency to cake (i.e., joined together to form a mass) due to the presence of moisture in the solid.
Caking of solids is a major problem in the industry and attempts to solve this problem include adding anti-caking agents and changing the crystal size.
However, none of these attempts have completely solved the problem.
The addition of anti-caking agents to packages containing salts is undesirable because the anti-caking agents frequently include compounds that interfere with the pharmaceutical manufacturing process.
Over time the bridges become stronger and, when a sufficient amount of moisture is present, the product can turn into a solid unusable mass.
This system has some drawbacks, including a drum that is expensive and can be difficult for the user to empty.
Moreover, with larger drums (60 Kg and above), the moisture removal through the large solid bed is not faster.

Method used

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  • Package system and method for inhibiting moisture entry
  • Package system and method for inhibiting moisture entry
  • Package system and method for inhibiting moisture entry

Examples

Experimental program
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Effect test

example 1

[0090]A model test bag was produced by heat sealing a multi-layer bag, which included an interior layer made of Tyvek® that provides a vapor transmission wall disposed between two outer layers made of substantially gas and moisture impermeable HDPE. The top edges of the three layers were aligned in registration and the interior Tyvek® layer extended to a point intermediate the first and second ends of the two outer layers. The bottom and two side perimetrical edges of the outer layers of HDPE were sealed together to form a first compartment and the perimetrical edges on the bottom and two sides of the Tyvek® layer were sealed to the first outer HDPE layer to form a second compartment. One kg of the test salt was placed in the first compartment from the top end of the bag on one side of the Tyvek® layer and the desiccant material was placed on the other side (five ⅙ clay type desiccants from Desicare) of the Tyvek® layer in the second compartment. The perimetrical edges of the three ...

example 2

[0091]A lab study was carried out to demonstrate the ability of the package system to maintain materials in the free-flowing state. In addition, tests were performed to compare the package system to a prior art single use bag. The new package system bag was filled with 11.3 kg of free-flowing sodium chloride and the end cap, clamp and clip were placed on the bag. Another standard single use bag without the compartment for the desiccant (i.e., the Flowmor™ technology) was filled with same amount of free-flowing sodium chloride and sealed in the same manner. Both bags were placed side by side in a stability chamber at 40° C. and 75% RH. Both bags were tested after 32 days; the sodium chloride in the package system (see the photograph in FIG. 12) was free flowing and cake free. The material in the prior art bag (see the photograph in FIG. 13) was caked and not free-flowing.

example 3

[0092]Studies were carried out under high moisture conditions (40° C., 90% RH) on the bags, to study moisture infusion rates into the wall of the bag. A bag was placed in the stability chamber with a weighed eight units of desiccant (approximately 8 ounces); the cap and clip were placed on the bag and sealed. The desiccant, after 96 hours, gained 6.5 grams of water, which showed that the desiccant would be used up in 30 days at this water vapor transmission rate. The bag was then placed in a Mylar® bag (or any suitable bag with low moisture vapor transmission rate) and heat sealed. The vapor transmission rate was significantly increased and the test results showed an expected shelf life of over 400 days.

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Abstract

A package system for maintaining the physicochemical integrity of the contents of the package system that includes: an inner bag formed from a gas and / or moisture permeable material, an outer bag formed from an impermeable polymer material, a discharge port that provides access to the interior of the outer bag; and a desiccant or gas scavenging material. The first end of the outer bag sealingly surrounds the exterior wall of the discharge port. The second end of the inner bag is sealed closed and the desiccant or gas scavenging material is disposed in an isolated compartment. The second end of the outer bag is sealed closed to isolate the interior from the environment exterior to the package system.

Description

[0001]This application claims priority from International patent application No. PCT / US2015 / 022981, filed on Mar. 27, 2015, which claims priority from U.S. provisional application Ser. No. 61 / 971,003, filed on Mar. 27, 2014, both of which are incorporated herein in their entirety.FIELD OF THE INVENTION[0002]The present invention is a package system that maintains the physicochemical integrity of its contents, free-flowing characteristics. In particular, the present invention relates to package systems that prevent the caking of salts used in the manufacture of biopharmaceuticals (e.g., in cell culture production).BACKGROUND OF INVENTION[0003]Various salts and buffers are used in the manufacturing operations associated with biopharmaceuticals production (e.g., cell culture production and protein purification). These chemicals are dissolved under sterile conditions to make up a variety of solutions. A common problem with delivering granular solids is that they have a tendency to cake ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B65D81/26B65D75/38B65D65/38B65D75/56B65D75/58B65D41/02B65D30/22B65D75/52
CPCB65D81/266B65D31/12B65D75/38B65D65/38B65D75/56B65D75/5872B65D41/02B65D75/522B65D2205/00B65D81/268
Inventor FARINA, JAMESBOLESSA, EVONDEORKAR, NANDU
Owner AVANTOR PERFORMANCE MATERIALS LLC
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