Package system and method for inhibiting moisture entry

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 ...

AI Technical Summary

Benefits of technology

[0007]In accordance with the present invention, a package system for inhibiting moisture entry into the contents of the package and continuous removal of any free moisture in the contents is provided. In a preferred embodiment, the package system has a first end and a second end and comprises, consists of or consists essentially of: 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 formed from a gas and / or moisture permeable material and has an interior, a first end and a second end. The outer bag is formed from a gas and / or moisture impermeable polymeric material (e.g., HDPE, various LDPEs, and other similar polymeric materials) and has a first end and a second end. The outer bag is also clear to facilitate rapid identification of the package system's contents by Raman spectroscopy (e.g., a handheld Raman spectrometer).

[0008]The discharge port has an exterior wall that defines an interior passage that provides access to the interior of the outer bag. The pressure equalizing port vents air from the interior of the inner bag, when it is being filled, and allows filtered or inert gas to enter the interior, when the inner bag is being emptied. The desiccant(s) or gas scavenging material can be a moisture or gas absorbing material that can be used safely with pharmaceutical products.

[0010]After desiccant(s) and / or gas scavenging material are disposed inside the inner bag (also referred to herein as the second compartment), the second end of the inner bag is sealed closed. The bottom end of the inner bag that contains the desiccant material can be heat sealed or fused along a line that extends horizontally and parallel to the second end of the inner bag. The heat seal is located at least 4 inches above the bottom port, preferably a minimum of 5 inches from the bottom port and most preferably 6 or more inches. The function of this seal is to keep the inner bag containing the desiccant away from the discharge port so that it does not impede the flow of material during emptying operations. After the desiccant material is added to the inner bag, the second ends of the inner and outer bags are sealed closed to isolate the intermediate space from the environment exterior to the package system. The HDPE liner does not include slip agents or block agents; however, an antistatic agent can be added to the HDPE liner to ensure that all of the product is delivered and prevents sticking of the product to the walls due to static buildup.

[0011]In a second embodiment, the first end of the inner bag is sealingly attached to the exterior wall of the discharge port and the first end of the outer bag sealingly surrounds the first end of the inner bag and is sealingly attached around the exterior wall of the discharge port to form an intermediate space (also referred to herein as a compartment or the second compartment) between the inner bag and the outer bag. The desiccant(s) and / or gas scavenging material are disposed in the intermediate space and the second end of the inner bag is sealed closed. The function of this seal at the bottom end of the inner bag is to keep the inner bag from falling to the bottom of the package system and impeding the flow of material through the discharge port during emptying operations. The second end of the outer bag is then sealed closed to isolate the intermediate space (i.e., first compartment) from the environment exterior to the package system. HDPE liner does not include slip agent, or block agents, however an antistatic agent is added to the HDPE liner to ensure that all of the product is delivered and prevents sticking of the product to the walls due to static buildup.

[0012]The discharge port is used to fill and discharge materials contained in the interior of the inner bag. The first end of the HDPE outer bag forms a seal around the exterior wall of the discharge port. The discharge port is located at the bottom of the packaging system in the HDPE outer bag. The discharge port can have a removable cap for closing and sealing the discharge port. The removable cap isolates the contents of the package system from the outside environment during transportation and storage. The package system can also include a handle attached to the second end of the package system to facilitate the handling of the package system by the user.

[0013]The pressure equalizing port is located near the second end of the package system and has a passage that extends between the interior of the inner bag and the environment exterior to the package system. The passage of the pressure equalizing port contains one or more filter materials that contain at least one desiccant and / or gas scavenging materials, which can selectively prevent moisture or certain gases from entering the interior of the inner bag. The pressure equalizing port can also facilitate 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.

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