Container for a solution of human plasma proteins and method for obtaining thereof
Inventors
ROURA FERNANDEZ, CARLOS • GARCIA GARCIA, JOSE ANTONIO • LLORENS MASAS, Estela • MARZO ADAM, Nuria
Assignees
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Publication Number
US-11458070-B2
Publication Date
2022-10-04
Expiration Date
Abstract
A container for a solution of human plasma proteins has a primary inner bag made up of a first multilayer polymer film with two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer, and a secondary outer bag made up of a second multilayer film with layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP), referred to as multilayer PP-SiOx.
Core Innovation
The invention relates to a container for a solution of human plasma proteins that uses a primary inner bag and a secondary outer bag. The primary inner bag comprises a first multilayer polymer film having two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer, and the secondary outer bag comprises a second multilayer polymer film including layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx), and polypropylene (PP).
The problem addressed is the gas/water vapor permeability of plastic bags, which is identified as causing container issues in storage of human plasma protein solutions. The combination of the specific primary inner multilayer film and the specific secondary outer multilayer film reduces container weight loss and maintains immunoglobulin solution color and quality over stability studies.
The container further includes structural and closure features associated with inlet/cap and hermetic closure, including reversible then irreversible closure, inlet welding using inlet small wings to avoid side-channel leakage, and a cap twist-off valve with an inner toric protrusion for hermetic punch sealing. Optional welding is described, including ultrasound welding and heat-contact welding, and a peelable secondary bag is included.
Claims Coverage
Independent claim clm-00001 defines a container for a solution of human plasma proteins with two-part bag construction, specifying two inventive features in the material layer structures for both bags.
Primary inner bag multilayer film with PE and EVOH copolymer
A primary inner bag comprising a first multilayer polymer film, wherein the first multilayer polymer film comprises two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer.
Secondary outer bag multilayer film with PET-SiOx, OPA, PP-SiOx and PP
A secondary outer bag comprising a second multilayer polymer film, wherein the second multilayer polymer film comprises layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP).
The claim coverage is centered on the specific multilayer constructions of the primary inner bag film and the secondary outer bag film for holding solutions of human plasma proteins.
Stated Advantages
Reduces container weight loss.
Maintains immunoglobulin solution color and quality over stability studies.
Documented Applications
Container for solutions of human plasma proteins, including immunoglobulins and albumin.
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