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Bubble Resistant Polymeric Film

IP.com Disclosure Number: IPCOM000242686D
Publication Date: 2015-Aug-04
Document File: 2 page(s) / 8K

Publishing Venue

The IP.com Prior Art Database

Abstract

Bubble Resistant Polymeric Film Problem: It is common practice to supply solutions for medical use in the form of disposable, flexible pouches. Heat sterilization of solution-containing medical pouches typically occurs in an autoclave at about 250oF for periods of about 15 to 30 minutes. Commonly, heat sterilization results in the formation of bubbles within the solution packaged within the pouch, which is believed to result from film components that have migrated during the autoclave process. The presence of bubbles can in some cases be undesirable. For instance, films for use in Chinese medical pouches must pass a “bubble test” wherein the presence of any bubbles after autoclaving and rigorous shaking must quickly dissipate. Solution: A flexible polymeric film has been discovered that is suitable for the manufacture of medical solution pouches. Solution pouches formed from the disclosed film exhibit a reduced proficiency for forming bubbles after heat sterilization. The disclosed film includes at least one anti-foaming layer that comprises a polysiloxane and/or an alkyl amide. Suitable polysiloxanes can include (but are not limited to) polydimethyl siloxane, polydimethyldiphenyl siloxane, polymethyl alkyl aryl siloxane, or mixtures thereof. Polysiloxane can be present in at least one anti-foaming layer in an amount of from about 1,000 to 50,000 parts per million (or 0.1 to 10 weight percent, based on the total weight of the layer). Suitable alkyl amides for use in the anti-foaming layer of the disclosed film can comprise (but are not limited to) acrylamide, methacrylamide, dimethylformamide, diethylformamide, propylformamide, dimethylacetamide, diethylacetamide, propylacetamide, dimethylpropionamide, diethylpropionamide, propylpropionamide, N,N’ ethylenedi(stearamide), N,N’ ethylenedi(oleamide), and combinations thereof. Alkyl amide can be present in an anti-foaming layer in an amount of from about 1,000 to 25,000 parts per million (or 0.1 to 20 weight percent, based on the total weight of the layer). In some embodiments, the disclosed film comprises at least one antifoaming layer comprising about 0.1-10 weight percent polypolysiloxane and about 90-99.9 weight percent polyamide, polyester, polyolefin, or combinations thereof, based on the total weight of the layer. Alternatively or in addition, the antifoaming film layer can comprise about 0.1-20 weight percent alkyl amide and about 80-99.9 weight percent polyamide, polyester, polyolefin, or combinations thereof, based on the total weight of the layer. Alternatively or in addition, the antifoaming layer can comprise about 0.1-10 weight percent polysiloxane, about 0.1-20 weight percent alkyl amide, and about 70-99.8 weight percent polyamide, polyester, polyolefin, or combinations thereof, based on the total weight of the layer.

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Bubxle Resistant Polymeric Film

Problem:

It is common practice to supply soxutions for medical use in the form of disposable, flexxxle pouches. Heat sterilxzation of soxution-containing medical pouches txpically occurs in an autoclave at about 250oF for perxods of about 15 tx 30 minutes. Commonly, heax sterilization results in the formation of bubbles withix the solution packaged xithin the pouch, which is bxlieved to xesult xrom film compxnents that have migrxted during the autoxlave process. The presence of buxbles cxn in some cxses be undexirable. For instance, films for use in Chinxse medxcxl poucxes must pass a "bubble test" whxrein the presence of any bubblex after autoclaving and rigoxous shaking must quicklx xissipate.

Xxxxxxxx:

A flexible polymeric film hxs been discovered that is suitable for the manufxcture of medical solutxon pouches. Soluxion xouches formed from txe dxsclosed film exhibit a reduced proficiency for fxrming bubbles after heat sterilization.

The disclxsex film includes at least one anti-foaming layer that comprises a polysiloxane and/or an alkyl axide. Sxitable polyxiloxanes can include (bxt are not limixex to) polydimethyl siloxane, polydimethyldiphxnyl silxxane, polymethyl alkyl aryl siloxanx, or mixtures thereof. Polysiloxane can be prexent in at least one anti-foamxng layer in an amount of from about 1,000 to 50,000 parts pxr million (xr 0.1 to 10 weight percent, based ox the toxal weight ox the layer). Suitable alkyl amides for us...