{"id":11014,"date":"2026-03-29T14:24:29","date_gmt":"2026-03-29T07:24:29","guid":{"rendered":"https:\/\/chemicalexpressth.com\/?p=11014"},"modified":"2026-08-11T15:45:38","modified_gmt":"2026-08-11T08:45:38","slug":"pureflex-single-use-process-container-films-merck","status":"publish","type":"post","link":"https:\/\/chemicalexpressth.com\/th\/articles\/product-guide-articles\/pureflex-single-use-process-container-films-merck\/","title":{"rendered":"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &#038; Novaseptum\u00ae Pharma Applications"},"content":{"rendered":"<style>  .chx-standalone-article h1 {       color: #222 !important;       line-height: 1.2 !important;       font-weight: bold !important;       text-align: center !important;       margin-top: 40px !important;       margin-bottom: 30px !important;      text-transform: none !important;   }  .chx-standalone-article h2 {      color: #24326d !important;      font-weight: bold !important; 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}  }<\/style>\n<div class=\"chx-standalone-article\">\n<h1>PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications<\/h1>\n<div style=\"margin-bottom: 32px; text-align: center;\"><img decoding=\"async\" class=\"lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img data-src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" decoding=\"async\" class=\"lazyload lazyload lazyload lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\" \/><noscript><img decoding=\"async\" class=\"lazyload lazyload lazyload lazyload lazyload lazyload lazyload\" style=\"width: 100%; max-width: 800px; height: auto; border-radius: 0px !important;\" src=\"https:\/\/chemicalexpressth.com\/wp-content\/uploads\/2026\/03\/image-205.jpg\" alt=\"PureFlex\u2122 Single-Use Process Container Films by Merck \u2013 Robust, Chemically Resistant Films for Mobius\u00ae &amp; Novaseptum\u00ae Pharma Applications\"><\/noscript><\/noscript><\/noscript><\/noscript><\/noscript><\/noscript><\/noscript><\/noscript><\/div>\n<p>PureFlex\u2122 Single-Use Process Container Films by Merck are engineered for pharma and biopharma manufacturing environments that demand safety, scalability, and chemical resistance. Offering high-purity, low extractable, robust materials designed for Mobius\u00ae and Novaseptum\u00ae single-use bioprocessing assemblies, PureFlex\u2122 films minimize contamination risk and optimize productivity across every stage of drug production.<\/p>\n<h2>Why Choose PureFlex\u2122 Single-Use Process Container Films?<\/h2>\n<ul>\n<li><strong>Full-process compatibility:<\/strong> Supports use of a single fluid-contact material across all stages of drug manufacturing, reducing validation and implementation effort.<\/li>\n<li><strong>Contamination risk reduction:<\/strong> Zero animal-derived components and a low extractable profile help protect product integrity throughout biopharmaceutical processes.<\/li>\n<li><strong>Scalable process design:<\/strong> Available in sizes from 100 mL to 200 L, enabling biomanufacturers to scale operations without changing film materials.<\/li>\n<li><strong>Enhanced integrity assurance:<\/strong> Helium Integrity Manufacturing Release Testing is available for applications requiring the highest level of container integrity confidence.<\/li>\n<li><strong>Broad regulatory compliance:<\/strong> Passes USP, Ph. EUR., ISO, and FDA biocompatibility standards, supporting regulatory submissions with confidence.<\/li>\n<\/ul>\n<h2>PureFlex\u2122 Film Construction &amp; Key Features<\/h2>\n<ul>\n<li><strong>Film architecture:<\/strong> High-purity, medical-grade coextruded, multi-layer construction comprising an ultra-low-density polyethylene (ULDPE) fluid contact layer, a polyethylene vinyl alcohol copolymer (EVOH) gas barrier layer, and an ethylene vinyl acetate (EVA) flexibility layer.<\/li>\n<li><strong>PureFlex\u2122 Plus outer layer:<\/strong> Constructed with linear low-density polyethylene (LLDPE) in place of ULDPE for a tougher outer surface, while retaining the same ULDPE fluid contact layer.<\/li>\n<li><strong>Gas barrier performance:<\/strong> Low gas permeability design achieved through the EVOH barrier layer, limiting oxygen and CO\u2082 transmission.<\/li>\n<li><strong>Gamma irradiation compatibility:<\/strong> Both PureFlex\u2122 and PureFlex\u2122 Plus films are validated post-gamma irradiation, with PureFlex\u2122 tested at &gt;45 kGy and PureFlex\u2122 Plus at 25\u201340 kGy.<\/li>\n<li><strong>Operating temperature range:<\/strong> Rated from -112\u00b0F to 140\u00b0F (-80\u00b0C to 60\u00b0C), with freezing applications requiring film support.<\/li>\n<\/ul>\n<h2>Technical Specifications of PureFlex\u2122 Films<\/h2>\n<p><strong>Physical Data (Post-gamma irradiation)<\/strong><\/p>\n<div class=\"res-table-wrapper\">\n<table>\n<thead>\n<tr>\n<th>Properties<\/th>\n<th>Tests<\/th>\n<th>PureFlex\u2122 Film Average Values\u00b9<\/th>\n<th>PureFlex\u2122 Plus Film Average Values\u00b2<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Tensile Strength<\/td>\n<td>ASTM D882<\/td>\n<td>2700 psi (18.6 MPa)<\/td>\n<td>2245 psi (15.4 MPa)<\/td>\n<\/tr>\n<tr>\n<td>Elongation<\/td>\n<td>ASTM D882<\/td>\n<td>570%<\/td>\n<td>630%<\/td>\n<\/tr>\n<tr>\n<td>Yield Strength<\/td>\n<td>ASTM D882<\/td>\n<td>1360 psi (9.4 MPa)<\/td>\n<td>2000 psi (13.7 MPa)<\/td>\n<\/tr>\n<tr>\n<td>Secant Modulus<\/td>\n<td>ASTM D882<\/td>\n<td>37 kpsi (255 MPa)<\/td>\n<td>39 kpsi (269 MPa)<\/td>\n<\/tr>\n<tr>\n<td>Toughness<\/td>\n<td>ASTM D882<\/td>\n<td>9100 in.-Lbf\/in.\u00b3 (63 MJ\/m\u00b3)<\/td>\n<td>10500 in.-Lbf\/in.\u00b3 (73 MJ\/m\u00b3)<\/td>\n<\/tr>\n<tr>\n<td>Seam Strength<\/td>\n<td>ASTM D882<\/td>\n<td>18 Lbf\/in. (32 N\/cm)<\/td>\n<td>20 Lbf\/in. (36 N\/cm)<\/td>\n<\/tr>\n<tr>\n<td>O\u2082 Transmission Rate<\/td>\n<td>ASTM F1307 at 23\u00b0C<\/td>\n<td>0.063 cc\/100 in.\u00b2\/24 hrs (0.98 cc\/m\u00b2\/24 hrs)<\/td>\n<td>0.017 cc\/100 in.\u00b2\/24 hrs (0.26 cc\/m\u00b2\/24 hrs)<\/td>\n<\/tr>\n<tr>\n<td>CO\u2082 Transmission Rate<\/td>\n<td>ASTM F2476 at 23\u00b0C<\/td>\n<td>0.13 cc\/100 in.\u00b2\/24 hrs (92 g\/m\u00b2\/24 hrs)<\/td>\n<td>&lt;0.065 cc\/100 in.\u00b2\/24 hrs (&lt;46.02 g\/m\u00b2\/24 hrs)<\/td>\n<\/tr>\n<tr>\n<td>MVTR<\/td>\n<td>ASTM F1249 at 23\u00b0C<\/td>\n<td>0.034 g\/100 in.\u00b2\/24 hrs (0.53 g\/m\u00b2\/24 hrs)<\/td>\n<td>0.067 g\/100 in.\u00b2\/24 hrs (1.1 g\/m\u00b2\/24 hrs)<\/td>\n<\/tr>\n<tr>\n<td>Haze<\/td>\n<td>ASTM D1003<\/td>\n<td>23%<\/td>\n<td>30%<\/td>\n<\/tr>\n<tr>\n<td>Glass Transition Temperature<\/td>\n<td>ASTM D5026<\/td>\n<td>-15\u00b0F (-26\u00b0C)<\/td>\n<td>-13\u00b0F (-25\u00b0C)<\/td>\n<\/tr>\n<tr>\n<td>Film Thickness<\/td>\n<td>ASTM D374<\/td>\n<td>0.01 in. (0.25 mm)<\/td>\n<td>0.012 in. (0.30 mm)<\/td>\n<\/tr>\n<tr>\n<td>Operating Temperature Range\u00b3<\/td>\n<td><\/td>\n<td>-112\u2013140\u00b0F (-80\u201360\u00b0C)<\/td>\n<td>-112\u2013140\u00b0F (-80\u201360\u00b0C)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><em>\u00b9 PureFlex\u2122 film values reported after gamma irradiation at &gt;45 kGy.<\/em><br \/><em>\u00b2 PureFlex\u2122 Plus film values reported after gamma irradiation at 25\u201340 kGy.<\/em><br \/><em>\u00b3 Freezing requires the film to be supported.<\/em><\/p>\n<p><strong>Biocompatibility Data for PureFlex\u2122 and PureFlex\u2122 Plus Films (Post-gamma irradiation at \u226540 kGy)<\/strong><\/p>\n<div class=\"res-table-wrapper\">\n<table>\n<thead>\n<tr>\n<th>Properties<\/th>\n<th>Tests<\/th>\n<th>Result<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Biological Reactivity<\/td>\n<td>USP &lt;88&gt; Class VI<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Cytotoxicity<\/td>\n<td>USP &lt;87&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Bacterial Endotoxin<\/td>\n<td>USP &lt;85&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Heavy Metals<\/td>\n<td>USP &lt;661&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Buffering Capacity<\/td>\n<td>USP &lt;661&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Non-volatile Residuals<\/td>\n<td>USP &lt;661&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Residue on Ignition<\/td>\n<td>USP &lt;661&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Hemolysis<\/td>\n<td>ISO 10993-4<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Appearance<\/td>\n<td>Ph. EUR. 3.2.2.1<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Acidity and Alkalinity<\/td>\n<td>Ph. EUR. 3.2.2.1<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Absorbance<\/td>\n<td>Ph. EUR. 3.2.2.1<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Reducing Substances<\/td>\n<td>Ph. EUR. 3.2.2.1<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Transparency<\/td>\n<td>Ph. EUR. 3.2.2.1<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Particulate Matter<\/td>\n<td>USP &lt;788&gt;<\/td>\n<td>Passed<\/td>\n<\/tr>\n<tr>\n<td>Indirect Food Additives<\/td>\n<td>FDA 21 CFR 177.1520<\/td>\n<td>Passed<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2>Biopharmaceutical Applications of PureFlex\u2122 Single-Use Process Container Films<\/h2>\n<ul>\n<li><strong>Media and Buffer Preparation:<\/strong> PureFlex\u2122 films provide a chemically resistant, inert contact surface suitable for preparing and holding media and buffer solutions prior to use in downstream processes.<\/li>\n<li><strong>Cell Culture:<\/strong> The film&#8217;s low extractable profile and inert ULDPE contact layer make it appropriate for direct use in cell culture process containers where product purity is critical.<\/li>\n<li><strong>Purification:<\/strong> Process containers constructed from PureFlex\u2122 films support fluid handling during purification steps, maintaining chemical resistance throughout.<\/li>\n<li><strong>Intermediate Product Storage and Mixing:<\/strong> PureFlex\u2122 film-based assemblies are used to store and mix intermediate drug substances, with the film&#8217;s operating temperature range supporting both ambient and frozen storage conditions.<\/li>\n<li><strong>Sterile Sampling:<\/strong> PureFlex\u2122 films are used in the construction of Novaseptum\u00ae sampling bags for sterile sampling applications within biopharmaceutical processes.<\/li>\n<li><strong>Fill and Finish Operations:<\/strong> The film&#8217;s robustness and flexibility support its use in final fill and finish stages of drug manufacturing.<\/li>\n<\/ul>\n<p>Chemical Express, with over 23 years of expertise, is the official distributor of Merck in Thailand. PureFlex\u2122 Single-Use Process Container Films and related Merck and Novaseptum\u00ae products can be ordered directly from us, ensuring quality assurance and dedicated technical support throughout your fluid management and bioproduction needs.<\/p>\n<div style=\"text-align: center; margin-top: 64px; padding-bottom: 60px;\">\n<h3 style=\"margin-bottom: 8px;\">Request a Quote or Get Expert Advice on PureFlex\u2122 Single-Use Process Container Films<\/h3>\n<p>Simply fill out our Inquiry Form or chat with us instantly on Line using the buttons below.<br \/>We&#8217;re here to help!<\/p>\n<div style=\"display: flex; justify-content: center; align-items: center; gap: 16px; flex-wrap: wrap; margin-bottom: 20px;\"><a style=\"display: inline-flex; align-items: center; justify-content: center; padding: 14px 28px; background: #0b5ed7; color: #ffffff; text-decoration: none; border-radius: 8px; font-weight: 600; font-size: 16px; line-height: 1; white-space: nowrap;\" 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