{"id":3561,"date":"2026-09-16T12:10:00","date_gmt":"2026-09-16T11:10:00","guid":{"rendered":"https:\/\/seamlessbio.de\/produkt\/3d-single-use-bioprocessing-bag-50-l-1000-l-mpx-tubing-gmp\/"},"modified":"2026-09-22T07:12:43","modified_gmt":"2026-09-22T06:12:43","slug":"3d-single-use-bioprocessing-bag-50-l-1000-l-mpx-tubing-gmp","status":"publish","type":"product","link":"https:\/\/seamlessbio.de\/de\/product\/3d-single-use-bioprocessing-bag-50-l-1000-l-mpx-tubing-gmp\/","title":{"rendered":"3D Single-Use Bioprocessing Bag | 50 L \u2013 1000 L | MPX Tubing | GMP"},"content":{"rendered":"<style>\n.sb-pd{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,sans-serif;max-width:100%;color:#202020;line-height:1.75}\n.sb-pd .def{background:#e9fbfa;border-left:4px solid #18b7b2;border-radius:0 10px 10px 0;padding:16px 20px;margin:0 0 28px}\n.sb-pd .def .lb{font-size:11px;font-weight:800;text-transform:uppercase;letter-spacing:.09em;color:#139b97;display:block;margin-bottom:5px}\n.sb-pd .def p{font-size:15px;margin:0;font-weight:500}\n.sb-pd h2{font-size:21px;font-weight:800;margin:32px 0 10px;color:#111;border-bottom:2px solid #e2eceb;padding-bottom:7px}\n.sb-pd h3{font-size:15px;font-weight:700;color:#18b7b2;margin:18px 0 5px}\n.sb-pd p{margin:0 0 12px;font-size:15px}\n.sb-pd ul{margin:0 0 12px;padding-left:20px}\n.sb-pd li{margin-bottom:6px;font-size:14px}\n.sb-pd .cards{display:grid;grid-template-columns:repeat(3,1fr);gap:12px;margin:14px 0 20px}\n.sb-pd .card{background:#f1faf9;border:1px solid #daf3f2;border-top:3px solid #18b7b2;border-radius:0 0 10px 10px;padding:14px}\n.sb-pd .card h3{margin:0 0 5px;font-size:13px;color:#111}\n.sb-pd .card p{margin:0;font-size:12px;color:#5b6b71}\n.sb-pd table{width:100%;border-collapse:collapse;font-size:14px;margin:14px 0 20px}\n.sb-pd th{background:#18b7b2;color:#fff;text-align:left;padding:9px 13px;font-weight:700}\n.sb-pd td{padding:9px 13px;border-bottom:1px solid #e2eceb;vertical-align:top}\n.sb-pd tr:nth-child(even) td{background:#f8fffe}\n.sb-pd td:first-child{font-weight:600;color:#111;width:35%}\n.sb-pd .qa{background:#f8fffe;border:1px solid #daf3f2;border-radius:8px;padding:14px 16px;margin:10px 0}\n.sb-pd .qa .q{font-weight:700;color:#111;margin:0 0 5px;font-size:14px}\n.sb-pd .qa .a{margin:0;font-size:13px;color:#444}\n.sb-pd .cta{background:linear-gradient(135deg,#e4f6f5,#f4fbfb);border:1px solid rgba(24,183,178,.2);border-radius:12px;padding:20px;margin-top:28px;text-align:center}\n.sb-pd .cta h3{margin:0 0 7px;font-size:17px;color:#111}\n.sb-pd .cta p{margin:0 0 14px;font-size:13px;color:#5b6b71}\n.sb-pd .btn{display:inline-block;background:#18b7b2;color:#fff!important;padding:9px 20px;border-radius:7px;font-weight:700;font-size:13px;text-decoration:none!important;margin:0 4px}\n.sb-pd .btn-o{display:inline-block;border:2px solid #18b7b2;color:#18b7b2!important;padding:7px 20px;border-radius:7px;font-weight:700;font-size:13px;text-decoration:none!important;margin:0 4px}\n.sb-pd a{color:#18b7b2;font-weight:600}\n@media(max-width:600px){.sb-pd .cards{grid-template-columns:1fr}}\n<\/style>\n<div class=\"sb-pd\">\n<h2>Product Overview<\/h2>\n<p><strong>SeamlessBio 3D Single-Use Bioprocessing Bags<\/strong> are cube-shaped tote bags engineered for large-scale sterile fluid management in upstream and downstream biopharmaceutical manufacturing. Built on a <strong>multi-layer PE film with integrated EVOH gas barrier<\/strong> (fluid contact: ULDPE), they are designed as 1:1 compatible replacements for Sartorius Flexel\u00ae and Thermo Fisher Hyperforma\u00ae systems \u2014 fitting directly into existing stainless steel and plastic totes without hardware modification. Pre-configured with <strong>MPX (Body\/Stem) connectors<\/strong> as standard; fully customised manifold designs available on request. Available from <strong>50 L to 1,000 L<\/strong>, gamma irradiated to SAL 10\u207b\u2076 (ISO 11137), ADCF, USP Class VI, and ISO 10993 compliant. Manufactured in ISO Class 7 cleanroom conditions and stocked in Germany for EU-wide delivery.<\/p>\n<p><em>Flexel\u00ae is a registered trademark of Sartorius Stedim Biotech. Hyperforma\u00ae is a trademark of Thermo Fisher Scientific. SeamlessBio is an independent provider of compatible single-use solutions and is not affiliated with or endorsed by these companies.<\/em><\/p>\n<h2>Technische Daten<\/h2>\n<table>\n<thead>\n<tr>\n<th>Parameter<\/th>\n<th>Spezifikation<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Volume range<\/td>\n<td>50 L \u00b7 100 L \u00b7 200 L \u00b7 500 L \u00b7 1,000 L<\/td>\n<\/tr>\n<tr>\n<td>Film material<\/td>\n<td>Multi-layer PE with EVOH gas barrier; fluid contact layer: ULDPE<\/td>\n<\/tr>\n<tr>\n<td>Temperature range<\/td>\n<td>\u221280 \u00b0C to +60 \u00b0C<\/td>\n<\/tr>\n<tr>\n<td>Main connectors<\/td>\n<td>MPX (Body\/Stem) \u2014 standard configuration<\/td>\n<\/tr>\n<tr>\n<td>Probenahmeanschl\u00fcsse<\/td>\n<td>Luer Lock or Needleless Site<\/td>\n<\/tr>\n<tr>\n<td>Tubing material<\/td>\n<td>Clear weldable TPE or platinum-cured silicone \u2014 customer-specified lengths<\/td>\n<\/tr>\n<tr>\n<td>Sterility assurance<\/td>\n<td>Gamma irradiated \u2014 SAL 10\u207b\u2076 (ISO 11137); 25\u201350 kGy<\/td>\n<\/tr>\n<tr>\n<td>Material compliance<\/td>\n<td>100% Animal-Derived Component Free (ADCF); USP Class VI; ISO 10993<\/td>\n<\/tr>\n<tr>\n<td>Manufacturing environment<\/td>\n<td>ISO Class 7 cleanroom<\/td>\n<\/tr>\n<tr>\n<td>Hardware compatibility<\/td>\n<td>1:1 fit for Sartorius Flexel\u00ae and Thermo Fisher Hyperforma\u00ae cube totes<\/td>\n<\/tr>\n<tr>\n<td>Haltbarkeit<\/td>\n<td>24\u201336 months (unopened)<\/td>\n<\/tr>\n<tr>\n<td>Dokumentation<\/td>\n<td>CoA, CoO, Leachables\/Extractables\/Tox Validation Guide \u2014 batch-specific<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Anwendungen<\/h2>\n<table>\n<thead>\n<tr>\n<th>Anwendung<\/th>\n<th>Description<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Media &amp; buffer hold<\/strong><\/td>\n<td>Large-volume sterile storage of culture media, buffer solutions, and WFI for bioreactor feeding \u2014 eliminates cleaning validation cycles between batches<\/td>\n<\/tr>\n<tr>\n<td><strong>Bioreactor harvest<\/strong><\/td>\n<td>Secure, sterile collection of cell culture supernatant post-harvest, compatible with MPX connections on harvest manifolds<\/td>\n<\/tr>\n<tr>\n<td><strong>Downstream purification hold<\/strong><\/td>\n<td>Intermediate product storage between chromatography, filtration, and UF\/DF processing steps in GMP purification trains<\/td>\n<\/tr>\n<tr>\n<td><strong>Bulk drug substance storage<\/strong><\/td>\n<td>Safe, documented hold of bulk drug substance prior to fill-finish; film rated to \u221280 \u00b0C for cryogenic storage configurations<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Available Formats<\/h2>\n<table>\n<thead>\n<tr>\n<th>Format<\/th>\n<th>Size<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>3D Cube Bag<\/td>\n<td>50 l<\/td>\n<\/tr>\n<tr>\n<td>3D Cube Bag<\/td>\n<td>100 L<\/td>\n<\/tr>\n<tr>\n<td>3D Cube Bag<\/td>\n<td>200 l<\/td>\n<\/tr>\n<tr>\n<td>3D Cube Bag<\/td>\n<td>500 l<\/td>\n<\/tr>\n<tr>\n<td>3D Cube Bag<\/td>\n<td>1,000 L<\/td>\n<\/tr>\n<tr>\n<td>Benutzerdefiniert<\/td>\n<td>On request \u2014 volume, connector, tubing, manifold layout<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Key Benefits<\/h2>\n<div class=\"cards\">\n<div class=\"card\">\n<h3>Drop-In Compatibility<\/h3>\n<p>1:1 fit for Sartorius Flexel\u00ae and Thermo Fisher Hyperforma\u00ae totes \u2014 switch supplier without hardware modification or process re-validation.<\/p>\n<\/div>\n<div class=\"card\">\n<h3>Vollst\u00e4ndige Dokumentation<\/h3>\n<p>Batch-specific CoA, CoO, and Leachables\/Extractables\/Tox Validation Guide \u2014 from ISO Class 7 GMP manufacturing facilities. Additional regulatory documents on request.<\/p>\n<\/div>\n<div class=\"card\">\n<h3>EU &amp; Swiss Supply<\/h3>\n<p>Stocked in Germany \u2014 fast cold-chain delivery across EU, UK and Switzerland. Custom manifold configurations available with short lead times.<\/p>\n<\/div>\n<\/div>\n<h2>H\u00e4ufig gestellte Fragen<\/h2>\n<div class=\"qa\">\n<p class=\"q\">Are SeamlessBio 3D bags compatible with Sartorius Flexel\u00ae or Thermo Fisher Hyperforma\u00ae stainless steel totes?<\/p>\n<p class=\"a\">Yes \u2014 SeamlessBio 3D bags are designed as 1:1 form-fit-function replacements for cube-shaped tote systems from Sartorius (Flexel\u00ae) and Thermo Fisher (Hyperforma\u00ae). The bag dimensions and MPX connector configuration match the standard hardware interfaces, allowing direct drop-in use without modification to existing tote frames or manifold connections. Switching to SeamlessBio typically requires only change-control documentation rather than full process re-validation, though the extent of bridging testing depends on your internal SOPs and the regulatory submissions that reference the bag. SeamlessBio is an independent supplier and is not affiliated with or endorsed by Sartorius or Thermo Fisher.<\/p>\n<\/div>\n<div class=\"qa\">\n<p class=\"q\">What sterility assurance level do the 3D bags achieve, and what is the irradiation standard?<\/p>\n<p class=\"a\">All SeamlessBio 3D bioprocessing bags are gamma irradiated at 25\u201350 kGy to a Sterility Assurance Level (SAL) of 10\u207b\u2076, in accordance with ISO 11137. This is the accepted terminal sterilization standard for single-use components in GMP pharmaceutical manufacturing. Bags are produced in ISO Class 7 cleanroom conditions prior to irradiation to ensure a low baseline bioburden. Batch-specific irradiation certificates are available on request as part of the documentation package.<\/p>\n<\/div>\n<div class=\"qa\">\n<p class=\"q\">Can the 3D bags be used for cryogenic storage or freezing applications?<\/p>\n<p class=\"a\">The film material (multi-layer PE\/EVOH, fluid contact ULDPE) is rated from \u221280 \u00b0C to +60 \u00b0C, making it compatible with cryogenic storage in principle. However, large-scale freezing in 3D cube bags \u2014 particularly at 200 L and above \u2014 requires careful consideration of freezing rate, tote hardware, and thaw protocol to avoid mechanical stress on the bag and film. For cryogenic applications, contact our technical team with your target volume, freezing rate, and hardware configuration for a specific recommendation.<\/p>\n<\/div>\n<div class=\"qa\">\n<p class=\"q\">Are custom manifold configurations available beyond the standard MPX connector setup?<\/p>\n<p class=\"a\">Yes \u2014 while the standard configuration features MPX (Body\/Stem) main connectors with Luer Lock or Needleless Site sampling ports, fully customised manifold designs are available on request. This includes additional sterile connectors (e.g. AseptiQuik\u00ae, Kleenpak Nova), alternative tubing materials and lengths (weldable TPE or platinum-cured silicone), additional sampling or vent ports, and multi-port assemblies tailored to your upstream or downstream process layout. Contact our team with your process requirements and we will provide a configuration recommendation and lead time.<\/p>\n<\/div>\n<div class=\"qa\">\n<p class=\"q\">What documentation is provided for GMP compliance and regulatory submissions?<\/p>\n<p class=\"a\">Every batch ships with a batch-specific Certificate of Analysis (CoA), Certificate of Origin (CoO), and a Leachables, Extractables &amp; Toxicological (Tox) Validation Guide. The manufacturing facility operates under ISO 9001 quality management. On request: irradiation certificate (ISO 11137), USP Class VI compliance statement, ADCF declaration, ISO 10993 biocompatibility documentation, and customer-specific qualification support packages for IND, CTA, and MAA submissions. There is no fixed minimum order quantity \u2014 contact our team with your volume and timeline.<\/p>\n<\/div>\n<div class=\"cta\">\n<h3>Request a Quote or Custom Configuration<\/h3>\n<p>48h response \u00b7 EU &amp; Swiss Supply \u00b7 Custom manifold configurations \u00b7 Full GMP documentation<\/p>\n<p>  <a href=\"https:\/\/seamlessbio.de\/de\/request-quote\/\" class=\"btn\">Request Quote \u2192<\/a><br \/>\n  <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/single-use-bioprocessing\/\" class=\"btn-o\">Bioprocessing Portfolio \u2192<\/a>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>3D Single-Use Bioprocessing Bag | 50 L \u2013 1000 L | MPX Tubing | GMP. Available in 100L, 500L, 1000L, 200L, 50L. Price on request \u2014 contact our team for availability, batch documentation and delivery. <\/p>\n<div style='margin-top:12px'><a href='https:\/\/seamlessbio.de\/de\/sammelreservierung\/' style='display:block;background:#fff;border:2px solid #18b7b2;color:#18b7b2;padding:10px 24px;border-radius:8px;font-weight:700;font-size:14px;text-decoration:none;text-align:center;'>Test Sample &amp; Batch Reservation \u2192<\/a><\/div>","protected":false},"featured_media":2441,"template":"","meta":{"_eb_attr":""},"product_brand":[],"product_cat":[97],"product_tag":[115,116,117,118,119],"class_list":["post-3561","product","type-product","status-publish","has-post-thumbnail","product_cat-single-use-bioprocessing","product_tag-3d-single-use-bioprocessing-bag","product_tag-bioprocess-bag-50l-1000l","product_tag-gmp-bioprocessing-bag","product_tag-mpx-tubing","product_tag-single-use-bioprocessing","first","instock","taxable","shipping-taxable","product-type-simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>3D Single-Use Bioprocessing Bags 50\u20131000 L | MPX | GMP<\/title>\n<meta name=\"description\" content=\"SeamlessBio 3D cube bioprocessing bags \u2014 PE\/EVOH film, gamma irradiated SAL 10\u207b\u2076, ADCF &amp; USP Class VI. Drop-in replacement for Sartorius Flexel\u00ae and Thermo Fisher Hyperforma\u00ae. MPX connectors standard; custom manifolds available. Stocked in Germany.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/produkt\/3d-single-use-bioprocessing-bag-50-l-1000-l-mpx-tubing-gmp\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"3D Single-Use Bioprocessing Bags 50\u20131000 L | MPX | GMP\" \/>\n<meta property=\"og:description\" content=\"SeamlessBio 3D cube bioprocessing bags \u2014 PE\/EVOH film, gamma irradiated SAL 10\u207b\u2076, ADCF &amp; USP Class VI. Drop-in replacement for Sartorius Flexel\u00ae and Thermo Fisher Hyperforma\u00ae. MPX connectors standard; custom manifolds available. 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