{"id":134,"date":"2026-04-11T17:05:57","date_gmt":"2026-04-11T17:05:57","guid":{"rendered":"https:\/\/ivpacks.com\/wordpress\/?p=134"},"modified":"2026-04-11T17:35:32","modified_gmt":"2026-04-11T17:35:32","slug":"134","status":"publish","type":"post","link":"https:\/\/ivpacks.com\/wordpress\/index.php\/2026\/04\/11\/134\/","title":{"rendered":""},"content":{"rendered":"\n<p><\/p>\n\n\n\n<!-- USP <71> Sterility Testing Blog Post \u2014 WordPress HTML (paste into WP HTML\/Code Editor) -->\n<!-- Google Fonts: add to your theme or Customizer > Additional CSS, or keep the @import below -->\n \n<style>\n@import url('https:\/\/fonts.googleapis.com\/css2?family=Playfair+Display:wght@400;600&family=DM+Sans:wght@300;400;500&display=swap');\n \n.usp71-blog *,\n.usp71-blog *::before,\n.usp71-blog *::after { box-sizing: border-box; }\n \n.usp71-blog {\n  max-width: 820px;\n  margin: 0 auto;\n  padding: 2rem 1.25rem 3rem;\n  font-family: 'DM Sans', Arial, sans-serif;\n  color: #1a1a1a;\n  line-height: 1.8;\n}\n \n\/* ---- HEADER ---- *\/\n.usp71-tag {\n  display: inline-block;\n  background: #E6F1FB;\n  color: #185FA5;\n  font-size: 11px;\n  font-weight: 500;\n  letter-spacing: 0.07em;\n  text-transform: uppercase;\n  padding: 4px 10px;\n  border-radius: 4px;\n  margin-bottom: 1.2rem;\n}\n \n.usp71-blog h1 {\n  font-family: 'Playfair Display', Georgia, serif;\n  font-size: 2.1rem;\n  font-weight: 600;\n  line-height: 1.22;\n  margin: 0 0 1rem;\n  color: #1a1a1a;\n}\n \n.usp71-subtitle {\n  font-size: 1.05rem;\n  color: #555;\n  line-height: 1.65;\n  margin: 0 0 1.4rem;\n  font-weight: 300;\n}\n \n.usp71-meta {\n  display: flex;\n  flex-wrap: wrap;\n  align-items: center;\n  gap: 12px;\n  font-size: 12px;\n  color: #888;\n  border-top: 1px solid #e8e8e8;\n  border-bottom: 1px solid #e8e8e8;\n  padding: 10px 0;\n  margin-bottom: 2rem;\n}\n \n.usp71-meta-dot {\n  width: 3px;\n  height: 3px;\n  border-radius: 50%;\n  background: #ccc;\n  display: inline-block;\n}\n \n.usp71-accent-bar {\n  width: 40px;\n  height: 3px;\n  background: #185FA5;\n  border-radius: 2px;\n  margin-bottom: 2rem;\n}\n \n\/* ---- TYPOGRAPHY ---- *\/\n.usp71-blog h2 {\n  font-family: 'Playfair Display', Georgia, serif;\n  font-size: 1.5rem;\n  font-weight: 600;\n  margin: 2.5rem 0 0.7rem;\n  color: #1a1a1a;\n}\n \n.usp71-blog h3.usp71-section-label {\n  font-family: 'DM Sans', Arial, sans-serif;\n  font-size: 10px;\n  font-weight: 500;\n  letter-spacing: 0.1em;\n  text-transform: uppercase;\n  color: #185FA5;\n  margin: 1.5rem 0 0.5rem;\n  border: none;\n}\n \n.usp71-blog p {\n  font-size: 1rem;\n  line-height: 1.82;\n  margin: 0 0 1.1rem;\n  font-weight: 300;\n}\n \n.usp71-blog strong { font-weight: 500; 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min-width: 200px; }\n \n.usp71-cta-text h3 {\n  color: #B5D4F4;\n  font-size: 0.8rem;\n  text-transform: uppercase;\n  letter-spacing: 0.08em;\n  font-weight: 500;\n  margin: 0 0 5px;\n  font-family: 'DM Sans', Arial, sans-serif;\n}\n \n.usp71-cta-text p {\n  color: #E6F1FB;\n  font-size: 1rem;\n  font-weight: 400;\n  margin: 0;\n  line-height: 1.5;\n}\n \n.usp71-cta-btn {\n  flex-shrink: 0;\n  background: #378ADD;\n  color: #E6F1FB;\n  border: none;\n  padding: 11px 22px;\n  border-radius: 8px;\n  font-size: 14px;\n  font-weight: 500;\n  cursor: pointer;\n  text-decoration: none;\n  display: inline-block;\n  white-space: nowrap;\n  font-family: 'DM Sans', Arial, sans-serif;\n}\n \n.usp71-cta-btn:hover {\n  background: #185FA5;\n  color: #fff;\n  text-decoration: none;\n}\n \n\/* ---- DIVIDER ---- *\/\n.usp71-divider {\n  border: none;\n  border-top: 1px solid #e8e8e8;\n  margin: 2.5rem 0;\n}\n \n\/* ---- REFERENCES ---- *\/\n.usp71-refs h2 {\n  font-family: 'DM Sans', Arial, sans-serif;\n  font-size: 0.78rem;\n  font-weight: 500;\n  text-transform: uppercase;\n  letter-spacing: 0.08em;\n  color: #999;\n  margin: 0 0 0.85rem;\n}\n \n.usp71-ref {\n  font-size: 0.8rem;\n  line-height: 1.6;\n  color: #888;\n  margin-bottom: 0.5rem;\n  font-family: 'DM Sans', Arial, sans-serif;\n}\n \n.usp71-ref-num {\n  font-weight: 600;\n  color: #185FA5;\n  margin-right: 4px;\n}\n \n.usp71-keywords {\n  font-size: 0.78rem;\n  color: #aaa;\n  margin-top: 1.5rem;\n  font-style: italic;\n  line-height: 1.65;\n}\n \n\/* ---- RESPONSIVE ---- *\/\n@media (max-width: 600px) {\n  .usp71-blog h1 { font-size: 1.6rem; }\n  .usp71-blog h2 { font-size: 1.25rem; }\n  .usp71-product-header { flex-direction: column; }\n  .usp71-cta { flex-direction: column; }\n  .usp71-spec-grid { grid-template-columns: repeat(2, 1fr); }\n}\n<\/style>\n \n<article class=\"usp71-blog\">\n \n  <!-- HEADER -->\n  <span class=\"usp71-tag\">Sterile Compounding &middot; Quality &amp; Compliance<\/span>\n \n  <h1>Sterility Testing That Starts Before the Sample: Choosing the Right SCDM and Capsule Filters for USP &lt;71&gt; Compliance<\/h1>\n \n  <p class=\"usp71-subtitle\">How<a style=\"color: blue;\"\nhref=\"https:\/\/ivpacks.com\/dehydrated-microbiological-media\/545-bd-bbl-trypticase-soy-broth-usp-ep-211768.html\">\nBD BBL\u2122 Trypticase\u2122 Soy Broth (Cat. 211768)<\/a> and <a\nstyle=\"color: blue;\"\nhref=\"https:\/\/ivpacks.com\/24-whatman-polycap-filters\">Whatman Cytiva\nPolycap\u2122 Capsule Filters<\/a> work together to give compounding\npharmacies a defensible, reproducible sterility testing workflow \u2014 from\nmedia preparation through final filtration.<\/p>\n \n  <div class=\"usp71-meta\">\n    <span>April 11, 2026<\/span>\n    <span class=\"usp71-meta-dot\"><\/span>\n    <span>Quality Control &amp; Lab Supplies<\/span>\n    <span class=\"usp71-meta-dot\"><\/span>\n    <span>12 min read<\/span>\n  <\/div>\n \n  <div class=\"usp71-accent-bar\"><\/div>\n \n  <!-- INTRO -->\n  <p>Most discussions of <strong>USP &lt;71&gt; sterility testing<\/strong> focus on what happens in the incubator: 14 days of observation, two media types, a pass\/fail read at the end. But for compounding pharmacies serious about defensible results, sterility assurance actually begins much earlier &mdash; at the moment the culture medium is prepared and sterilized. The quality of media going <em>into<\/em> the test is just as critical as the conditions of the test itself.<\/p>\n \n  <p>This post examines how two product lines &mdash; <strong>BD BBL&#8482; Trypticase&#8482; Soy Broth (Catalog 211768)<\/strong> and the <strong>Whatman Cytiva Polycap&#8482; capsule filter series<\/strong> &mdash; work in tandem across the sterility testing workflow: from reconstituting and sterilizing bulk SCDM media through to filtering compounded sterile preparations (CSPs) in compliance with USP &lt;71&gt; and USP &lt;797&gt;.<\/p>\n \n  <!-- SECTION 1 -->\n  <h2>Why SCDM quality is the foundation of reliable sterility testing<\/h2>\n \n  <p>Soybean Casein Digest Medium (SCDM), also called Tryptic Soy Broth (TSB), is one of two culture media mandated by USP &lt;71&gt; for sterility testing. Incubated at 20&ndash;25&deg;C for 14 days, it detects aerobic bacteria and fungi &mdash; including all three of the reference organisms specified in the USP growth promotion test for SCDM: <em>Aspergillus brasiliensis<\/em>, <em>Bacillus subtilis<\/em>, and <em>Candida albicans<\/em>. Before any batch of SCDM is used in a sterility test, USP &lt;71&gt; requires that it pass a growth promotion test demonstrating visible microbial growth within the specified timeframe.<\/p>\n \n  <p>This means the medium itself must be nutritionally complete, correctly prepared at the right concentration, and sterilized without damaging its growth-promoting components. Substandard media &mdash; whether from inconsistent formulation, improper sterilization, or contamination during preparation &mdash; is a direct path to false-negative results, failed method suitability, and regulatory findings.<\/p>\n \n  <div class=\"usp71-callout\">\n    <p>USP &lt;71&gt; requires that every lot of culture medium pass growth promotion testing before use. Dehydrated media that conforms to harmonized USP\/EP\/JP specifications &mdash; and that carries documented lot-by-lot QC &mdash; is the only appropriate starting point for a compliant sterility program.<\/p>\n  <\/div>\n \n  <!-- PRODUCT 1 -->\n  <h2>Product spotlight: BD BBL&#8482; Trypticase&#8482; Soy Broth<\/h2>\n \n  <div class=\"usp71-product-card\">\n \n    <div class=\"usp71-product-header\">\n      <div class=\"usp71-product-icon\">\n        <svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#185FA5\" stroke-width=\"1.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\">\n          <rect x=\"5\" y=\"2\" width=\"14\" height=\"20\" rx=\"2\"\/>\n          <path d=\"M9 7h6M9 11h6M9 15h4\"\/>\n        <\/svg>\n      <\/div>\n      <div>\n <p class=\"usp71-product-mfr\">BD Diagnostics \u00b7 Dehydrated Culture Media<\/p>\n<p style=\"color: blue;\" class=\"usp71-product-name\"><a\nhref=\"https:\/\/ivpacks.com\/dehydrated-microbiological-media\/545-bd-bbl-trypticase-soy-broth-usp-ep-211768.html\">BD\nBBL\u2122 Trypticase\u2122 Soy Broth (Soybean-Casein Digest Medium)<\/a><\/p>\n<p style=\"color: blue;\" class=\"usp71-product-cat\"><a\nhref=\"https:\/\/ivpacks.com\/dehydrated-microbiological-media\/545-bd-bbl-trypticase-soy-broth-usp-ep-211768.html\">Catalog\nNo. 211768 \u00b7 500 g dehydrated powder<\/a><\/p>\n      <\/div>\n    <\/div>\n \n    <p class=\"usp71-product-desc\">BD BBL&#8482; Trypticase&#8482; Soy Broth is the industry-standard dehydrated SCDM used in pharmaceutical quality control laboratories worldwide. It is explicitly listed in the United States Pharmacopeia as a sterility test medium and for use in microbial enumeration testing &mdash; making it a natural, defensible choice for compounding pharmacies preparing SCDM in-house for USP &lt;71&gt; compliance. Its rich dual-peptone formulation supports growth of aerobic, facultative, and anaerobic bacteria as well as fungi, covering all USP &lt;71&gt; reference test strains. It conforms to harmonized USP, EP, and JP specifications, and has been validated across AOAC, BAM, CLSI, ISO, and USDA standards.<\/p>\n \n    <h3 class=\"usp71-section-label\">Key specifications<\/h3>\n    <div class=\"usp71-spec-grid\">\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Catalog No.<\/span><span class=\"usp71-spec-val\">211768<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Format<\/span><span class=\"usp71-spec-val\">Dehydrated powder<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Pack size<\/span><span class=\"usp71-spec-val\">500 g<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Compendial<\/span><span class=\"usp71-spec-val\">USP \/ EP \/ JP<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Incubation temp.<\/span><span class=\"usp71-spec-val\">20&ndash;25&deg;C<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Incubation duration<\/span><span class=\"usp71-spec-val\">14 days<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">pH (prepared)<\/span><span class=\"usp71-spec-val\">7.3 &plusmn; 0.2<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Preparation<\/span><span class=\"usp71-spec-val\">30 g\/L in purified water<\/span><\/div>\n    <\/div>\n \n    <h3 class=\"usp71-section-label\">Formulation (approximate per liter of prepared medium)<\/h3>\n    <div class=\"usp71-spec-grid\">\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Pancreatic Digest of Casein<\/span><span class=\"usp71-spec-val\">17.0 g<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Papaic Digest of Soybean<\/span><span class=\"usp71-spec-val\">3.0 g<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Sodium Chloride<\/span><span class=\"usp71-spec-val\">5.0 g<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Dipotassium Phosphate<\/span><span class=\"usp71-spec-val\">2.5 g<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Dextrose<\/span><span class=\"usp71-spec-val\">2.5 g<\/span><\/div>\n    <\/div>\n \n    <h3 class=\"usp71-section-label\">Why it matters for USP &lt;71&gt; compliance<\/h3>\n    <div class=\"usp71-why-grid\">\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Harmonized pharmacopeial compliance<\/strong>Meets USP, EP, and JP specifications &mdash; acceptable to inspectors across all major regulatory jurisdictions.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Broad-spectrum growth support<\/strong>Dual-peptone formulation promotes growth of fastidious and non-fastidious organisms, including all USP &lt;71&gt; reference test strains.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Lot-documented QC<\/strong>Each lot is tested for growth promotion by BD prior to release, supporting your in-house growth promotion records.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Flexible preparation<\/strong>Dehydrated format allows preparation of precisely the volume needed, minimizing waste and media hold-time issues.<\/div>\n      <\/div>\n    <\/div>\n \n    <div class=\"usp71-callout\">\n      <p>BD Cat. 211768 is also recommended by the USDA APHIS for detecting viable bacteria in live vaccines, and complies with AOAC, BAM, CLSI, EP, EPA, ISO, JP, SMD, and USP standards &mdash; making it one of the most broadly validated SCDM formulations available for pharmaceutical use.<\/p>\n    <\/div>\n \n    <div class=\"usp71-catalog-row\">\n      <span class=\"label\">Order as:<\/span>\n      <span class=\"usp71-cat-pill\">BD 211768<\/span>\n      <span class=\"label\">&nbsp;&middot;&nbsp; Available from Fisher Scientific, VWR, McKesson, and authorized BD distributors<\/span>\n    <\/div>\n \n  <\/div><!-- \/product card 1 -->\n \n  <!-- SECTION 2 -->\n  <h2>From powder to sterile medium: where capsule filters come in<\/h2>\n \n  <p>Once BD Trypticase&#8482; Soy Broth is reconstituted in purified water, it must be sterilized before use. Most compounding pharmacy laboratories sterilize liquid SCDM by <strong>autoclaving<\/strong> (15 minutes at 121&deg;C) or by <strong>membrane filtration through a 0.22 &micro;m capsule filter<\/strong> &mdash; the latter being preferred when heat-sensitive additives are present or when preparing smaller volumes for immediate use. This is precisely the first and critical application for the Whatman Cytiva Polycap&#8482; capsule filter series: <em>sterilizing the culture medium itself<\/em>, before it ever touches a test sample.<\/p>\n \n  <p>A second role for capsule filters emerges during the USP &lt;71&gt; membrane filtration method: the compounded product being tested is passed through a sterilizing-grade capsule filter under aseptic conditions, trapping any microorganisms, which are then transferred to culture media for 14-day incubation. Choosing filters purpose-built for pharmaceutical filtration &mdash; with pre-sterilized, thermally fused, biosafe housings and documented integrity testing &mdash; is essential for both applications.<\/p>\n \n  <!-- PRODUCT 2 -->\n  <h2>Product spotlight: Whatman Cytiva Polycap&#8482; AS capsule filters<\/h2>\n \n  <div class=\"usp71-product-card\">\n \n    <div class=\"usp71-product-header\">\n      <div class=\"usp71-product-icon\">\n        <svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#185FA5\" stroke-width=\"1.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\">\n          <ellipse cx=\"12\" cy=\"8\" rx=\"5\" ry=\"7\"\/>\n          <path d=\"M7 15c0 3 2.2 5 5 5s5-2 5-5\"\/>\n          <path d=\"M12 3v14\"\/>\n        <\/svg>\n      <\/div>\n      <div>\n        <p class=\"usp71-product-mfr\">Cytiva (Whatman) &middot; Capsule Filtration<\/p>\n        <p class=\"usp71-product-name\">Whatman&#8482; Polycap&#8482; AS Capsule Filter &mdash; Aqueous Solutions Series<\/p>\n        <p class=\"usp71-product-cat\">Nylon membrane &middot; 0.2 &micro;m &middot; GMF Prefilter &middot; Pre-sterilized<\/p>\n      <\/div>\n    <\/div>\n \n    <p class=\"usp71-product-desc\">The Polycap AS (Aqueous Solutions) series combines a glass microfiber (GMF) prefilter with a 0.2 &micro;m nylon final membrane inside a thermally fused polypropylene housing &mdash; with no glues, adhesives, or mold-releasing agents that could leach into the filtrate. Designed for high-volume sterile filtration of aqueous solutions, it is the workhorse choice for sterilizing reconstituted BD Trypticase&#8482; Soy Broth and other pharmaceutical culture media prior to use in USP &lt;71&gt; testing. The nylon membrane is inherently hydrophilic (no pre-wetting required), low in extractables, and biosafe, with an effective filtration area of 400 cm&sup2;.<\/p>\n \n<h3 class=\"usp71-section-label\">Select the right variant for your\nworkflow<\/h3>\n<div class=\"usp71-variant-grid\">\n<div class=\"usp71-variant-card\"> <a\nhref=\"https:\/\/ivpacks.com\/whatman-polycap-filters\/374-whatman-6705-3602-polycap-36as-capsule-filter-02um.html\"><span\nclass=\"usp71-variant-cat\">Cat. 6705-3602<\/span><\/a>\n<p><strong><a\nhref=\"https:\/\/ivpacks.com\/whatman-polycap-filters\/374-whatman-6705-3602-polycap-36as-capsule-filter-02um.html\">Polycap\nAS 36<\/a> \u2014 Standard (no filling bell)<\/strong> 0.2 \u00b5m nylon + GMF\nprefilter. \u00bc\u201d\u2013\u215c\u201d hose barb inlet and outlet. For peristaltic pump or\npressure filtration into closed receiver vessels.<\/p>\n<\/div>\n<div class=\"usp71-variant-card\"> <a style=\"color: blue;\"\nhref=\"https:\/\/ivpacks.com\/whatman-polycap-filters\/377-whatman-6706-3602-polycap-36-capsule-filter-with-filling-bell-02um.html\"><span\nclass=\"usp71-variant-cat\">Cat. 6706-3602<\/span><\/a>\n<p><a style=\"color: blue;\"\nhref=\"https:\/\/ivpacks.com\/whatman-polycap-filters\/377-whatman-6706-3602-polycap-36-capsule-filter-with-filling-bell-02um.html\"><strong>Polycap\nAS 36 \u2014 With Filling Bell<\/strong><\/a> Same 0.2 \u00b5m nylon + GMF\nconfiguration, plus a protective filling bell at the outlet to shield\nthe receiver vessel from airborne contamination during media transfer\ninto open bottles.<\/p>\n<\/div>\n<\/div>\n \n    <h3 class=\"usp71-section-label\">Key specifications<\/h3>\n    <div class=\"usp71-spec-grid\">\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Membrane<\/span><span class=\"usp71-spec-val\">Nylon (hydrophilic)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Pore size<\/span><span class=\"usp71-spec-val\">0.2 &micro;m<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Prefilter<\/span><span class=\"usp71-spec-val\">GMF (glass microfiber)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Filter area<\/span><span class=\"usp71-spec-val\">400 cm&sup2;<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Housing<\/span><span class=\"usp71-spec-val\">Polypropylene (thermally fused)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Connections<\/span><span class=\"usp71-spec-val\">&frac14;&rdquo;&ndash;&#8540;&rdquo; stepped barb<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Sterile<\/span><span class=\"usp71-spec-val\">Yes (pre-sterilized)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Integrity test<\/span><span class=\"usp71-spec-val\">Bubble point \/ pressure decay<\/span><\/div>\n    <\/div>\n \n    <h3 class=\"usp71-section-label\">Why it matters for USP &lt;71&gt; media preparation<\/h3>\n    <div class=\"usp71-why-grid\">\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>No adhesives or glues<\/strong>Thermally fused PP housing eliminates extractables from bonding agents that could inhibit microbial growth in prepared media.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Dual-layer protection<\/strong>GMF prefilter extends nylon membrane life when filtering particulate-laden broth reconstituted from dehydrated powder.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Integrity-testable<\/strong>Supports bubble point, pressure decay, and forward flow testing for complete validation documentation in your quality system.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Filling bell option<\/strong>The 6706-3602 variant protects the receiver vessel during open-bottle media filling, reducing the risk of environmental contamination.<\/div>\n      <\/div>\n    <\/div>\n \n    <div class=\"usp71-catalog-row\">\n      <span class=\"label\">Catalog Nos.:<\/span>\n      <span class=\"usp71-cat-pill\">6705-3602<\/span>\n      <span class=\"usp71-cat-pill\">6706-3602<\/span>\n    <\/div>\n \n  <\/div><!-- \/product card 2 -->\n \n  <!-- PRODUCT 3 -->\n  <h2>For biologics-sensitive applications: Polycap&#8482; TC (PES) series<\/h2>\n \n  <div class=\"usp71-product-card\">\n \n    <div class=\"usp71-product-header\">\n      <div class=\"usp71-product-icon\">\n        <svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#185FA5\" stroke-width=\"1.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\">\n          <circle cx=\"12\" cy=\"12\" r=\"9\"\/>\n          <path d=\"M12 3v9l5 3\"\/>\n        <\/svg>\n      <\/div>\n      <div>\n        <p class=\"usp71-product-mfr\">Cytiva (Whatman) &middot; Capsule Filtration<\/p>\n        <p class=\"usp71-product-name\">Whatman&#8482; Polycap&#8482; TC Capsule Filter &mdash; Tissue Culture \/ Low-Protein-Binding<\/p>\n        <p class=\"usp71-product-cat\">Dual-layer PES membrane &middot; 0.8\/0.2 &micro;m &middot; Filling Bell &middot; Pre-sterilized<\/p>\n      <\/div>\n    <\/div>\n \n    <p class=\"usp71-product-desc\">The Polycap TC series is Cytiva&rsquo;s solution for filtration of biologically sensitive aqueous solutions where protein retention must be minimized. The dual-layer polyethersulfone (PES) membrane &mdash; a 0.8 &micro;m clarifying layer followed by a sterilizing 0.2 &micro;m final membrane &mdash; delivers high throughput and efficient bacteria and fungi removal while maintaining extremely low protein adsorption (HSA: 0.4 &micro;g\/cm&sup2;; Insulin: 2.0 &micro;g\/cm&sup2;; Gammaglobulin: 1.5 &micro;g\/cm&sup2;). This makes the Polycap TC the filter of choice when sterilizing enriched or protein-supplemented SCDM variants, or for direct filtration of biological CSPs during USP &lt;71&gt; membrane filtration sterility testing. Catalog 6715-3682 includes a filling bell to protect the receiving vessel during open-air filling operations.<\/p>\n \n    <h3 class=\"usp71-section-label\">Key specifications &mdash; Cat. 6715-3682<\/h3>\n    <div class=\"usp71-spec-grid\">\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Membrane<\/span><span class=\"usp71-spec-val\">PES (dual-layer)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Pore sizes<\/span><span class=\"usp71-spec-val\">0.8 &micro;m + 0.2 &micro;m<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Filter area<\/span><span class=\"usp71-spec-val\">380 cm&sup2;<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Housing<\/span><span class=\"usp71-spec-val\">Polypropylene (fused)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Max pressure<\/span><span class=\"usp71-spec-val\">60 psi \/ 4.1 bar<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Connections<\/span><span class=\"usp71-spec-val\">&frac14;&rdquo;&ndash;&#8540;&rdquo; stepped barb<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Endotoxin<\/span><span class=\"usp71-spec-val\">LAL tested &le;0.5 EU\/mL<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">QMS<\/span><span class=\"usp71-spec-val\">ISO 9001<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Sterile<\/span><span class=\"usp71-spec-val\">Yes (pre-sterilized)<\/span><\/div>\n      <div class=\"usp71-spec-chip\"><span class=\"usp71-spec-label\">Filling bell<\/span><span class=\"usp71-spec-val\">Included<\/span><\/div>\n    <\/div>\n \n    <h3 class=\"usp71-section-label\">Why it matters for USP &lt;71&gt; compliance<\/h3>\n    <div class=\"usp71-why-grid\">\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>HIMA challenge tested<\/strong>Meets the sterilizing-grade filter bacterial retention challenge test &mdash; directly supporting USP &lt;71&gt; method suitability documentation.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Low protein binding<\/strong>Minimal loss of growth factors during media filtration preserves the nutritional integrity of SCDM for growth promotion testing.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>1% integrity-tested at manufacture<\/strong>Results correlated to microbial retention &mdash; providing a starting documentation trail for your validation files.<\/div>\n      <\/div>\n      <div class=\"usp71-why-item\">\n        <div class=\"usp71-why-icon\">&#10003;<\/div>\n        <div class=\"usp71-why-text\"><strong>Endotoxin controlled<\/strong>LAL-tested at &le;0.5 EU\/mL ensures the filter itself does not introduce endotoxin burden into sterilized media or test samples.<\/div>\n      <\/div>\n    <\/div>\n \n    <div class=\"usp71-catalog-row\">\n      <span class=\"label\">Catalog No.:<\/span>\n      <span class=\"usp71-cat-pill\">6715-3682<\/span>\n      <span class=\"label\">&nbsp;&middot;&nbsp; Polycap TC 36, PES, 0.8\/0.2 &micro;m, sterile, with filling bell<\/span>\n    <\/div>\n \n  <\/div><!-- \/product card 3 -->\n \n  <!-- WORKFLOW SECTION -->\n  <h2>How the products fit the USP &lt;71&gt; workflow end-to-end<\/h2>\n \n  <p>Understanding exactly where each product belongs in the process eliminates guesswork and supports a complete, auditable SOP.<\/p>\n \n  <p><strong>Step 1 &mdash; Media preparation:<\/strong> Reconstitute BD BBL&#8482; Trypticase&#8482; Soy Broth (Cat. 211768) at 30 g\/L in purified water. The dehydrated format allows batch-controlled preparation of precisely the volume required for your testing schedule, minimizing waste and media hold-time concerns.<\/p>\n \n  <p><strong>Step 2 &mdash; Media sterilization by filtration:<\/strong> Pass the reconstituted SCDM through a pre-sterilized <strong>Polycap AS 36 (Cat. 6705-3602 or 6706-3602)<\/strong> at 0.2 &micro;m using a peristaltic pump or pressure source. The GMF prefilter removes particulates from the broth, extending membrane life and preventing premature clogging. Use <strong>Cat. 6706-3602<\/strong> (with filling bell) when dispensing directly into open media bottles to maintain asepsis at the point of transfer. For protein-enriched or biologically sensitive SCDM variants, the <strong>Polycap TC (Cat. 6715-3682)<\/strong> is the superior choice, given its low-protein-binding PES membrane and LAL-tested endotoxin performance.<\/p>\n \n  <p><strong>Step 3 &mdash; Growth promotion verification:<\/strong> Inoculate a portion of sterilized BD Trypticase&#8482; Soy Broth with the USP &lt;71&gt; reference organisms (<em>Aspergillus brasiliensis<\/em>, <em>Bacillus subtilis<\/em>, <em>Candida albicans<\/em>) and confirm visible growth within the specified incubation periods. Document lot numbers, preparation date, sterilization method, and results in your growth promotion records.<\/p>\n \n  <p><strong>Step 4 &mdash; USP &lt;71&gt; sterility testing:<\/strong> For membrane filtration sterility tests, pass the CSP through a validated sterilizing-grade capsule filter (0.45 &micro;m nominal). Rinse the membrane at least three times with validated sterile flush fluid, then add the sterilized BD Trypticase&#8482; Soy Broth and Fluid Thioglycollate Medium for 14-day incubation &mdash; SCDM at 20&ndash;25&deg;C, FTM at 30&ndash;35&deg;C.<\/p>\n \n  <!-- CTA -->\n  <div class=\"usp71-cta\">\n    <div class=\"usp71-cta-text\">\n      <h3>Ready to standardize your USP &lt;71&gt; media program?<\/h3>\n      <p>Source BD BBL&#8482; Trypticase&#8482; Soy Broth (211768) and Whatman Cytiva Polycap&#8482; capsule filters through your authorized distributor &mdash; or contact us for volume pricing and SOP consultation.<\/p>\n    <\/div>\n    <!-- Replace href=\"#\" with your contact page URL -->\n    <a href=\"https:\/\/ivpacks.com\/contact-us\" class=\"usp71-cta-btn\">Request a quote &rarr;<\/a>\n  <\/div>\n \n  <!-- METHOD SUITABILITY -->\n  <h2>A note on method suitability and filter validation<\/h2>\n \n  <p>USP &lt;71&gt; requires that the sterility test method be validated for suitability against each product formulation. For compounding pharmacies using membrane filtration, this validation includes confirming that the capsule filter does not retain or destroy the USP reference organisms at levels that would compromise test sensitivity. The Polycap TC series, with its documented HIMA challenge test performance and 1% per-unit integrity testing, provides a strong starting point for this validation documentation. Any change in filter type, membrane material, or pore size requires re-validation of method suitability before continued use in sterility testing.<\/p>\n \n  <p>Similarly, any change in the SCDM supplier or lot that results in altered growth promotion performance must be investigated and documented before that medium is used in a sterility test. The consistent, harmonized formulation of BD Cat. 211768 &mdash; supported by BD&rsquo;s own lot release QC &mdash; reduces the likelihood of inter-lot variability and simplifies your growth promotion records.<\/p>\n \n  <hr class=\"usp71-divider\">\n \n  <!-- REFERENCES -->\n  <div class=\"usp71-refs\">\n    <h2>Scientific references<\/h2>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[1]<\/span> United States Pharmacopeial Convention. <em>USP General Chapter &lt;71&gt; Sterility Tests.<\/em> USP&ndash;NF, current edition. Rockville, MD: USP.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[2]<\/span> United States Pharmacopeial Convention. <em>USP General Chapter &lt;797&gt; Pharmaceutical Compounding &mdash; Sterile Preparations.<\/em> Official November 1, 2023. Rockville, MD: USP.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[3]<\/span> BD Diagnostics. <em>Product Insert: BBL&#8482; Trypticase&#8482; Soy Broth (Soybean&ndash;Casein Digest Medium), Catalog No. 211768.<\/em> Becton, Dickinson and Company; Franklin Lakes, NJ.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[4]<\/span> Cytiva (Whatman). <em>Polycap AS Capsule Filter Product Documentation.<\/em> Catalog Nos. 6705-3602, 6706-3602. Cytiva Life Sciences.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[5]<\/span> Cytiva (Whatman). <em>Polycap TC Capsule Filter Product Documentation.<\/em> Catalog No. 6715-3682. Cytiva Life Sciences.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[6]<\/span> Corbet S, et al. Sterility testing of cellular therapy products: what is the role of the clinical microbiology laboratory? <em>Journal of Clinical Microbiology.<\/em> 2020;58(7):e00045-20. doi:10.1128\/JCM.00045-20.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[7]<\/span> Sutton S. Laboratory considerations of USP Chapter &lt;71&gt; sterility tests. <em>International Journal of Pharmaceutical Compounding.<\/em> 2018;22(2).<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[8]<\/span> Food and Drug Administration. <em>Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing &mdash; Current Good Manufacturing Practice.<\/em> FDA; September 2004.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[9]<\/span> United States Pharmacopeial Convention. <em>USP General Chapter &lt;1211&gt; Sterility Assurance.<\/em> USP&ndash;NF, current edition. Rockville, MD: USP.<\/p>\n    <p class=\"usp71-ref\"><span class=\"usp71-ref-num\">[10]<\/span> European Directorate for the Quality of Medicines (EDQM). <em>European Pharmacopoeia, Chapter 2.6.1: Sterility.<\/em> 11th ed. Strasbourg: Council of Europe; 2023.<\/p>\n \n    <p class=\"usp71-keywords\">Keywords: USP 71 sterility testing compounding pharmacy, BD Trypticase Soy Broth 211768, SCDM USP compounding, Whatman Polycap capsule filter 6705-3602 6706-3602 6715-3682, Cytiva Polycap AS PES nylon sterile, membrane filtration media sterilization, USP 797 sterility media, soybean casein digest medium compounding, capsule filter media sterilization pharmacy, sterile culture media preparation<\/p>\n  <\/div>\n \n<\/article>\n","protected":false},"excerpt":{"rendered":"<p>Sterile Compounding &middot; Quality &amp; Compliance Sterility Testing That Starts Before the Sample: Choosing the Right SCDM and Capsule Filters for USP &lt;71&gt; Compliance How BD BBL\u2122 Trypticase\u2122 Soy Broth (Cat. 211768) and Whatman Cytiva Polycap\u2122 Capsule Filters work together to give compounding pharmacies a defensible, reproducible sterility testing workflow \u2014 from media preparation through &hellip; <a href=\"https:\/\/ivpacks.com\/wordpress\/index.php\/2026\/04\/11\/134\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\"><\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-134","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/134","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/comments?post=134"}],"version-history":[{"count":8,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/134\/revisions"}],"predecessor-version":[{"id":143,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/134\/revisions\/143"}],"wp:attachment":[{"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/media?parent=134"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/categories?post=134"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ivpacks.com\/wordpress\/index.php\/wp-json\/wp\/v2\/tags?post=134"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}