{"id":106624,"date":"2026-06-12T05:53:23","date_gmt":"2026-06-12T05:53:23","guid":{"rendered":"https:\/\/teeptrak.com\/us-pharma-medical-device-oee-case-study-2026-2\/"},"modified":"2026-06-12T08:56:02","modified_gmt":"2026-06-12T08:56:02","slug":"us-pharma-medical-device-oee-case-study-2026-2","status":"publish","type":"post","link":"https:\/\/teeptrak.com\/en\/us-pharma-medical-device-oee-case-study-2026-2\/","title":{"rendered":"Pharma &#038; Medical Device OEE Case Study: 64% \u2192 79% With Faster Changeovers and Digital Quality"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Blog Content&#8221; _builder_version=&#8221;4.x&#8221;]<br \/>\n[et_pb_row _builder_version=&#8221;4.x&#8221;]<br \/>\n[et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.x&#8221;]<br \/>\n[et_pb_text _builder_version=&#8221;4.x&#8221;]<\/p>\n<h1>Pharma &#038; Medical Device OEE Case Study: 64% \u2192 79% With Faster Changeovers and Digital Quality<\/h1>\n<p><strong>A US contract manufacturer of pharmaceutical and medical-device products \u2014 roughly $120M revenue across two FDA-regulated sites \u2014 raised packaging\/filling-line OEE from 64% to 79% (+15 points), cut changeover time 30%, and replaced paper quality checks with digital ones<\/strong> within about five months of deploying TeepTrak. In a validated environment, the win was twofold: more capacity, and audit-ready documentation as a byproduct of how the line runs.<\/p>\n<p><em>Representative case study \u2014 customer anonymized; figures reflect typical TeepTrak outcomes and industry benchmarks.<\/em><\/p>\n<h2>The challenge: validation overhead caps the line<\/h2>\n<p>Regulated manufacturing lives with heavy changeover and cleaning (CIP) overhead, plus a mountain of paper batch records and manual quality checks. This CMO&#8217;s filling and packaging lines ran at <strong>64% OEE<\/strong>, with much of the loss buried in changeover\/CIP time that wasn&#8217;t precisely measured \u2014 and with quality documentation on paper, every audit was a scramble. The pressure was constant: do more volume, keep right-first-time high, and stay inspection-ready.<\/p>\n<h2>The TeepTrak solution: OEE + digital quality<\/h2>\n<p>The team paired <strong>PerfTrak<\/strong> (real-time OEE) with <strong>QualTrak<\/strong> to digitize quality controls \u2014 replacing paper checks with structured digital ones \u2014 and <strong>ProcessTrak<\/strong> to capture process parameters and traceability, all via the TeepTrak Box. For the first time, changeover and CIP were timed precisely per product, and quality checks were completed and recorded in the system rather than on clipboards. This is the foundation for SMED and for documentation that supports, rather than contradicts, the written procedures.<\/p>\n<h2>The results: +15 points, 30% faster changeovers<\/h2>\n<p>Within about five months: OEE rose from <strong>64% to 79% (+15 points)<\/strong>, changeover time fell <strong>30%<\/strong> through SMED on the now-measured steps, and quality-check completion and traceability improved while documentation time dropped. Audit preparation went from a scramble to a routine, because the operational record was being captured continuously. Payback landed around six months.<\/p>\n<blockquote style=\"border-left:4px solid #EB352C;background:#fff5f5;padding:16px 20px;margin:24px 0;font-style:italic;color:#232120;\"><p>&#8220;QualTrak replaced clipboards with digital checks. Our operators spend their time making product, not paperwork &mdash; and audits stopped being a scramble.&#8221;<br \/><strong style=\"color:#EB352C;font-style:normal;\">&mdash; Quality &amp; Operations Lead, contract manufacturer<\/strong><\/p><\/blockquote>\n    <div class=\"teeptrak-asset-container tta-style-highlight\">\n                    <h3 class=\"tta-title\">Download the Full Pharma &amp; Medical Device Case Study<\/h3>\n                            <p class=\"tta-subtitle\">Instant download. No email confirmation needed.<\/p>\n        \n        <form id=\"tta-form-6a2bf9656faa7\" class=\"teeptrak-asset-form\" data-asset-id=\"pharma-medical-oee-case-study-na-2026\">\n            <div style=\"position:absolute;left:-9999px;top:-9999px;width:1px;height:1px;overflow:hidden;\" aria-hidden=\"true\"><input type=\"text\" name=\"website_url\" tabindex=\"-1\" autocomplete=\"off\"><input type=\"text\" name=\"fax_number\" tabindex=\"-1\" autocomplete=\"off\"><\/div>\n            <input type=\"hidden\" name=\"asset_id\" value=\"pharma-medical-oee-case-study-na-2026\">\n            <input type=\"hidden\" name=\"asset_label\" value=\"Pharma &amp; Medical Device OEE Case Study (+15 Points)\">\n            <input type=\"hidden\" name=\"pdf_url_en\" value=\"https:\/\/teeptrak.com\/wp-content\/uploads\/2026\/06\/teeptrak-pharma-medical-oee-case-study-na-2026.pdf\">\n            <input type=\"hidden\" name=\"pdf_url_fr\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_cn\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_de\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_es\" value=\"\">\n            <input type=\"hidden\" name=\"pdf_url_nl\" value=\"\">\n            <input type=\"hidden\" name=\"page_url\" value=\"https:\/\/teeptrak.com\/en\/us-pharma-medical-device-oee-case-study-2026-2\/\">\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>First name <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"first_name\" required autocomplete=\"given-name\">\n                <\/div>\n                <div class=\"tta-field\">\n                    <label>Last name <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"last_name\" required autocomplete=\"family-name\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>Business email <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"email\" name=\"email\" required autocomplete=\"email\">\n                <\/div>\n            <\/div>\n\n            <div class=\"tta-row tta-row-half\">\n                <div class=\"tta-field\">\n                    <label>Company <span class=\"tta-required\">*<\/span><\/label>\n                    <input type=\"text\" name=\"company\" required autocomplete=\"organization\">\n                <\/div>\n                                <div class=\"tta-field\">\n                    <label>Job title<\/label>\n                    <input type=\"text\" name=\"job_title\" autocomplete=\"organization-title\">\n                <\/div>\n                            <\/div>\n\n                        <div class=\"tta-row\">\n                <div class=\"tta-field\">\n                    <label>Phone (optional)<\/label>\n                    <input type=\"tel\" name=\"phone\" autocomplete=\"tel\">\n                <\/div>\n            <\/div>\n            \n            <div class=\"tta-row\">\n                <label class=\"tta-consent\">\n                    <input type=\"checkbox\" name=\"consent_marketing\" value=\"1\">\n                    <span>I agree to receive occasional TeepTrak updates (unsubscribe anytime).<\/span>\n                <\/label>\n            <\/div>\n\n            <div class=\"tta-row\">\n                <button type=\"submit\" class=\"tta-submit\">\n                    <span class=\"tta-submit-text\">Download the Case Study<\/span>\n                    <span class=\"tta-submit-loading\" style=\"display:none;\">Processing\u2026<\/span>\n                <\/button>\n            <\/div>\n\n            <div class=\"tta-legal\">\n                By submitting, you agree to our privacy policy. We use your email only to follow up on this download.            <\/div>\n\n            <div class=\"tta-message\" style=\"display:none;\"><\/div>\n        <\/form>\n    <\/div>\n    \n<h2>Why digital quality and OEE belong together<\/h2>\n<p>In pharma and medical devices, the same data that proves you&#8217;re efficient also proves you&#8217;re compliant. Digitizing quality with <a href=\"https:\/\/teeptrak.com\/en\/oee-software\/\">an integrated platform<\/a> means operators spend time making product, not paperwork, and inspectors get a continuous, time-stamped record. Industry benchmarks put medical-device OEE around 78% and pharma packaging lower (validation overhead), so a line at 64% has clear, capturable upside \u2014 without compromising compliance.<\/p>\n<h2>The replicable pattern<\/h2>\n<p>The method transfers to any regulated packaging or filling operation: measure changeover\/CIP precisely with <a href=\"https:\/\/teeptrak.com\/en\/real-time-production-monitoring\/\">real-time monitoring<\/a>, digitize quality checks, apply SMED to the measured steps, and let the documentation fall out of the system. TeepTrak&#8217;s published ROI model shows 3\u201312 month payback; the changeover lever often delivers inside the first months, as the verified Nutriset case (+18 points in 4 weeks) demonstrates in adjacent F&#038;B packaging.<\/p>\n<h2>What it would take in your plant<\/h2>\n<p>Pick your highest-changeover validated line, instrument it, and run two to four weeks to baseline OEE and the changeover\/CIP breakdown \u2014 then digitize the quality checks operators already perform. The download includes the full case and a changeover + digital-quality checklist; start your own baseline with a <a href=\"\/en\/free-poc\/\">free proof of concept<\/a>.<\/p>\n<h2>Frequently asked questions<\/h2>\n<h3>What OEE is typical for pharma and medical-device lines?<\/h3>\n<p>Industry benchmarks put medical-device OEE around 78%, with pharma packaging often lower due to validation and changeover overhead. This anonymized CMO started at 64% and reached 79% (+15 points) in about five months.<\/p>\n<h3>How does TeepTrak help with FDA audit readiness?<\/h3>\n<p>By digitizing quality checks (QualTrak) and capturing process parameters and traceability (ProcessTrak) in real time, the operational record is created continuously \u2014 so documentation supports the written procedures and audit prep becomes routine rather than a scramble.<\/p>\n<h3>What drove the OEE improvement?<\/h3>\n<p>Precise changeover\/CIP measurement enabled SMED, cutting changeover time 30%, while digital quality checks reduced documentation time and improved right-first-time. Together they lifted OEE from 64% to 79%.<\/p>\n<div style=\"background:#EB352C;color:#fff;padding:24px;border-radius:8px;text-align:center;margin-top:32px;\">\n<p style=\"margin:0 0 12px 0;font-size:18px;font-weight:bold;\">More capacity \u2014 and audit-ready by default.<\/p>\n<p style=\"margin:0 0 16px 0;font-size:14px;\">Measure changeover precisely and digitize quality. Get a baseline of your validated line in weeks.<\/p>\n<p><a href=\"\/en\/free-poc\/\" style=\"background:#fff;color:#EB352C;padding:12px 28px;border-radius:4px;text-decoration:none;font-weight:bold;display:inline-block;\">Start your free POC \u2192<\/a><\/div>\n<p>[\/et_pb_text]<br \/>\n[\/et_pb_column]<br \/>\n[\/et_pb_row]<br \/>\n[\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Blog Content&#8221; _builder_version=&#8221;4.x&#8221;] [et_pb_row _builder_version=&#8221;4.x&#8221;] [et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.x&#8221;] [et_pb_text _builder_version=&#8221;4.x&#8221;] Pharma &#038; Medical Device OEE Case Study: 64% \u2192 79% With Faster Changeovers and Digital Quality A US contract manufacturer of pharmaceutical and medical-device products \u2014 roughly $120M revenue across two FDA-regulated sites \u2014 raised packaging\/filling-line OEE from 64% to 79% (+15 points), [&hellip;]<\/p>\n","protected":false},"author":384731,"featured_media":106520,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","ai_seo_title":"","ai_meta_description":"","ai_focus_keyword":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-106624","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharma &amp; Medical Device OEE Case Study 2026: 64%\u219279% | TeepTrak<\/title>\n<meta name=\"description\" content=\"How a US pharma\/medical-device CMO raised packaging OEE from 64% to 79% (+15 pts), cut changeover 30%, and digitized quality checks with TeepTrak. 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