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<section id="main"><div id="title-container"><div class="center clear" style="display:none;"><ul class="vb breadcrumb"><li><a href="/">Home</a>/</li><li><a href="/global-supply-chain">Global Supply Chain</a>/</li><li><a href="/global-supply-chain/onboarding-process">Onboarding Process</a>/</li></ul><h1 class="vb">Special Process Evaluation</h1></div><hr style="display:none;" ><div style="height:35px;background-color:white;"></div></div><div id="alerts-container" class="vb center"><noscript><div class="alert"><h4>JavaScript is currently not supported or is disabled by this browser. Please enable JavaScript for full functionality.</h4></div></noscript></div><div class="clearfix" style="-webkit-font-smoothing: antialiased;"><a href="#sideNav"></a><div class="center"><section id="outlier" class="two-column clearfix vb"><section id="sideNav"><h5>Global Supply Chain</h5><nav><ul><li><a class="" href="/global-supply-chain">Global Supply Chain</a><ul><li><a class="" href="/global-supply-chain/german-supply-chain-act">German Supply Chain Act</a></li><li><a class="" href="/global-supply-chain/types-of-suppliers">Types of Suppliers</a></li><li><a class="" href="/global-supply-chain/onboarding-process">Onboarding Process</a><ul><li><a class="" href="/global-supply-chain/onboarding-process/documentation-requirements-quality">Documentation Requirements - Quality</a></li><li><a class="" href="/global-supply-chain/onboarding-process/documentation-requirements-accounting">Documentation Requirements - Accounting</a></li><li><a class="" href="/global-supply-chain/onboarding-process/audit-types-and-frequency">Audit Types and Frequency</a></li><li><a class="selected" href="/global-supply-chain/onboarding-process/special-process-evaluation">Special Process Evaluation</a></li><li><a class="" href="/global-supply-chain/onboarding-process/certificate-of-compliance">Certificate of Compliance</a></li><li><a class="" href="/global-supply-chain/onboarding-process/production-part-approval-process">Production Part Approval Process (PPAP)</a></li></ul></li><li><a class="" href="/global-supply-chain/request-for-quotes">Request For Quotes (RFQ)</a></li><li><a class="" href="/global-supply-chain/arthrex-sba-supplier-base-program">Arthrex SBA Supplier Base Program</a></li><li><a class="" href="/global-supply-chain/arthrex-global-trade-compliance">Arthrex Global Trade Compliance</a></li><li><a class="" href="/global-supply-chain/supplier-performance-management">Supplier Performance Management</a></li><li><a class="" href="/global-supply-chain/sustaining-business-relationships">Sustaining Business Relationships</a></li><li><a class="" href="/global-supply-chain/supplier-sustainability">Sustainability</a></li><li><a class="" href="/global-supply-chain/arthrex-supplier-applications">Arthrex Applications</a></li><li><a class="" href="/global-supply-chain/supplier-contact-page">Become a Prospective Supplier</a></li><li></li></ul></li></ul></nav></section><section><article><div class="contributor-content">Arthrex requires suppliers to validate the special processes, both in-house and outsourced, that they plan to perform for Arthrex. In accordance with ISO 13485:2016 and 21 CFR Part 820, this includes any process in which the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use.These processes may include but are not limited to:<ul><li>Anodizing</li><li>Brazing and welding</li><li>Cleaning (in process or final)</li><li>Electropolishing</li><li>Gluing</li><li>Heat treating</li><li>Labeling</li><li>Painting</li><li>Final packaging</li><li>Nonsterile or sterile barrier packaging</li><li>Passivation</li><li>Sterilization</li><li>Coating</li></ul>Validations shall follow the Installation Qualification (OQ), Operational Qualification Q), and Performance Qualification (PQ) formats and shall be conducted using statistically valid techniques that take into consideration the product risk associated with that process&rsquo;s output. All other equipment that is not considered a special process still requires IQ and OQ.Arthrex considers final cleaning to be any finishing manufacturing process that is intended to provide medical devices that are physically and biologically clean. Final cleaning processes shall be the final manufacturing process performed, with the exclusion of subsequent assembly, packaging, and sterilization processes. Examples include passivation, anodizing, electropolishing, etc.Products that are final cleaned must meet the device cleanliness requirements shown on the following page.&nbsp;<table style="height: 1391px; width: 945px;" border="1" cellspacing="1" cellpadding="1"><tbody><tr style="height: 26px;"><td style="width: 636.008px; height: 26px;" colspan="5">Microbiological and Chemical Testing Specifications</td><td style="width: 302.031px; height: 26px;" colspan="2">Notes</td></tr><tr style="height: 67px;"><td style="width: 150.511px; height: 67px;">Category</td><td style="width: 91.3068px; height: 67px;">Test</td><td style="width: 136.449px; height: 67px;">Test Method/ Standard</td><td style="width: 136.449px; height: 67px;">Acceptance Criteria</td><td style="width: 109.361px; height: 67px;">Minimum Sample Requirement</td><td style="width: 135.455px; height: 67px;">Instrument</td><td style="width: 163.594px; height: 67px;">Implant</td></tr><tr style="height: 71px;"><td style="width: 150.511px; height: 760px;" rowspan="5">&nbsp;&nbsp;&nbsp;Physical/Chemical</td><td style="width: 91.3068px; height: 142px;" rowspan="2">Particulate</td><td style="width: 136.449px; height: 142px;" rowspan="2">USP &lt;788&gt;Device extraction (automatic, HIAC ROYCO), STER 800-02-1989 R1</td><td style="width: 136.449px; height: 71px;">10 &mu;m &lt;24,000per device</td><td style="width: 109.361px; height: 142px;" rowspan="2">5 devices</td><td style="width: 135.455px; height: 142px;" rowspan="2">&nbsp;</td><td style="width: 163.594px; height: 142px;" rowspan="2">&nbsp;</td></tr><tr style="height: 71px;"><td style="width: 136.449px; height: 71px;">25 &mu;m &lt;4000per device</td></tr><tr style="height: 188px;"><td style="width: 91.3068px; height: 188px;">Heavy Metals</td><td style="width: 136.449px; height: 188px;">Total content &ndash; migration in water (72 hours at 50&deg; C per ISO 10993-12), followed by microwave digestion and ICP/MS analysis</td><td style="width: 136.449px; height: 188px;">Heavy metal profile below established margins of safety</td><td style="width: 109.361px; height: 188px;">2.6 g</td><td style="width: 135.455px; height: 188px;">&nbsp;</td><td style="width: 163.594px; height: 188px;">&nbsp;</td></tr><tr style="height: 251px;"><td style="width: 91.3068px; height: 251px;">Volatile / Semivolatile Compounds</td><td style="width: 136.449px; height: 251px;">Migration inn-Hexane/IPA/water/ (72 hours at 50&deg; C&nbsp; per ISO 10993-12),followed by GC/MS analysis including headspace for water</td><td style="width: 136.449px; height: 251px;">Extractable/ leachable profile below established margins of safety</td><td style="width: 109.361px; height: 251px;">2.6 g per extract</td><td style="width: 135.455px; height: 251px;">X(3 extracts) VOC &ndash; Water SVOC &ndash; Water SVOC &ndash; Hexane</td><td style="width: 163.594px; height: 251px;">X(4 extracts) VOC &ndash; WaterSVOC &ndash; Water SVOC &ndash; Hexane SVOC &ndash; IPA</td></tr><tr style="height: 179px;"><td style="width: 91.3068px; height: 179px;">Nonvolatile Compounds</td><td style="width: 136.449px; height: 179px;">Migration inn-Hexane/IPA/water/ (72 hours at 50&deg; C&nbsp; per ISO 10993-12),followed by LC/MS analysis</td><td style="width: 136.449px; height: 179px;">Extractable/ leachable profile below established margins of safety</td><td style="width: 109.361px; height: 179px;">2.6 g per extract</td><td style="width: 302.031px; height: 179px;" colspan="2">New polymers/plastics that have not been previously tested could require additional nonvolatile testing</td></tr><tr style="height: 98px;"><td style="width: 150.511px; height: 538px;" rowspan="3">&nbsp;&nbsp;&nbsp;Biological</td><td style="width: 91.3068px; height: 98px;">Cytotoxicity</td><td style="width: 136.449px; height: 98px;">ISO 10993-5MEM elution method</td><td style="width: 136.449px; height: 98px;">No cytotoxic grade can be greater than 2 on a scale of 0 to 4</td><td style="width: 109.361px; height: 98px;">Surface area of 60 cm2</td><td style="width: 302.031px; height: 98px;" colspan="2">Chemical characterization can supersede cytotoxicity testing for postdesign products</td></tr><tr style="height: 144px;"><td style="width: 91.3068px; height: 144px;">Bacterial Endotoxin (BET)</td><td style="width: 136.449px; height: 144px;">USP &lt;85&gt;Bacterial endotoxin test: kinetic chromogenic method</td><td style="width: 136.449px; height: 144px;">&lt;20.0 EU/device spike recovery between 50% and 200%</td><td style="width: 109.361px; height: 144px;">3 devices</td><td style="width: 135.455px; height: 144px;">&nbsp;</td><td style="width: 163.594px; height: 144px;">&nbsp;</td></tr><tr style="height: 296px;"><td style="width: 91.3068px; height: 296px;">Bioburden With Recovery</td><td style="width: 136.449px; height: 296px;">ISO 11737Aerobic/fungal with inoculated recovery</td><td style="width: 136.449px; height: 296px;">&lt;1000 CFU/devicerecovery 50% (approximate target)</td><td style="width: 109.361px; height: 296px;">5 devices &ndash; bioburden 3 devices &ndash; recovery</td><td style="width: 302.031px; height: 296px;" colspan="2">Due to the variability of design, materials, manufacturing processes, etc, it is not always required to obtain 50% recovery efficiency (RE). Considering the data used for device cleanliness assessments (eg, bioburden screening), a lower RE would cause higher bioburden worse- case condition. Therefore, a lower RE would be a conservative estimate for this bioburden data. If bioburden RE fall below the 50% target, attempts may be made to improve the recovery efficiency. However, attempts for RE are not always required based on the use of the data.</td></tr></tbody></table>&nbsp;</div></article></section></section></div></div></section>