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190name=header.jpg 6000w" sizes="(max-width: 2000px) 100vw, 2000px"></span></div><!--end layout-widget-wrapper --> 191</div><!--end widget-span --> 192</div><!--end row--> 193</div><!--end row-wrapper --> 194 195<div class="row-fluid-wrapper row-depth-1 row-number-3 "> 196<div class="row-fluid "> 197<div class="span12 widget-span widget-type-cell wrapper top-space" style="" data-widget-type="cell" data-x="0" data-w="12"> 198 199<div class="row-fluid-wrapper row-depth-1 row-number-4 "> 200<div class="row-fluid "> 201<div class="span12 widget-span widget-type-header " style="" data-widget-type="header" data-x="0" data-w="12"> 202<div class="cell-wrapper layout-widget-wrapper"> 203<span id="hs_cos_wrapper_module_147135033799116130" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_header" style="" data-hs-cos-general-type="widget" data-hs-cos-type="header"><h1>Medical/BioPharma</h1></span></div><!--end layout-widget-wrapper --> 204</div><!--end widget-span --> 205</div><!--end row--> 206</div><!--end row-wrapper --> 207 208</div><!--end widget-span --> 209</div><!--end row--> 210</div><!--end row-wrapper --> 211 212</div><!--end widget-span --> 213</div><!--end row--> 214</div><!--end row-wrapper --> 215 216<div class="row-fluid-wrapper row-depth-1 row-number-5 "> 217<div class="row-fluid "> 218<div class="span12 widget-span widget-type-custom_widget " style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 219<div id="hs_cos_wrapper_module_1603949629985254" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="half-col-section "> 220 <div class="wrapper"> 221 <div class="half-col-inner-container image-right"> 222 <div class="half-text-col"> 223 <h2>Stringent Purification Process </h2> 224 225 <div class="half-col-content"> 226 <p>Phasex works with established medical and biopharma companies that require the most stringent purity levels in their devices for exacting processes. Supercritical fluids extract toxic residues and residual monomers for the purification of medical products.</p> 227 </div> 228 229 </div> 230 231 <div class="half-img-col"> 232 233 234 235 236 237 <img src="https://www.phasex4scf.com/hubfs/October%202020%20/images/medical-bipharma.jpg" alt="medical-bipharma" style="max-width: 100%; height: auto;"> 238 </div> 239 240 </div> 241 242 </div> 243</div></div> 244 245</div><!--end widget-span --> 246</div><!--end row--> 247</div><!--end row-wrapper --> 248 249<div class="row-fluid-wrapper row-depth-1 row-number-6 "> 250<div class="row-fluid "> 251<div class="span12 widget-span widget-type-custom_widget " style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 252<div id="hs_cos_wrapper_module_1604913477329319" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="half-col-section two-col-text-section section-text" style="background:rgba(242, 242, 242, 1.0 )"> 253 <div class="wrapper"> 254 255 <div class="section-heading "> 256 <h2>Services</h2> 257<h3>Phasex offers a complete package of supercritical fluids technology services for all markets, including the following (click on the links for more information about each service):</h3> 258 </div> 259 260 <div class="half-col-inner-container"> 261 262 <div class="half-text-col"> 263 <div class="half-col-content"> 264 <p><a href="/supercritical-fluids/supercritical-fluids-feasibility?hsLang=en" rel="noopener"><strong>Feasibility Studies </strong></a>âThese are short, fast-response feasibility studies to demonstrate that processing with supercritical fluids can achieve your desired goals, both technically and economically.</p> 265<p><a href="/supercritical-fluids-randd?hsLang=en" rel="noopener"><strong>Contract R&D</strong></a>âR&D projects are designed to achieve your goalsâfrom creating a new product, improving an existing one, recovering a by-product, or other purposes.</p> 266 </div> 267 </div> 268 269 <div class="half-text-col"> 270 <div class="half-col-content"> 271 <p><a href="/supercritical-fluids/supercritical-fluid-toll-processing?hsLang=en" rel="noopener"><strong>Toll Processing</strong></a>âOur ability to process 1,000 to 100,000 kg quantities enables you to evaluate supercritical fluids for their specific needs without investing early stage and high-risk capital</p> 272<p><a href="/supercritical-fluids/supercritical-fluid-technology-lice
272nsing?hsLang=en" rel="noopener"><strong>Technology Licensing</strong></a>âPhasex can develop technology for supercritical separations to be carried out as a part of a companyâs own manufacturing train.</p> 273 </div> 274 </div> 275 276 </div> 277 278 <divv class="sec_bottom_text"> 279 <h3 style="text-align: center;">What can we do for you? <a href="/supercritical-fluids/supercritical-fluids-contact-us?hsLang=en" rel="noopener">Contact us</a> today to begin the conversation.</h3> 280 </divv> 281 282 </div> 283</div></div> 284 285</div><!--end widget-span --> 286</div><!--end row--> 287</div><!--end row-wrapper --> 288 289<div class="row-fluid-wrapper row-depth-1 row-number-7 "> 290<div class="row-fluid "> 291<div class="span12 widget-span widget-type-custom_widget market-cta-section new-midd-sec" style="padding-bottom:0px;" data-widget-type="custom_widget" data-x="0" data-w="12"> 292<div id="hs_cos_wrapper_module_1621316660997106" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="img-cta-section"> 293 <div class="wrapper"> 294 <div class="img-cta-inner-section"> 295 296 <div class="img-box"> 297 298 299 300 301 302 <img src="https://www.phasex4scf.com/hubfs/Resources/cleaning_extraction_medical.png" alt="cleaning_extraction_medical" style="max-width: 100%; height: auto;"> 303 </div> 304 305 <div class="cta-box"> 306 307 308 309 310 311 312 313 314 315 <a href="https://www.phasex4scf.com/hubfs/Resources/phasex-supercritical-med-biopharma-3.29b_FINAL.pdf?hsLang=en" target="_blank" rel="nofollow noopener">Supercritical Fluids Ensure Purity Levels: Learn More About the Phasex Advantage</a> 316 </div> 317 </div> 318 </div> 319</div></div> 320 321</div><!--end widget-span --> 322</div><!--end row--> 323</div><!--end row-wrapper --> 324 325<div class="row-fluid-wrapper row-depth-1 row-number-8 "> 326<div class="row-fluid "> 327<div class="span12 widget-span widget-type-custom_widget " style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 328<div id="hs_cos_wrapper_module_1605004605854347" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="simple-text-module-section pb-0" style="background:rgba(255, 255, 255, 0.0 )"> 329 <div class="wrapper"> 330 <div class="simple-text-wrap"> 331 332 <div class="simple-text-section section-text"> 333 <h2>Purification of Medical Products</h2> 334<p>Increasingly stringent regulations have created the need for purer products in the medical industry. There has been increased concern about potentially migratable species that are present in many polymeric medical devices, such as brain shunts and aorta grafts that are surgically implanted in the body. Polymeric devices, especially those produced from silicone and polyester, typically contain several percent by-products and residual raw materials, which can be detrimental to the performance of the device and pose a serious health risk.</p> 335<p>Devices manufactured from silicones can contain reaction byproducts in the end product because even highly purified silicone raw materials are known to react further during the device manufacture. This reaction produces additional byproducts directly in the finished part. Thus, a means of removing these byproducts while maintaining the integrity of the finished component is crucial. This is where Phasex excels.</p> 336 337 </div> 338 339 <div class="simple-text-section section-text"> 340 <h2>Extraction that Preserves Product Integrity</h2> 341<p>Phasex has extracted medical polymers and final medical devices of their toxic residues without compromising overall product integrity. Supercritical carbon dioxide is extremely attractive for medical component extraction because of its technical attributes. CO<sub>2</sub> swells polymers sufficiently to allow impurities to be extracted from the internal structure. The absorbed CO<sub>2</sub> diffuses away when the pressure is reduced, and the component retains its original shapeand integrity</p> 342<p>Organic solvents, such as hexane and methylene chloride, could be used to extract objectionable materials from polymeric-based medical components, but vestiges of these solvents are themselves difficult to remove without degrading or altering the characteristics of the device.</p> 343<p>In some cases, the polymer can be purified before it is manufactured into a device. Raw polymer substrate used in the manufacturing of medical devices may contain a low MW constituent that can be deleterious to the body. Supercritical CO<sub>2</sub> can purify the raw polymer prior to fabrication of the final medical device. In addition to the ability of supercritical CO<sub>2</sub> to dissolve and extract impurities, the properties of supercritical CO<sub>2</sub> are uniquely applicable for cleaning microporous surfaces of biomedical components because there are no surface tension limitations as do exist with liquid solvents</p> 344<p><strong>Some examples of case studies of work carried out by Phasex for the purification of medical and biopharma application are described below.</strong></p> 345 346 </div> 347 348 </div> 349 </div> 350</div></div> 351 352</div><!--end widget-span --> 353</div><!--end row--> 354</div><!--end row-wrapper --> 355 356<div class="row-fluid-wrapper row-depth-1 row-number-9 "> 357<div class="row-fluid "> 358<div class="span12 widget-span widget-type-custom_widget market-cta-section" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 359<div id="hs_cos_wrapper_module_1603949939137260" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="img-cta-section"> 360 <div class="wrapper"> 361 <div class="img-cta-inner-section"> 362 363 <div class="img-box"> 364 365 366 367 368 369 <img src="https://www.phasex4scf.com/hubfs/cta-sc-fluid-cleaning-med-comps.jpg" alt="cta-sc-fluid-cleaning-med-comps" style="max-width: 100%; height: auto;"> 370 </div> 371 372 <div class="cta-box"> 373 374 375 376 377 378 379 380 <a href="https://www.phasex4scf.com/lp-scf-clean-extract-med-comps?hsLang=en" rel="nofollow">WHITE PAPER: Supercritical Fluids for Cleaning & Extraction of Medical Components</a> 381 </div> 382 </div> 383 </div> 384</div></div> 385 386</div><!--end widget-span --> 387</div><!--end row--> 388</div><!--end row-wrapper --> 389 390<div class="row-fluid-wrapper row-depth-1 row-number-10 "> 391<div class="row-fluid "> 392<div class="span12 widget-span widget-type-custom_widget " style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 393<div id="hs_cos_wrapper_module_1605004927353465" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="simple-text-module-section " style="background:rgba(242, 242, 242, 1.0 )"> 394 <div class="wrapper"> 395 <div class="simple-text-wrap"> 396 397 <div class="simple-text-section section-text"> 398 <h4>Purification of Medical Products Case Studies</h4> 399<h2>Case Study: Poloxamer 188 Studies for the National Heart, Lung, and Blood Institute<
399/h2> 400<p>The National Heart, Lung, and Blood Institute (NHLBI) sponsored work with Phasex to apply supercritical fluid extraction to the purification of Poloxamer 188 (Pluronic® F68, the trade name NHLBI called it). In brief, the EO-PO-EO block copolymer produced by BASF was found by NHLBI researchers and other companies they had funded to be an excellent surfactant in the formulation of substitute blood. Unfortunately, some of the special batches of Pluronic® F68 produced for NHLBI were found to be contaminated by allyl end-group impurities, and NHLBI sought solutions to the problem. Work carried out with Phasex supercritical CO<sub>2</sub> extraction over a wide range of conditions was shown to be an effective process to purify the surfactant.</p> 401<h4>Scalable Process</h4> 402<p>Following the NHLBI study, one pharma company sought a source of purified, allyl-free Pluronic® F68 product that was to be purified from commercial Poloxamer 188. Phasex was able to develop, at lab-scale, a scalable process to extract commercial Poloxamer 188 into a purified allyl-free product. After only about four months of development, the optimized process was verified over a range of several parameters and scaled up in the Phasex plant in continuous countercurrent column three-shift operation, producing 78 pounds a day of purified polymer.</p> 403<p>Alternative technologies and processes were available for consideration, yet one variation used a high temperature and another process used copious amounts of organic solvent. Operation of the process at high temperature led to concerns of polymer degradation. Also, operation with the solvent extraction process had questionable economics due to the cost of the solvent and subsequent waste disposal of the hazardous stream.</p> 404<p>For their direct relevance to this discussion, Phasex presents GPC data for one of the EO-PO-glycerol feed materials that we purified. (We also demonstrated the versatility of the SC CO<sub>2</sub> fractionation process, showing it was applicable to other medical/pharma polymeric feedstocks.)</p> 405<p>Figure 1 is a GPC of the raw material; the allyls are present at ~ 6% concentration. Figure 2 shows the allyls that have been extracted, and Figure 3, the purified product. With this particular feed and ~ 6% of the incoming material comprising allyls, the yield of purified product was ~ 92%. (94% is theoretical.)</p> 406 407 <div class="img-block-flex-wrap"> 408 409 <div class="img-block-col"> 410 411 412 413 414 415 416 <img src="https://www.phasex4scf.com/hubfs/October%202020%20/images/fig1-FPO.png" alt="fig1-FPO" style="max-width: 100%; height: auto;"> 417 418 </div> 419 420 <div class="img-block-col"> 421 422 423 424 425 426 427 <img src="https://www.phasex4scf.com/hubfs/October%202020%20/images/fig2-FPO.png" alt="fig2-FPO" style="max-width: 100%; height: auto;"> 428 429 </div> 430 431 <div class="img-block-col"> 432 433 434 435 436 437 438 <img src="https://www.phasex4scf.com/hubfs/October%202020%20/images/fig3-FPO.png" alt="fig3-FPO" style="max-width: 100%; height: auto;"> 439 440 </div> 441 442 </div> 443 444 </div> 445 446 <div class="simple-text-section section-text"> 447 <h2>Case Study: SC CO<sub>2</sub> Tissue Scaffold Purification</h2> 448<p><img src="https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=450&name=tissue_scaffold_puri.jpg" alt="tissue_scaffold_puri" width="450" style="width: 450px; float: right; margin: 5px 20px 20px;" srcset="https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=225&name=tissue_scaffold_puri.jpg 225w, https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=450&name=tissue_scaffold_puri.jpg 450w, https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=675&name=tissue_scaffold_puri.jpg 675w, https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=900&name=tissue_scaffold_puri.jpg 900w, https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=1125&name=tissue_scaffold_puri.jpg 1125w, https://www.phasex4scf.com/hs-fs/hubfs/October%202020%20/images/tissue_scaffold_puri.jpg?width=1350&name=tissue_scaffold_puri.jpg 1350w" sizes="(max-width: 450px) 100v
448w, 450px">One company approached Phasex to investigate the ability of SC CO<sub>2</sub> to purify protein-based tissue scaffolds to be surgically implanted into the body. Surgical meshes and scaffolds are commonly used for a range of abdominal wall defect repair procedures, including reconstruction surgeries, bladder slings, and hernia repair. Although major complications with permanent, synthetic meshes are rare, there is growing concern about infection, difficulties associated with revision surgery utilizing current mesh products, and scar-plate formation. The company that engaged Phasex was using a silk-based surgical scaffold as a robust, long-term, bioresorbable biomaterial to address the limitations of todayâs synthetic mesh products.</p> 449<p>The scaffold was required to be purified of contaminants and leachable oils that may have originated from its manufacturing process prior to end use. The concern was that solvent-based extraction (to purity the scaffold of residual oils and leachables) would, in turn, lead to residual levels of solvent with the implanted end product, and also, possibly denature the protein-based structure of the scaffold.</p> 450<p>Phasex developed a CO<sup>2</sup> purification process within two monthsâ time and was able to move to piloting and manufacturing with that same year. Through working with Phasex, the customer was able to generate purified tissue scaffolds for clinical trials without extensive outlay of funds to build a dedicated purification facility.</p> 451<p>It should be noted that Phasex worked with the customer and an engineering firm to help the customer bring the purification process in-house at some later time, once the product gained foothold and wider use in the medical industry.</p> 452 453 </div> 454 455 <div class="simple-text-section section-text"> 456 <h2>Case Study: SC CO<sub>2</sub> Purification of Hydrocephalus Shunts</h2> 457<p>One medical tubing company approached Phasex for the purification of implantable siloxane-based hydrocephalus shunts. Hydrocephalus is a condition in which an accumulation of cerebrospinal fluid (CSF) occurs within the brain. This typically causes increased pressure inside the skull. Hydrocephalus can occur due to birth defects or be acquired later in life. Shunting is the most common treatment for anyone with hydrocephalus. Hydrocephalus shunting involves the implantation of two catheters and flow-control valve system to drain the excess accumulation of CSF from the brainâs ventricles (or the lumbar subarachnoid space) to another part of the body where it can be absorbed.</p> 458<p>Phasex developed a CO<sub>2</sub> purification process to remove residual low MW impurities created during the manufacturing process of the siloxane-based shunts. Similar to the scaffold project, Phasex was able to develop and validate a process within four months and move to cGMP production of quantities used for clinical studies. Phasex supported the customerâs production requirements for several years and then aided to bring the purification process in-house to the customer.</p> 459 460 </div> 461 462 </div> 463 </div> 464</div></div> 465 466</div><!--end widget-span --> 467</div><!--end row--> 468</div><!--end row-wrapper --> 469 470<div class="row-fluid-wrapper row-depth-1 row-number-11 "> 471<div class="row-fluid "> 472<div class="span12 widget-span widget-type-custom_widget market-cta-section" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 473<div id="hs_cos_wrapper_module_1605008702952173" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="img-cta-section"> 474 <div class="wrapper"> 475 <div class="img-cta-inner-section"> 476 477 <div class="img-box"> 478 479 480 481 482 483 <img src="https://www.phasex4scf.com/hubfs/cta-form-sub-nanoparticles.jpg" alt="cta-form-sub-nanoparticles" 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