Editorial
Health and environmental effects of the use of N-methyl-2-pyrrolidone as a solvent in the manufacture of hemodialysis membranes: A sustainable reflexion
Efectos sobre la salud y el medio ambiente del uso de la N-metil-2-pirrolidona como disolvente en la fabricación de membranas de hemodiálisis: una reflexión sostenible
Faissal Tarrass
, Meryem Benjelloun
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Center of Hemodialysis 2 Mars, Casablanca, Morocco
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For the preparation of membrane, dissolution of polymer is done in an organic solvent and the membrane is formed by a de-mixing process with water.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">4</span></a> In the end of the procedure, solvents are removed by conducting the freshly spun fibers through a sequence of water baths.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">4</span></a> Thus, residual solvent and extractable and leachable substances are washed out of the membranes.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Solvents used in the manufacture of membranes provided their residual levels in the finished product comply with the acceptable limits set by regulatory agencies based on safety data. At worldwide level, the acceptable limits of residual solvents are defined in the “Guideline Q3C (R6) on impurities: guideline for residual solvents” issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Various solvents can be used for preparing the membrane, such as N-methyl-2-pyrrolidone (NMP), N-ethyl-2-pyrrolidone (NEP), N-octyl-2-pyrrolildone (NOP), dimethyl acetamide (DMAC), dimethyl formamide (DMF), dimethyl sulfoxide (DMSO) or gamma-butyrolactone (GBL) and mixtures thereof.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">6</span></a> The solvent will be present in an amount representing the balance to 100<span class="elsevierStyleHsp" style=""></span>wt.% of the polymer solution. The content of the solvent in the polymer solution preferably is from 60 to 80<span class="elsevierStyleHsp" style=""></span>wt.%, more preferably from 67 to 76.4<span class="elsevierStyleHsp" style=""></span>wt.%.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">6</span></a> N-methyl-2-pyrrolidone (NMP) is especially preferred because of its great stability compared to other solvents.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">6</span></a> Most of the dialysis membranes produced and sold in the world, are based on NMP in the production of the polymers polyethersulfones (PES) and polysulfones (PSU) and or of the membrane spinning solutions.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">NMP is not required to be present in the end product for the membrane properties.<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">7,8</span></a> Consequently, NMP is removed by washing at the end of the manufacturing process.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">8</span></a> However, even if the solvent is removed from the membrane at the end of manufacturing process, the possibility of remaining residual traces in the finished product still possible.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a> Experience residual NMP content in the membranes is well below 0.1% which is the general notifying threshold value for substances of very high concern of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requirements of the European Union.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Health risk for solvents exposure</span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Risk for hemodialysis patients</span><p id="par0030" class="elsevierStylePara elsevierViewall">Data regarding the amount of residual NMP in dialyzers after production still a sensitive subject to the industry.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a> According to the ICH guidelines, it is considered that amounts of residual NMP of 5.3<span class="elsevierStyleHsp" style=""></span>mg/day or less (corresponding to 530<span class="elsevierStyleHsp" style=""></span>ppm) in pharmaceuticals or medical devices would be acceptable without justification.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">5</span></a> In experimental model, chronic exposition of rabbits to 530<span class="elsevierStyleHsp" style=""></span>ppm (equivalent to 2000<span class="elsevierStyleHsp" style=""></span>mg/m<span class="elsevierStyleSup">3</span>: 1<span class="elsevierStyleHsp" style=""></span>ppm<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>4.12<span class="elsevierStyleHsp" style=""></span>mg/m<span class="elsevierStyleSup">3</span><a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">9</span></a>) of NMP can results in increased γ-GT in blood, with maternal and fetal toxicity.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">10</span></a> NMP has been shown to have neurotoxic, hepatotoxic, carcinogenic, genotoxic and mutagenic effects.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> In rats, NMP produced an increase in hepatocellular adenomas and carcinomas.<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">9</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The main route of excretion of NMP and its metabolites is by the kidneys through urine.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">12</span></a> Elimination of NMP is a saturable process, and unchanged NMP is intensively reabsorbed by the glomeruli.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">12</span></a> In reviewing the literature, we found no data of elimination kinetic of NMP in case of impaired kidney or dialysis. However, the physiologic perturbations associated with renal disease can have a pronounced effect on the kinetics of elimination of NMP and its metabolites from the body in the case of ESRD and dialysis.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Risk for membrane manufacturing workers</span><p id="par0040" class="elsevierStylePara elsevierViewall">The NMP volume used for the production of membranes is about 2000 to 4000<span class="elsevierStyleHsp" style=""></span>tons/year.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">7</span></a> Risks to workers are typically linked to acute and chronic exposures. Workers exposed to concentrations of NMP in air ranging from 3 to 6<span class="elsevierStyleHsp" style=""></span>mg/m<span class="elsevierStyleSup">3</span>, for even short period (30<span class="elsevierStyleHsp" style=""></span>min), reported severe eye irritation, headache and dermatitis.<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">13</span></a> Also a broad set of studies across multiple species show that NMP causes developmental toxicity (fetal death or decreased infant birth rates and reduced body weights) and other health effects.<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">13</span></a> The United State Environmental Protection Agency (EPA) estimates that 62,000 workers and 2 million consumers – including many women of childbearing age at risk of developmental effects – are exposed to NMP.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">14</span></a> EPA's analysis shows that these exposures present risks of cancer and non-cancer effects significantly above levels that EPA and other risk managers have traditionally considered unacceptable.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">14</span></a></p></span></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Impact of solvents on environmental pollution</span><p id="par0045" class="elsevierStylePara elsevierViewall">In recent years, societal awareness about protecting our environment and health has grown, prompting the membrane industry, among others, to fully consider the impact of its manufacturing processes. Due to the waste-intensive nature of membrane fabrication, billions of liters of contaminated wastewater are produced each year.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">15</span></a> The amount of wastewater generated from membrane manufacturing plants can be estimated to be approximately 100–500<span class="elsevierStyleHsp" style=""></span>L of wastewater per square meter of membranes produced,<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">16</span></a> and the solvent contamination in the wastewater always exceeds the allowable levels.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">NMP may enter the environment as emissions to the atmosphere, as the substance is volatile and widely used as a solvent, or it may be released to water as a component of municipal and industrial wastewaters.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> The substance is mobile in soil, and leaching from landfills is thus a possible route of contamination of ground water.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> In air, NMP is expected to be removed by wet deposition or by photochemical reactions with hydroxyl radicals. As the substance is completely miscible in water, it is not expected to adsorb to soil, sediments, or suspended organic matter or to bioconcentrate.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">11</span></a> NMP is not degraded by chemical hydrolysis, and its impact on the aquatic environment is crucial; the NMP is recognized as the most organic solvent to Daphnia magna.<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">17</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Sustainability for employed solvents</span><p id="par0055" class="elsevierStylePara elsevierViewall">To maintain the sustainable development of membrane technology, it is imperative to replace these toxic materials with environmental-friendly alternatives. In fact, this has been an active membranes research topic around the globe for this very reason.<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">18</span></a> In membrane preparation, solvents play a crucial role, and the properties of a solvent and its interaction with the polymer affects the membrane morphology and, thus, performance.<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">19</span></a> Hence, identifying a green solvent that can dissolve the polymer of interest is only a prerequisite, as the resulting membrane must exhibit a competitive performance to be adopted by the membrane industry. Furthermore, environmental regulations now restrict the use of toxic solvents for membrane production. Notably, REACH has classified DMF, DMAc, and NMP as substances with very high concerns, and the use of these solvents will be restricted after May 2020.<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">18,20</span></a> Recent reports on green solvent alternatives for membrane fabrication are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:3 [ "identificador" => "sec0005" "titulo" => "Health risk for solvents exposure" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Risk for hemodialysis patients" ] 1 => array:2 [ "identificador" => "sec0015" "titulo" => "Risk for membrane manufacturing workers" ] ] ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Impact of solvents on environmental pollution" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Sustainability for employed solvents" ] 3 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Undesirable \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Usable \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Greener alternative \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">HexanePentaneDioxaneChloroformBenzenePyridineTertrahydrofuran1-4 DioxaneDimethyl etherDimethylformaideN-methyl-2-pyrrolidoneDimethylacetamideDichloromethane1,2-DichloroethaneCarbone tetrachlorideTrifluroacetic acid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">TolueneCyclohexaneAcetoneDimethyl sulfoxideDimethyl isosorbideHeptaneAcetyl hydroxidet-ButanolMethanolMethyl ethyl ketoneP-XyleneTrifluorotoluéneIsooctaneCyclohexaneCyclopentyl methyl ether \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">WaterEthanolIonic liquidsSupercritical carbon dioxide1-HeptanolEthylene glycol1-Octanol1-Butanol1-PropanolGlycerol diacetateIsobutyl acetatePropylene carbonateDiethyl carbonateCyclopentanone \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2952395.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Recommendations for selecting solvents for membrane fabrication.<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">18</span></a></p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:20 [ 0 => array:3 [ "identificador" => "bib0105" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A critical analysis on various technologies and functionalized materialsfor manufacturing dialysis membrane" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "J.S. 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