{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T05:31:20Z","timestamp":1765344680786,"version":"3.46.0"},"reference-count":73,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T00:00:00Z","timestamp":1765152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004972","name":"Maryland Industrial Partnerships","doi-asserted-by":"crossref","award":["7302"],"award-info":[{"award-number":["7302"]}],"id":[{"id":"10.13039\/100004972","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Noxilizer, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Polymeric materials have become important components in prefilled syringes, drug delivery systems, and advanced medical devices. Background\/Objectives: Nitrogen dioxide gas is used for the terminal sterilization of drug delivery systems. For the implementation of sterilization methods, compatibility with materials must be demonstrated such that the materials maintain product requirements and specifications after sterilization and at the time of use (i.e., product shelf life). Methods: Commonly used polymers were selected based on their chemical structures to provide insight into the nature of reactions that occur at the temperature and NO2 concentration levels used in the sterilization process. After exposure to the NO2 process, materials were evaluated for chemical, mechanical, and biocompatibility properties. Results: In this paper, we demonstrated the compatibility of polymers comprising carbonyl, unsaturated ester, and ketone groups which have been used in medical devices sterilized with NO2. No significant chemical or physical changes were observed upon the treatment of Amorphous Polyester, Polysulfone (PSU), Polycarbonate (PC), PolyEtherEtherKetone (PEEK), PolyArylEtherKetone (PAEK), and Polypropylene (PP) with NO2 at a sterilization temperature of 20 \u00b0C. At this relatively low sterilization temperature, the reactions of NO2 with the polymer do not typically occur because the activation energies of these reactions require much higher temperatures. Conclusions: Not all materials will be compatible with NO2 sterilization, and even with the established data, many devices will need to have their polymers evaluated for compatibility before moving to NO2 sterilization. These results will provide guidance to device designers selecting materials for new drug delivery devices and to regulators that review the safety and efficacy of these devices.<\/jats:p>","DOI":"10.3390\/ph18121869","type":"journal-article","created":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T14:52:24Z","timestamp":1765205544000},"page":"1869","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Drug Delivery Device Design and Compatibility with Nitrogen Dioxide Gas Sterilization"],"prefix":"10.3390","volume":"18","author":[{"given":"Noelle","family":"Ray","sequence":"first","affiliation":[{"name":"Noxilizer, Inc., 1334 Ashton Road, Suite E, Hanover, MD 21076, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia Diane","family":"Schexnayder","sequence":"additional","affiliation":[{"name":"Department of Materials Science and Engineering, University of Maryland, College Park, MD 20742, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aiysha","family":"Ashfaq","sequence":"additional","affiliation":[{"name":"Department of Materials Science and Engineering, University of Maryland, College Park, MD 20742, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nusrat","family":"Sarwahrdy","sequence":"additional","affiliation":[{"name":"Department of Materials Science and Engineering, University of Maryland, College Park, MD 20742, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Delaney","family":"Lisco","sequence":"additional","affiliation":[{"name":"Noxilizer, Inc., 1334 Ashton Road, Suite E, Hanover, MD 21076, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minufar","family":"Abdollahi Khabisi","sequence":"additional","affiliation":[{"name":"Noxilizer, Inc., 1334 Ashton Road, Suite E, Hanover, MD 21076, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trevor","family":"Bateman","sequence":"additional","affiliation":[{"name":"Department of Materials Science and Engineering, University of Maryland, College Park, MD 20742, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Sadler","sequence":"additional","affiliation":[{"name":"Noxilizer, Inc., 1334 Ashton Road, Suite E, Hanover, MD 21076, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Opie","sequence":"additional","affiliation":[{"name":"Noxilizer, Inc., 1334 Ashton Road, Suite E, Hanover, MD 21076, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9666-616X","authenticated-orcid":false,"given":"Mohamad","family":"Al-Sheikhly","sequence":"additional","affiliation":[{"name":"Department of Materials Science and Engineering, University of Maryland, College Park, MD 20742, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,8]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Skalko-Basnet, N. (2014). Biologics: The Role of Delivery Systems in Improved Therapy. Biol. Targets Ther., 8.","DOI":"10.2147\/BTT.S38387"},{"key":"ref_2","unstructured":"Altasciences (2025, October 16). Terminal Sterilization of Pharmaceutical Products. The Altascientist 2021, 21. Available online: https:\/\/www.altasciences.com\/sites\/default\/files\/2021-12\/The-Altascientist_issue-21_Terminal-Sterilization.pdf."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1208\/s12249-021-01949-4","article-title":"Container Closure and Delivery Considerations for Intravitreal Drug Administration","volume":"22","author":"Parenky","year":"2021","journal-title":"AAPS PharmSciTech"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Mollah, M.Z.I., Rahaman, M.S., Faruque, M.R.I., Khandaker, M.U., Osman, H., Alamri, S., and Al-Assaf, S. (2021). Effects of Radiation Sterilization Dose on the Molecular Weight and Gelling Properties of Commercial Alginate Samples. Front. Mater., 8.","DOI":"10.3389\/fmats.2021.761995"},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Naikwadi, A.T., Sharma, B.K., Bhatt, K.D., and Mahanwar, P.A. (2022). Gamma Radiation Processed Polymeric Materials for High Performance Applications: A Review. Front. Chem., 10.","DOI":"10.3389\/fchem.2022.837111"},{"key":"ref_6","unstructured":"Styron LLC (2025, August 11). Advances in Polycarbonate Color Compensation Technology to Withstand Sterilization by Irradiation Methods. Med. Des. Briefs 2012, September Issue. Available online: https:\/\/www.medicaldesignbriefs.com\/component\/content\/article\/14641-advances-in-polycarbonate-color-compensation-technology-to-withstand-sterilization-by-irradiation-methods."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.xphs.2021.09.003","article-title":"Chemical-Gas Sterilization of External Surface of Polymer-Based Prefilled Syringes and Its Effect on Stability of Model Therapeutic Protein","volume":"111","author":"Fujiwara","year":"2022","journal-title":"J. Pharm. Sci."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/S0378-5173(00)00423-3","article-title":"Lyophilization and Development of Solid Protein Pharmaceuticals","volume":"203","author":"Wang","year":"2000","journal-title":"Int. J. Pharm."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1093\/clinchem\/hvaa282","article-title":"Limitations of Accelerated Stability Model Based on the Arrhenius Equation for Shelf Life Estimation of In Vitro Diagnostic Products","volume":"67","author":"Ebrahim","year":"2021","journal-title":"Clin. Chem."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1835","DOI":"10.1002\/app.1987.070340505","article-title":"Transport of Ethylene Oxide through Polymer Films","volume":"34","author":"Phatak","year":"1987","journal-title":"J. Appl. Polym. Sci."},{"key":"ref_11","unstructured":"Chempedia (2025, June 20). Gas Permeability of Polymers and Rubbers. Available online: https:\/\/chempedia.info\/info\/gas_permeability_of_polymers_and_rubbers\/."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Gitsov, I.P.I., Liu, Y., Saylor, D.M., Hendrick, A.L., Gronda, A.M., Sinha, M.N., Long, E., Liu, S., Hu, R., and Weeks, J.W. (2025). Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)Urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Hydrogen Peroxide. J. Biomed. Mater. Res. B Appl. Biomater., 113.","DOI":"10.1002\/jbm.b.35567"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"2038","DOI":"10.1016\/j.xphs.2022.01.028","article-title":"Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach","volume":"111","author":"Mehta","year":"2022","journal-title":"J. Pharm. Sci."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"472","DOI":"10.5731\/pdajpst.2022.012749","article-title":"Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25 mL Prefilled Syringe","volume":"77","author":"Evans","year":"2023","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"244","DOI":"10.5731\/pdajpst.2025.25205","article-title":"Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks from Your Prefilled Devices and Combination Drug Products","volume":"79","author":"Gillet","year":"2025","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_16","unstructured":"Zaikov, G., Davydov, E., Pariiskii, G., Gapanova, I., and Pokholok, T. (2009). Interaction of Polymers with Polluted Atmosphere: Nitrogen Oxides, Smithers Rapra. Available online: http:\/\/ndl.ethernet.edu.et\/bitstream\/123456789\/58268\/1\/Gennady%20Zaikov_2009.pdf."},{"key":"ref_17","unstructured":"McDonnell, G., and Hansen, J. (2020). Nitrogen Dioxide. Block\u2019s Disinfection, Sterilization, and Preservation, Lippincott Williams & Wilkins."},{"key":"ref_18","unstructured":"U.S. Food and Drug Administration, Center for Drug Evaluation and Research (2025, October 16). Approval Package for: Pavblu (Aflibercept-Ayyh) Injection, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2025\/761298Orig1s000Approv.pdf."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"379","DOI":"10.5731\/pdajpst.2024.012997","article-title":"Nitrogen Dioxide Sterilization Follows Log-Linear Microbial Inactivation Kinetics Using Geobacillus Stearothermophilus Biological Indicators","volume":"79","author":"Richards","year":"2025","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_20","unstructured":"(2009). Sterilization of Health Care Products\u2014General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Standard No. ISO 14937:2009)."},{"key":"ref_21","first-page":"43","article-title":"Bactericidal Action of Nitrogen Dioxide on the Vegetative and Sporous Forms of Bacillus anthracis","volume":"24","author":"Polyakov","year":"1963","journal-title":"Mikrobiol. Zh"},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"de Souza, F.M., Kahol, P.K., and Gupta, R.K. (2021). Introduction to Polyurethane Chemistry. Polymer Chemistry for Advanced Applications, American Chemical Society.","DOI":"10.1021\/bk-2021-1380.ch001"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Majka, T.M., Berkowicz-P\u0142atek, G., and \u017bukowski, W. (2021). Modeling of the Kinetics of Polyoxymethylene Decomposition under Oxidative and Non-Oxidative Conditions. Materials, 14.","DOI":"10.3390\/ma14092281"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"281","DOI":"10.23939\/chcht04.04.281","article-title":"Reactivity of Polymers on Exposure to Nitrogen Dioxide","volume":"4","author":"Davydov","year":"2010","journal-title":"Chem. Chem. Technol."},{"key":"ref_25","unstructured":"Brentwood Industries (2025, October 16). Top 8 Materials for Medical Device Packaging. Available online: https:\/\/www.brentwoodindustries.com\/resources\/learning-center\/medical\/top-8-materials-for-medical-device-packaging\/."},{"key":"ref_26","unstructured":"Aprios (2025, November 21). PETG: The Go-To Resin for Clarity and Durability in Diverse Applications. 2025. Available online: https:\/\/www.aprios.com\/insights\/petg-the-go-to-resin-for-clarity-and-durability-in-diverse-applications."},{"key":"ref_27","unstructured":"Genesis Medical Plastics (2025, October 16). Plastics for Implantable Medical Devices. Available online: https:\/\/www.genesismedicalplastics.com\/materials\/implantable-medical-devices\/."},{"key":"ref_28","unstructured":"Foster Corporation (2025, November 21). Polysulfones in Healthcare Applications. Available online: https:\/\/www.fostercomp.com\/polysulfones-in-healthcare-applications\/."},{"key":"ref_29","unstructured":"(2025, October 16). Covestro AG. High-Quality Plastics for Drug Delivery: Medical-Grade Polycarbonates, PC+ABS Blends and Thermoplastics for Drug Delivery Devices. 2021. Available online: https:\/\/solutions.covestro.com\/en\/highlights\/articles\/theme\/applications\/drug-delivery."},{"key":"ref_30","unstructured":"Invibio Biomaterial Solutions (2025, October 16). Active Implants & Drug Delivery\u2014Application Areas. Available online: https:\/\/www.invibio.com\/en\/application-areas\/medical-devices\/."},{"key":"ref_31","unstructured":"Sprovieri, J. (2025, November 21). New Plastics for Medical Devices. Available online: https:\/\/www.assemblymag.com\/articles\/94276-new-plastics-for-medical-devices."},{"key":"ref_32","unstructured":"Drake Plastics (2025, October 16). Life Science & Medical\u2014High-Performance Thermoplastics for Life Science, Medical and Analytical Equipment Applications. Available online: https:\/\/drakeplastics.com\/life-science-medical\/."},{"key":"ref_33","unstructured":"Solvay Specialty Polymers USA, LLC (2025, November 21). ConMed Linvatec Launches First UL-Approved Autoclavable Battery for Powered Surgical Tools. Available online: https:\/\/www.solvay.com\/sites\/g\/files\/srpend616\/files\/tridion\/documents\/ConMed_Linvatec_Lithium_Battery_System_Uses_AvaSpire%20PAEK_Final_EN.pdf."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.bmt.2023.11.002","article-title":"Polyaryletherketones: Properties and Applications in Modern Medicine","volume":"6","author":"Sacks","year":"2024","journal-title":"Biomed. Technol."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"242","DOI":"10.3109\/15569527.2015.1089884","article-title":"Needle-free nasal delivery of glucagon for treatment of diabetes-related severe hypoglycemia: Toxicology of polypropylene resin used in delivery device","volume":"35","author":"Reno","year":"2016","journal-title":"Cutan. Ocul. Toxicol."},{"key":"ref_36","unstructured":"ResMart (2025, November 21). Applications of Medical-Grade Polypropylene: A Versatile Solution for Healthcare Needs. Available online: https:\/\/resmart.com\/news\/post\/applications-of-medical-grade-polypropylene-a-versatile-solution-for-healthcare-needs1.html."},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Nicolau, S.T., and Matzger, A.J. (2024). An Evaluation of Resolution, Accuracy, and Precision in FT-IR Spectroscopy. Spectrochim. Acta A Mol. Biomol. Spectrosc., 319.","DOI":"10.1016\/j.saa.2024.124545"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"1352","DOI":"10.1366\/0003702011953478","article-title":"Optical Contact in ATR\/FT-IR Spectroscopy","volume":"55","author":"Ekgasit","year":"2001","journal-title":"Appl. Spectrosc."},{"key":"ref_39","first-page":"106707","article-title":"Polyethylene Terephthalate (PET) in the Packaging Industry","volume":"86","year":"2020","journal-title":"Polym. Test."},{"key":"ref_40","doi-asserted-by":"crossref","unstructured":"Black, J., and Hastings, G. (1998). Handbook of Biomaterial Properties, Springer. Available online: https:\/\/link.springer.com\/book\/10.1007\/978-1-4615-5801-9.","DOI":"10.1007\/978-1-4615-5801-9"},{"key":"ref_41","doi-asserted-by":"crossref","unstructured":"Brunelle, D.J. (2006). Polycarbonates. Encyclopedia of Polymer Science and Technology, Wiley.","DOI":"10.1002\/0471440264.pst255.pub2"},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"951","DOI":"10.1002\/app.1988.070360510","article-title":"Thermal Degradation of Poly(Aryl-Ether-Ether-Ketone) (PEEK): A Differential Scanning Calorimetry Study","volume":"36","author":"Day","year":"1988","journal-title":"J. Appl. Polym. Sci."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"2147","DOI":"10.1007\/s10973-018-7292-x","article-title":"Thermal, Mechanical and Dielectric Behaviour of Poly(Aryl Ether Ketone) with Low Melting Temperature","volume":"135","author":"Audouit","year":"2018","journal-title":"J. Therm. Anal. Calorim."},{"key":"ref_44","first-page":"1","article-title":"Polypropylene as a Promising Plastic: A Review","volume":"6","author":"Maddah","year":"2016","journal-title":"Am. J. Polym. Sci."},{"key":"ref_45","unstructured":"Wunderlich, B. (2005). Thermal Analysis of Polymeric Materials, SpringerLink B\u00fccher; Springer."},{"key":"ref_46","doi-asserted-by":"crossref","unstructured":"Yi, N., Chaplin, A., Grasmeder, J., and Ghita, O. (2024). Adaptable Polyaryletherketones (PAEKs) with Competing Crosslinking and Crystallisation Mechanisms. Sci. Rep., 14.","DOI":"10.1038\/s41598-024-51231-3"},{"key":"ref_47","doi-asserted-by":"crossref","unstructured":"Alvaredo, A., Mart\u00edn, M., Castell, P., Guzm\u00e1n de Villoria, R., and Fern\u00e1ndez-Bl\u00e1zquez, J. (2019). Non-IsothermalCrystallization Behavior of PEEK\/Graphene Nanoplatelets Composites from Melt and Glass States. Polymers, 11.","DOI":"10.3390\/polym11010124"},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"1702","DOI":"10.1063\/1.1137606","article-title":"Test of Wall Coatings for Controlled Moist Air Experiments","volume":"55","author":"Liebe","year":"1984","journal-title":"Rev. Sci. Instrum."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"2523","DOI":"10.1021\/ef8010096","article-title":"Carbon-Centered Free Radicals in Particulate Matter Emissions from Wood and Coal Combustion","volume":"23","author":"Tian","year":"2009","journal-title":"Energy Fuels"},{"key":"ref_50","doi-asserted-by":"crossref","unstructured":"Green, U., Shenberger, Y., Aizenshtat, Z., Cohen, H., and Ruthstein, S. (2014). Exploring the Radical Nature of a Carbon Surface by Electron Paramagnetic Resonance and a Calibrated Gas Flow. J. Vis. Exp., 51548.","DOI":"10.3791\/51548"},{"key":"ref_51","doi-asserted-by":"crossref","unstructured":"Azevedo, A.M., Mendon\u00e7a da Silveira, P.H.P., Lopes, T.J., Costa, O.L.B., Monteiro, S.N., Veiga-J\u00fanior, V.F., Silveira, P.C.R., Cardoso, D.O., and Ben-Hur da Silva Figueiredo, A. (2025). Ionizing Radiation and Its Effects on Thermoplastic Polymers: An Overview. Polymers, 17.","DOI":"10.3390\/polym17081110"},{"key":"ref_52","unstructured":"Saint-Gobain Performance Plastics (2025). Effect of Sterilization on the Mechanical Properties of Silicone Rubbers, Saint-Gobain Biopharm. Available online: https:\/\/www.biopharm.saint-gobain.com\/sites\/hps-mac3-lifesciences-bioprocess\/files\/effect-of-sterilization-on-the-mechanical-properties-of-silicone-rubbers.pdf."},{"key":"ref_53","unstructured":"Wild, N. (2025, November 21). Everything You Need to Know about Color\u2014Delta E. Available online: https:\/\/blog.hybridhelix.com\/everything-you-need-to-know-about-color-delta-e\/."},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1002\/col.20070","article-title":"The CIEDE2000 Color-Difference Formula: Implementation Notes, Supplementary Test Data, and Mathematical Observations","volume":"30","author":"Sharma","year":"2005","journal-title":"Color Res. Appl."},{"key":"ref_55","unstructured":"(2025, November 21). BASF SE. Antioxidants\u2014Plastic Additives for Plastics and Rubber. Available online: https:\/\/plastics-rubber.basf.com\/global\/en\/plastic_additives\/products\/antioxidants."},{"key":"ref_56","first-page":"662","article-title":"Hindered Phenolic Antioxidants as Heat-Oxygen Stabilizers for HDPE","volume":"28","author":"Wang","year":"2020","journal-title":"Polym. Polym. Compos."},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"21007","DOI":"10.1021\/acs.iecr.3c03205","article-title":"NO2 Absorption in Aqueous Solutions with Phenolic Additives: Hydroquinone and 4-Methylaminophenol Sulfate","volume":"62","author":"Schmid","year":"2023","journal-title":"Ind. Eng. Chem. Res."},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1007\/s10856-025-06951-x","article-title":"A Review of Cytotoxicity Testing Methods and In Vitro Study of Biodegradable Mg-1%Sn-2%HA Composite by Elution Method","volume":"36","author":"Jhamb","year":"2025","journal-title":"J. Mater. Sci. Mater. Med."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/0142-9612(95)92115-M","article-title":"Cytotoxicity of medical materials sterilized with vapour-phase hydrogen peroxide","volume":"16","author":"Ikarashi","year":"1995","journal-title":"Biomaterials"},{"key":"ref_60","unstructured":"(2008). Biological Evaluation of Medical Devices\u2014Part 7: Ethylene Oxide Sterilization Residuals (Standard No. ISO 10993-7)."},{"key":"ref_61","doi-asserted-by":"crossref","first-page":"548","DOI":"10.1002\/jbm.b.10036","article-title":"Residual ethylene oxide in medical devices and device material","volume":"66","author":"Lucas","year":"2003","journal-title":"J. Biomed. Mater. Res. B Appl. Biomater."},{"key":"ref_62","first-page":"2","article-title":"Polysulfones and Their Applications","volume":"7","author":"Athipatla","year":"2023","journal-title":"J. High Sch. Sci."},{"key":"ref_63","unstructured":"Nova Chemicals (2019). Preventing Gas Fading in Polyethylene, Nova Chemicals. Available online: https:\/\/www.novachem.com\/wp-content\/uploads\/NOVA-Chem-Tech-Bulletin-GasFading-FINAL-2019.pdf."},{"key":"ref_64","doi-asserted-by":"crossref","first-page":"pgae385","DOI":"10.1093\/pnasnexus\/pgae385","article-title":"Rapid Aqueous-Phase Dark Reaction of Phenols with Nitrosonium Ions: Novel Mechanism for Atmospheric Nitrosation and Nitration at Low pH","volume":"3","author":"Cai","year":"2024","journal-title":"PNAS Nexus"},{"key":"ref_65","unstructured":"(2022). Standard Test Method for Tensile Properties of Plastics (Standard No. ASTM D638-22)."},{"key":"ref_66","unstructured":"(2021). Biological Evaluation of Medical Devices\u2014Part 12: Sample Preparation and Reference Materials (Standard No. ISO 10993-12:2021)."},{"key":"ref_67","unstructured":"(2023). Standard Practices for General Techniques of Infrared Quantitative Analysis (Standard No. ASTM E168-16 (2023))."},{"key":"ref_68","unstructured":"(2021). Standard Test Method for Transition Temperatures of Polymers by Differential Scanning Calorimetry (Standard No. ASTM D3418-21)."},{"key":"ref_69","unstructured":"(2020). Standard Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods (Standard No. ASTM E2655-14 (R20))."},{"key":"ref_70","unstructured":"(2021). Standard Test Method for Rubber Property\u2014Durometer Hardness (Standard No. ASTM D2240-15 (R21))."},{"key":"ref_71","unstructured":"(2020). Standard Test Method for Color and Color-Difference Measurement by Tristimulus (Filter) Colorimetry (Standard No. ASTM E1347-06 (2020))."},{"key":"ref_72","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1016\/j.marchem.2014.03.002","article-title":"A Fast and Direct Spectrophotometric Method for the Sequential Determination of Nitrate and Nitrite at Low Concentrations in Small Volumes","volume":"162","author":"Corzo","year":"2014","journal-title":"Mar. Chem."},{"key":"ref_73","unstructured":"(2009). Biological Evaluation of Medical Devices\u2014Part 5: Tests for In Vitro Cytotoxicity (Standard No. ISO 10993-5:2009)."}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/12\/1869\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T05:28:37Z","timestamp":1765344517000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/12\/1869"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,8]]},"references-count":73,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["ph18121869"],"URL":"https:\/\/doi.org\/10.3390\/ph18121869","relation":{},"ISSN":["1424-8247"],"issn-type":[{"type":"electronic","value":"1424-8247"}],"subject":[],"published":{"date-parts":[[2025,12,8]]}}}