Pharmaceutical Packaging And Medical Devices

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Pharmaceutical packagingand medical devicesPolypropylene, polyethylene and EVA copolymers

Differentiated solutions forthe healthcare industryCommitmentDedicated storage facilitiesand quality managementprotocols to ensure the highestquality standards.Repsol offerHigh quality productsReady to be part of new projectsCapable of developing tailor-made gradesExcellent logistics serviceTechnical service and developmentOur driveTo fulfill our customers’ needs:GuaranteeCertifying our products to meetEuropean & US Pharmacopoeias(USP/EP).Product reliability and traceabilityComplianceLong term commitmentServiceAligning our Quality System withthe Good Manufacturing Practicesrequired by the Industry. REPSOL QUIMICA, S.A. 2020. All rights reserved.

RepsolOverdecades of experiencein the world of energyOne of the largest energy companies worldwideand one of the biggest private oil & gas companies.Repsol Campus, Corporate Headquarters in MadridLEED Platinum certificate, awarded by the prestigious US Green Building Council(USGBC), for new buildings constructionRepsol is committed to our customers’ global strategy puttingour entire organization at their disposal to achieve a commongoal: to create long-term relationships which enable us to riseto the common challenges our business presents.

ChemicalsOvercountrieswhere we market our productsAdded valueRepsol’s Chemicals Division, with a high degree ofintegration, focuses its strategy in the constant generationof value through differentiated products and services.referencesOverRepsol manufactures a wide variety of products, rangingfrom base petrochemicals to derivatives.Base petrochemicals: ethylene, propylene, butadiene and benzene.Intermediate products: styrene, propylene oxide, polyether polyols,and propylene glycols.Polyolefins: polypropylene (PP) and PP compounds, both high andlow-density polyethylene (HDPE and LDPE), metallocene linear lowdensity polyethylene (mLLDPE), ethylene vinyl acetate (EVA) andethylene butyl acrylate (EBA) copolymers.Overscientists and researchersworking for youIncluding qualified personnel specialised on Product Stewardship.Repsol’s commitment to R&D is an evidence of the company’s aimto attain business excellence to meet future horizons. REPSOL QUIMICA, S.A. 2020. All rights reserved.

ChemicalsOur goalTo manufacture and sell polyolefins or pharmaceutical packaging andmedical devices, offering he maximum quality, service, commitment andcompliance worldwide, keeping the patients’ safety as our number one priority.Overyears of experienceproducing and selling polyolefinsGrowing from our strengthsOver 40 years of experience producing and selling polyolefins wi h a well-builtprestige in Europe.Three integrated production facilities in the Iberian Peninsula. We haveexperience launching products with the maximum cleanliness and stringentmanipulation procedures.Food packaging: we supply regularly to the food packaging industry.Qualified in pharmaceutical applications. Repsol’s propylene glycol USP/EP isqualified and app oved for use as an excipient in pharmaceutical applications. REPSOL QUIMICA, S.A. 2020. All rights reserved.

34Overgrades for healthcarePolyolefins for pharmaceutical packagingand medical devicesRepsol takes another step in differentiating its solutions and offers A suitable range of polyolefins: high and low density polyethylene (HDPE,LDPE), ethylene vinyl acetate copolymers (EVA) and polypropylene (PP). An outstanding and differentiated level of service. Willingness to seek continuous improvement. We put your needs first, always. Our tailor-made solutions are proofof our commitment to your singular cause. Our industry is full of challenges awaiting inspired solutions.That’s where we come in.Results OrientationIntrapreneurshipInspiring LeadershipAccountabilityCollaboration REPSOL QUIMICA, S.A. 2020. All rights reserved.

Polypropylene homopolymerPropertiesGradeMFIISO 1133 g/10'230ºC 2.16 kgAdditivesCharpy impactstrength notchedISO 179 kJ/m2Melting pointºCFlexuralmodulusISO 178 SP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Pharmaceutical packaging, closures and pouches.HPP08G841641500-3.1.3 / 3.1.6661.1HPP08N831641800Nucleating agent3.1.3 / 3.1.6661.1HPP09M931641500Slip agent / AntiblockIn compositionIn compositionUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Pharmaceutical packaging, caps and closures.HPP12G1241641550-3.1.3 / 3.1.6661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Injection molding, caps and closures andpharmaceutical packaging.HPP25G2531641600-3.1.3 / 3.1.6661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Syringe parts, caps and closures, pharmaceuticalpackaging, injection molding items.HPP25G12541571250-3.1.3 / 3.1.6661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Improved impact resistance. Syringe parts, pharmaceuticalpackaging, caps and closures, injection molding itemsHPP40N402.51641700Nucleating agent3.1.3 / 3.1.6661.1Thin wall injection molding, labware, dispensers.NEWHPP55RMD552.51641800Clarifying agent/Radiation Resistant-In compositionUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11NEWHPP55CMD552.51641800Clarifying agent/Antistatic-In compositionUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Injection molding medical applications and labware.Offers stiffness and high transparency.Pharmaceutical packaging, caps and closures, labware,dispensers, holders, gaskets.Gamma ray and E-beam resistant high fluidity PPresin. Offers stiffness and excellent transparency.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) Please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.comAll our Polypropylene grades are phthalate freeHeterophasic polypropylene copolymerPropertiesGradeMFIISO 1133 g/10'230ºC 2.16 kgHPB15NMD15AdditivesCharpy impactstrength notchedISO 179 kJ/m2Melting pointºCFlexuralmodulusISO 178 Mpa61641600Nucleating y-In compositionUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Injection molding medical applications. Offers excellentimpact/stiffness balance.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) Please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.comThe information contained herein is based on REPSOL QUIMICA’s current knowledge and experience and is presented in good faith for guidance only. Although REPSOL QUIMICA declares to have been most diligent when including the information contained herein, takinginto account that several and different factors may affect the processing, application or use of the products, the convertor shall be responsible in every case for the conditions under which the products are transformed as well as for the final use given to them. REPSOLQUIMICA warns that this information may undergo variations or improvements; therefore REPSOL QUIMICA is not obliged to reflect these in this document or to communicate them to whomever may have access to it. Moreover, these readers should be aware that someor all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A. 2020. All rights reserved.

Polypropylene homopolymer & Heterophasic polypropylene copolymerHPP08NHPP55RMD HPP55CMD1800HPP40NFlexural Modulus (MPa)ISO 1781700 1600HPP25GHPB15NMDHPP12G HPP08G1500HPP09MPolypropylene homopolymerHeterophasic Polypropylene copolymer14001300HPP25G112000102030MFI (g/10' 230ºC, 2.16 kg)ISO 1133405060Over 40 years of experience producing and sellingpolyolefins with a well-built prestige in EuropeThe information contained herein is based on REPSOL QUIMICA’s current knowledge and experience and is presented in good faith for guidance only. Although REPSOL QUIMICA declares to have been most diligent when including the information contained herein, takinginto account that several and different factors may affect the processing, application or use of the products, the convertor shall be responsible in every case for the conditions under which the products are transformed as well as for the final use given to them. REPSOLQUIMICA warns that this information may undergo variations or improvements; therefore REPSOL QUIMICA is not obliged to reflect these in this document or to communicate them to whomever may have access to it. Moreover, these readers should be aware that someor all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A. 2020. All rights reserved.

Polypropylene random copolymerGradeAdditivesPropertiesMFIISO 1133 g/10'230ºC 2.16 kgCharpy impactstrength notchedISO 179 kJ/m2Melting pointºCFlexuralmodulusISO 178 MpaHPR02CMD1.6 9143800HPR02W1.6 anceEurPhApplicationsUSPBiocompatibilityUSP 87 USP Cytotoxicity (Elution Test)Medical packaging, film and pouches, vials.USP 88 class VI ISO 10993-4, -5, -10, -11-In composition-3.1.3. / 3.1.6.661.1.USP 87 USP Cytotoxicity (Elution Test) Large volume parenteral blow fill seal bottles apt for autoclaveUSP 88 class VI ISO 10993-4, -5, -10, -11 sterilization at 121ºC. Medical packaging, film and pouches.950-3.1.3 / 3.1.6661.1.USP 87 USP Cytotoxicity (Elution Test) Barefoot grade. Medical packaging, films and pouches.USP 88 class VI ISO 10993-4, -5, -10, -11 Injection moulding items.145950Slip agent / AntiblockIn compositionIn compositionUSP 87 USP Cytotoxicity (Elution Test) Contains slip and antiblock. Medical packaging, labware, capsUSP 88 class VI ISO 10993-4, -5, -10, -11 and closures and ISBM.61491050Clarifying agent / Antistatic-In compositionUSP 87 USP Cytotoxicity (Elution Test)Caps and closures, syringe parts, medical device components.USP 88 class VI ISO 10993-4, -5, -10, -113861491050-In compositionHPR50CMD5051491150Clarifying agent / Antistatic-In compositionHPR75CMD7561491050Clarifying agent / Antistatic-In compositionClarifying agentClarifying agent /Radiation resistanceUSP 87 USP Cytotoxicity (Elution Test) Caps and closures, syringe parts, tubes, labware. Gamma andUSP 88 class VI ISO 10993-4, -5, -10, -11 E-beam rad.USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11 Caps and closures, syringe parts, medical device components.USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11 Small syringes, thin wall parts.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.com1200HPR50CMDFlexural Modulus (MPa)ISO PR09M900Stringent production procedures to ensureproduct consistency and the highest qualitystandards. All our Polypropylene grades arephthalate freeHPR02CMDHPR02W80070060001020304050607080MFI (g/10' 230ºC, 2.16 kg)ISO 1133The information contained herein is based on REPSOL QUIMICA’s current knowledge and experience and is presented in good faith for guidance only. Although REPSOL QUIMICA declares to have been most diligent when including the information contained herein, takinginto account that several and different factors may affect the processing, application or use of the products, the convertor shall be responsible in every case for the conditions under which the products are transformed as well as for the final use given to them. REPSOLQUIMICA warns that this information may undergo variations or improvements; therefore REPSOL QUIMICA is not obliged to reflect these in this document or to communicate them to whomever may have access to it. Moreover, these readers should be aware that someor all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A. 2020. All rights reserved.

Low density polyethyleneGradePropertiesMFIISO 1133 g/10'190ºC 2.16 kgNEWHLD01S0.3AdditivesDensityISO 1183kg/m3Melting pointºC922110ComplianceNo 01S10.55928117No additives3.1.3. / 3.1.4.661.1HLD02S2920110No additives3.1.3 / 3.1.4661.1HLD02G2920110Antioxidants / Antiblock/ Slip agent3.1.3 / 3.1.4661NEWHLD08S8920109No additives3.1.3. / 3.1.4.661.1NEWHLD20S22923104No additives3.1.3. / 3.1.4.661.1.Small volume parenteral bottles and ampoules for steam autoclave treatmentup to 110ºC.Very flexible grade for ampoules. LDPE for pharmaceutical bags, pouches andmedical devices.USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Soft LDPE containing slip and antiblock. For pharmaceutical packaging, caps andclosures and other medical devices.USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Excelllent flexibility for small volume parenteral bottles and ampoules.Extrusion coating and medical films.Caps and lids. Injection molded parts that require flexibility.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.com930HLD01S1HLD01SDensity (kg/m3)ISO 1183NEWUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, 82022MFI (g/10' 190ºC, 2.16 kg)ISO 1133A comprehensive range of products designedaccording to the standards of pharmaceuticalpackaging and medical devices

High density polyethyleneGradeAdditivesPropertiesMFIISO 1133 g/10'190ºC 2.16 kgMFIISO 1133 g/10'190ºC 5 kgMFIISO 1133 g/10'190ºC 21.6 kgDensityISO 1183kg/m3Melting lityHHD50G0.25-20950135Antioxidants3.1.3 / 3.1.5661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Typical extrusion blow moulding grade for pill jars, offering increased densityand barrier properties. Typically also converted in IBM process.HHD55G0.25-25955135Antioxidants3.1.3 / 3.1.5661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Blow molding HDPE grade presenting stiffness and excellent stress crackingresistance. Grade used for pill jars and containers for pharmaceutical packaging.HHD62G0.3-30962137Antioxidants3.1.3 / 3.1.5661.1USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Packaging, diagnostic and tubes, blow moulding bottles.HHD55G1-245.5955136Antioxidants3.1.3. / 3.1.5.661.1.USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Extrusion blow molding HDPE grade for pharmaceutical packaging includingBFS processes. Good process stability.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.com980Density (kg/m3)ISO 1183 HHD62G960HHD55GHHD50GHHD55G1 HHD50G HHD55G HHD62G940 92090000.51.01.522.533.544.555.5620MFI (g/10' 190ºC)ISO 1133A helping hand on technical matters to obtain the best performance2530MFI 2.16 kgMFI 21.6 kg

EVA copolymerGradeAdditivesPropertiesMFIISO 1133 g/10'190ºC 2.16 kgComplianceVA oxidantsUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11It is used for transdermal patches but can also be used for small blow molding, injection molding or tubing.HVA18G10.718AntioxidantsTesting in progressExtrusion of medical film and production of medical bags, ntsHVA28G2728AntioxidantsUSP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11USP 87 USP Cytotoxicity (Elution Test)USP 88 class VI ISO 10993-4, -5, -10, -11Medical film and bags, tubing, seals and closures.Medical film.Injection moulding medical devices.Repsol Healthcare grades are DMF listed. For more detailed information on DMF listing, European Pharmacopoeia (Ph Eur.) and United States Pharmacopoeia (USP) please contact Repsol's Technical Service & Development Department atd poliolefinas@repsol.com4030HVA28G2HVA28G1VA Content(%)2520HVA18G1HVA18G1510HVA08G5001234MFI (g/10' 190ºC, 2.16 kg)ISO 1133567Qualified in more pharmaceutical applications:Repsol’s propylene glycol USP/EP is qualifiedand approved for use as an excipient inpharmaceutical applications

SterilizationRepsol HealthcareAutoclaveEtOGamma and E-beam radiationPolypropylene Homopolymer HPPOnly for HPP55RMDPolypropylene Random Copolymer HPROnly for HPR35RMDLow Density Polyethylene HLDHigh Density Polyethylene HHDEVA Copolymer HVAMEDICAL POLICY DISCLAIMERS/ The use of this product in any Medical Device must comply with the following criteria: Class I Medical Devices (European Union and/or U.S. FDA): the product may only be used for this purpose with prior notification to REPSOLQUIMICA, S.A. of each specific final application. Class II Medical Devices (European Union and/or U.S. FDA): the product may only be used for this purpose with REPSOL QUIMICA, S.A.’s priorwritten approval.This product may not be used for implantable devices and for Class III Medical Devices (European Union and/or U.S. FDA)./ REPSOL QUÍMICA, S.A. makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shallconstitute any warranty of merchantability or fitness for a particular purpose./ Before using a product sold by REPSOL QUÍMICA, S.A. users should make their ownindependent determination that the product is safe, lawful and technicallysuitable for the intended use./ REPSOL QUÍMICA, S.A. accepts no liability from the use of its materials inconjunction with other materials.A global company that seeks the welfare ofpeople and is a step ahead in building a betterfuture through the development of smart energyThe information contained herein is based on REPSOL QUIMICA’s current knowledge and experience and is presented in good faith for guidance only. Although REPSOL QUIMICA declares to have been most diligent when including the information contained herein, takinginto account that several and different factors may affect the processing, application or use of the products, the convertor shall be responsible in every case for the conditions under which the products are transformed as well as for the final use given to them. REPSOLQUIMICA warns that this information may undergo variations or improvements; therefore REPSOL QUIMICA is not obliged to reflect these in this document or to communicate them to whomever may have access to it. Moreover, these readers should be aware that someor all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A. 2020. All rights reserved.

Building trust through safety and transparencyExcellence is intrinsic to Repsol’s values. It infuses our daily work and helps guide ourdecisions and actions, contributing to achieve the commitment made to our customers,stakeholders, employees, suppliers / partners and society to build a better future.Safety is our priorityQualityPetrochemical complexes, packaging facilities and logisticscentres all have OHSAS 18001.2007 (Occupational Healthand Safety Assessment Series) certifi ation for their rigoroussafety measures.All petrochemical plants are compliant with the currentISO 9001:2015 standards, for the quality of processes frommanufacture to distribution, transport managementand end product warehousing.Petrochemical complexes, packagingfacilities and logistics centresAll petrochemical plantsOHSAS 18001.2007ISO 9001:2015FSSC 22000Technical Data Sheets and MSDS are available on: www.repsol.com REPSOL QUIMICA, S.A. 2020. All rights reserved.

EnvironmentWe set up and deploy ambitious energy efficie y programmes to reduceenergy consumption and GHG emissions as one of the key elements of ourstrategy. These programmes pursue long term targets which have beenmade public in order to facilitate their progress by the stakeholders. In thissense, Repsol Química has attained a final eduction of 0.56 million tonnesof GHG emissions at the end of the 2006-2013 period. Repsol is currentlyworking on a new target covering the period 2014-2020, that involves anadditional reduction of 0.42 million tonnes of CO2.All petrochemical complexes, have ISO 14001 certifi ation for theirenvironmental management and the reduction of the impact of theirfacilities; and ISO 14064 for the annual verifi ation of greenhouse gas(GHG) emissions.The Chemical area of our complexes in Tarragona (2015), Puertollano(2013) and Sines (2016), has implemented an Energy Management systemaccording to the requirements indicated in the International StandardISO 50001. This system is dedicated to developing and implementing ourorganization’s energy policy, as well as manage the energy aspects of ouractivities, products or services. The objective is to increase and improve ourenergy efficie y, based on systems’ implementation aimed at continuousenergy performances improvement and thus contribute to a more efficienand sustainable use of energy.Repsol reinforced its commitment with sustainability by signing the “ParisPledge for Action” document. An historical agreement in which bothdeveloped countries and less developed countries and companies engagedto contribute towards a low CO2 emission economy.Puertollano, Tarragona and SinesISO 50001 / ISO 14001 / ISO 14064December 2020 REPSOL QUIMICA, S.A. 2020. All rights reserved.

Customer CareSPAINITALYTel.: 900 10 32 39Tel.: 800 60 509 999Tel.: 34 91 753 18 01Tel.: 34 91 753 18 04PORTUGALGERMANYTel.: 800 60 501 111Tel.: 800 60 504 444Tel.: 34 91 753 18 05Tel.: 34 91 753 18 00FRANCEUNITED KINGDOMTel.: 800 60 503 333Tel.: 800 60 502 222Tel.: 34 91 753 18 02Tel.: 34 91 753 18 03sacrq@repsol.comwww.repsol.com

Corporate HeadquartersMéndez Álvaro, 4428045 Madrid. SpainTel.: 34 91 753 81 00www.repsol.comTechnical Service & DevelopmentRepsol Technology LabCtra. de Extremadura A5, km 1828931 Móstoles, Madrid. SpainTel.: 34 91 753 86 00atd poliolefinas@repsol.comResults OrientationCollaborationIntrapreneurshipInspiring LeadershipAccountability

medical devices, offering he maximum quality, service, commitment and compliance worldwide, keeping the patients’ safety as our number one priority. . USP 88 class VI ISO 10993-4, -5, -10, -11 Medical packaging, film and pouches, vials. Large v

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