Entering a new market. Polyolefins for pharmaceutical packaging and medical devices

Transcription

1 Entering a new market Polyolefins for pharmaceutical packaging and medical devices

2 New A new step forward polyolefins for pharmaceutical packaging and medical devices Our strengths will allow us to become an active player in the Healthcare segment with: Guarantee Commitment Service REPSOL QUIMICA, S.A All rights reserved.

3 Repsol Over decades of experience in the world of energy One of the largest energy companies worldwide and one of the biggest private oil & gas companies. Chemicals Over countries where we market our products Added value Repsol s Chemicals Division, with a high degree of integration, focuses its strategy in the constant generation of value through differentiated products and services. REPSOL QUIMICA, S.A All rights reserved.

4 Chemicals Over references Repsol manufactures a wide variety of products, ranging from base petrochemicals to derivatives. Base petrochemicals: ethylene, propylene, butadiene and benzene. Over scientists and researchers working for you Including qualified personnel specialised on Product Stewardship. Repsol s commitment to R&D is an evidence of the company s aim to attain business excellence to meet future horizons. Intermediate products: styrene, propylene oxide, polyether polyols, and propylene glycols. Polyolefins: polypropylene (PP) and PP compounds, both high and low density polyethylene (HDPE and LDPE), metallocene linear low density polyethylene (mlldpe), ethylene vinyl acetate (EVA) and ethylene butyl acrylate (EBA) copolymers. REPSOL QUIMICA, S.A All rights reserved.

5 Healthcare Our goal To manufacture and sell polyolefins for pharmaceutical packaging and medical devices, offering the maximum quality, service, commitment and compliance worldwide, keeping the patients safety as our number one priority. Our drive To fulfill our customers needs: Product reliability and traceability Compliance Long term confidence Guarantee Commitment Service Over years of experience producing and selling polyolefins Growing from our strengths Over 40 years of experience producing and selling polyolefins with a well-built prestige in Europe. Three integrated production facilities on the Iberian Peninsula. We have experience launching products with the maximum cleanliness and stringent manipulation procedures. Food packaging: we supply regularly to the food packaging industry. Qualified in pharmaceutical applications. Repsol s propylene glycol USP/EP is qualified and approved for use as an excipient in pharmaceutical applications. REPSOL QUIMICA, S.A All rights reserved.

6 Over grades for healthcare Polyolefins for pharmaceutical packaging and medical devices Repsol 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 Long-term commitment Willingness to seek continuous improvement A helping hand on technical matters to obtain the best performance Globalization Vision Efficiency Responsability Safety Differentiation REPSOL QUIMICA, S.A All rights reserved.

7 Our tools Dialogue Understanding our potential customers needs, quality, performance and service requirements. Guarantee Certifying our products to meet European & US Pharmacopoeias (USP/EP). Commitment Working on production and storage facilities in order to offer the maximum quality and cleanliness. Service Aligning our Quality System with the Good Manufacturing Practices required by the Industry. To offer the best solutions for pharmaceutical packaging and medical devices REPSOL QUIMICA, S.A All rights reserved.

8 Polypropylene homopolymer Grade ISO 1133 g/10 min 230ºC, 2.16 kg Charpy impact strength notched ISO 179 kj/m 2 Melting point ºC Flexural modulus ISO 178 MPa Additives Compliance Applications HPP08G Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Pharmaceutical packaging, closures and pouches HPP08N Nucleating agent Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Pharmaceutical packaging, caps & closures HPP09M Slip agent / Antiblock Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Pharmaceutical packaging, caps & closures HPP09SMD Slip agent / Antiblock / Antistatic Composition is compliant only with USP Pharmaceutical packaging, caps & closures HPP09W Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Pharmaceutical packaging, caps & closures HPP12G Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Injection moulding, caps & closures and pharmaceutical packaging HPP25G Compliance with Eur Ph and 3.1.6, USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Syringe barrels, caps & closures and pharmaceutical packaging HPP40N Nucleating agent Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Medical devices and thin wall injection moulding HPP08N Over 40 years of experience producing and selling polyolefins with a well-built prestige in Europe Notes of interest: / These products may not be used in: any U.S. FDA Class I and/or European Union Class I Medical Devices (Non-invasive devices), without prior notification to Seller for each specific product and application. the manufacture of any of the following, without prior written approval by Seller for each specific product and application: U.S. FDA Class II and/or European Union Class II Medical Devices: - Category IIa: Invasive devices with limited risk: e.g. syringes, lancets, insulin pens. - Category IIb: Invasive devices with higher risk: e.g. pouches for dialysis processes. U.S. FDA Class III, and/or European Class III Medical Devices; Category III: Very high risk devices: long-term (> 29 days) or permanent implants, long term (> 29 days) applications in direct contact with any body part or any body fluid. / Repsol makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shall constitute any warranty of merchantability or fitness for a particular purpose. / Repsol accepts no liability from the use of Repsol products in conjunction with other materials. / Before using a product sold by Repsol, users should make their own independent determination that the product is safe, lawful and technically suitable for the intended use. Flexural Modulus ISO 178 MPa HPP08G HPP09M HPP09SMD HPP09W HPP12G ISO 1133 g/10 min 230ºC, 2.16kg HPP25G The 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, taking into 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. REPSOL QUIMICA 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 some or all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A All rights reserved. HPP40N

9 Polypropylene random copolymer Grade ISO 1133 g/10 min 230ºC, 2.16 kg Charpy impact strength notched ISO 179 kj/m 2 Melting point ºC Flexural modulus ISO 178 MPa Additives Compliance Applications HPR02CMD Clarifying Agent Composition is compliant only with USP Medical packaging, film & pouches HPR08W Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Medical packaging, film & pouches HPR09G Compliance with Eur Ph 3.1.3, Eur Ph and USP Medical packaging, pouches, caps & closures HPR09SMD Slip agent / Antiblock / Antistatic Composition is compliant only with USP Medical packaging, pouches, caps & closures HPR11M Slip Agent / Antiblock Composition is compliant with Eur Ph 3.1.3, Eur Ph and USP Medical packaging, film & pouches HPR35CMD Clarifying agent / Antistatic Composition is compliant only with USP Healthcare applications, caps & closures, hypodermic syringe parts HPR35PMD Clarifying agent / Antistatic / Slip agent Composition is compliant only with USP Healthcare applications, caps & closures, hypodermic syringe parts HPR50CMD Clarifying agent / Antistatic Composition is compliant only with USP Medical devices and thin wall packaging 1200 HPR50CMD Experience launching products with maximum 1100 HPR35CMD HPR35PMD cleanliness and stringent manipulation procedures 1000 Flexural Modulus ISO 178 MPa HPR09G HPR09SMD HPR02CMD HPR11M Notes of interest: / These products may not be used in: any U.S. FDA Class I and/or European Union Class I Medical Devices (Non-invasive devices), without prior notification to Seller for each specific product and application. the manufacture of any of the following, without prior written approval by Seller for each specific product and application: U.S. FDA Class II and/or European Union Class II Medical Devices: - Category IIa: Invasive devices with limited risk: e.g. syringes, lancets, insulin pens. - Category IIb: Invasive devices with higher risk: e.g. pouches for dialysis processes. U.S. FDA Class III, and/or European Class III Medical Devices; Category III: Very high risk devices: long-term (> 29 days) or permanent implants, long term (> 29 days) applications in direct contact with any body part or any body fluid. / Repsol makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shall constitute any warranty of merchantability or fitness for a particular purpose. / Repsol accepts no liability from the use of Repsol products in conjunction with other materials. / Before using a product sold by Repsol, users should make their own independent determination that the product is safe, lawful and technically suitable for the intended use HPR08W ISO 1133 g/10 min 230ºC, 2.16kg The 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, taking into 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. REPSOL QUIMICA 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 some or all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A All rights reserved.

10 Low density polyethylene Grade ISO 1133 g/10 min 190ºC, 2.16 kg Density ISO 1183 kj/m 2 Melting point HLD02S No additives HLD02G ºC Additives Compliance Applications Antioxidants / Antiblock / Slip agent Compliant with Eur Ph 3.1.3, Eur Ph 3.1.4, USP and USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Compliant with Eur Ph and Eur Ph Pharmaceutical packaging like bags, pouches, blow-fill-seal applications, medical films, small blow moulding bottles Pharmaceutical packaging like bags, pouches, blow-fill-seal applications, medical films, small blow moulding bottles 940 Density ISO 1183 KJ/m HLD02S HLD02G ISO 1133 g/10 min 190ºC, 2.16 kg We supply regularly to the food packaging industry Notes of interest: / These products may not be used in: any U.S. FDA Class I and/or European Union Class I Medical Devices (Non-invasive devices), without prior notification to Seller for each specific product and application. the manufacture of any of the following, without prior written approval by Seller for each specific product and application: U.S. FDA Class II and/or European Union Class II Medical Devices: - Category IIa: Invasive devices with limited risk: e.g. syringes, lancets, insulin pens. - Category IIb: Invasive devices with higher risk: e.g. pouches for dialysis processes. U.S. FDA Class III, and/or European Class III Medical Devices; Category III: Very high risk devices: long-term (> 29 days) or permanent implants, long term (> 29 days) applications in direct contact with any body part or any body fluid. / Repsol makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shall constitute any warranty of merchantability or fitness for a particular purpose. / Repsol accepts no liability from the use of Repsol products in conjunction with other materials. / Before using a product sold by Repsol, users should make their own independent determination that the product is safe, lawful and technically suitable for the intended use. The 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, taking into 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. REPSOL QUIMICA 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 some or all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A All rights reserved.

11 High density polyethylene Grade ISO 1133 g/10 min 190ºC, 2.16 kg ISO 1133 g/10 min 190ºC, 21.6 kg Density ISO 1183 kj/m 2 Melting point HHD50G Antioxidants HHD55G Antioxidants HHD62G Antioxidants HHD55G Antioxidants ºC Additives Compliance Applications Composition is compliant with Eur Ph and Eur Ph and USP Compliance with Eur Ph and 3.1.6, USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Composition is compliant with Eur Ph and Eur Ph and USP Composition is compliant with Eur Ph and Eur Ph and USP Used for packaging or use in diagnostic and tube applications Used for packaging or use in diagnostic and tube applications Used for packaging or use in diagnostic and tube applications Typically used in jerrycans, such as drums or IBCs or as inner layer for coextruded industrial packaging HHD62G Density ISO 1183 KJ/m HHD50G ISO g/10 min 190ºC, 2.16 kg HHD55G1 HHD55G ISO g/10 min 190ºC, 21.6 kg Notes of interest: / These products may not be used in: any U.S. FDA Class I and/or European Union Class I Medical Devices (Non-invasive devices), without prior notification to Seller for each specific product and application. the manufacture of any of the following, without prior written approval by Seller for each specific product and application: U.S. FDA Class II and/or European Union Class II Medical Devices: - Category IIa: Invasive devices with limited risk: e.g. syringes, lancets, insulin pens. - Category IIb: Invasive devices with higher risk: e.g. pouches for dialysis processes. U.S. FDA Class III, and/or European Class III Medical Devices; Category III: Very high risk devices: long-term (> 29 days) or permanent implants, long term (> 29 days) applications in direct contact with any body part or any body fluid. / Repsol makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shall constitute any warranty of merchantability or fitness for a particular purpose. / Repsol accepts no liability from the use of Repsol products in conjunction with other materials. / Before using a product sold by Repsol, users should make their own independent determination that the product is safe, lawful and technically suitable for the intended use. The 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, taking into 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. REPSOL QUIMICA 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 some or all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A All rights reserved.

12 EVA copolymer Grade ISO 1133 g/10 min 190ºC, 2.16 kg VA content HVA08G Antioxidants HVA18G Antioxidants HVA18G 2 18 Antioxidants HVA28G Antioxidants HVA28G Antioxidants % Additives Compliance Applications Composition is compliant with Eur Ph and Eur Ph Composition is compliant with Eur Ph and Eur Ph Compliance with Eur Ph and 3.1.7, USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Composition is compliant with Eur Ph and Eur Ph Composition is compliant with Eur Ph and Eur Ph It is used for transdermal patches but can also be used for small blow moulding or injection moulding for healthcare applications It is used for the extrusion of medical film and production of medical bags It is used for the extrusion of medical film and production of medical bags It is used for production of medical tubing and drainage but can also be used for medical film extrusion and injection moulding for healthcare applications It is used for production of medical tubing and drainage but can also be used for injection moulding for healthcare applications 40 Repsol s propylene glycol USP/EP is qualified and approved for use as an excipient in pharmaceutical applications HVA28G1 HVA28G2 20 HVA18G1 HVA18G VA Content % HVA08G 5 Notes of interest: / These products may not be used in: any U.S. FDA Class I and/or European Union Class I Medical Devices (Non-invasive devices), without prior notification to Seller for each specific product and application. the manufacture of any of the following, without prior written approval by Seller for each specific product and application: U.S. FDA Class II and/or European Union Class II Medical Devices: - Category IIa: Invasive devices with limited risk: e.g. syringes, lancets, insulin pens. - Category IIb: Invasive devices with higher risk: e.g. pouches for dialysis processes. U.S. FDA Class III, and/or European Class III Medical Devices; Category III: Very high risk devices: long-term (> 29 days) or permanent implants, long term (> 29 days) applications in direct contact with any body part or any body fluid. / Repsol makes no warranties, express or implied, which extend beyond the description contained herein. Nothing herein shall constitute any warranty of merchantability or fitness for a particular purpose. / Repsol accepts no liability from the use of Repsol products in conjunction with other materials. / Before using a product sold by Repsol, users should make their own independent determination that the product is safe, lawful and technically suitable for the intended use ISO 1133 g/10 min 190ºC, 2.16kg The 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, taking into 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. REPSOL QUIMICA 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 some or all of the products might be protected by intellectual property rights. REPSOL QUIMICA, S.A All rights reserved.

13 A comprehensive range of products designed according to the standards of pharmaceutical packaging and medical devices Certifications Quality, Safety and Environment All petrochemical plants and part-owned subsidiaries ISO 9001:2008 Petrochemical complexes, packaging facilities and logistics centres OHSAS ISO ISO Puertollano and Tarragona (Sines in process) ISO Excellence is intrinsic to Repsol s values. It infuses our daily work and helps guide our decisions and actions, contributing to realize the commitment made to our customers, shareholders, employees, suppliers/partners and society to build a better future. All petrochemical plants and part-owned subsidiaries run by Repsol Química comply with the current ISO 9001:2008 Standards, for the quality of processes from manufacture to distribution, transport management and end product warehousing. Petrochemical complexes, packaging facilities and logistics centres all have OHSAS (Occupational Health and Safety Assessment Series) certifications for their rigorous safety measures. They also have ISO certification for their environmental management and the reduction of the impact of their facilities; and ISO for the annual verification of Greenhouse Gas (GHG) Emissions. Likewise, our petrochemical facilities in Puertollano and Tarragona are certified according to ISO 50001, as part of a process of continuous improvement, we continue to implement an Energy Management System, while Sines is in the process of obtaining it. We set up and deploy ambitious energy efficiency programmes to reduce energy consumption and GHG emissions as one of the key elements of our strategy. Repsol launched an energy and carbon plan between 2006 and Through this plan Repsol Química achieved a reduction of 0.56 million tonnes of CO 2 and is currently working on a new target covering the period , that aims for an additional reduction of 0.42 million tonnes of CO 2 by Repsol Química. From 2006 to 2013, Repsol s activities as a whole attained a reduction of over 3.1 million tonnes of CO 2. And for the period another 1.9 million tonnes of GHG emissions are expected to be decreased. November 2017 REPSOL QUIMICA, S.A All rights reserved.

14 Customer Care SPAIN Tel.: Tel.: ITALY Tel.: Tel.: PORTUGAL Tel.: Tel.: GERMANY Tel.: Tel.: FRANCE Tel.: Tel.: UNITED KINGDOM Tel.: Tel.: sacrq@repsol.com

15 Corporate Headquarters Méndez Álvaro, Madrid. Spain Tel.: Technical Service & Development Repsol Technology Centre Ctra. de Extremadura A5, km Móstoles, Madrid. Spain Tel.: Transparency Flexibility Integrity Innovation Responsibility