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

3 Our strengths will allow us to become an active player in the Healthcare segment with: Guarantee Commitment Service

4 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. references Over Repsol manufactures a wide variety of products, ranging from 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 and low density polyethylene (HDPE and LDPE), metallocene linear low density polyethylene (mlldpe), ethylene vinyl acetate (EVA) and ethylene butyl acrylate (EBA) copolymers.

5 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. 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. 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.

6

7 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

8 Our drive To fulfill our customers needs: Product reliability and traceability Compliance Long term confidence Guarantee Commitment Service To offer the best solutions for pharmaceutical packaging and medical devices

9 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.

10 Polypropylene homopolymer Grade MFI 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 HPP08G HPP08N Nucleating agent HPP09SMD Slip agent / Antiblock / Antistatic HPP09WMD HPP12G HPP20D Slip agent HPP25G HPP08N Flexural Modulus ISO 178 MPa HPP12G HPP20D HPP25G 1500 HPP08G HPP09SMD HPP09WMD MFI ISO 1133 g/10 min 230ºC, 2.16kg Over 40 years of experience producing and selling polyolefins with a well-built prestige in Europe

11 Compliance Applications Additives compliant with EP 3.1.3, EP and USP Additives compliant with EP 3.1.3, EP and USP Additives compliant only with USP Additives compliant only with USP Additives compliant with EP 3.1.3, EP and USP Additives compliant with EP 3.1.3, EP and USP Compliance with EP and , USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Pharmaceutical packaging, closures and pouches Pharmaceutical packaging, caps and closures Pharmaceutical packaging, caps and closures Pharmaceutical packaging, caps and closures Injection moulding, caps and closures and pharmaceutical packaging Syringe barrels and needle covers. Low surface friction Syringe barrels, caps & closures and pharmaceutical packaging

12 Polypropylene random copolymer Grade MFI 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 HPR08WMD HPR09G HPR09SMD HPR11MMD HPR20CMD HPR20PMD HPR35CMD HPR35PMD HPR50CMD Slip agent / Antiblock / Antistatic Slip agent / Antiblock Clarifying agent / Antistatic Clarifying agent / Antistatic / Slip agent Clarifying agent / Antistatic Clarifying agent / Antistatic / Slip agent Clarifying agent / Antistatic 1200 HPR20CMD HPR20PMD HPR35CMD HPR35PMD HPR50CMD 1000 Flexural Modulus ISO 178 MPa HPR09G HPR09SMD HPR11MMD 700 HPR08W MFI ISO 1133 g/10 min 230ºC, 2.16kg

13 Compliance Applications Additives compliant only with USP Additives compliant with EP 3.1.3, EP and USP Additives compliant only with USP Additives compliant only with USP Additives compliant only with USP Additives compliant only with USP Additives compliant only with USP Additives compliant only with USP Additives compliant only with USP Medical packaging, film and pouches Medical packaging, pouches, caps and closures Medical packaging, pouches, caps and closures Medical packaging, film and pouches Caps and closures. Syringe barrels (3-part) Caps and closures. Syringe barrels (2-part) Healthcare applications, caps and closures, hypodermic syringe parts Healthcare applications, caps and closures, hypodermic syringe parts Medical devices and thin wall packaging Experience launching products with maximum cleanliness and stringent manipulation procedures

14 Low density polyethylene Grade MFI ISO 1133 g/10 min 190ºC, 2.16 kg Density ISO 1183 kj/m 2 Melting point ºC Additives HLD02S No additives HLD02G Antioxidants / Antiblock / Slip agent High density polyethylene Grade MFI ISO 1133 g/10 min 190ºC, 2.16 kg MFI ISO 1133 g/10 min 190ºC, 21.6 kg Density ISO 1183 kj/m 2 Melting point ºC Additives HHD50G Antioxidants HHD55G 25* Antioxidants HHD62G Antioxidants HHD60G Antioxidants HHD55G1 5.5* Antioxidants HHD62G High density polyethylene Density ISO 1183 KJ/m HHD50G Low density polyethylene HHD60G HLD02S HLD02G HHD55G1 HHD55G MFI ISO 1133 g/10 min 190ºC

15 Compliance Applications Compliant with EP and EP and USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Additives compliant with EP and EP and USP It is used for pharmaceutical packaging like bags, pouches, blow-fill-seal applications, medical films, small blow moulding bottles It is used for pharmaceutical packaging like bags, pouches, blow-fill-seal applications, medical films, small blow moulding bottles Compliance Applications Additives compliant with EP and EP and USP Compliance with EP and , USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO Additives compliant with EP and EP and USP Additives compliant with EP and EP and USP Additives compliant with EP and EP 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 for closures, seals and tube shoulders Typically used in jerrycans, such as drums or IBCs or as inner layer for coextruded industrial packaging Repsol s Pharma facilities are located in our Tarragona and Puertollano sites

16 EVA copolymer Grade MFI ISO 1133 g/10 min 190ºC, 2.16 kg VA content % Additives Compliance HVA08G Antioxidants Additives compliant with EP and EP HVA18G Antioxidants Additives compliant with EP and EP HVA18G 2 18 Antioxidants Compliance with EP and 3.1.7, USP 88 class VI Biocompatibility and ISO , ISO , ISO , ISO HVA28G Antioxidants Additives compliant with EP and EP HVA28G Antioxidants Additives compliant with EP and EP HVA28G1 HVA28G VA Content % 15 HVA18G1 HVA18G 10 HVA08G MFI ISO 1133 g/10 min 190ºC, 2.16kg

17 Applications 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 Repsol s propylene glycol USP/EP is qualified and approved for use as an excipient in pharmaceutical applications

18 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: longterm (> 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. A comprehensive range of products designed according to the standards of pharmaceutical packaging and medical devices

19 Quality, safety and environment Certifications 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. March 2017 The information contained herein is based on REPSOL QUÍMICA s current knowledge and experience and is presented in good faith for guidance only. Although REPSOL QUÍMICA 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 QUÍMICA warns that this information may undergo variations or improvements; therefore REPSOL QUÍMICA 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 QUÍMICA, S.A All rights reserved.

20 Corporate Headquarters Méndez Álvaro, Madrid. Spain Tel.: Customer Care SPAIN Tel.: Tel.: PORTUGAL Tel.: Tel.: FRANCE Tel.: Tel.: A global company that seeks the welfare of people and is a step ahead in building a better future through the development of smart energy ITALY Tel.: Tel.: GERMANY Tel.: Tel.: UNITED KINGDOM Tel.: Tel.: sacrq@repsol.com Transparency Integrity Flexibility Responsibility Innovation Technical Service & Development Repsol Technology Centre Ctra. de Extremadura A5, km Móstoles. Madrid. Spain Tel.: atd_poliolefinas@repsol.com