OEE-Consultancy by Fette Compacting Integrated optimization of the processes.

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OEE-Consultancy by Fette Compacting Integrated optimization of the processes www.fette-compacting.com

Pharmaceutical production of the future uniform quality standards worldwide The global pharmaceuticals market is poised to undergo fundamental changes. While in the boom years drug companies were mainly occupied with growing faster than the competition, going forward the principle issues will revolve around fierce international competition and cost pressures. The demands these place upon firms will become even tougher. Recent studies 1 show trendlines which directly impact production in the pharmaceutical industry: Patent crisis Between 2009 and 2012, drugs generating total revenue of 140 billion US dollars lost patent protection. In the US, roughly 80% of patents are due to expire by the year 2015. Over the next few years, the share of generics in the overall market is set to rise by over 20%, an impact of around 400 billion US dollars. This will result in falling profits, rising development costs and R&D shifting to emerging markets. By the year 2020, the Chinese government intends to establish basic health care services for its more than 1.3 billion citizens. By 2020, sales in the Indian market are projected to reach 50 billion US dollars. In growth markets, efficiency is no longer simply a means of reducing costs, but rather a prerequisite for managing growth. At the same, pharmaceutical firms are having to optimize their global supply chain. Like in the automotive industry, individual production sites are increasingly being targeted by competitors. 1 Source: PwC (Link: www.pwc.com/pharma2020; www.imshealth.com) Growth in pharmerging markets Countries like China and Brazil are growing three times faster than the global market on average. TECHNOLOGY covers all products in the tableting technology; from tablet presses, to process equipment and tableting tools. SERVICE includes all services related to machinery and equipment, such as: spare parts supply, installation, system upgrades and technical field service. COMPETENCE is the generic term for our process-related services. This includes our training programs and compression trials, as well as application and OEE consulting, and engineering.

OEE Consultation Integrated Optimization of Your Processes The concept of Overall Equipment Effective ness (OEE) is a metric devised by the Japan Institute of Plant Maintenance. It has become established in the industry as a measurement of the value of plant and equipment assets. OEE value is derived from three factors: In a simplified formula, these factors are multiplied together, each factor representing the actual situation in relation to the target: + System availability + Machine performance + Product and process quality actual availability OEE = planned availability actual capacity planned capacity actual quality planned capacity OEE in pharma production The average OEE level in pharmaceutical production is 30%. Reasons for this relatively low overall equipment effectiveness level are: + unstable production process caused by the particular characteristics of the product to be pressed + excessively long planned and unplanned system downtimes + very high equipment cleaning and setup expense The range of values and the overall indicator lies between 0 and 100 %. This means that overall equipment effectiveness may be low despite relatively satisfactory or even very good individual values. This is where OEE analysis comes into play. This snapshot of processes and evaluation of results reveal potential efficiency gains and specific starting points for optimization efforts. Potential approaches for sustainably raising output are: + optimize the production process with respect to product properties + deploy new technologies + train and certify personnel + introduce risk management for replacement part inventories An OEE analysis can be used as a basis for optimizing and coordinating these factors in in-house pharmaceutical production. OEE contact at Fette Compacting: Phone +49 4151/12761 Fax +49 4151/1277761 consulting@fette-compacting.com

OEE consulting by Fette Compacting comprehensive optimization of your processes and equipment Fette Compacting provides OEE consulting in multiple areas Receipt of goods Mixing Granulating Filling Storage Compression Coating Packaging Cartoning Storage Basic OEE-competence Expanded OEE-competence OEE-core competence Step by step to optimal performance OEE consulting is done in systematic phases of target setting, analysis, planning, implementation and measurement. Targets are regularly reviewed and adjusted as necessary based on the data obtained. 1. Target definition Our OEE consultants work with you through out this process to ensure that your equipment reaches optimal performance. 5. Measure 2. Analysis 4. Implementation 3. Planning

Availability Production time (365 Days = 8760 h) + Cleaning time + Changeover time + Downtime + Maintenance and inspection Performance Output (8760 h Performa) Effected by: + Production speed + Product transfer + Format change + Handling Yield Product quality Loss of material/features: + Weight + Hardness + Thickness + Wear + Visual appearance = 52 % = 58 % = 95 % 52 % 58 % 95 % = OEE Level 29 % Example of OEE calculation The OEE analysis is based on four core components which we analyze in order to formulate recommendations. These four components are: Tool Management Maintenance Management Customized Training Production Excellence BENEFITS OF OEE ANALYSIS + Unbiased measurement and evaluation of overall equipment effectiveness + Shorter downtimes and changeover times + Identification of bottlenecks + Greater machine availability + Better capacity utilization + Higher product quality + Improved efficiency in the production process An important fact about this method is that data collected in OEE analysis do not allow conclusions regarding the performance of individual employees. The data is solely used to measure equipment and process losses, thereby rendering equipment value creation transparent. The benefit of OEE analysis is to provide production managers a valid, understandable basis for identifying optimization potential and make informed capital expenditure decisions. Excellence United Areas which we do not view as our core competency are covered by our Excellence United partners as needed (Bausch + Stroebel, Glatt, Harro Höfliger and Uhlmann). If your company s equipment is not made by one of our partners, we deploy personnel who have the corresponding expertise. Excellence United is a strategic alliance of independent companies in the field of special machine engineering for the pharmaceutical production. Each company is a leader in the engineering, processing and methods of their industry.

150566 E Fette Compacting GmbH Grabauer Strasse 24 21493 Schwarzenbek Germany Phone +49 4151 12-0 Fax +49 4151 3797 tablet@fette-compacting.com Fette Compacting America, Inc. 400 Forge Way Rockaway N.J. 07866 USA Phone +1 973 5868722 Fax +1 973 5860450 sales@fetteamerica.com Fette Compacting America Latina Ltda. Av. Cambacica, 1200 módulo 10 Parque Imperador CEP 13097-160 Campinas / SP Brazil Phone/Fax +55 19 37969910 contato@fette-compacting.com.br Fette Compacting Mexico, SA de CV Adolfo Prieto No. 1638 Colonia Del Valle Sur 03100 Mexico, DF Mexico Phone +52 55 4000 0653 tablet@fette-compacting.com Fette (Nanjing) Compacting Machinery Co., Ltd. 8 Phoenix Road Jiangning Development Zone 211100 Nanjing China Phone +86 25 52121818 Fax +86 25 52129951 fcn@fette-compacting.com Fette Compacting Machinery India Private Limited Sales Office A-301/302, Citi Point Co-op Society Premises Andheri-Kurla Road, J.B Nagar Andheri East, Mumbai 400 059 Phone +91 22 61220300 sales@fette-compacting.in Competence Centre: Plot No S 115, Phase III B Verna Industrial Estate Verna, Goa 403 722 India Phone +91 832 6690307 Fette Compacting Asia Pacific Pte Ltd. 107 Eunos Avenue 3, #01-01 Singapore 409837 Singapore Phone +65 6592 5654 Fax +65 6547 1939 infoasiapacific@fette-compacting.com Fette Compacting Ibérica, SL Calle Saturno 1 28760 Tres Cantos Spain Phone +34 91 8039689 Fax +34 91 1730017 fcib@fette-compacting.com ECOPAC A Fette Compacting and Uhlmann Company 1, Rue du Centre 93160 Noisy Le Grand France Phone +33 155 812121 Fax +33 155 812120 ecopac@ecopac.fr www.fette-compacting.com