Fine Chemicals Newsletter 8 (us Version)

Transcript

Fine Chemicals Industrial Weighing & Product Inspection 8 News Increase productivity with cGMP weighing solutions Comply with current Good Manufacturing Practice (cGMP) and increase the process efficiency of your Multi Purpose Unit: with METTLER TOLEDO process weighing solutions productivity and compliance go hand in hand. Best Practice GMP for quality built-into products Under GMP, weighing is more than just using a scale and calibrating it regularly. Weighing becomes a qualified process solution ensuring consistent and documented quality in critical manufacturing steps. With innovative solutions, such as MinWeigh®, calibration management or user access levels, METTLER TOLEDO is your expert partner ensuring today’s best practice GMP. Versatile technology boosts efficiency Offering standard or tailor-made equipment, quick and easy configuration, and seamless integration with your existing networks, our solutions enhance the efficiency of your Multi Purpose Units With METTLER TOLEDO weighing solutions, such as the IND560 weighing indicator and a set of Centerlign weigh modules, you can increase the speed of your filling process and keep it accurate and reliable. Courtesy Altana Courtesy Altana Process weighing under GMP Managing measurement uncertainty MinWeigh® ensures all weights are within the acceptable tolerance of your weighing process Working under Good Manufacturing Practice requires knowing the accuracy of a measurement or, in other words, the measurement uncertainty. As long as the uncertainty is smaller than the tolerance of the weighing process, everything is fine. But how do you ensure that your measurements are always within the required tolerance? The relative measurement uncertainty increases exponentially with decreasing weight values. As a consequence, a minimum weight limit exists for every weighing instrument, below which the measurement uncertainty becomes larger than the tolerance that you accept for your weighing process. MinWeigh® Publisher Mettler-Toledo AG Industrial Heuwinkelstrasse CH-8606 Nänikon Switzerland The quality principle of embraces: • On-site determination of measurement uncertainty of the scale within your real process environment conditions • MinWeigh® function warns the operator when weight is below the minimum weight threshold • Calculation and documentation of the minimum weight in relation to the process tolerances Production MarCom Industrial CH-8606 Nänikon Switzerland Subject to technical changes © 11/2009 Mettler-Toledo AG Printed in the USA 2 • Easy and fast recalculation of the minimum weight, since tolerances may change from one process to the next METTLER TOLEDO Fine Chemicals News 8 MinWeigh® function activated on the IND560 indicator: the star icon indicates that the weight is below the minimum weight limit Embedded in all our new weighing indicators such as IND4xx series, IND560, and IND690, MinWeigh® warns the operator by displaying a dedicated icon when the weight is below the minimum weight threshold. For the 150kg analog floor scale in the example below, the icon appears when the weight is below 1kg. Analog floor scale – 150kg weighing range – Readability 0.05kg 1kg [minimum weight] 149kg [acceptable weighing range] 150kg High precision digital floor scale – 150kg weighing range – Readability 0.001kg 0.02kg [minimum weight] 149.98kg [acceptable weighing range] 150kg Typical acceptable weighing range (green bar) for an analog versus a high-precision floor scale (for 5% weighing tolerance) Zone 2/22, Division 2 Enhance efficiency Of your multi purpose units The IND560 weighing terminal empowers you to increase speed during filling steps without reducing your accuracy or reliability. The IND560 is now approved for use inside hazardous areas classified as Zone 2/22 or Division 2, bringing with it all of the reliability and flexibility you have come to expect from this well rounded industrial terminal. filling the Fill-560 application software adds further sequences and component inputs. Quickly configure standard filling sequences or create custom filling and blending applications without complex or costly additional programs. The versatile features of the IND560, combined with these new hazardous area approvals, make it the right solution for applications requiring high performance in the toughest of conditions. Designed to operate in the most demanding of conditions, the IND560 is a highly accurate weighing terminal built to last. To withstand the environments of the pharmaceutical or chemical industries, the IND560 is NEMA Type 4/12 (panel) and IP69K (Desk) protection approved. The units AISI304 stainless steel construction and polished sanitary finish is designed to resist aggressive cleaning agents and high pressure and temperature cleaning requirements. It is compliant with EHEDG and NSF guidelines. The IND560 excels in controlling filling and dosing applications. It delivers best in class performance with a fast A/D conversion rate of 366 Hz and a target update rate of 50 Hz. This allows the IND560 to deliver precise, repeatable measurements in manual, semi-automatic or fully automatic operations. For more advanced Desk/wall-mount – Analog only ATEX: II 3G EEx nL[nL] IIB T4 cULUS: Class I, Div 2, Groups A–D Class I, Zone 2, Group IIC -10ºC<=Ta<=+40ºC/T4 Panel-mount – Analog and IDNet ATEX: II 3G EEx nL[nL] IIB T4 II 3D T85ºC -10ºC<=Ta<=+40ºC IP6X cULUS: Class I, II, III, Div 2, Groups A–D,F,G Class I, Zone 2, Group IIC -10ºC<=Ta<=+40ºC/T4 For more information log onto: www.mt.com/IND560 www.mt.com/hazardous METTLER TOLEDO Fine Chemicals News 8 3 Hazardous Area Weighing Terminal Power and performance for advanced weighing applications Have you had complex processes or manual weighing applications that required you to either sacrifice performance or compromise between conflicting solutions? The IND780 provides all the power, reliability and flexibility in a single terminal to overcome these challenges. Designed to meet the most demanding requirements, the IND780 can be used as a highly intuitive manual control weighing terminal or as a high speed process con- troller. The IND780 is now rated for use in Division 2 or Zone 2/22 hazardous locations without the need for expensive purge or explosion proof housings. It of- fers a true total control solution with the right combination of weighing technology, connectivity features and user interface controls. Hazardous area IND780 Feeder controls via Internal solid state I/O’s Up to 4 scales connectivity analogue or digital Tank scale with weigh modules With its bright full color display the IND780 provides the operator with clear visual guidance for both automatic and manual weighing operations. The IND780 can show the individual weight data for each of its 4 scales simultaneously. Its 4 METTLER TOLEDO Fine Chemicals News 8 high speed multi-tasking processor with fast A/D rate of 366 HZ enables simultaneous filling or dosing on multiple scales for increased throughput. The IND780 is also built for robust environments. It is constructed of stainless steel and is NEMA Type 4/12 protection approved. Using non-incendive circuits, the IND780 makes an easy direct connection to approved load cells and scales without the need for barriers. Zone 2/22, Division 2 Embedded web based diagnostics The IND780 can contact a service technician via email if a fault develops. The technician can then remotely access the terminal directly using a standard web browser allowing simple diagnostic checks to be performed. Safe area Serial printer SQL database server Ethernet TCP/IP PLC fieldbus interface Additional features: The IND780 also contains the following advanced technology. • Choice of Ethernet, RS232/422/485, AB®-RIO, Profibus™, DeviceNet™, EtherNet/IP™, ControlNet™ and ModbusTCP interfaces. • TaskExpert™: opens up the IND780 for customized programming. • TraxDSP™: advanced vibration filtering • CalFREE™: calibrate scales with no test weights • MinWeigh® function: warns operator when weighing below the minimum weight • TraxEMT™: The built-in predictive maintenance and diagnostics features help predict errors and plan scale maintenance, rather than react after a scale is already down. Bright 145 mm QVGA graphical LCD display available in monochrome or Active TFT Color. Desk/wall-mount No version available Panel-mount ATEX: II 3G EEx nL[nL] IIB T4 II 3D T85ºC -10ºC< =Ta<=+40ºC IP6X CULUS: Class I, II, III, Div 2, Groups A–D, F, G Class I, Zone 2, Group IIC -10ºC<=Ta<=+40ºC/T4 TraxEMT™ For More information log onto: www.mt.com/IND780 www.mt.com/hazardous METTLER TOLEDO Fine Chemicals News 8 5 IPac IPac for Industrial Weighing Qualification and validation protocols and documentation solutions that satisfy the demand of the FDA and other regulatory bodies. At METTLER TOLEDO we appreciate the importance of obtaining the optimum performance of new equipment from day one. Our comprehensive IPac qualification package ensures new machines are providing a return on your investment right from the start. Knowledgeable service professionals will confirm satisfactory installation of new weighing systems and commission your equipment to achieve the highest level of performance. When you purchase an IPac, you are getting the best from your weighing system, providing peace of mind for you and guaranteed product quality for your customers. Ongoing performance levels are assured through hands-on operator familiarization training. With IPac you will: • Achieve and maintain the qualified state • Reduce the chance of audit challenges • Ensure proper results using OEM protocols • Lower the expense of in-house solutions IPac delivers a professional installation for weighing equipment in production and is designed to meet the requirements of GMP and other quality systems. IPac is for new equipment qualification or re-qualification of equipment that is repurposed, moved or lacks adequate documentation. Industrial weighing: IPac Initial Qualification Package (IQ, OQ, PQ) IPac is designed to be consistent with the requirements of GMP and other quality systems. Execution of an IPac by a trained METTLER TOLEDO service representative delivers a self-contained solution for new equipment qualification or for re-qualification of equipment that is re-purposed, moved or lacks adequate documentation. IPac delivers optimized performance ISO standards state: “Equipment shall be verified at specific intervals, or prior to use. The basis for verification shall be recorded. Records of the results of calibration and verification shall be maintained.” ISO22000 & ISO9001 CI 7.6 The IPac qualification package supports your verification processes and includes: • Confirmation of acceptable equipment installation standards • Initial commissioning, set up and testing using your own products 6 METTLER TOLEDO Fine Chemicals News 8 • Generation of an initial performance verification certificate • A proposal and schedule for a continuous performance verification program For more information log onto: www.mt.com/service Ensure the quality of your API technology with fast moisture content verification Moisture analyzers enable efficient control of the raw materials on the production floor, on a 24/7 basis, and in compliance with current GMP. Courtesy LANXESS According to the pharmacopeias e.g. USP, moisture determination with the drying oven is the established reference method. However, process time is very long and requires many complex process steps. In contrast, moisture determination with the METTLER TOLEDO Halogen Moisture Analyzer HR83 is a significantly faster and an easy-to-use solution. Cross-validation experiments have shown that moisture results obtained with the HR83 method can effectively match the pharmacopeia-compliant drying oven results. Such a moisture solution is already in use and approved by FDA-inspected pharmaceutical companies. • Outstanding reproducibility and reliability • High resolution of 0.1mg – same resolution as required by Pharmacopeia for balances when using reference method METTLER TOLEDO provides the entire solution for the HR83, including: • Qualified installation (IQ, OQ, PQ) with IPac moisture • Temperature calibration of HR83 exactly at point of use Courtesy Givenchy Key benefits • Time to result is reduced from hours to a few minutes • Save 3–5 hours of process time for the majority of all measurements METTLER TOLEDO Fine Chemicals News 8 7 Hazardous Dust Compliance OSHA & NFPA Compliant Keeping Your Plant Safe from Dust Explosions Background Over the last few decades, industries in the US have been plagued by fires and explosions caused by the ignition of gases, vapors, mists or combustible dust. In testimony in front of Congress in 2008, Assistant Secretary of Labor declared that OSHA intends to step up it’s enforcement and regulatory activities and issue citations and stiff fines to companies that fail to comply with standards 29 CFR 1910.22\1910.176 and 29 CFR 1910.307. In March of 2008, OSHA reissued its Combustible Dust National Emphasis Program (NEP) issuing notices to approximately 30,000 companies nationwide that they will be targeted for inspections over the next few years. The following is a listing of just some of the citations that a company could receive under the OSHA Combustible Dust NEP 29CFR 1910.22 General Housekeeping Citations The general housekeeping standard requires that “all places of employment, passageways, storerooms, and service areas shall be kept clean and orderly and in a sanitary condition.” OSHA has stated that they will issue citations for the presence of combustible dust under this standard if dust accumulations exceed 1/32 inch deep, cover at least 5 % of a room’s total area, and are combustible. Dust accumulations on overhead beams, joists, on top and under equipment are included in the determination of the total dust coverage area. OSHA Fact Sheet In response to the growing problem of explosive dust OSHA developed a 2 page fact sheet highlighting the key points associated with explosive dust. Extracts from this fact sheet can be seen opposite. FactSheet Hazard Alert: Combustible Dust Explosions Combustible dusts are fine particles that present an explosion hazard when suspended in air in certain conditions. A dust explosion can be catastrophic and cause employee deaths, injuries, and destruction of entire buildings. In many combustible dust accidents, employers and employees were unaware that a hazard even existed. It is important to determine if your company has this hazard, and if you do, you must take action now to prevent tragic consequences. How Dust Explosions Occur In addition to the familiar fire triangle of oxygen, heat, and fuel (the dust), dispersion of dust particles in sufficient quantity and concentration can cause rapid combustion known as a deflagration. If the event is confined by an enclosure such as a building, room, vessel, or process equipment, the resulting pressure rise may cause an explosion. These five factors (oxygen, heat, fuel, dispersion, and confinement) are known as the “Dust Explosion Pentagon”. If one element of the pentagon is missing, an explosion cannot occur. Catastrophic Secondary Explosions An initial (primary) explosion in processing equipment or in an area where fugitive dust has accumulated may dislodge more accumulated dust into the air, or damage a containment system (such as a duct, vessel, or collector). As a result, if ignited, the additional dust dispersed into the air may cause one or more secondary explosions. These can be far more destructive than a primary explosion due to the increased quantity and concentration of dispersed combustible dust. Many deaths in past accidents, as well as other damage, have been caused by secondary explosions. Initial Explosion Secondary Explosion A pharmaceutical plant after a dust explosion. Industries at Risk Combustible dust explosion hazards exist in a variety of industries, including: agriculture, chemicals, food (e.g., candy, sugar, spice, starch, flour, feed), grain, fertilizer, tobacco, plastics, wood, forest, paper, pulp, rubber, furniture, textiles, pesticides, pharmaceuticals, tire and rubber manufacturing, dyes, coal, metal processing (e.g., aluminum, chromium, iron, magnesium, and zinc), recycling operations, and fossil fuel power generation (coal). Prevention of Dust Explosions To identify factors that may contribute to a explosion, OSHA recommends a thorough hazard assessment of: • All materials handled; • All operations conducted, including byproducts; • All spaces (including hidden ones); and • All potential ignition sources. 8 METTLER TOLEDO Fine Chemicals News 8 Explosive Dust Understand the risks How Dust Explosions Occur In addition to the familiar fire triangle of oxygen, heat, and fuel (the dust), dispersion of dust particles in sufficient quantity and concentration can cause rapid combustion known as a deflagration. If the event is confined by an enclosure such as a building, room, vessel, or process equipment, the resulting pressure rise may cause an explosion. These five factors (ox- ygen, heat, fuel, dispersion, and confinement) are known as the “Dust Explosion Pentagon”. If one element of the pentagon is missing, an explosion cannot occur. Catastrophic Secondary Explosions An initial (primary) explosion in processing equipment or in an area where fugitive dust has accumulated may dislodge more accumulated dust into the air, or Dust cloud formed damage a containment system (such as a duct, vessel, or collector). As a result, if ignited, the additional dust dispersed into the air may cause one or more secondary explosions. These can be far more destructive than a primary explosion due to the increased quantity and concentration of dispersed combustible dust. Many deaths in past accidents, as well as other damage, have been caused by secondary explosions. Heat from primary explosion ignites dust cloud Blast Wave Dust Accumulation Primary Explosion Industries at Risk Combustible dust explosion hazards exist in a variety of industries, including: agriculture, chemicals, food (e.g., candy, sugar, spice, starch, flour, feed), grain, fertilizer, tobacco, plastics, wood, forest, paper, pulp, rubber, furniture, textiles, pesticides, pharmaceuticals, tire and rubber manufacturing, dyes, coal, metal Secondary Explosion processing (e.g., aluminum, chromium, iron, magnesium, and zinc), recycling operations, and fossil fuel power generation (coal). Ignition Control Recommendations In addition to other methods it is recomended to use appropriate electrical equipment and wiring methods How METTLER TOLEDO can help Contact your METTLER TOLDEO representative to discuss how our hazardous area weighing technology can reduce the risk of your process. For more information go to www.mt.com/hazardous METTLER TOLEDO Fine Chemicals News 8 9 Online Tools Use www.mt.com as a Work Efficiency Resource Webinars – Learn more with little time and effort Join a wide array of webinars to learn about various topics from choosing the right technology to process optimization. We offer both Live Webinars where you can speak directly with our specialists and recorded On Demand Webcasts which are available at your convenience, 24 hours a day. View the full range of webinars: www.mt.com/webinars Value calculators – find out how to save money Download our calculators and work out how much you could be saving. Colored weight control system saves both time and money: www.mt.com/ind-colorweight-calculator Save money with quality control and correct filling: www.mt.com/sqc-calculator Eliminate unnecessary costs during formulation and maximize your profitability: www.mt.com/formulation-calculator 10 METTLER TOLEDO Fine Chemicals News 8 Download comprehensive product documentation METTLER TOLEDO Safeline PowerPhasePRO metal detectors provide the ultimate in metal detection performance. They help manufacturers increase productivity, reduce overall manufacturing costs and improve competitiveness. www.mt.com/safeline-powerphasepro The largest selection of hazardous area weighing equipment on the market has been combined into one easy to use catalogue combing regulatory guidelines and comprehensive product information. www.mt.com/ind-hazcat Case Studies Looking for solutions to a problem? No problem. Read case studies of real problems and see how METTLER TOLEDO found a solution. www.mt.com/case_studies Free guides and white/technical papers METTLER TOLEDO has published a range of authoritative guides and white papers that cover focus areas which enable you to select the right solutions to improve your processes. From statistical quality control, installing equipment in an explosive area and Good Weighing Practice™ these free guides provide comprehensive information on how you can improve your process, comply with hazardous legislation and ensure you weigh to your regulations. Request your free copy here. www.mt.com/sqc-guide www.mt.com/GWP www.mt.com/hazardous Hi-Speed Checkweighing Guide Safeline Metal Detection Guide Safeline X-ray Inspection Guide GWP® Good Weighing Practice™ Good Weighing Practice™ Free technical guides These guides offer support in installing an all-encompassing product inspection program and provide advice to help you in achieving compliance with standards, regulations and legislation. Request your free guides: www.mt.com/pius-guides Guaranteed Quality Minimized Risk Reduced Costs Secure Audits Minimize Weighing Risk by Adopting Good Weighing Practice™ SQC Guide Hazardous area Good Weighing Practice™ METTLER TOLEDO Fine Chemicals News 8 11 Making a measurable impact on productivity Realizing, maintaining and improving the productivity of your specialty chemical processes require thoughtful equipment design, proactive care and dependable partners. When you are accountable day-in and dayout to meet internal production targets or make just-in-time deliveries to customers, you can’t just leave things to chance. The productivity of your process depends on the application of the right weighing equipment, proper maintenance and verification that your process meets requirements. The right equipment must satisfy process accuracy, application, operational and duty-cycle requirements, as well as size and functional specifications. The on-going productivity and quality of your process, even with the perfect equipment, depends on a proactive maintenance and calibration certification plan. An effective proactive maintenance plan begins with an evaluation of your business risks associated with potential downtime and inaccuracy. A weighing equipment device in one process may only need occasional maintenance to ensure its availability, whereas in another process, the same device may need frequent and specific periodic maintenance to guarantee its uptime. METTLER TOLEDO is uniquely qualified to make a correct assessment of the maintenance requirements USA Mettler-Toledo, Inc. 1900 Polaris Parkway Columbus, OH, 43240 Tel. (1) 800 523 5123 Your METTLER ­ ­­ TOLEDO contact: for your weighing equipment. We evaluate the risks, use, operational complexity, work environment and your maintenance budget. Based on this evaluation we design the right proactive maintenance plan to ensure productivity and quality. With METTLER TOLEDO service, you get productivity that meets or exceeds your requirements. Whether you need to satisfy ISO9001/17025 requirements or follow GLP/GMP, BRC, IFS, SQF or ISO22000 standards, we offer the required services. Our factory-trained service technicians also know and care about safety. When instructed, we adhere to your safety policies and procedures with an unparalleled level of professionalism. And, our service representatives will be there at the right time, with the right parts, the right tools and the right skills to meet your needs. Contact your local METTLER TOLEDO service provider to arrange an assessment of your maintenance and calibration needs. You can also ask us to contact you at www.mt.com/service USA Mettler-Toledo Hi-Speed 5 Barr Road Ithaca, NY, 14850 Tel. (1) 800 836 0836 Key benefits • Properly maintained equipment to ensure productivity and optimize process performance • Simplified compliance with industry specific standards and regulations • Clear and precise documentation that equipment meets requirements to reduce the risk of non-compliance The ServiceXXL portfolio needs • Analysis and consultation • Installation and commissioning • Calibration and certification • Proactive maintenance • Emergency on-site repair • Modernization and upgrades • OEM service parts • Repair center exchange plans • Guaranteed response • Training programs • Comprehensive agreements USA Mettler-Toledo Safeline 6005 Benjamin Road Tampa, Florida, 33634 Tel. (1) 800 447 4439 Canada Mettler-Toledo, Inc. 2915 Argentia Road, Unit 6 Mississauga, Ontario, L5N 8G6 Tel. (1) 905 821 4200 www.mt.com/ind-api For more information