Solutions for your successful Life Science Environments – Powered by DESIGO™ Building Technologies s DESIGO™ – for optimum environmental Conditions in the Life Sciences Industry The life sciences industry fully relies on comprehensive control of environmental conditions. This is where a building automation and control system that reliably meets technical and regulatory requirements comes in. Deciding in favor of DESIGO™ means to invest in the future of your company. DESIGO™ optimally controls and monitors sensitive process environments. To achieve this goal, special requirements from different applications are considered to the maximum, e.g. through energy-optimized fume-hood control in research, exact differential pressure control for cleanrooms as well as reliable monitoring of warehouses by applying Mean Kinetic Temperature (MKT) calculations. Combining a scalable system and our application know-how from hundreds of life sciences projects makes DESIGO what it is: a first-rate choice for the life sciences industry. 2 Developed for the life sciences industry During development of DESIGO, we apply measures that are as stringent as those applied to the life sciences industry. Our strict development process influenced by GAMP is successfully audited internally and externally on a regular basis by the pharmaceutical industry. As a rule, life science-specific functionality is developed in close cooperation with the pharmaceutical indus try. This allows us to guarantee that DESIGO will easily master any challenge within your environment. User-friendly solution DESIGO offers user-friendly operation at all system levels. Local operator units feature transparent, intuitive operation and clear, graphic displays. Management station operation is based on Microsoft Windows and is thus designed as ergonomically as possible. Each user can retrieve the required information e.g. in the lab, production, or logistics with just a few mouse clicks. As a result, operating personnel requires only little training, and building infrastructure is securely protected. An investment that is well worth the money Introducing DESIGO does not result in an abrupt change of the system world, as step-by-step migration from existing systems to DESIGO can easily be accomplished. Your investment is protected based on the compatibility of DESIGO with existing systems. Any possible impact of changes on the validated system status as well as all required testing and qualification measures are documented extensively. That‘s what we call investment protection. DESIGO grows with you and your requirements: from a small biotech research lab to a globally active pharmaceutical company – our system always fits your processes. Our broad, modular automation station product range, various operator units, and a flat system topology allow for cost-effective introduction of DESIGO even in small projects. At the same time, small projects can be extended any time to complex, large projects. 3 DESIGO™ – gain Advantages through Consistency The future belongs to building automation and control that convinces by consistency. A system that allows for standardizing automated processes. A guarantee for comprehensive monitoring and harmonized operation of the entire building. The DESIGO™ pharmaceutical applications were developed in close cooperation with the pharmaceutical industry. Regular vendor audits provide documented proof that DESIGO is particularly suited to validated environments. Other advantages are: 4 Individual management station operation: • Harmonized view and pictures • Simple, multi-disciplinary operation • Common log and alarm management ■ Peer-to-peer communications: • Information available where it is needed • Automatic interaction and data exchange ■ Flexibility: • Changes without rewiring and new hardware ■ Operational efficiency improves profitability: • Low operating costs • Low training costs ■ Support 21 CFR Part 11 compliance DESIGO supports the safety of electronic data and electronic signatures as per 21 CFR Part 11 and EU Annex 11 through comprehensive measures such as access control, audit-trail, backup and archiving functions. DESIGO provides intuitive access to all required information of the building infrastructure. Integration options cover the following functionality and are extended on an ongoing basis. Optimum climate DESIGO allows you to control room conditions to exactly what‘s required for the processes. Accurate temperature and humidity control provide optimum environmental conditions e.g. in production. Monitoring and reporting All quality-relevant parameters are recorded reliably and archived for decades in protected databases. Intuitive and automatically generated reports provide exactly that information that you require e.g. to provide proof for the long-term stability of your products. Optimized power supply We can increase your system availability, reduce down-time and provide for transparent energy consumption data by integrating your plants used to supply, convert and distribute high and low voltages. Integrated coordination signals optimize operation of various HVAC plants, e.g. by means of demand-controlled cooling and heating generation in dependence of room demand. Thus, electrical consumption, among others, can be directly controlled and optimized. Fast intervention in the event of a fire Reliable fire detection is a special challenge in the life sciences industry due to the high air change volumes. The systems by Siemens detect – deceptionproof – a fire in its earliest state and are able to differentiate between various types of flame and smoke. Integration in DESIGO significantly increases safety of personnel and assets, as e.g. ventilation control allows to optimally coordinate reactions to a fire. Integrated safety In critical environments, handling toxic substances, for example, represents a constant threat to the health of personnel. DESIGO controls the pressure difference as well as the air change rate for the safety of personnel. And, the lab management application monitors itself and triggers an alarm upon each malfunction or bad operator action. Integration of the entire physical safety e.g. through access control and video surveillance systems further enhances safety for both personnel and processes. Comfortable conditions that allow you to focus on your core processes Complex research and development processes in the life sciences industry require that experts work at their very best within comfortable environmental settings. DESIGO supports this type of challenge by integrating operation of all room functions such as lighting and blinds control with automatic access control systems that are also used to secure IT-systems and pay for food purchases at the canteen. 5 DESIGO™ – easily communicate with worldwide Standards Intelligent communications are a decisive factor in evaluating the benefits of a building automation and control system: Smooth data exchange with the existing infrastructure and common applications are a prerequisite. BACnet is a globally recognized standard. Management Level DESIGO INSIGHT Client InfoCenter Server DESIGO INSIGHT Server Printer DESIGO Tool Set Printer ETHERNET TCP/IP BACnet IP Router Automation Level Integral DESIGO PX LON VISONIK PX compact PXM20-E PX modular Typical topology for a building automation and control network for the life sciences industry. Avoiding costly gateway solutions to exchange data is increasingly important when installing a building automation and control system. BACnet, the communications protocol, can easily combine conformant devices. Thus, all network members in a building can access the functions and data of the connected devices. Consistent communications DESIGO™ uses the open communications protocol BACnet (Building Automation and Control Network) to exchange data between the DESIGO PX automation stations and the automation and management levels. BACnet, a global, 6 future-oriented standard, was developed under the auspices of ASHRAE (American Society of Heating, Refrigerating and Air Conditioning Engineers) with building technology in mind. The flexible communications solutions allow for reliable separation of GxP- and non-GxP-relevant systems, thereby increasing security of sensitive data and significantly lower validation efforts. Our planning guidelines for the life sciences industry ensure that your sensitive data are protected as per EU GMP and cGMP requirements in cross-discipline communications. DESIGO – sensitive environmental Conditions under Control Plant Viewer Practical pictures allow for fast, target-oriented system monitoring and operation. Transparent and consistent operation opens up new dimensions to reliably monitor processes in research and development, production or warehouses. The DESIGO INSIGHT management station helps visualize and operate different processes in a building. It contains a comprehensive set of applications tailored to building automation and control that is easy to handle and economic at the same time. The capacity of DESIGO INSIGHT is impressive: Many buildings can be centrally operated from one single management station, which greatly reduces operating costs. Flexible alarm management DESIGO INSIGHT allows you to centrally acquire, edit and evaluate alarms from all integrated systems. The high-performance alarm routing function allows you to route alarms to SMS, fax, E-mail, pager regardless of where operators are and if the management station is manned. Developed for 21 CFR Part 11 conformance DESIGO INSIGHT secures sensitive data at system and database level and applies further technical measures to support conformance to 21 CFR Part 11. Access to data is protected reliably and each change can be traced in the integrated audit-trail. Pharma-specific backup and archiving functions secure the system and data over the entire life cycle. Targeted optimization Fully integrated, historic and real-time data processing allows for fast and targeted plant optimization. Comprehensive reporting functions and GxP-conformant long-term archiving are provided as part of InfoCenter. Economic application We integrate the energy consumption meters of the various plants in the building. The building automation and control system continuously registers the corresponding data. This allows for comparing consumption values to budgets. Regular reports (e.g. energy signature) track the efficiency of optimization measures and provide the basis for further, meaningful measures. Scalable and extendable systems DESIGO INSIGHT can be used for any building size. The offering ranges from small systems with just a few data points to solutions for large building campuses with several thousand data points. DESIGO INSIGHT offers an ideal solution for independent research laboratories to pilot production plants to large-scale production of generic drugs. Time Scheduler Central programming of all timecontrolled, building services functions including individual room control. Simple graphical operation of weekday, holiday, and exception day programs. Alarm Viewer Detailed alarm overview for several buildings. Users can directly access the corresponding plant picture for fast troubleshooting. Alarm Router Flexible, time-dependent alarm routing via SMS, fax, E-mail and pager ensures optimum deployment of service technicians. Log Viewer / Audit-Trail All events (alarms, system messages and user activities, etc.) are recorded in chronological order and can be displayed any time for further analysis. 7 DESIGO™ – simple Display of complex Matters Processes depicted on a building automation and control system‘s user interface are very complex. For this reason, user-friendly graphical displays are a must. The same is true for easy, logical operation. DESIGO™ INSIGHT converts complex matters into easy-to-understand graphics. The graphics‘ options offered by the DESIGO™ user interface satisfy every wish. Complex, climatic relationships such as h/xdiagrams, load shedding or heating curves are displayed in an easy-to-understand manner. Integration of AutoCAD™ plans and other formats compatible with Windows allows for displaying e.g. sensitive measured values in your rooms by using the floor plan. Simple integration Consequent and targeted deployment of standard technologies as well as the integrated SCADA software (Supervisory Control and Data Acquisition) guarantee that third-party systems can easily and without problems be connected to DESIGO INSIGHT via BACnet, OPC (OLE for Process Control) or other interfaces. This allows for harmonized operation of all technical installations in a building. Trend Viewer Historic and real-time data processing allows for fast and targetoriented operating optimization. Object Viewer Allows for fast access to all objects and parameters in the system and the technical plants. DESIGO™ Terminal Server Access to the entire management system on the network. Further applications Applications to configure the system, energy and maintenance management, system diagnostics, etc. complement the multifaceted selection of functions. Distributed and efficient operation using the DESIGO terminal server The DESIGO terminal server offers all system functions as terminal services in the network, allowing operators to concurrently access the data in independent sessions. Configuration management and project validation efforts are reduced drastically, as the DESIGO INSIGHT client does not need to be installed on each operator system. Standardized technology The DESIGO INSIGHT management station applies a broad range of standard technologies such as ActiveX, DCOM, OLE and Microsoft SQL server. For this reason, it can easily be installed in standard IT-systems and seamlessly integrated in the existing IT-infrastructure. Third-party software Third-party programs can be integrated via standard interfaces. 9 InfoCenter – GxP-compatible Monitoring and Reporting Security The access to electronic records and reports is highly protected. Archiving Reliable archiving of your sensible data through the entire life cycle. 21 CFR Part 11 ready Support 21 CFR Part 11 compliance with technical measures and comprehensive validation support. InfoCenter Spreadsheet Dynamic but secure data processing of InfoCenter databases e.g. with Microsoft Excel. Integration of 3rd party systems Efficient data acquisition from 3rd party systems as OPC client or via API interface. 10 In addition to exact room conditions control, the life sciences industry not only requires efficient, documented proof of it but also must be able to store this information for decades. InfoCenter was developed with exactly these tasks in mind. Each day, the DESIGO™ building automation and control system provides important information on current room conditions, user intervention, alarms, warnings, and system functions. The respective processes and installations determine the type of information that must be used for quality-relevant decisions. InfoCenter enables us to prepare this information allowing you to gain a quick overview commensurate with the target audience‘s needs and make well-grounded decisions. As head of production, you for example receive a complete report printout, a pdf file on your network or a report that you can open via the web. Data security InfoCenter was designed for large data volumes and is based on the strength and flexibility offered by Microsoft SQL server. Data access is controlled by comprehensive security measures and any change is recorded meticulously in the integrated audit trail. Reliable data archiving InfoCenter automatically archives your sensitive data and reports securely and reliably. Reading back archives e.g. in the case of an inspection occurs automatically, and the system even recognizes time periods distributed across several archiving media. Technical solutions for 21 CFR Part 11 InfoCenter was developed for and in cooperation with the life sciences industry. For this reason, it supports without compromise the required security functions under 21 CFR Part 11 such as data security, access control, audit trail, backup and archiving. We support your conformance by our comprehensive validation services along with extensive training of your users through our modular training program developed for the life sciences industry. InfoCenter – turns raw Data into Information InfoCenter turns raw report data into transparent sets of information. Trend curves for room conditions as well as tables for queued alarms on limit value violations along with user activity information on the same page are just one example. The integrated Report Manager allows you to create an individual report template with just a few mouse clicks. You can display statistical evaluations, system messages, limit value violations, etc. in addition to the underlying building automation and control system data. An “out-of-specification report“ that only shows deviations of required limit values is just one mouse click away. Comprehensive mathematical functions allow for highly complex calculations from average value to Mean Kinetic Temperature (MKT). The reports created in InfoCenter can be signed using electronic authentication and are thus considered a full replacement of traditional, printed copies. Protected web access to the InfoCenter server provides exactly the information each user needs. Remote operation allows e.g. starting reports and analyzing audittrails. Calibrated sensors record sensitive data on site. For technical personnel. Comfortable reading of all necessary system information. On-site operation via local touch panel offering the entire functionality of DESIGO™ INSIGHT. For technical personnel. Customized manual and emergency operator levels provided in the control panel. 12 DESIGO™ – profit from our comprehensive Solution All-rounder in its truest meaning: DESIGO™ PX controls and monitors, i.e. it manages heating, ventilation, air conditioning and other building services plants. DESIGO PX convinces not just by the scalability of its programmable automation stations with various operator units, but also by its openness. A family of programmable automation stations DESIGO™ PX offers maximum flexibility through its family of freely programmable automation stations. Allowing for optimum control and monitoring of building services plants. Comprehensive system functions such as alarming, scheduler programs and trend cover all technical requirements in a building. The automation stations work autonomously and decentralized, and are available in two series. The open BACnet protocol on LON or Ethernet/IP is used for communications. DESIGO PX compact series Compact series ■ Peripherals can be connected directly ■ Compact, space-saving constructions featuring digital and universal I/Os for the most varied applications. The process periphery is connected directly to the automation stations. A family of programmable automation stations DESIGO I/O module product range DESIGO PX modular series ■ Modular ■ Flexible data point mix ■ Manual operation via modules featuring switches and display ■ Optimum adaptation to technical plants The DESIGO I/O module product range can be connected to the modular series. The various I/O modules allow for optimum manual/emergency operation of various plants and thus offer service operation for technical personnel in the event of emergencies. Engineering, commissioning and service We provide professional software tools and a number of tested application blocks to engineer and edit automation stations. User-friendly function and application blocks in D-MAP (DESIGO Modular Application Programming) are the basis for engineering program functions. The application library was specified and tested in detail and is configured for your project and your application. The blocks correspond to GAMP software category 4; as a result, only the application needs to be validated for your project, significantly speeding up validation as a whole. The graphical user interface of the software tools guarantees efficient handling. Trend, reporting and analysis functions support commissioning. Professional software tools Long-term experience DESIGO is based on many years of experience in building automation and control and the pharmaceutical industry. D-MAP and all system functions are proven functions employed successfully in hundreds of projects. Ventilation plant 13 Volume flow controller for laboratory fume-hoods DESIGO™ – for top-notch Security, Energy Efficiency and Comfort in Laboratories Secure and efficient control of laboratories places high requirements on building automation and control. Thanks to its comprehensive LabManagement solution, DESIGO™ offers the highest possible energy efficiency, security and comfort for laboratory ventilation. Sensor to acquire the front slider position of the lab fume-hood Lab rooms comprising fume-hoods represent the heart of a lab. We offer a comprehensive solution for each lab and each fume-hood based on DESIGO™. Top-notch quality, flexibility and cost efficiency is guaranteed by means of the global LONWorks communications standard and components from the DESIGO system. Operating unit for laboratory fume-hoods 14 Security The system offers maximum control stability and accuracy combined with fast damper actuators and accurate volume flow control. Sophisticated monitoring of the entire system along with the volume flows allows for immediately detecting any system errors or problems with lab operations, alerting the operator to the events. The messages are displayed clearly on the DESIGO INSIGHT manage ment station. Efficiency Saving energy and costs begins in the planning phase and ends in ongoing optimization of the laboratory. Each cubic meter of air that does not need to be treated positively influences your energy balance. Nevertheless, this cannot be at the expense of security, and regulatory requirements e.g. on air change rates must be upheld at all times. DESIGO is able to support all of these tasks, and we will support you to exploit your building‘s energy savings potential through competent consultancy for building planning and operational optimization. DESIGO – LabManagement Comfort Simple and functional operation is prerequisite to secure and comfortable operations. Reliable reduction of drafts, avoiding ventilation noise emissions, and stable temperature control significantly impact performance of personnel working in such environments. DESIGO offers intuitive operation of all room functions together with lighting and blinds control, allowing you to focus on your core competencies. Integrated precision and system stability ■ The front slider position in the fumehood is recorded to determine the fume-hood volume flow setpoint. Compensating for external influences significantly improves system stability. ■ Acting pressure procedures are applied to volume flow measurement for fumehoods and labs. High-precision pressure sensors calibrated and monitored automatically are used as sensing elements. ■ Highly dynamic actuators with integrated damper angle measuring equipment are used to position the damper. ■ The setpoint for room supply air volume flow is formed via the volume flow balance of the entire extract air to increase system stability within the laboratory. 15 Siemens Ltd Building Technologies Units 1006-10 10/F, China Resources Building 26 Harbour Road HK - Wanchai Tel. +852 2870 7888 Fax +852 2870 7880 Siemens Building Technologies Ltd Hawthorne Road Staines Middlesex TW18 3AY England Tel. +44 1784-46 16 16 Fax +44 1784-46 46 46 www.sbt.siemens.com/uk Siemens Pte Ltd Building Technologies The Siemens Center 60 MacPherson Road SG-Singapore 348615 Tel. +65 6490 6000 Fax +65 6490 6001 The information in this document contains general descriptions of technical options available, which do not always have to be present in individual cases. The required features should therefore be specified in each individual case at the time of closing the contract. Subject to change • Order no. 0-91999-en • © Siemens Switzerland Ltd • Printed in Switzerland • 20607 Ni/Ah www.siemens.com/buildingtechnologies-pharma Pictures with kind support of Spirig Pharma Ltd., Egerkingen, Switzerland Siemens Switzerland Ltd Building Technologies Group International Headquarters Gubelstrasse 22 CH-6301 Zug Tel. +41 41-724 24 24 Fax +41 41-724 35 22 www.siemens.com/buildingtechnologies