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How can I reduce life cycle costs and minimize risks?
Integrated cleanroom solutions increase protection and reduce costs through optimized safety, security, efficiency and regulatory compliance.
Answers for infrastructure.
How can I meet the growing requirements placed on cleanrooms? Whether due to high-risk substances and processes or the most stringent quality standards – cleanroom environments place the very highest demands on the protection of products, people and the environment. The building’s infrastructure sets the general parameters for these demands. Cleanroom solutions from Siemens minimize risks, increase efficiency and ensure verifiable compliance with all relevant regulations. They integrate all the areas of building technology required to control and monitor cleanrooms, thus ensuring maximum safety and security and high levels of system synergies that will pay off for many years.
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How do I benefit from integrated cleanroom solutions? ■ Long-term investment protection thanks to networking across all systems The protection of personnel, product quality and the environment depends on environmental conditions. That’s why Siemens combines all systems in a comprehensive solution tailored to your specific needs and degrees of purity – from HVAC plants to safety and security technology. This approach is clearly superior to operating parallel systems: it reduces complexity, speeds up fault correction, provides valuable information for making decisions, and ensures optimal, efficient production conditions over the long term. ■ High efficiency through reduced complexity Siemens integrated solutions are based on a standard IT infrastructure and offer a common user interface for the entire building infrastructure. For you, that means simpler operation and reduced personnel and training costs. In addition, each integrated system has a limited amount of data that can be linked and processed into information. Because the only information displayed is that which is required for a specific task, security personnel can assess a situation and respond quickly and correctly. ■ Important support for decisions thanks to intelligent data evaluation Data evaluation across systems ensures a high level of transparency and simplifies the search for optimization opportunities, for example by supplying informative overviews of all types of energy usages and costs for electricity, heat and refrigeration. In addition, automated occupancy plans and individual reports simplify operation. Plant-specific disturbance statistics provide a solid basis for continuous
optimization. Preventive maintenance reports allow the best possible scheduling of repairs and maintenance. And thanks to the comprehensive display of all GxPcritical environmental parameters, these can be monitored in a targeted way. ■ Tested integration solutions for long-term regulatory compliance By networking the different systems via internationally standardized interfaces and protocols such as BACnet, LON, OPC and M-Bus, cleanroom solutions from Siemens guarantee compatibility throughout the entire life cycle. Moreover, the compatibility of Siemens-certified interfaces is already tested ex works. ■ The security of a strong partner With an extensive network of cleanroom experts and in-depth solution expertise, Siemens provides reliable support throughout every phase of your project. Right from the planning phase, the comprehensive experience and complete expertise of a strong partner are at your disposal. Your project will be completed reliably and on time. Even after the systems are in operation, you will continue to receive the support you need.
Highlights ■ High efficiency and investment protection through scalable cleanroom solutions for all building services ■ Reduced complexity, increased operational safety and clear criteria for making decisions ■ Proven compatibility throughout the entire operating phase thanks to Siemens-certified interfaces ■ Comprehensive support and cleanroom expertise for planning, implementation and operation
Cleanroom solutions from Siemens cover a broad range of applications, including nano, electro and surface technology, pharmaceuticals, medical technology and hospitals as well as laboratories and the food and beverage industry.
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How do I protect people and values and avoid downtimes? Whether for access control, fire protection or evacuation – integrated cleanroom solutions from Siemens reliably protect your personnel and assets, thereby increasing your efficiency. ■ Cleanrooms call for highest safety and security Long-term safety, security and successful production can be achieved only when you reliably protect your personnel and valuable production assets against hazards. Cleanroom environments require technical protective measures at the highest level. The handling of toxic and highly active substances, the use of hydrogen peroxide as a disinfectant or the risk of dust explosions all contribute to a greater fire load. Cleanroom solutions from Siemens offer you maximum protection against these hazards. ■ Integrated personal protection – indoors and outdoors – Precise control and monitoring of lowturbulence air flow volumes (T, F, P) – Control of cleanroom pressure differentials depending on substance activity – Monitoring of overflows and flow directions – Control of air exchange based on measured gas concentration – Integrated access control systems to avoid cross contamination caused by persons and protect the product
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– Centralized recording of user activities and a clear overview of all persons present – Integrated monitoring of emissions into the environment ■ Integrated fire protection – from detection to extinguishing – Foolproof fire detection based on intelligent fire alarms, providing reliable protection against false alarms while offering maximum detection reliability thanks to ASAtechnology™ – Detection characteristics specific to cleanrooms and an environment with high air exchange rates – Aspirating smoke detectors for earliest possible fire detection in the presence of high air exchange rates – Automatic extinguishing systems based on chemical extinguishing agents or combined gas-water solutions for insulators, safety benches or laboratory fume hoods – Guided operation and automated actions in hazardous situations
■ Integrated explosion protection – everything for explosion-hazard areas – Ex-protected measuring transducers for connecting Ex-protected and safe areas – Ex-protected field devices such as damper and valve actuators – Ex smoke detectors, thermo-differential detectors, flame detectors and manual call points – Safety barriers for intrinsically safe fire protection installations in Ex-protected areas – Comprehensive application guidelines for HVAC control and fire protection in Ex areas – Expert support for planning, development and implementation in Exprotected areas
■ Rapid alarm intervention Integrated cleanroom solutions permit rapid and efficient alarm intervention. Any deviation from the normal status is immediately indicated both visually and acoustically. Intelligent algorithms differentiate between the initial and subsequent alarms. Integrated video surveillance systems permit direct viewing of the cause of the alarm. In addition, standardized, intuitive operation ensures error-free responses even under stress: The user has only one interface for all of the integrated systems. Both alarm escalation and alarm forwarding are performed in the same manner for all systems.
■ Integrated evacuation – clear announcements in emergency situations – Safe, rapid evacuation based on a voice alarm system – Verbal description of the emergency situation and clear instructions on how to proceed – Optimized building evacuation in phases in line with the local hazard – Differentiation between the order to evacuate and pre-evacuation information – Digitally-stored voice alarms as well as live announcements when necessary
Highlights ■ Rapid, efficient intervention thanks to immediate alarming, video images and standardized, error-free operation ■ Maximum safety and security through the integration of personal, fire and explosion protection plus evacuation
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How can I optimize the efficiency of my cleanrooms without compromising product and personal protection? Integrated cleanroom solutions reduce life cycle, operating and energy costs over the long term while increasing protection for personnel and products. ■ Cost advantages in every phase With integrated cleanroom solutions, you benefit from simplified planning because the interfaces and functionality are already defined. At the same time, using standardized solutions reduces the time and effort needed for coordination. Implementation is extremely efficient as well. Despite the solution’s comprehensive functionality, it can be implemented economically, rapidly and reliably. That’s because the range of functions is defined early on, and there is no need for project-specific integration solutions. An additional advantage: comprehensive analyses performed during the planning phase mean that fewer modifications will be required during implementation. Validation is also simplified. Only systems that have a direct impact on product quality are validated and the solutions used are preconfigured and pretested.
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■ Optimized operating costs The operating costs of the building infrastructure throughout its life cycle are about seven times higher than the initial investment. That’s why Siemens already takes the operating phase into account during planning. Moreover, integrated cleanroom solutions make it possible to periodically analyze and exploit optimization potential during operation.
■ Lower personnel costs with higher functionality An integrated solution requires only a small number of trained personnel to reliably run the entire building infrastructure. What makes this possible, for example, is simple, standardized operation, automatic focusing on important information and direct access to all systems.
Investment costs – – – – –
Planning costs Coordination costs Modification costs Implementation costs Validation costs
Operating costs – – – – – – –
Energy costs Personnel costs Maintenance costs Downtime costs Out-of-spec costs Modernization costs Change-of-use costs
■ Innovative approaches for lower energy costs Heating, air conditioning and ventilation technology account for up to 70% of the total energy costs for cleanrooms. Consequently, the only way to lower energy costs is to optimize these systems. Siemens is an innovative leader in this area, providing such functions as the control of air exchange rates based on particle concentration, the detection of necessary overflow and demand-driven, dynamic adaptation of control to the processes.
■ Optimized maintenance and fewer downtimes The integrated solution approach optimizes maintenance scheduling. Various parameters can be examined together and necessary service measures can be scheduled at the same time. In addition, comprehensive performance indicators provide information on necessary maintenance jobs well in advance and reduce unscheduled plant downtimes.
Highlights ■ Increased planning security through standardized solutions ■ Reduced implementation costs despite extensive functionality ■ Efficient operation thanks to standardized user guidance and direct access to all technical equipment ■ Reduced energy costs through demand-driven control including monitoring and control of particle concentration and flow direction ■ Optimized maintenance scheduling and prevention of unscheduled downtimes
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How can I use regulatory requirements as a competitive advantage? With integrated cleanroom solutions, you can verify regulationcompliant product quality and obtain essential information for optimizing your processes. ■ Validation requires expertise Successful validation is possible only when there is comprehensive expertise in the area of regulatory requirements, relevant system parameters and the interrelationships between the two. Such expertise requires detailed product and process know-how to be able to reliably determine factors that potentially influence patient safety and security, product quality and data integrity. Siemens therefore supports you in the validation process with technical functions, but also with in-depth knowledge plus extensive experience and documentation.
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■ Validation services Thanks to Siemens’ cooperation with and participation in ISPE and GAMP groups, we can support you in the evaluation of site-specific factors impacting product quality for the entire infrastructure. This includes, for example, the analysis of crucial influences on product quality and risk analyses for modernizations and functional changes.
■ Technical functions to ensure regulatory compliance With the precise control of volume flows, solutions from Siemens provide you with the optimal basis for achieving the necessary cleanroom class. Compliance with specified limit values is supervised through a preset alarm threshold, analysis options and automatic calibration information.
The unique Advantage™ Services Program gives you access to additional comprehensive services for maintaining the validated state of your entire building infrastructure. In addition, Siemens offers specific validation training courses for you and your personnel at the Siemens Life Science Academy.
As proof of production quality, the cleanroom solutions integrate continuous particle counting as well as the monitoring and long-term archiving of all qualityrelated environmental parameters. The hygienic purity of raw materials and finished products is protected by reliable access control and video surveillance. Comprehensive reports provided by the InfoCenter cleanroom monitoring system document all quality-related parameters of the building’s infrastructure, alarm and disturbance statistics as well as audit trail information.
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■ Expert support for rapid and efficient validation The latest validation recommendations, such as GAMP 5, suggest that expert suppliers be involved in the validation process whenever possible. Siemens has fully integrated these functions in the Electronic Validation Tool (EVT). The EVT increases the efficiency of validation services by up to 20% while simultaneously improving quality. It supplies detailed information via an intuitive user interface and permits comprehensive document management. Finally, the EVT provides an extensive library of complete application and validation documents.
■ Regulatory aspects of the technology used Naturally, Siemens’ cleanroom solutions take official requirements into account: – Physical and/or logical split between validated and non-validated systems – Tamper-proof storage of all qualityrelated data throughout the entire life cycle – Unambiguous access protection with password complexity and aging – Integrated audit trail to record all changes made to quality-related data – Implemented technologies for the backup and archiving of quality-related data – Consistent change management and analysis of the impact on the complete system
Highlights ■ Optimized validation through detailed knowledge of qualityrelated parameters ■ Assured compliance with specified limit values thanks to precise control, analysis and advance warning ■ Verifiable production and product quality through monitoring, longterm data archiving, access control and report function ■ Increasing validation efficiency up to 20% thanks to the Electronic Validation Tool EVT ■ Compliance with all regulatory requirements
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Standardized interfaces and certified solutions ensure integration over the entire life cycle.
Total Building Solutions (TBS) – for more intelligent, more productive buildings Cleanroom solutions are part of Siemens’ TBS concept for perfect coordination of all technical building systems. ■ Reduced complexity through total integration Total Building Solutions are based on a standard IT infrastructure – with protected operation from any location. All systems of the technical building infrastructure are integrated, including heating, ventilation, air conditioning, refrigeration system, electrical systems, access control, video surveillance, fire detection, alarming, evacuation and lighting. Additional building technology, such as elevators and technical laboratory systems, can also be integrated via standardized interfaces.
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■ Long-term security thanks to standards and certification Total Building Solutions ensure the reliable functioning of integrated systems throughout their entire life cycle – with no unpleasant surprises, for example when the first update is installed. This security is based on the rigorous application of internationally standardized interfaces such as BACnet, LON, OPC and M-Bus. The second essential requirement is met through the systematic certification of the integration interfaces in the TBS certification center from Siemens.
Highlights ■ Reliable integration thanks to Siemens-certified interfaces throughout the entire life cycle ■ Individual autonomous functions as well as data transparency across all systems ■ High flexibility thanks to internationally standardized technical interfaces
A wide range of products for an integrated cleanroom solution from Siemens To ensure optimal cleanroom operation, Siemens combines a wide range of products and systems into a single comprehensive system solution.
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Fire detection
Thanks to intelligent ASAtechnology, Sinteso™ S-LINE fire detectors provide exceptionally precise and rapid fire detection and alarming. If air flows or air conditioning and ventilation systems prevent smoke from reaching the fire detectors, aspirating smoke detectors ensure earliest possible detection. In addition, the Sinteso Video Fire Controller transmits live images, allowing you to visually assess the situation. The recorded images permit subsequent analyses and a clarification of the cause of an event.
Video surveillance
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The video surveillance system monitors sensitive areas and records the processes before and after an event. If the system detects a critical deviation, such as unauthorized persons, it automatically transmits an alarm to the control center and activates the camera in the relevant area.
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Air flow measurement Whether monitoring the laminar flow unit or measuring overflow, thermal flow sensors reliably measure the flow speed and record the flow direction. This enables a dynamic adjustment of air exchange rates and a continuous monitoring of the flow.
Airlock Interlocking System (AIS)
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The Siemens Airlock Interlocking System (AIS) – the integrated airlock control based on LOGO! microautomation offers numerous advantages: The entire airlock control system operates autonomously and can be quickly and flexibly adapted to individual requirements. Integration additionally enables features such as locking by the gas detection technology and dynamic adjustment of purge times. Integrated access control reliably controls people flow.
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Environment monitoring with CMT Compact Monitoring Technology (CMT) reliably monitors room conditions and particles in critical environments. A preconfigured control cabinet contains all the components necessary for data acquisition, visualization and archiving. Operation is done via an integrated touch panel or networked PC. Additionally, linking to an airlock control system or presence detectors, for example, is also possible. CMT ensures compliance with FDA Rule 21 CFR Part 11.
Particle measurement EU GMP Directive Annex 1 requires continuous particle measurement for class A cleanrooms and recommends it for class B cleanrooms. The integrated solution from Siemens not only permits simple monitoring and analysis of measured values from all channels, but also uses the information to dynamically adjust air flow rates and thus substantially reduce energy costs.
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Room control Convenient room displays provide a quick overview of critical room parameters. Warnings and limit value violations are automatically highlighted by a change in color. In addition, critical alarms are displayed in plain text. 4 1 3
HVAC control For many years, reliable controlling and monitoring of all parameters concerning ventilation and air conditioning has been a core competency of Siemens. Exact, modulating magnetic valves for drop-by-drop precise control, dynamic pressure and volume flow controls as well as calibrated humidity and temperature sensors are just a few examples. High product quality and reliability are combined with highest possible energy efficiency when operating a building’s largest energy consumers.
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Lighting Only buildings with highly integrated building automation systems can qualify for energy efficiency class A. The integrated solutions from Siemens offer the best platform for achieving this distinction because the demand-driven adjustment of light and shadow is a basic component of our cleanroom concepts.
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The entire building technology at a glance Thanks to Total Building Solutions, you can view your entire technical infrastructure on a single screen. This has many benefits, including intuitive operation, common alarming, rapid intervention and optimized maintenance scheduling. Plus, Siemenscertified interfaces ensure that your systems operate reliably throughout their entire life cycle.
Intuitive navigation through the entire building infrastructure
Comprehensive overview of the communication status of autonomous substations
Detailed overview of the various cleanroom zones
Status of fire detection technology and gas detection in the Ex area
Direct view inside the plants with integrated video surveillance systems
Complete overview of the refrigeration system
Comprehensive overview of the entire electrical infeed
Uninterrupted, securely monitored power supply
Intuitive operation of the ventilation systems in 3D mode
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Answers for infrastructure. Megatrends driving the future The megatrends – demographic change, urbanization, climate change and globalization – are shaping the world today. These have an unprecedented impact on our lives and on vital sectors of our economy. Innovative technologies to answer the associated toughest questions Throughout a 160-year history of proven research and engineering talent, with more than 50,000 active patents, Siemens has continuously provided its customers with innovations in the areas of healthcare, energy, industry and infrastructure – globally and locally.
Increase productivity and efficiency through complete building life cycle management Building Technologies offers intelligent integrated solutions for industry, commercial and residential buildings and public infrastructure. Over the entire facility’s life cycle, our comprehensive and environmentally conscious portfolio of products, systems, solutions and ser vices in the fields of electrical installation technology, building automation, fire safety and electronic security, ensures the: – optimum comfort and highest energy efficiency in buildings, – safety and security for people, processes and assets, – increased business productivity.
Siemens Switzerland Ltd Industry Sector Building Technologies Division International Headquarters Gubelstrasse 22 6301 Zug Switzerland Tel +41 41 724 24 24 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. © Siemens Switzerland Ltd • Order no. 0-92176-en • 3,50903 Ah
www.siemens.com/cleanroom