MANUFACTURING

Integrated building management
and process control

Walfried Laibacher, Honeywell Life Sciences

The Life Science industry around the world shares the same business goals – to satisfy regulatory compliance, deliver products to market ever-faster, and to keep manufacturing costs under control. But how best to do more with fewer resources, now and in the future? The key lies in process efficiency, the ability to combine building management and manufacturing process control into a single, streamlined system with a common set of procedures. Indeed, pharma companies are realising that automated architecture combining process and building management underpins optimal asset utilisation and cost reduction, critically without compromise to product quality and regulatory compliance.

Integrating key building management and process control technologies enables manufacturers to see the “big picture” and do a much better job of monitoring and controlling the environment at every stage of drug development and manufacture. Whether you’ve a single bioscience research laboratory or multiple manufacturing facilities around the world, an intelligent approach mitigates risk and reduces the impact of changes in temperature, humidity and air quality on product integrity. No surprise then that more companies are investing in integrated building and process automation systems.

Automated process controls deliver visibility and responsiveness. In making all relevant information accessible from one operating station, companies have the wherewithal to better manage the manufacturing lifecycle of a product. Automated process control systems can also have a significant impact on an organisation’s ability to improve productivity, product quality and safety. Concurrently, innovative building automation technology is helping to hone optimal facility and asset management. It is enabling holistic control of building (HVAC and air quality), security (access permissions, time and attendance monitoring, asset management) and life safety (fire detection) management – as well as electronic validation frameworks that ensure and prove regulatory compliance.

Whilst legacy BASs were developed as separate, standalone applications, the real power lies in managing them as one integrated solution. Bringing automated process control and automated building management control systems together acts as a catalyst enabling proactive management of the product development lifecycle; it harnesses all the key elements of good manufacturing – people, processes, materials, facilities, equipment, documentation and production – in one common solution for optimal drug discovery and production.

Out with the old

Working with multiple, standalone technologies for building, security and life safety restricts information to narrow silos, and slows response times in an emergency. Independent operation is characterised by nonexistent data exchange; it fails to leverage the full potential of all the data available. It limits the pharma manufacturer’s ability to make the building or plant function as a whole and makes it nigh-on impossible to implement proactive strategies that address business issues. Much confusion remains as to what actually constitutes an integrated system. Honeywell identifies four levels of process and building control integration:

Non-integration: automation by silo with controls such as HVAC, security, fire and manufacturing control working alone and independent of each other. This scenario is characterised by non-existent data exchange, lack of centralised event storage, high operating costs and expensive expansions.

Partial systems integration: still no real intelligence. Minor data exchange, separate control and scant central events storage make it difficult to validate for regulatory compliance. Operating costs and risk remain high.

Total facility integration: inter-operation between building management and process control systems with a common platform for the development of applications that are scalable, robust and manageable from a single point of control. Integration delivers peer-to-peer control, full data management and centralised events storage. Embedded intelligence cuts operating costs and risk and improves functionality/efficiency.

Enterprise-wide integration: the ultimate panacea supporting the transition from sharing information to managing it. Utilising a common platform, this business model supports workflow processes, complete systems’ inter-relationships, central alarm management and maximum control over security and life safety functions. It delivers performance improvement without detriment to service level.

Integrating core building automation systems and process controls supports process efficiency. Sharing information between departments, core building management and process functions supports an enterprise-wide view. It enables automated control processes to perform on the basis of all available information within the different systems – increasing productivity yet reducing energy use, installation and operating costs and risk at every stage.

Want more visibility and control?

Changing security and regulatory standards also exert pressure on companies to implement a system with a high degree of visibility and control. In the biosciences in particular it is important to manage and track all aspects of production, thereby enforcing good manufacturing practices. For pharma manufacturers, calorimetry and other temperature sensitive processes put emphasis upon sound deviation handling capabilities to manage out any potential issues. This scenario shows the importance of integration with proven environmental control solutions as the information can then be used within the Manufacturing Control System (MCS) to improve cycle time, yield, schedule attainment, asset utilisation, quality rate and throughput.

Likewise, self-documentation, electronic change management of control configurations and enforcement, and verification of operating instructions, enable an automated system to facilitate validation for regulatory compliance. Electronic record-keeping with electronic signature more than pays for itself in this respect. It is vital that process and asset management tools continuously assess the health of the sensors and all other factors with the potential to impact product integrity. The ideal solution will proactively enforce best practices, quality controls and regulatory compliance. It will monitor the system 24/7 all the time helping to avoid the risks, costs and time delays of waste and errors.

A measurable ROI

Collaborative building management and process control delivers two key advantages: it facilitates advanced control and monitoring and it pulls all facility information on to a single screen. This enables operators to quickly evaluate and influence operations. It helps them to make sense of a lot of information.

An intelligent building and process management system incorporating access control, CCTV and process automation control can, for example, leverage data contained within an ID badge. It can bar entry to a clean room – even stop production – in the event of unauthorised entry or lapsed training credentials. Any attempted breach in security automatically triggers CCTV surveillance and digital video recording of the alarm incident. Likewise it can watch over people working alone in a hazardous environment or deny the untrained access to dangerous equipment. Automatic alerts can also be generated in the event of a process control system being accessed by a key cardholder fraudulently using a second key card to make system changes under a different name. Even though this second card would, in principle, permit access to the PCS, process control login is denied because the corresponding key owner has not physically entered the control room.

Unlike standalone systems which would necessitate three different process steps, the access control event generating an alarm in one database with video recording in another and manual intervention to change the plant process – an integrated solution sees all these events built into a single screen/alarm notification. Verification between the different applications only serves to enhance security in a regulated manufacturing environment.

The bigger picture

Smart automation control technology enables the life sciences to satisfy seemingly conflicting goals. Tapping into the big picture brings with it the means to optimise building and production management while bundling information provides operators with the information needed to quickly evaluate and better respond to events. Manufacturers can also tie these systems into core functions. A 30% improvement in operator efficiency. Having one platform for multiple automation control makes for simplicity; it reduces risk of human error and cuts down on training time. An enterprisewide view also helps operators to make sense of a lot of data – real and/or historical time.

The possibilities for integrating security with enterprise systems are virtually limitless. Time and attendance monitoring can provide an electronic feed to HR and payroll – useful to those manufacturers operating around the clock. An intelligent system also help to cut energy costs. Facility managers can analyse occupant information and compare energy consumption with the real-time costs of using internal co-generation or outside utilities. Card reader data can verify occupancy levels throughout a campus, allowing the system to automatically adjust HVAC and lighting accordingly.

How to get it

It is clear that the strength of intelligent technologies lies in data gathering, analysis and reporting. From this comes optimal process efficiency. You’ll need to establish an Operations Centre to manage the integrated building management and process control functions. Ideally, the shared platform should be designed to support converged networks – TCP/IP networking and web-based interfaces – and connects with the appropriate process and building systems and IT databases. Wireless technology is another consideration as it will allow you to make changes without the additional time and costs associated with hard-wired installations.

That said, owner involvement is a prerequisite. Be clear about your needs, goals and expectations during the initial planning/design phase and through implementation. Design, construction and integration of the process equipment and interfaces are crucial to ensuring that collected data is relevant and representative of process and product attributes. Work with an integration partner that understands integration at the highest level and can factor in such variables as desired financial goals and the need for local and regulatory compliance – now and in the future.

In order to build a strong case for integration, look at how new integration technologies and techniques will benefit both the company as a whole and the individual stakeholders – the many production and facility managers responsible for multiple buildings – who must work together to make it happen. A comprehensive lifecycle cost/benefit analysis is key to soliciting buy-in to the potential of intelligent technology. Since departments often compete for limited resources, working together towards the same goal is vital. Adopting an holistic approach and involving the different facets of a company makes it possible to convince decision-makers that integration will deliver a measurable return on investment. Look to an integration provider to help develop business models showing a measurable ROI. With a realistic case made, the evidence for integration in the quest for optimal drug discovery and production cannot be ignored.

Inspired by the goals of optimising performance and providing paperless recordkeeping, Process Control Systems (PCS) and Manufacturing Execution Systems (MES) have improved manufacturing operations for many lifescience companies worldwide. Fuelled by the adoption of industry standards and advances in technology, these two systems are providing plants with a high ROI. The MES is widely regarded as an IT system because of its commercial software, servers and applications, and the PCS as an engineering function for its control and alarm monitoring capabilities.

Systems that operate independently of one another, however, are not enough to answer the changing requirements of the lifesciences industry. To improve operational performance, plants require a seamless, synchronised system architecture that provides benefits such as common electronic batch records, common exception reporting for automation and production management with resource traceability. Merging PCS and MES to create a Manufacturing Control System (MCS) is an effective way to achieve these requirements, while generating a streamlined, more consistent operation. It also provides more efficient control of unit operations. For these reasons, MCS could emerge as the new standard manufacturing solution by 2010.

Walfried Laibacher

Walfried Laibacher holds a diploma of applied sciences for electrical engineering. Based in Germany, he oversees Honeywell’s specialist validation sales and engineering teams, ensuring that they apply common validation practices for environmental conditions to the company’s growing pharmaceutical customer base. This includes on-site project support. Since joining Honeywell in 1988, Walfried has held several positions in software development, from software engineer to project leader for HVAC and Building Management Solutions in an SEI CMM Level 3 certified organisation.

As member of the GAMP D-A-CH Community of Practice he contributes to its Special Interest Group (SIG) on “Co-operation Models between Users and Suppliers”. For more info please contact Walfried at: walfried.laibacher@honeywell.com

www.honeywell.com

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