Cleanrooms and labs: A system to meet all needs
Cleanrooms and laboratories are resource-intensive working environments where high-risk substances are researched and produced according to the strictest quality standards. Intelligent building technology solutions ensure validated conditions in workspaces, and protect both people and the working environment.
Quality control and protecting both people and the environment are utmost priorities in the production of medicines. For this reason, intelligent building technology solutions should be installed to create and continually document the precise operating conditions validated for production processes. At the same time, the systems should also be able to detect and eliminate all inherent risks – such as gradual changes to the environmental or production conditions due to worn-out or defective components – before any damage even occurs.
Developing new drugs is a costly and time-consuming process. On average, it takes between eight to twelve years until a new drug is approved with just the right combination of ingredients, and launched on the market. The work leading up to that may involve developing and testing up to 100,000 different substances, formulae and combinations in the laboratory under strictly regulated conditions. Naturally, patient safety is a constant focus in work of this kind. Which is why the stages of research, development and manufacturing are subject to strict international guidelines such as Good Manufacturing Practice (GMP) or the European Good Automated Manufacturing Practice (GAMP 5). These guidelines recommend building technology for protecting laboratories and production facilities as effectively and efficiently as possible from all factors that might compromise quality or safety during manufacturing.
Protection for staff members, the drug itself, as well as the environment, is of vital importance and must be ensured throughout the entire production cycle. In order to reduce the risk of injury or contamination as far as possible, building management systems continuously monitor the laboratory’s fume hoods, thereby protecting precise pre-defined zones. They control the fume extraction depending on requirements and prevent the formation of contaminated or explosive substances and uncontrolled reflow back into the room. In addition, particle counters instantly detect suspended particles in the air that may be damaging to either the environment or the production process. The systems then adjust the air exchange rate dynamically to lower the concentration and ensure safe levels are restored.
Validating working conditions
In the interests of public health, and to promote safety in cleanrooms and laboratories, regulatory authorities require tamper-proof, documented evidence that parameters such as temperature, moisture levels, air pressure, airflow speed and particle emissions are adhered to and validated. To achieve this, precise sensors are capable of continually monitoring up to one-hundred process-critical, quality-related environment parameters. These sensors have been specifically certified for the purpose and feature significantly lower measurement tolerances than similar sensors used elsewhere in building automation.
Data processing is conducted using intelligent algorithms. If a validated upper or lower limit is exceeded for one of the environment parameters, an alarm is signaled immediately. Whenever a staff member makes adjustments to the system, this must be recorded and fully documented. Each user must identify themselves with a unique name or code word, or alternatively, biometric methods may also be used. Seamless protocoling is completed automatically via audit-trails, while a 'mandatory comment’ function requires users to indicate any reason for a change. All of this enables the highest degree of transparency.
All throughout the lengthy period from the development of a new drug to its eventual market launch, an abundance of data is generated, which all has to be archived in a non-proprietary format. After all, transparency can play a decisive role in the pharmaceuticals industry. At the same time, global cooperation in research and development, and collaboration and production across numerous locations require sensitive and secure handling of the ever-increasing volumes of data. To respond to this demand, Siemens developed its Compact Monitoring Technology (CMT). Developed on a risk-based approach utilizing standard technologies, this is a GMT-compliant solution that can be adapted to suit the individual needs of life science facilities.
CMT records the vast volumes of data from various life science facilities on an hourly, daily and weekly basis in compliance with regulations, and stores it in a tamper-proof manner. The data is then analyzed according to the project's specifications and processed automatically. In the event of a fault, this means that all prior processes can be traced.
Protecting sensitive workplaces
Security is an integral part of modern life. Protecting people and assets from a wide variety of dangers and influences is a primary concern for all businesses. Security is not only a pressing issue for the chemical and pharmaceutical industry – scientific facilities researching new drugs and substances also contend with high risks. In addition to creating the ideal conditions in the workplace, a building management system also guarantees the safety and security of cleanrooms. This starts with access control, as cleanrooms and laboratories contain raw materials, intellectual property and valuable finished property – all of which must be protected from tampering, industrial espionage and theft. As well as this, the system covers fire protection and danger management. In order to ensure the necessary transparency on-site, building management systems also monitor and control all subsystems from heating, ventilation and air conditioning to fire protection, security systems and perimeter protection, thus optimizing operations for energy efficiency.
This combination of access control and video monitoring means facilities can, for example, effectively prevent unauthorized persons from gaining access to buildings. By linking access profiles to the building management system, it is also possible to control lighting and air conditioning according to the individual needs of various user groups. Depending on the location, certified smoke, heat and flame detectors for explosion-protected zones monitor areas subject to fire and explosion hazards. The very first signs of any incident are detected within seconds by dedicated fire protection systems, and the extinguishers are activated automatically.
An integrated building management system allows constant higher-level monitoring of the operating states of the fume hoods, any alarm conditions and any drop in the pressure of the extinguishing medium in the event of a fire. It is even possible to automate certain processes in emergency situations and adapt them to suit the individual needs of the environment. For example, an increase in toxic gas concentration levels can automatically increase the volume of air extracted from the room, or exterior window blinds can be raised in the event of a fire being detected. This supports fire fighting efforts and gives the fire services a better overview of the situation. Evacuation and voice alarm systems can also be integrated to reduce the potential for panic and guide people safely out of the building. The evacuation procedures are automatically adapted according to the scale of the incident and the current situation at the location, while the personnel receive clear and precise instructions – all of which assists the emergency response.
Safety through integration
Efficient operation and rapid intervention require transparency and full integration. A range of subsystems must be integrated into an intelligent building management system that provides a clear overview based on information from thousands of data points. This is why Siemens developed Desigo with its unique integrated building management platform Desigo CC that combines all data sets supplied from each individual system within a building, and displays them clearly in relation to each other. This makes it easier to control, monitor and optimize each individual system. Which can make all the difference in the life science industry, with its strict guidelines and regulations and means that laboratories and cleanrooms can be operated as economically, conveniently and safely as possible.
Author: Roland Hensel
Picture credits: © iStock.com/dmbaker, © Siemens AG
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