Managing Regulated Environments
A regulated environment is a precisely controlled environment where strict standards, rules or regulations dictate its functioning. Regulated environments tend to involve the use of sensitive and high-risk substances, such as laboratories, production facilities and cleanrooms, and are commonly used in the life sciences and pharmaceuticals industry.
Many international guidelines and protocols recommend using high-level building technology to meet these requirements. Such technology is characterised by precise monitoring systems and alarm applications, reliable functionality and fast communication processes. It is designed to:
- guarantee quality control;
- ensure safety;
- enhance transparency;
- enable documentation;
- mitigate risk; and
- increase security
Guarantee quality control and ensure safety
Quality control is essential in a regulated environment. Not only does this ensure the integrity of the environment (and everything in it), but it equally ensures the safety of its occupants.
For these reasons, state-of-the-art air-handling systems are indispensable.
For example, continuous monitoring of fume hoods and the control of fume extraction is of utmost importance in environments dealing with chemical or toxic substances. A BMS endowed with the appropriate hardware and technology will prevent contamination and direct airflow for optimum safety. At the same time, particle counters operate instantaneously to detect suspended particles in the air that may be damaging to the laboratory environment.
The BMS can adjust air exchange rates in both systems simultaneously to lower the concentration of the particles and restore the laboratory environment to safe operating levels.
Enhance transparency and enable documentation
Many regulatory authorities require documented evidence that strict parameters such as temperature, moisture levels, air pressure, airflow speed and particle emissions are adhered to and validated. More often than not, documentation is critical because it increases transparency.
This is especially so in the pharmaceutical industry, where drugs and vaccines ultimately end up on the market for consumption.
For example, the World Health Organisation Recommendations for the production and control of the influenza vaccine requires that the vaccine be stable at the recommended storage temperature. Manufacturers and researchers must demonstrate their compliance to the satisfaction of the national regulatory authority.
Recommend storage temperatures are input into the BMS so that the vaccine is stored at the precise temperature. Using precise sensors with low measurement tolerances, the BMS can continuously regulate, maintain, and document the temperature, evidencing compliance.
Security is important for regulated environments. This applies to data security as well as user security.
Take drug research and development for example. It takes, on average, between eight and twelve years to research, develop and launch a drug onto the market. During this time, up to 100,000 different substances, formulae and combinations are developed and tested. An abundance of data is generated over this time, collected, collated and monitored via the BMS.The BMS ensures sensitive and secure data handling, transfers, archiving and storage.
What about user security? Occupants and staff must luse unique codes or identifiers to access and make adjustments to the system. An ‘audit-trail’ of user activity and system changes are documented and retained for complete transparency and to avoid data tampering.
Regulated environments are inherently risky. A BMS can detect changes to environment or production conditions. These can be both immediate or gradual changes.
For example, gradual changes in worn-out or defective components are detected before any damage even occurs. Efficient alarm triggering and automated response mechanisms mitigate risk.
Similarly, an increase in toxic gas concentration levels automatically increase the volume of air extracted from the room. If the level of toxicity reaches alarm levels, evacuation and voice alarms will notify occupants and guide them safely out the building.
An integrated BMS solution to meet all needs
Dedicated, high-level equipment and systems are important, if not necessary, for regulated environments. But like all building environments, comfort levels, lighting, energy consumption and cost efficiencies are important too.
An integrated BMS solution ticks all of these boxes – regulatory or not, to meet the various needs of owners and occupants alike.
Desigo CC is an integrated building management platform that helps companies to perfect the balancing act between efficiency, safety and regulatory compliance for regulated environments. Not only does the platform integrate various automation systems and disciplines (such as lighting and HVAC systems), it also features intelligent software specific to regulated environments: specifically clean rooms and laboratories.