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Enhancing pharmaceutical industry compliance using building management systems technology

Maintaining the optimum working environment is essential for the pharmaceutical industry to help ensure the safe and compliant manufacture of medication. A modern building management system can be crucial to support that outcome, explains Paddy Gunn, pharmaceutical business development manager, Trend.

The pharmaceutical sector is under great scrutiny, primarily driven by the COVID-19 pandemic. Many people are more aware about drug production after following the development of and approvals for new vaccine and therapeutic treatments to help curb the virus’ potential spread. What might come as a surprise to many is that a Building Energy Management System (BEMS), which controls key building systems from air quality to lighting and more, plays an important role in helping to create an optimal production environment.

A well designed BEMS should be able to control and monitor important environmental parameters including temperature, pressure, relative humidity and ventilation. All these factors are important for safeguarding the quality of pharmaceutical products during manufacture and in storage.

 

Managing regulatory compliance
Put simply, maintaining a controlled environment is essential for all aspects of drug manufacturing, but there are difficulties that system specifiers need to overcome to deliver the best possible implementation. An important first step is to figuratively break down the walls between isolated systems and consider the production area from a holistic perspective.

Key factors to consider are complying to regulations, isolating airflow in critical spaces, meeting energy efficiency goals and supporting the well-being and comfort of employees. Properly managing this complex environment starts with an assessment of the space to identify potential improvements.

The pharmaceutical industry requires historic monitoring data to be easily retrievable for audit purposes to prove compliance with regulatory bodies, such as the European Medicines Evaluation Agency (EMEA). This data also needs to be secure, encrypted and linked to the ID of each drug batch for traceability purposes.

When considering indoor air quality and air flow, it is important to review air quality sensor data including delivery pressure, air volume and velocity. Maintaining these parameters is fundamental for creating an isolated airflow, which is essential to enhance containment to protect both staff and products from cross-contamination within a facility. Maintaining the correct air velocity is also critical to prevent interference with sensitive balances in weighing areas.

Energy efficiency is an increasingly important factor. It’s not just a matter of using more efficient equipment, it’s about adding intelligence to the equipment through the BEMS that allows for greater control of specific systems and spaces. For example, this may mean powering down part of a facility when unoccupied without interfering with the wider environment or increasing ventilation elsewhere for better occupant comfort.

It is also vital to establish the best possible monitoring and reporting to minimise system downtime, should an issue arise. For optimum results, all these factors must be considered as a whole and not simply as a series of individual unconnected activities such as an HVAC project, added to a lighting project, added to an energy efficiency project.

 

Bringing the past into the present
Many pharmaceutical facilities have legacy BEMS. For optimum efficiency and comprehensive operations, it is important to upgrade legacy infrastructure with a design that can help meet energy efficiency guidelines and enable best-in-class processes. Energy efficiency is an increasingly important part of the overall automation process delivered by a modern BEMS and may dictate some system upgrades.

Importantly, the proposed system must allow a large amount of design freedom to provide the most effective coverage. Connectivity, free programming and modularity, along with consistency of the solution for global and zone specific actions, are essential. The proposed system must be fully tested and documented to ease implementation, which can appear time consuming but it is essential to deliver an overall configuration that will deliver the required functionality. This, in turn, will accelerate and improve the efficiency of the installation.

 

Ensuring quality and performance
The two core facets of a modern BEMS, as far as installation is concerned, are quality of design and ease of installation. Other factors include operational efficiency and the level of optimisation the overall solution delivers. End users must also consider the full product lifecycle and the ease with which it can be upgraded.

Compliance is, of course, a global concern. For example, in the United States, audit trails, electronic records, signatures and system validations are regulated by FDA 21 CFR Part 11, while across the European Union there’s Annex 11, a Good Manufacturing Practice (GMP) guideline. Both sets of regulations can add pressure for system designers and integrators, too.

 

A trusted solutions provider
Maintaining air quality in a busy pharma manufacturing facility is mission critical. From a business continuity perspective, facility managers need to either consider that failure is not an option and have a standby system to immediately take over if issues arise or you guarantee a safe production stoppage until the required air quality parameters are re-established. This might not be acceptable when research shows that downtime is costing European manufacturers £180bn a year.

Implementing and maintaining a compliant and energy efficient environmental control system requires sector-specific expertise and access to the right tools and systems. The pharma sector should work with solution providers that have a proven track record of delivering bespoke solutions that fully meet the needs of their customers, now and in the future.

Find out more about Trend solutions here

Trend Control Systems is part of Honeywell Building Technologies. With a worldwide distribution and support network covering over 50 countries, Trend Control Systems is a major international supplier of building energy management solutions (BEMS).  The vast majority of Trend’s control systems are supplied, engineered and commissioned by approved systems integrators. Trend Control Systems is part of Honeywell Building Technologies.

  • Downtime costs UK manufacturers £180bn a year, The Manufacturer, Published: 17 October 2017 [Accessed: 12 January 2022]  supplied, engineered and commissioned by approved systems integrators. Trend Control Systems is part of Honeywell Building Technologies.