Regulations And The Mission Critical Facility
Read on for ways to negotiate the increasing, and often clashing, regulations for food and pharmaceutical mission-critical facilities.
The pharmaceutical and food industries are heavily regulated — now more than ever. How food and drugs are stored — often in large mission critical warehouses — isn’t just a matter of public safety; it very well can be a matter of life and death.
Because of the importance of these industries for life and health, it is a bit of a surprise to learn that other mission critical facilities, such as data centers, are often more sophisticated than some food and pharma warehouses in their approach to planning, maintaining, and measuring temperature controls. Often, the warehousing segment of the food and drug industries ends up leasing space in a facility originally intended for storing non-temperature-sensitive products like toys or toilet paper.
A frequent, but often misguided, solution to retrofitting these existing facilities is to just install more inexpensive rooftop heating, ventilation, and air conditioning (HVAC) units in order to increase temperature control capabilities. In other cases, those designing new warehouses don’t use advanced planning tools, such as computational fluid dynamics software to engineer a sophisticated system for temperature control. They, too, lay out a number of rooftops units — often more than they need. This HVAC “over-provisioning” tactic is expected to change, however, as new codes promulgated by the International Energy Conservation Code (IECC) and the U.S. Department of Energy will prohibit such “oversizing” and require more efficient and effective planning and design.
One of the biggest challenges facing the pharmaceutical and food industries is coming to terms with — and planning for — regulatory compliance, including new and evolving regulations for maintaining, measuring, and documenting temperature controls along with the need to comply with new, tougher standards for warehouse energy efficiency. Throw into the mix another trend: Warehouse construction is getting taller, making it even more difficult to maintain ambient temperatures that are consistent — whether at 1 ft off the ground or 40 ft up. Clearly, ensuring effective regulatory compliance that is economically efficient is critical.
THE CHALLENGES OF TEMPERATURE CONTROL – AND THE SOLUTIONS
Navigating the regulatory landscape. From farm to fork, and from bench to bedside, a number of governmental bodies — including the Food and Drug Administration, the Environmental Protection Agency, the Occupational Safety and Health Administration, the World Health Organization, and the Consumer Product Safety Commission — impose regulations and guidelines on the food and pharma industries.
While many of those regulations and guidelines concern the temperature and humidity parameters of facilities throughout the supply chain in order to protect product safety and efficacy, there is also a growing body of regulations designed to protect the environment through the use of more energy-efficient facilities.
Whether the goal is product safety or energy efficiency, a second challenge to regulatory compliance is lack of education on ever-evolving regulations around temperature-sensitive products. In other words, industries need not only make improvements to storage facilities and systems, but an ongoing plan for understanding and responding to the increasingly complex regulatory and physical environment.
For example, there are several classes of ambient conditions found in temperature-sensitive industries, including freezer, cold, cool, controlled cold room, and controlled room. Each of these classes has specific temperature and humidity ranges that are either tightly or loosely defined depending upon the specifications of the products to be stored. In some of the classes there are also strict requirements for ventilation rates, particulate filtering, and airflow management.
Furthermore, in pharmaceutical storage applications, and increasingly in the food industry, very sophisticated monitoring and record keeping of temperature and humidity monitoring is mandatory.
To achieve regulatory compliance today, facility managers need the right equipment, tools, procedures, and knowledge to navigate the regulatory environment
Larger buildings, bigger temperature-control challenges. Controlling temperature in very large, very tall, open buildings, such as warehouses (or data centers), is an HVAC problem to solve. Managing temperature stratification, air movement velocity, and overall coverage of the space is much easier in smaller, lower overall volume rooms.
In uncontrolled or poorly controlled warehouse spaces, it is not uncommon to see temperatures vary by almost 1°F per foot from the floor of the space to the bottom of the roof structure. If the product being stored in that warehouse is something non-critical, like toys, or if the product is only in the space for a very short time, as in cross-dock distribution centers, that much temperature variation is acceptable.
However, for the storage of pharmaceutical products for human or veterinary use in the controlled room class of building, the temperature mandate allows no more than a total of 1° or 2° variation for the entire height and width of the space of a warehouse that could be 150 ft x 200 ft, with a height of 40 ft. Regulations will require that the variation be constantly monitored and that any deviation sets off an alarm.
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Demand for temperature controlled food and pharma warehousing is increasing.
• Seven of the top 10 global pharmaceutical products are biopharmaceuticals that require temperature-controlled storage.
• Nearly 40% of all life sciences products are temperature sensitive.
• Beyond knowing where products are in the supply chain, manufacturers also need real-time data about the temperature and humidity conditions in which the products are stored.
• The U.S. imports nearly two-thirds of its fruits and vegetables. In 2015, the volume of imported regulated foods is expected to be triple what it was in 2007.
• In the so-called “cold chain,” 25% of all food products are wasted due to fluctuations in temperature.
• The Food Safety Modernization Act was signed into law in 2011 and significantly expands the powers of the Food and Drug Administration, allowing the agency more control of policing safety in the food industry, which historically has regulated itself. It is considered the first major federal legislation on food safety since the 1930s. Part of the act focuses on the monitoring and tracking of product location and temperature throughout the supply chain.
STRATEGIES FOR REGULATORY COMPLIANCE
Leverage sophisticated tools to design warehouses. Where mission-critical food and pharma warehouse facility leaders may learn from their data center brethren is the importance of using computational fluid dynamics (CFD) software during the facility planning stage. The same analysis tools should be used in designing a temperature-sensitive product storage facility, especially one that falls into the controlled room class of building.
It is not uncommon to run CFD models with over 10 million grid cells for a typical 25,000-sq-ft pharmaceutical warehouse. A model with a mesh density of that size can take hours to run but the results are crucial to analyze before recommending the best equipment configuration and layout for maintaining temperature controls and maximizing energy efficiency.
Selecting the most appropriate HVAC solutions. These CFD models often point out the difficulty of maintaining the required tight conditions using conventional HVAC equipment. This is also where corporate sustainability goals, regulations, and first cost considerations collide. HVAC product solutions that can provide a low first cost will very often fail to meet tighter temperature requirements. Those tighter temperature requirements may also affect the corporate goals of reducing energy use if the equipment layout doesn’t optimize the performance of the HVAC solution.
While it might be possible to meet the temperature requirements by simply throwing more low-first-cost equipment at the problem, the energy efficiency of such a solution would likely not meet proscribed targets. New building design criteria that meets the criteria of the International Energy Conservation Code (IECC) also all but prohibits over-provisioning of the HVAC system as a way to provide tighter temperature control in large open spaces.
Real-time temperature monitoring and recording. Once the building is constructed, additional tools must be used to ensure compliance with the codes, guidelines, and other criteria for temperature-sensitive products. Constant real-time monitoring and recording of data is required and is subject to review by almost any of those regulatory agencies mentioned previously. Annex 9 of the World Health Organization (WHO) Technical Report Series 908 specifically calls for detailed temperature mapping of specific pharmaceutical storage facilities and maintenance of those records for at least one year.
A crucial next step is the development of open, standards-based technology that allows all systems in the chain to integrate seamlessly. Traceability, or the ability to monitor the supply chain and verify every aspect of products’ movement and conditions — including temperature — is crucial for troubleshooting, assessing liability in the event of failures and managing efficiency.
Fault detection and diagnosis. Some of these steps can be accomplished by the HVAC equipment itself as new codes and standards require the HVAC equipment to monitor itself and provide at least some level of fault detection and diagnosis (FDD). Automatic notification of failures is required for specific pharmaceutical applications, and many of the modern HVAC products that incorporate direct digital control (DDC) systems are capable of that function. Of course, this level of monitoring will only accomplish part of the task, and depending upon the type of equipment on the building, might only provide information about conditions at that specific piece of equipment.
As mentioned previously, codes and standards for the storage of pharmaceuticals require information to be gathered from multiple points in the storage space itself. To meet this requirement, it is also a distinct advantage when DDC systems are compatible and integrate with a wide range of equipment within the facility and along the supply chain.
Multiple sensor points. Placing and enabling multiple sensor points for monitoring air conditions not only complies with regulatory requirements, but helps resolve another problem with heating or cooling large warehouse spaces: where to locate thermostats and sensors for HVAC unit control. In a space that encloses thousands of square feet and up to 45 ft of wall height, it is almost impossible to accurately control a piece of HVAC equipment with a single sensor and provide consistent floor-to-roof temperatures.
Some HVAC equipment uses DDC technology that can enable multiple sensors for each piece of equipment and can control that equipment based on the “worst case” or “average” reading. Since most of these warehouse facilities are too large to be controlled by a single unit, the ability to deploy multiple sensors for each HVAC unit and to have each HVAC unit communicate with its sister units has obvious benefits from a space temperature control point of view. This cross-communication can also provide energy-saving benefits by minimizing “fighting” between HVAC units as one senses a need for cooling while another senses a need for heating.
Collection of operational data – available anytime, anywhere. The collection of operational data for the HVAC equipment on a local, piece-by-piece basis is mandatory but only useful on-site, at the warehouse. Evidence demonstrates that the most effective compliance strategies — those that address both energy efficiency and temperature control — often include a new breed of digital dashboards that are part of the HVAC system. These digital dashboards put executives and facility managers on the same page for monitoring temperature, humidity, and energy costs in real time — from anywhere there is an internet connection.
Food and pharmaceutical distribution are global industries, and it is sometimes not practical for a corporation to place full-time facilities people at each and every location. HVAC equipment with DDC systems based on recognized global communication protocols, such as BACnet or LonWorks, can not only communicate with other like equipment, but can also stream information via dashboard displays, allowing management to view it anywhere, anytime through remote access capabilities.
In summary, with increasing regulation of food and pharma storage temperature controls, coupled with often-conflicting new regulations for energy efficiency, operators of mission-critical facilities in these industries will continue to face regulatory compliance challenges. The key to success will largely depend on how well they stay abreast of evolving regulatory changes. From a compliance standpoint, and with the help of knowledgeable HVAC experts, they should also leverage advanced HVAC planning tools (such as computational fluid dynamics software) in the design of new facilities, select the right HVAC equipment, install multiple control sensor arrays, and use an informational dashboard to monitor, measure, and report operational data 24/7.