by Robert Cunningham
Innovation — finding new treatments and therapies — continues to be a hot topic in the pharma industry. Keeping up with new research and drug discovery trends means today’s pharma companies must be agile and adaptable, with flexible facilities that are able to change with minimum disruptions.
With the many complex processes used in the life sciences industry today, how do companies stay flexible while still giving researchers all the tools they need?
Case study: designing product testing systems for today’s pharma labs
Testing products and detecting the quality of products before allowing them to be sold in the global market is of primary importance. One process that poses a set of complex risks for the lab manager/facility owner is called high-performance liquid chromatography (HPLC). HPLC plays a critical role in the field of pharmaceutical analysis, because it is used to test products and detect the quality of products before they go to market.
The challenge: The equipment needed for the HPCL process can require up to five different solvents to run. Typical solvents used are methanol, heptane, ethyl acetate, dichloromethane, and acetonitrile. These solvents are all classified as 1B flammable liquids per the National Fire Protection Association (NFPA), and their storage and use is strictly regulated by building fire and life safety codes. Stated simply, the goal of the codes is to segregate these volatile chemicals into controlled areas.
Building codes allow the facility owner several methods to handle these hazardous materials. The control area approach, creating defined control areas within a facility, is one way to separate areas that use flammable (hazardous) liquids. Each floor of a facility can be divided into several control areas, maximizing the amount of flammable liquids that can be stored/used. However, the number of control areas allowed per floor and the quantity of flammable liquids allowed are reduced as floors get higher.
Another compliance method, and the one we’ll examine further, is the hazardous use group (H-3) approach. This approach defines a specific area that stores chemicals in excess of the amount allowed in a control area. An H-3 area has no limit on the quantity of flammable liquids it can store, but it must meet the limitations of NFPA 30: Flammable and Combustible Liquids code for an “inside storage area.” This method keeps all the flammable liquids to one area while maintaining flexibility in the lab spaces. Increased ventilation and other additional requirements need to be addressed, but the H-3 approach allows for the remainder of the facility to keep a lower-hazard B (business) occupancy, which can also reduce initial construction costs.
Responsive design: So, what would this central system be comprised of?
While there a several ways to design a central dispensing system, the best design is a system that had very few points of potential failure, multiple safeguards, and provides a safe, innovative, economical, and code-compliant system that gives researchers exactly what they need.
In a recent application, a member of the AKF team designed a system that delivered five different solvents to users on multiple floors through a welded stainless steel piping network. In each lab, we provided manual draw-off stations located inside solvent-dispensing fume hoods. The dispensing hood was designed to distribute no more than one liter at a time, and an emergency stop feature added to the controls as well. Dispensing one liter at a time ensured that the hood had the capability to exhaust the vapors from a spill. The entire system was controlled by a PLC-based system located just outside of the solvent supply room.
Within the solvent supply room are 10 200-liter containers, two for each solvent. The solvents are displaced from the containers by pressurizing them with nitrogen, pushing the solvent through the distribution lines. There are no pumps in this system, which removes the greatest chance for failure within the system. Automated valves switch from an empty container to the back-up container, and an alarm is sounded so an operator knows the back-up container is in use.
The solvent supply room is monitored for leaks, oxygen depletion, and other potentially dangerous scenarios, and when any alarm condition is detected, the system shuts down automatically.
The system incorporated safety features to protect the lab, staff, and the environment by offering controls preventing unwanted flow and keeping the handling of flammable liquids by lab personnel to a minimum.
What we believe
Weaving together the needs for accurate and reliable operation, the flexibility to make process adjustments, adherence to safety requirements and building codes, and the ease of use by the staff requires a high level of understanding and coordination between the design team and end users. The designers’ level of understanding of the lab process is key, as this case study demonstrates. As the complexities of lab processes and regulations continue to grow, the successful design team will be the one who understands the technologies of those whose needs they are addressing and can translate those needs into a successful design.
Robert Cunningham
Robert Cunningham, CPD, CIPE, is AKF’s director of science and technology and an active member of the Construction Institute.
