Manufacturing drugs, particularly biopharmaceuticals, is a mission-critical business demanding continuous uptime. Loss of power or other utilities can have impacts that reach far beyond the plant floor and the individual batch, affecting patients and investors, and damaging corporate and brand reputation.
In R&D facilities, a single power outage can destroy months or even years of experimental data. On the manufacturing and production side, a power loss can compromise product integrity, threaten vital sanitation standards and potentially jeopardize a pharmaceutical manufacturers ability to meet stringent government regulatory requirements.
Currently, the industrys capacity utilization rate is said to average around 33%. However, this might be the wrong factor to focus on. In fact, what is really needed is an uptime-focused engineering design process. Taking this approach would allow operational reliability studies to be conducted early in the design process, to maximize facility effectiveness and enhance the value of capital investment. It would also allow cost/benefit strategies to be developed early on, to ensure the reliability of a plants mechanical and electrical systems.
Maintaining maximum operational continuity should not only be seen as a strategic business goal, but also as an essential to any facilitys or companys survival. Executives and facility operators continually must ask themselves: How much would my company lose in revenue if our manufacturing facility lost production capability for a day? An hour? A few minutes?
This article will touch on some of the design, construction and maintenance issues affecting mission-critical drug manufacturing facilities, offering some best practices and opportunities for adding value.
The heating/ventilation/air conditioning (HVAC) areas are typically the largest and most energy-intensive parts of any drug manufacturing plant. HVAC and power systems must be designed for as close to 100% uptime as possible, taking into consideration both scheduled maintenance and unplanned power failures. With the annual cost of energy approaching the installation cost of the mechanical/electrical systems, even slight improvements in energy efficiency mean significant operating cost savings.
DOE and EPA data have shown that energy efficiency costs can be very quickly recouped (see "Improving Energy Efficiency in Pharmaceutical Manufacturing Operations"). Therefore, any time spent considering energy efficiency improvement options is likely to pay off. Computer-based building performance simulation tools can be extremely effective weapons in the war against downtime. They offer a way to evaluate system redundancy options and optimize the relative reliabilities of different power and mechanical system alternatives.
Pharmaceutical Design Challenges
Operational effectiveness and environmental sterility are key design factors for any pharmaceutical facility. Early focus on addressing manufacturing requirements is critical to maximizing the value of the capital investment. Good engineering increases value by improving productivity, minimizing downtime and reducing the cost of goods.
Controlled, ultra-clean environments are required for aseptic manufacturing, but they often require high water consumption levels, and heat loads approaching 100 watts per square foot. Economic design strategies are essential to meeting requirements while improving efficiency. Various codes and regulations define the environmental cleanliness levels and measures of particle concentrations, temperature and humidity required for specific processing steps. Air filtration, air circulation rates, robust cleaning and controlled operational procedures all must support the different cleanliness levels required. At cleanroom entries, for example, air pressure cascades drive air and particle movement towards lower classification areas to maintain environmental control.
All systems must be designed to support commissioning and validation activities, and to facilitate rapid restart after unplanned outages. Using installation inspection, commissioning and maintenance documentation can support validation activities, saving time and money during project implementation, and improving facility reliability and performance thereafter.
Pharmaceutical projects require precise documentation to meet regulatory requirements and to justify capital costs. Documenting specific client requirements is essential to understanding and fulfilling them effectively. Balancing cost expenditures in proportion to benefits derived helps identify the best choice from many design options.
Overstating quality requirements and tolerances may result in unnecessary costs. Consider the existing utility infrastructure closely, and take full advantage of any synergies. Higher air flows and pressures require more HVAC capacity. Since most engineering decisions will have an impact on HVAC systems, it is important to recognize opportunities to seek the best engineering solutions.
The Three Rs and the Value of N
Pharmaceutical manufacturing facility designs should emphasize operational effectiveness, minimize downtime and allow for quick recovery after unplanned outages. The concept of the 3Rs redundancy, reliability and recovery must be incorporated throughout the design process: reliable products with a proven track record must be provided, redundant equipment and systems must be installed, and facilities must be designed for quick recovery after unplanned outages.
It is also critical to determine the degree of redundancy required to ensure reliability. Any additional costs for back-up chillers or other equipment must be weighed against the value of lost production to determine the proper level of redundancy required.