What is the real age
of your biopharmaceutical facilities?
Five questions life sciences leaders should ask to help streamline operations and mitigate risk
Despite the millions of square feet of new life sciences facilities constructed in recent years, your company may operate in a space originally built years or even decades ago. Amidst the rapid pace of mergers and acquisitions in recent years, companies often have inherited facilities of unknown condition. And, the pressure to bring new life-saving treatments to market–quickly–can easily push facility infrastructure risks to the backburner. If your operations occupy an aging facility, or you’re considering renovating an older space, knowing the risks will help prioritize your long-term goals—or help you decide it’s time to mothball the building.
Here are the five questions you should be asking to help prioritize resources and avoid costly breakdowns and regulatory fines.
1. What is the overall condition of my facility: structures, systems and equipment?
While you may know when your space or building was constructed, the facility age may or may not adequately reflect the condition of its components. A facility condition assessment can help you understand the useful life of everything from the roofing to heating and cooling to finishes and fixtures. A thorough visual inspection can reveal clues to potential issues. For instance, damaged vinyl or old paint can be difficult to properly clean and introduce microbial contamination into a cleanroom. An aging roof could spring a leak at any moment, threatening an entire production batch or critical laboratory operations.
2. Is the current infrastructure appropriate for the scale and type of work being performed?
If a facility has been in continuous use for many years, its infrastructure may not be keeping pace with operations. Increases in staffing, production volume, the number of instruments in use and other changes in scope can strain building equipment beyond its intended capacity. These sustained increases in scope can lead to excessive wear and tear on building systems, increasing the risk of failure.
3. Does critical building equipment require repair or replacement?
Deferred maintenance is common in older facilities, resulting in building equipment in need of long-overdue performance testing, repair or replacement. Also critical, infrastructure may not support operations at the level required to ensure quality and safety. An aging air-supply system, for example, may not provide the proper volume of air and air exchanges to prevent cross-contamination of production or research areas. Another common issue is a lack of power redundancy—a necessity for protecting research samples or products that require precise temperature and humidity controls.
4. Is my building in compliance with regulatory requirements?
Beyond routine preventative maintenance work, you may not be aware that your facility is at risk of violating current good manufacturing processes (cGMPs) that could result in costly fines or a halt in operations as issues are remediated. Even clinical trial manufacturing is subject to GMPs, proving that regulations touch operations broader than those intended for commercial sale. Older equipment that has not been well-maintained may not meet current requirements for cleaning validation. Even if it has been maintained, a facility may lack a regimented facility management program and documentation of equipment changes, creating uncertainty about validation and reliability. Environmental risks are also a possibility if, for instance, waste streams are improperly managed.
5. How much should I be forecasting for building equipment and major maintenance?
Following a facility condition assessment and review of the utilities, cleaning and sterilization, air quality, and regulatory requirements for your facility operations, you can prioritize and budget for capital investments. An objective, data-driven capital plan will help your organization avoid the potentially devasting and costly results of unplanned outages, and make predictable capital allocations for building equipment and major maintenance items.
Whether you lease or own, knowing the true age of your facility may seem daunting—but being unaware of the risks is even more so. Assessing the structures, systems and equipment of your space can help you to plan and modernize areas that are critical for regulatory compliance and smooth, safe operations.