When planning new construction or renovations of pharmaceutical laboratory spaces, it is crucial to ensure that safety and efficiency are addressed early to mitigate potential hazards, protect personnel and ensure laboratory operations run smoothly. In an industry where the estimated average cost to move a new drug from discovery to launch is $2.3 billion per drug, the stakes are high for ensuring quality and cleanliness.
Whether building or renovating an existing medical or pharmaceutical facility, facility executives have many elements to consider. The following steps can increase safety and efficiency in laboratory and cleanroom construction.
Managers can get the ball rolling months before breaking ground with a robust pre-planning and design process to guarantee everything is built safely and meets compliance standards. This tactic will inform the way the space will be used and determine the way construction will impact nearby work areas or drug packaging production.
Construction teams should use a lean planning approach to generate the most accurate schedules and track milestones. This approach also helps reduce non-value-added steps in the design and planning process, avoiding product delays. It is the most effective way to eliminate uncertainty and deliver the best outcomes.
Starting demolition on a new pharmaceutical space only to realize that a key component is on back order is less than ideal. This is especially true when certain tools and equipment can have a 12- to 52-week lead time. This situation can delay construction, which could cost owners millions of dollars in lost revenue and potentially create safety issues if workers rush to meet deadlines once supplies arrive. Early ordering of critical materials is essential to avoid these issues and keep the process moving on schedule.
Situations change quickly in the pharmaceutical industry with new products, variations in batch sizes and regulatory updates, meaning that designing laboratories and cleanrooms for easy adaptation to changing production needs is essential. Incorporating 3D modeling tools allows teams to analyze needs and optimize the safest, most efficient layouts.
Including features such as modular design, knock-out panels, adaptable utilities and multi-purpose space layouts can make it easier for owners and managers to facilitate future expansions and modifications.
Complex plans and unpredictable schedules are part of the construction world. Juggling these challenges while adhering to budgets starts with an accurate estimating process that evaluates and accounts for all possible scenarios that could occur.
In the pharmaceutical industry, a manufacturer might need to speed up a timeline to get a drug to market sooner, which requires the flexibility to move at a moment’s notice or move people to different projects. Accounting for these unexpected challenges when designing a laboratory or cleanroom space is crucial.
Owners and managers need to look beyond the traditional cost-per-square-foot estimate model and historical costs to consider a combination of client needs, project specs and local market conditions and pricing to create the most accurate cost estimate.
For example, how does the plan anticipate the shutdowns the team needs to prepare for, and how does it account for work during weekends or evenings to ensure production can proceed on busy workdays?
Ensuring stringent compliance is essential when juggling the many essential tasks involved in pharmaceutical manufacturing, from research and development to stability testing and post-market surveillance. Evolving pharmaceutical regulations add to the challenge.
As a result, construction teams must be well-versed in good manufacturing practice standards set by the U.S. Food and Drug Administration and understand the many complexities of laboratory and cleanroom construction, such as commissioning, validation and qualifying capacity expansion. Using the latest proven equipment and technology will help teams guarantee product quality and purity and establish best practices that benefit owners.
Essential equipment to make life-saving drugs cannot operate if all necessary utilities are not connected properly. In the pharmaceutical industry, air handling units, compressed air, HVAC, water, nitrogen and reverse osmosis deionized water are all vital to the manufacturing process.
That means construction teams need to be trained in safely connecting these utilities according to compliance and safety standards. Planning early to properly execute schedules and processes for shutdowns includes cutting into, cleaning and turning back on utilities correctly.
Joe Gilbert is an owner of Riley Construction and project executive who manages the firm’s science and technology projects.
