Securing the integrity of pharma production processes is crucial across a range of diverse industries from pharmaceutical to medical devices. With the average cost to progress a new drug from discovery to launch estimated at roughly $2.3 billion per drug [1], the stakes are high for companies to build the safest labs and cleanrooms possible.
With over 45 years of leadership in the science and tech market, Riley Construction has the experience to build or renovate these projects on time, within budget and consistent with your company’s mission.
Here are four ways to address safety risks in lab and cleanroom construction and build for a flexible future.
Start pre-planning Early
Whether you are building from the ground up or renovating an existing pharma or medical manufacturing facility, there are many critical elements to consider to ensure that everything is built safely and meets compliance standards. That starts with robust pre-planning early in the design process. The team pinpoints exactly how the space will be used and how construction will impact nearby labs and production areas.
Speed-to-market is a driving factor in pharma and medical manufacturing construction. Riley’s proprietary InSTEP® planning process then provides accurate schedules and tracks milestones. This improves efficiency and helps maintain flexibility with the inevitable adjustments. Riley works tirelessly to eliminate any non-value-added steps in their design and planning process, ensuring no project delays. Using their Lean planning approach, they eliminate uncertainty and ultimately, deliver customer satisfaction.
Also essential is the early ordering of tools and equipment as there can be a 12-to-52-week lead time for materials. The last thing a pharma or medical manufacturer wants is to start demolition on a space only to realize that they are missing a key component which may delay construction and their product entry to market for months.
Estimate and Prepare for the Unexpected
Despite the best-laid plans, unexpected changes will inevitably occur when designing a lab or cleanroom space. A manufacturer may need to escalate a timeline to get a drug to market sooner which will require the flexibility to move at a moment’s notice or move people to different projects.
“Often, we’re building around an existing fully operating facility, so we do have shutdowns from the owner’s side that we have to prepare for,” says Joe Gilbert, Riley owner and project executive. He adds that this often means the crew needs to work during weekends or evenings to ensure that production can proceed during busy workdays.
Managing these complex and unpredictable schedules while staying on budget takes effective and clear team communication throughout the project. But it also starts with an accurate estimating process that considers many potential scenarios that could happen and estimate accordingly. Riley takes a unique approach to estimating called Smart Rates. These rates look beyond historical costs and consider a combination of client needs, project specs and local market conditions and pricing to create a highly accurate cost estimate.
Make Critical Utility Connections
In the pharmaceutical industry, utilities like Air Handling Units (AHU), Compressed Air, HVAC (Heating, Ventilation and Air Conditioning), Water, Nitrogen and RODI are critical to the manufacturing process. Equipment essential to produce these life-saving drugs cannot be mechanically completed until all the utilities are connected to it. So it is vital that construction teams be experienced in ensuring these utilities are safely connected in alignment with compliance standards. And that the teams plan for and properly execute detailed processes for shutdowns including cutting into, cleaning and turning utilities back on properly.
Meet Good Manufacturing Practices (GMP) Compliance
Construction teams working on pharma projects must closely adhere to Good Manufacturing Practice (GMP) standards as set forth by the Food and Drug Administration. Competent project teams that leverage proven state-of-the art equipment and technology to ensure product quality and purity will help establish best practices that benefit owners. Look to a team like Riley Construction which understands the complexities of lab and cleanroom construction including commissioning, validating and qualifying capacity expansion.
Getting an early start on planning, anticipating potential surprises, preparing for all critical processes that ensure adherence to compliance standards will lead to a successful construction process that delivers for owners.
To learn more about Riley Construction’s Science and Technology experience, reach out to Joe Gilbert, Riley owner and project executive at JoeG@rileycon.com or Jim Moczynski, JimM@rileycon.com, Riley’s Senior Operations Manager.