Thought Leadership

Reason Four in the Five-Part Series: How to Maximize Returns on Lab Protocol Change

Laboratories uphold some of the strictest compliance requirements among businesses. These requirements are evaluated and updated more frequently than lower-risk requirements, engaging laboratory managers in a constant puzzle to adapt operations.  

Whether a lab focuses on high-precision production or research and development of products for a future pipeline, labs must first maintain compliance to deliver current and future value to customers.  

It’s no wonder then, that a combination of sudden and compounded shifts in regulatory requirements can evolve a laboratory’s size and configuration over time. Below are three common types of regulatory change which can impact the infrastructure and layout of laboratory space.  

1. Changes in quality control (QC) hold time  

The duration and volume of product in a QC hold equally drive space requirements for this laboratory function. Square footage available for QC hold is often planned as flexible space, but regulatory mandates to hold more material for a longer time can force laboratories to optimize existing space and plan for expansion. When this happens, lab management and ownership must decide whether to create additional QC space within the existing workflow or to utilize surrounding or offsite space. While more operationally efficient, additional space for QC within the existing workflow is typically limited, leading to renovations of surrounding or offsite space with sufficient contamination control and environmental stability.  

2. Changes in required proximity between functions 

Regulations to protect employee health and safety in high precision laboratory environments can also change the landscape of a laboratory layout. Too often, laboratory clients know that certain amenities should exist near each other such as showers and chemical hoods, or should have the greatest possible distance between them like an autoclave and hazardous materials storage, but these adjacencies can be overlooked when they are not mandated. Over time as OSHA and related regulations tighten, these key proximities become mandated and require business owners and leasing agencies to remodel. Required remodeling for this reason can almost always be prevented with thoughtful collaboration between design teams and laboratory end-users early in the design process.  

3. Changes in privacy requirements  

Customers and regulators can both tighten privacy requirements for laboratories. Customers may request minor privacy measures such as naming occlusion on their products or require major alterations such as implementation of separate manufacturing benches for their proprietary formula. Broad privacy-increasing regulations are more likely to impact patient sample testing services than other types of laboratory production, but the solution for improving privacy is often the same: manage data and sight lines. Although most data management and documentation is virtual, additional staff and server capacity can swell physical space requirements. Additionally, when key customers and regulators visit a lab, they assume proprietary or privacy-protected information visible to them will be equally visible to others. To maintain trust and compliance, lab management and ownership must strategically orient login, production, and R&D areas to maximize visibility for internal staff, while obscuring private information from visitors. This may sound challenging, but never underestimate the capability of great design!  

In Conclusion 

Laboratories can’t choose how often regulations change or which regulations to follow, but laboratory management and ownership can choose how to respond to changes in regulatory requirements. As the regulations impacting your lab space evolve, we encourage scientific teams to leverage necessary change into opportunities to improve overall lab functionality – not constrain it. Only with this mindset can lab teams and lab designers truly enable laboratories to achieve the broader societal impacts they are designed to serve.  

As your customer behaviors, regulations, and technology continue to evolve the needs of your laboratory, Progressive AE is here for you as a trusted advisor in laboratory space. We’d love to help you navigate today’s challenges to find tomorrow’s success.