7 Key Considerations When Building a Cold Room for Life Sciences
When it comes to cold storage in life sciences, maintaining the right temperature is only the beginning.
From pharmaceutical manufacturing and biotechnology to cell and gene therapy, temperature-controlled environments play an important role in protecting sensitive materials, maintaining product integrity, and supporting regulatory compliance.
Yet designing a cold room involves much more than selecting a temperature set-point and installing refrigeration equipment. Decisions made early in the planning process can significantly impact performance, operating costs, and the facility’s ability to adapt as production requirements evolve.
For life sciences companies considering a new cold room or expanding an existing facility, here are seven important factors to evaluate before construction begins.
1. Start With What You’re Storing
Not all cold rooms serve the same purpose, and understanding the materials being stored should drive the design process.
Pharmaceutical products, biologics, raw materials, and research samples can have very different storage requirements. Some materials require refrigerated environments, commonly between 2°C and 8°C, while others require frozen or ultra-low-temperature conditions.
Beyond temperature, considerations such as humidity sensitivity, storage density, product movement, and handling procedures can influence the overall design.
The key question: Is the space being designed around the specific requirements of the materials, or simply around a target temperature?
2. Temperature Consistency Matters as Much as Temperature Control
A cold room operating at a set-point of 5°C doesn’t necessarily mean every location within the room maintains that exact temperature.
Air circulation, shelving configurations, refrigeration placement, and frequent door openings can create temperature variations throughout the space.
For facilities operating under applicable Good Manufacturing Practice (GMP) requirements, demonstrating consistent environmental performance may be essential.
Temperature mapping helps identify potential hot and cold spots, evaluate performance under operating conditions, and determine appropriate monitoring locations.
Considering airflow and temperature uniformity during design can help reduce complications during commissioning and qualification.
3. Plan for the Unexpected: Redundancy and Backup Systems
What happens if a refrigeration system fails overnight?
For facilities storing valuable or temperature-sensitive materials, an unexpected temperature excursion can have significant consequences, potentially resulting in product investigations, disposal, operational disruptions, or lost research.
- Depending on the risk associated with the stored materials, facilities may consider:
- Redundant refrigeration capacity, including N+1 configurations
- Emergency or backup power
- Automated temperature alarms and remote notifications
- Defined response procedures for temperature excursions
- Preventive maintenance and service accessibility
Redundancy is not necessarily a requirement for every application, but evaluating the consequences of equipment failure early in the design process is an important step in determining the appropriate level of protection.
4. Think Beyond Monitoring to Qualification
Installing temperature sensors is only one part of maintaining a controlled environment.
For regulated applications, facilities may need documented evidence that a cold room performs as intended under defined operating conditions.
This can include temperature mapping, calibration, alarm verification, and qualification activities appropriate to the product and intended use.
Monitoring systems should also be designed with daily operations in mind. Sensor placement, data recording, alarm escalation, and integration with existing building or environmental monitoring systems can all influence long-term reliability.
Planning for these requirements before construction can reduce the need for costly modifications later.
5. Don’t Overlook Doors, Traffic, and Daily Operations
Some of the most significant challenges to cold-room performance come from everyday use.
Every door opening introduces the potential for temperature fluctuations, humidity infiltration, and additional refrigeration demand.
Frequent movement of personnel, carts, and materials can influence how quickly a room recovers after a disturbance.
Door selection, traffic patterns, shelving layout, and material-handling procedures should therefore be considered as part of the overall cold-room design.
Depending on the application, features such as rapid-close doors, vestibules, or improved door seals may help minimize temperature disruptions.
A well-designed cold room should support the way people actually work, not just perform well when the doors remain closed.
6. Energy Efficiency Starts With the Building Envelope
Refrigeration equipment often receives the most attention during cold-room planning, but the room’s walls, ceiling, flooring, and doors are equally important to long-term performance.
Insulation, thermal bridging, air leakage, and moisture control can directly affect refrigeration demand and energy consumption.
For California facilities, these considerations are particularly relevant as project teams navigate state energy-efficiency requirements and work to manage operating costs.
The 2025 California Building Energy Efficiency Standards, effective January 1, 2026, include provisions applicable to certain refrigerated facilities and equipment.
Selecting appropriate insulated panel systems, considering the complete thermal envelope, and coordinating refrigeration requirements early in the project can support both operational efficiency and regulatory planning.
7. Design for Where the Business Is Going, Not Just Where It Is Today
Life sciences facilities frequently evolve as research programs advance, manufacturing scales, or new products are introduced.
A cold room designed only for current requirements may eventually become a limitation as storage volumes, workflows, or operational needs change.
Modular cold-room construction can offer advantages when future expansion, reconfiguration, or integration into an existing facility is anticipated.
Before finalizing a design, consider whether the space can accommodate additional storage capacity, equipment upgrades, or changes in material-handling requirements.
Incorporating flexibility at the outset may help minimize future disruptions and avoid unnecessary reconstruction.
The Bigger Picture: Cold Storage Is a Critical Part of Facility Infrastructure
Cold rooms may appear straightforward compared with other highly controlled spaces in a life sciences facility, but their performance can have a direct impact on product quality, operational continuity, and long-term costs.
The most successful projects begin by looking beyond the temperature requirement and considering how the space will function throughout its entire lifecycle.
At CleanSpace, we work with life sciences organizations to develop temperature-controlled environments, including modular cold rooms, designed around their specific operational and facility requirements. From early planning through construction, our team helps clients evaluate practical solutions for performance, scalability, and integration into existing or new facilities.
As California’s life sciences industry continues to evolve, thoughtful cold-room planning can help companies create infrastructure that supports both today’s operations and tomorrow’s growth.
If you’d like to discuss an upcoming cold room or controlled environment project, please contact Chelsea Lauridsen at CleanSpace to explore how our team can support your facility needs: [email protected]