Temperature-Controlled Storage
Three qualified temperature ranges in one cGMP- and GDP-compliant Louisville facility, each independently monitored, each with alarm and notification on excursion.
Qualified ranges
Each temperature range specifically designed for the life of your products
Each zone is qualified, independently monitored on-site and remotely, and backed by redundant power and failover. Capacity is reported as pallet locations.
Zone 01
Specialty Freezers at −35°C
Validated plasma specialty deep freezers for fresh frozen plasma. Two freezer halls totaling roughly 2,600 pallet locations, the second of which is a recently completed expansion adding approximately 1,400 locations of frozen capacity.
Zone 02
Refrigerated Storage at +2°C to +8°C
Validated refrigerated storage for finished plasma-derived products, intermediates, and refrigerated biologics. The range most finished therapies ship and store in.
Zone 03
Controlled Room Storage at +20°C to +25°C
Controlled room temperature storage for product that must stay within a tight ambient band — not merely indoors, but qualified, monitored, and alarmed like every other zone in the facility.
Monitoring & redundancy
Every zone is double-monitored and backed up
Temperature zones are independently monitored, continuously, on-site and remotely. An alarm and a notification call are triggered whenever a setpoint is exceeded — not logged for review, called out.
Independent per zone
Each temperature zone is monitored on its own instrumentation, on-site and remotely, so a single point of failure cannot blind an entire hall.
Alarm and phone call
Any setpoint excursion triggers both an alarm and a notification call, with immediate containment and reporting under SOP.
Standby generator
Independent generator backup for uninterrupted refrigeration, tested on schedule with documented maintenance records.
Redundant refrigeration
Redundant cooling and failover on the storage plant, so a single unit going down doesn't put a zone out of range.
Allocated quarantine
Dedicated quarantine, hold, and release areas keep unreleased, released, and returned product physically separated.
24/7 monitored site
Remote security and fire monitoring around the clock, with electronic access control restricting each zone to staff with a business purpose there.
Facility standards
Housekeeping is a quality control
- Routine FDA-grade pest control, interior and exterior
- No interior substances that could contaminate product
- Daily sanitation across storage and dock areas
- No product stored at aisle heads or on the floor
- Aisles and bays swept and cleared of dunnage
- Electronic access keys with unique identification
- Receipt, storage, packing, and shipping under one roof
- Inventory management with reporting to the customer
Need capacity held by a date?
Storage beyond 60 days is supported with advance notice. Tell us the volume and the window.