Rafael Estrella's Contact Details

Rafael Estrella's Company Details

Precision Stability Storage, LLC

Black Mountain, North Carolina, United States • 11 - 50 Employees
Pharmaceuticals

Precision Stability Storage (PSS) provides multiple pharmaceutical stability chambers for contract storage of products that require environmental conditions that must adhere to ICH guidelines in four locations (Wilson, NC; Hopewell, MA; Fort Lauderdale, FL; El Segundo, CA). Our cGMP facilities contain various chambers and rooms that have been validated for pharmaceutical stability storage plus freezers for bio-storage.Our stability rooms and chambers are designed for FDA mandated shelf life studies per ICH Q1A (R2). Our facility offers:Long-Term and Intermediate conditions of 25°C/40%Rh, 25°C/60%Rh, 30°C/65%Rh, 30°C/75%Rh, 30°C/35%Rh Accelerated storage of 40°C/not more than (NMT) 25%Rh, 40°C/75%RhRefrigerated and Freezer storage conditions of 2°C - 8°C (5°C), -20°C, -80°C, and LN2 freezers.Each location maintains back up conditioners/chambers, emergency electrical generator to power complete facility, and part 11 compliant 24/7 monitoring and alarm system for each chamber.