Reliable Stability Storage for Regulatory-Driven Programs

Secure, compliant, and scalable storage for large collections of biological materials requiring validated cryogenic, ultra-low, frozen, refrigerated, and ambient environments.

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STABILITY STORAGE SERVICES IN CALIFORNIA

Validated Storage. Built for Regulated Environments.

Selecting the right stability storage partner is critical to protecting not only the materials stored but also the integrity of data, timelines, and regulatory outcomes. Pacific Science Bio Services provides Stability Storage services designed for pharmaceutical, biotech, and clinical organizations.

Our validated environments, continuous monitoring systems, and SOP-driven processes ensure that temperature- and humidity-sensitive materials are maintained under tightly controlled conditions, preserving product quality and stability data.

Whether managing early-phase development, clinical trials, or commercial shelf-life programs, our team delivers secure, monitored, compliant, and scalable storage solutions that align with cGMP, FDA, and ICH expectations and serve as a trusted extension of your quality and operations teams.

ICH-COMPLIANT STABILITY STORAGE CONDITIONS

Pacific Science Bio Services provides both standard ICH stability storage conditions and custom environmental protocols tailored to specific program requirements. All environments are mapped, validated, and continuously monitored, giving teams confidence in both data integrity and compliance.

Standard Conditions

  • 25°C / 60% RH (long-term)
  • 30°C / 65% RH (intermediate)
  • 40°C / 75% RH (accelerated)

Extended Capabilities

  • Refrigerated stability (2–8°C)
  • Frozen stability (-20°C, -80°C)
  • Controlled ambient (15–25°C)
  • Custom temperature and humidity profiles

All environments are:

  • Walkins and Chambers are mapped and validated
  • Continuously monitored (24/7)
  • Alarmed with defined response protocols

STABILITY STORAGE FOR PHARMACEUTICAL AND BIOLOGICAL MATERIALS

ICH-Stability Storage for a range of pharmaceutical and biologic materials. Supported by SOP-driven processes and documented chain-of-custody procedures, ensuring traceability and protection throughout the storage lifecycle.

Drug & Pharmaceutical Materials

  • Drug substances (APIs)
  • Finished drug products
  • Biologics and vaccines
  • Cell-based materials

Stability Study Samples

  • Retain samples
  • Shelf-life and long-term study materials
  • Accelerated and stress-testing samples
  • Degradation study materials

ADVANCED STORAGE FACILITY & INFRASTRUCTURE

  • Restricted Access to the Facility
  • 24/7/365 Security & Fire Alarm Systems
  • Temperature & Environmental Monitoring
  • Inventory Control
  • Seismic Zone 4 Compliant Building
  • Onsite Backup Generators
  • Backup Freezers
  • Onsite Bulk LN2 Supply
  • Custom Configurations (per box, dedicated freezer)
  • Routine Freezer Maintenance
  • Temperature Mapping & Calibration
  • Disaster Recovery Systems

COMPLETE SAMPLE CONTROL FROM INTAKE TO RETRIEVAL

Delivering full-lifecycle sample management, Pacific Science Bio Services ensures every material is accurately tracked, securely stored, and readily accessible when needed.

Intake & Handling

  • Verified receipt and condition checks
  • Sample logging and identification
  • Controlled placement into validated environments

Tracking & Retrieval

  • Inventory management systems
  • Sample traceability and location tracking
  • Controlled retrieval and distribution

Chain of Custody

Every step is:

  • Documented
  • Time-stamped
  • Audit-ready

SCALABLE & FLEXIBLE STORAGE SOLUTIONS

Whether starting a pilot study or managing a large-scale program, Pacific Science Bio Services provides flexible, scalable solutions. As programs evolve, our infrastructure and team adapt with our customers, ensuring continuity, compliance, and operational efficiency.

Program Types Supported

  • Early-stage development studies
  • Clinical trial stability programs
  • Commercial shelf-life programs

Flexible Options

  • Dedicated chambers
  • Shared environments
  • Custom storage configurations
  • Capacity planning aligned with program growth

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