Ultra-Low Temperature Storage

Ultra-low temperatures (-80°C) are critical to the long-term preservation of sensitive biological material, including cell therapies, vaccines, blood, DNA, and active pharmaceutical ingredients (API). Precision understands that the quality and integrity of biological materials are vital and directly affect research efforts’ outcomes and validity.

Precision Stability Storage provides cGMP-compliant biorepository services to maintain critical materials under controlled temperature environments. Our biorepositories include industry-leading cold storage equipment, 21 CFR Part 11-compliant monitoring, access control, robust security systems, and highly trained personnel to ensure the integrity of the materials stored, making us a trusted partner for long and short-term storage.

Freezer rack in ultra-low temperature storage conditions

Contact Us

Operational Efficiencies: Outsourcing storage can improve efficiency by allowing organizations to focus on their core activities, such as research, development, and production, while leaving the management of biological collections to experts in the field.

Space and Resource Optimization: Offsite storage allows laboratories to free up valuable space for critical activities. It eliminates the need for organizations to invest in CapX and maintain costly storage infrastructures.

Risk Mitigation: Offsite storage providers like Precision have robust disaster recovery plans and redundancies. This helps mitigate risks associated with unexpected events, such as power outages, equipment failures, or natural disasters.

Read on to learn about ultra-low temperature storage solutions and the benefits of storing and preserving samples offsite.

PRECISION’S OFFSITE ULTRA-LOW TEMPERATURE STORAGE

Precision offers a perfect solution for preserving biological materials at ultra-low temperatures over extended periods. With coast-to-coast locations, we provide a comprehensive, cost-effective biorepository service. Our highly trained employees set the industry standard and are vital in delivering top-tier off-site cGMP storage and ISO-compliant solutions.

  • High-quality ultra-low temperature freezers with leading ENERGY STAR ratings.
  • Compliance with regulatory standards (cGMP, ISO, and FDA)
  • Highly customizable solutions to meet specific storage needs.
  • Remote temperature monitoring systems to detect fluctuations and send alerts.
  • 24/7/365 security with controlled access and alarm response.
  • Precision can store material within customer-owned units or in our freezers.

Ultra-low freezers safeguard temperature-sensitive biological materials and other products, such as:

Biologics

DNA

RNA

Viruses

Proteins

Small Molecules

Vaccines

Nucleic Acids

Drug Products

API

Get a quote from Precision today!

Stability Storage FAQs

Why are stability studies required? +

Stability studies are required to ensure a product maintains its intended quality, safety, and efficacy throughout its shelf life under various environmental conditions. They help guarantee that products perform as expected from manufacture to end use.

How do you test stability? +

Stability testing involves placing products in stability chambers that meticulously control environmental conditions such as temperature and humidity. Over designated time periods, products are assessed to monitor changes in their properties, such as efficacy, safety, and physical appearance.

What are stability zones and stability conditions? +

Stability zones refer to specific geographical regions defined by their climatic conditions. The International Council for Harmonisation (ICH) identifies several major stability zones, including Zone I (temperate), Zone II (subtropical with possible high humidity), Zone III (hot and dry), and Zone IV (hot and humid). These zones dictate the environmental parameters like temperature and humidity for stability studies, ensuring that products are tested under conditions that accurately reflect the climates in which they will be sold and used.

How long is stability testing? +

The duration of stability testing varies based on the product type, projected shelf life, and applicable regulatory guidelines. Accelerated stability studies, which expose products to extreme conditions to speed up aging, typically last around 6 months. Real-time and long-term stability studies, which assess products under conditions closer to those they will encounter in the market, can extend from 12 months to several years, depending on the product’s intended shelf life and the regulatory requirements it must meet.

How are stability storage conditions determined? +

The conditions used in stability testing are carefully selected based on the climate of the intended market and the specific formulation of the product to ensure it is tested under environmental stresses that mimic those it will face in real-world scenarios.

What is the difference between accelerated and real-time stability testing? +

Explain that accelerated stability testing involves exposing products to conditions beyond their normal storage parameters to speed up the aging process, and real-time stability testing evaluates the product under normal storage conditions over its expected shelf life.

How does regulatory compliance impact stability storage and testing? +

Regulatory compliance plays a crucial role in stability storage and testing because adherence to standards set by bodies such as the FDA, EMA, or ICH ensures the reliability and validity of stability data. Compliance with these guidelines is essential for demonstrating that a product maintains its quality, safety, and efficacy throughout its shelf life. This data is critical for gaining product approvals and supporting marketability because it confirms that the product meets the stringent requirements necessary for distribution.

Can stability testing predict product shelf life? +

Stability testing can predict product shelf life by identifying how time and various environmental factors, such as temperature and humidity, impact product quality. These studies are essential for determining and setting scientifically validated expiration dates and ensuring that products remain effective and safe for consumer use throughout their intended lifespan.