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Precision Stability Storage

We provide GMP/FDA-compliant off-site stability storage services for temperature-sensitive products that require ICH specified environmental conditions.

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Precision announces West Coast Facility

Precision Stability Storage is pleased to announce “coast to coast” coverage with the addition of our fourth “off-site” cGMP stability and bio-storage facility.

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What We Provide

In strategic alliance with Parameter Generation & Control, Precision offers the highest-quality equipment and facilities available for environment and humidity control. Read more about what PSS can offer on our Why Precision page.

Short/Long Term, Overflow & Backup storage

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Short/Long Term, Overflow & Backup storage

We are happy to work with you for a variety of reasons. Precision can provide:

  • 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%Rh
  • Refrigerated and Freezer storage conditions of 2°C – 8°C (5°C), -20°C, -80°C, LN2
  • Ambient storage conditions of 15°C – 30°C

 

Off-site storage may represent a cost-effective alternative in comparison to the purchase, qualification, monitoring, operational costs of owning your own storage equipment. We can also offer affordable pricing for multi-year storage.

Storage Equipment

Vaccine Storage Freezers

Storage Equipment

Our goal is to provide world-class temperature and humidity-controlled contract storage that meets a variety of environmental conditions that our customers require to store products and samples. We leverage the best equipment manufacturers in the industry.

Redundancy and Backup

Backup Electrical Generator

Redundancy and Backup

PSS provides peace of mind with the necessary facility backups to protect your valuable materials.

Backup generators are installed and tested.

Backup room conditioners and storage units are maintained in case the product needs to be transferred.

Contracts with local chamber repair, calibration, and validation companies are established in case of an emergency.

Validation and Qualification

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Validation and Qualification

Fully validated and qualified contract storage covering a wide variety of environmental conditions and industrial requirements. This is to ensure compliance with strict temperature, humidity, and uniformity requirements.

Fully Validated Q1A (R2) Compliant.

Reach-in, walk-in, and ambient storage areas qualified to meet cGMP requirements often including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Quality System

PSS Compliance

Quality System

To support these efforts, we have policies and standard operating procedures to meet cGMP requirements. We also select industry-leading equipment such as Parameter Generation & Control amongst other manufacturers that provide the most stable and uniform environments for our customer’s materials.

Continuous Monitoring

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Continuous Monitoring

Our validated continuous monitoring system offers 24/7/365 data, reports, and alarming to protect your materials. Our systems are tested to meet FDA 21 CFR Part 11 compliance for monitoring all of our freezers, refrigerators, reach-in, walk-in, and ambient storage areas.

Site Security for proper levels of access to specific areas

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24/7 monitored Security and Access Control Systems

Physical security is accomplished by locks on all chamber doors and badge reader access to all areas of the facility, providing multiple levels of security. Visitors to the facility are logged, assigned visitor badges and escorted at all times. Additionally, Fire Alarm and Security systems are monitored 24/7 to ensure the safety and security of the product at the facility.

Industries We Serve

Precision Stability Storage provides a variety of off-site contract storage for a variety of industries including life sciences such as pharmaceutical and biotechnology, medical device, and cosmetics.

Why Choose Us?

Precision Stability Storage offers an extremely cost-effective alternative to providing stability rooms in-house.

The expense of purchasing and owning a storage chamber represents a significant investment at the beginning of a study. Contracting your storage space needs with us allows for significant cost reductions that can be spread across the duration of the the study, all while maintaining FDA/ICH stability requirements.

Precision Stability Storage has designed the facility to meet the needs of companies that may require short-term storage, back-up contingencies, and overflow capacity.

So is it more cost-effective to rent or own?
Learn more about what you should consider by reading our case study.

Learn More About Us Case Study
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Areas We Serve

Precision Stability Storage currently has four locations across the U.S.:

  1. Wilson, NC
  2. Hopedale, MA
  3. Fort Lauderdale, FL
  4. El Segundo, CA

With the new addition of the El Segundo site, we have “coast to coast” coverage for “off-site” cGMP stability and bio-storage.  While many of customers use express shipping from anywhere in North America to any of our facilities, some customers prefer to keep their samples in the same regional area.