Store in Our ICH Q1A (R2) Compliant Chambers
RELIABLE STORAGE CONDITIONS
Precision Stability Storage takes pride in providing consistent, reliable storage conditions for companies seeking compliance with the ICH harmonised tripartite guidelines for stability testing of new drug substances and products Q1A(R2).
In order to research the quality of your new drug formulation, you need to be sure the storage units that you use for your testing are able to reliably approximate the climatic conditions for each of the four climatic zones. Precision Stability Storage provides you with a capable, knowledgeable partner who can help you reach your goal of producing finished pharmaceutical products as efficiently as possible.
HIGH-QUALITY OFF-SITE STABILITY STORAGE
Precision Stability Storage provides off-site stability storage space for pharmaceutical products that require ICH specified environmental conditions. We offer the highest-quality equipment and facilities available for temperature and humidity control.
All of our rooms meet or exceed ICH guidelines and have been mapped and validated for FDA mandated long and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).
Our strategic partnership with Parameter Generation & Control allows us to offer Precision clients the highest-quality equipment and facilities available for environmental and humidity control for companies testing their new drug products.
Precision takes a proactive approach to excursions, our monitoring system provides multi-level alarming with text and e-mail out notifications allowing us to address most would be excursions before they happen. Team communication determines mitigation solution and path forward.
In the unlikely event of an excursion, our 21 car part 11 compliant equipment monitoring software provides an insight to the reason of excursion enabling us to minimize out of specification time. All excursions are addressed under Precision cGMP quality system.
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Features Of Precision Stability Storage Off-Site Stability Storage Facilities:
- ICH validated
- Various temperature and RH conditions available
- 100% redundant controls and conditioner
- Electric generator back-up (automatically switches on power loss)
- Continuous monitoring of each chamber that is Part 11 compliant
- Space and capacity to grow with your needs
Benefits Of Precision Stability Storage Off-Site Stability Storage Facilities:
- Exceeds required ICH and GMP specifications for temperature and humidity control
- Validated storage available at various conditions including 25°C/60%, 30°C/65%, 40°C/75%, and 5°C
- -20°C freezers
- Insurance against mechanical failure or utility service failure
- Capability to meet future storage needs or contingency requirements
Unique Parameter Chambers
Humidity generating systems from Parameter are unique. The sources for humidity, dehumidification, heating, cooling, and circulation are all packaged in one self contained unit.
Specific Humidity Conditions
The freezers provide tight overall chamber uniformity of ±0.85°C, remaining in ICH uniformity specification during defrost cycles.
24 Hour, Part 11 Compliant System
Stability rooms and chambers that are monitored 24 hours a day with part 11 compliant system and are connected to an automatic emergency generator power to ensure integrity of stored samples.
Fully Validated Q1A (R2) Compliant
Stability rooms and chambers that are fully validated to meet strict temperature, humidity and uniformity requirements.
Complete Backup System
Municipal redundancy for all utilities and an emergency generator in the event of a power outage. Precision Stability Storage also has a back up conditioner and controls in place that will maintain any stability room if the room’s primary conditioner goes down. All stability rooms are monitored 24/7 with alarm notification via text and email to multiple stakeholders for rapid response.
Precision Stability Storage has designed our facilities to meet the needs of companies that may also require short-term storage, back-up contingencies, and overflow capacity. With a range of options available to you, Precision can help to insure that your study will be successful no matter the situation.
Three locations to meet your needs:
Precision Stability Storage is located just outside of RTP—the main base of pharma in North Carolina—in Wilson, NC and in Hopedale, Mass., just west of Boston. Our third location, in Fort Lauderdale, FL recently opened for business in 2019. Learn more about our facilities.