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.
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.
• Exceeds required ICH and cGMP 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
Humidity generating systems from Parameter are unique. The sources for humidity, dehumidification, heating, cooling, and circulation are all packaged in one self contained unit.
The freezers provide tight overall chamber uniformity of ±0.85°C, remaining in ICH uniformity specification during defrost cycles.
Stability rooms and chambers that are fully validated to meet strict temperature, humidity and uniformity requirements.
25°C/60% RH
30°C/65% RH
40°C/25% RH
40°C/75% RH
30°C/75% RH
25°C/40% RH
5°C, -20°C, -60°C, -80°C, LN2 Cryogenic Freezers
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.
Each facility maintains an emergency generator to power the complete facility in the event of a power outage. Precision Stability Storage also has a back up conditioner and controls in place that will maintain any chamber if the primary conditioner goes down. All chambers 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.
Precision Stability Storage provides back-up stability storage to businesses whose own stability-storage facilities prove inadequate because of weather catastrophes, electrical failures or when you have excess clinical supplies.
Precision Stability Storage’s contingency management plan is customized to individual company requirements and is an uncomplicated approach to ensuring stability storage operations in case of an emergency.
As any company knows, the loss of products that have been in stability storage for a number of years could represent critical loss to a company and its customers. Experiencing fire, power outages, storms, aging equipment, hardware or software failure or any number of other events can significantly affect your stability storage operations. Our new contingency management plan guards against that loss.
Precision Stability Storage’s contingency management plan offers a resource for recovery efforts that is low cost and easy to execute.
We will work with you to develop a program that:
Precision Stability Storage utilizes Parameter rooms and chambers that are fully validated to meet strict temperature, humidity and uniformity controls. With conditions that meet International Conference on Harmonisation (ICH) guidelines, the chambers and rooms are monitored 24/7 and provide a regulatory compliant facility within a cGMP environment.
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. Our fourth location, in El Segundo, CA, opened in the summer of 2021.
