We use SenseAnywhere to monitor the biorepository for temperature and humidity. Our response team personnel are notified via SMS text, e-mail, cellular, and landline notifications for immediate response and recovery in the rare event of an excursion.
ICH Stability Storage Solutions
Alcami is the secure stability storage choice for the life sciences industry.
When you need to store your pharmaceuticals, medical devices, APIs, or other biopharma materials, the most important objective is to ensure the materials remain in their intended condition. The impact of improper storage can be extensive, affecting patient safety, company reputation, and bottom line. The challenge for life sciences companies of any size is that onsite storage demands sufficient space and oversight.
Alcami’s off-site cGMP stability storage chambers have solved that challenge for biotechs, pharmaceutical companies, and life sciences companies for the last decade. Our experienced team has nearly 40 years of experience with cGMP practices and FDA regulations, allowing them to manage our dedicated ICH stability storage facility expertly.
But stability goes beyond storing. For comprehensive analytical testing needs in support of your stability program, visit Alcami now.
Stability Storage Conditions
Our stability storage chambers meet ICH condition requirements and your specific requirements, even custom conditions. Some of the more standard ICH conditions customers require include:
- 40°C / 75% RH
- 30°C / 75% RH
- 30°C / 65% RH
- 25°C / 60% RH
- 25°C / 40% RH
The Advantages of Alcami’s Stability Storage Services
Alcami’s stability storage facilities are convenient and flexible, designed with our customers’ needs in mind. These state-of-the-art chambers are accessible by multiple major highways and international airports, making them convenient for global customers. In addition, regional customers have access to our ground transportation services.
We have also implemented a series of processes to ensure you receive maximum value and the highest level of care. These procedures include:
Our validated inventory management system, FootPrint, provides impeccable paperless tracking of product locations. We use the system to inventory every shipment that comes into our facility and to guarantee products are stored in the correct location within the specified conditions.
Before we even begin to store your materials, we ensure they remain in compliance from your door to ours. We use pre-qualified shipping containers with calibrated dataloggers, making it straightforward to track and receive the products. Once the products arrive at our door, we ensure their security with 24/7 video surveillance, keycards, and smart locks.