SERVICES
Pharmaceutical
Storage
SciSafe makes outsourcing the management of medical supplies and samples affordable, easy and more efficient for our clients.
Pharmaceutical/ICH Stability Storage
SciSafe offers a variety of storage conditions for pharmaceutical samples. We have the necessary temperature environments for ICH Stability Testing as well as Vaccine Storage, Bulk API, Clinical Retains, and all possible custom conditions. SciSafe undertakes many custom temperature stability storage projects, ranging from very hot and humid to ultra-cold as well as cycling studies. Whether clients are storing 1 cu ft or 10,000 cu ft, our pharmaceutical stability storage facilities located in New Jersey and Massachusetts offer the same customer-focused service, allowing for industry-leading control of and access to their samples. With integrated logistics, SciSafe is able to make pharmaceutical testing, outsourcing, and sample management seamless and efficient for our customers.
Pharmaceutical Storage Services
ICH Stability Storage (All standard and any custom condition)
vaccine storage
clinical trials
medical device
clinical retains
BULK API
SHIPPING LANE STUDIES
STRESS TESTING
PACKAGING/PALLET TESTING
CUSTOM
ICH Stability Storage (All standard and any custom condition)
vaccine storage
clinical trials
medical device
clinical retains
BULK API
SHIPPING LANE STUDIES
STRESS TESTING
PACKAGING/PALLET TESTING
CUSTOM
- ICH Stability Storage (all standard and any custom condition)
- Vaccine storage
- Clinical trials and pre-clinical research
- Medical device
- Clinical retains
- Bulk API
- Shipping lane studies
- Stress testing
- Packaging/pallet testing
- CAR-T and Immunotherapy
- Re-agent storage and fulfillment
- Cell line and compound libraries
- DNA storage and fulfillment
- Custom
Why choose SciSafe?
SciSafe’s leading principles are to provide its clients with the best quality of service & depth of knowledge available in the industry. SciSafe’s biorepository was built by applying conventional wisdom in an innovative way to maintain maximum efficiency in its daily operations.
SciSafe has over 86 Standard Operating Procedures (SOPs) within its network of facilities. A robust Quality Plan and Corrective and Preventative Action (CAPA) system modeled after the FDA required systems (21 CFR Parts 210 & 211) for pharmaceutical manufacturers make SciSafe a valued partner in every stage of drug development and distribution.
SciSafe is cGMP compliant. Its electronic systems including sample inventory, sample monitoring, chain of custody, document control and training are 21 CFR Part 11 compliant
The system works parallel with our SOPs and is entirely automated and fully compliant. The Sample Management System not only allows you to have visual access but also control of your samples, leaving clients feeling confident and in charge. For our Biorepository and Cryogenic Storage Suite, the client is able to request sample returns, access the real time conditions of their samples as well as running many other reports.
The SciSafe biological sample storage facility containing the Cryobank Suite uses the most accurate freezers and cryopreservation equipment available. Clients rest assured with SciSafe’s comprehensive backup procedures including redundant freezers, liquid nitrogen backups and on site redundant power generation. With SciSafe’s redundancy system, clients’ samples’ integrity will not be compromised and will remain safe throughout the samples’ lifecycles.
Our biological pharmaceutical rooms are constantly monitored by our market leading sample monitoring system and the client again has access to this real-time data.
SciSafe manages its own Cold Chain Logistics for shipping where we control and retrieve your samples from the minute they leave your facility to the minute they are returned to you. This ensures complete chain of custody and you are able to track the shipment in near real-time through SciSafe’s web portal. This can be particularly critical in cold storage conditions where an out-of-condition state can damage the specimens in a very short period of time. For our Cold Chain logistics, we use the Greenbox thermal management system to maintain your materials at the conditions specified in the protocol.