Stability Storage & Testing

Alcami offers stand-alone stability services as well as in-process studies

Pharmaceutical drug products and active pharmaceutical ingredients (APIs) are significant components of pharmaceutical development and commercial product monitoring. Finding a provider that offers comprehensive stability studies as part of full product development and as a stand-alone service can be difficult. Alcami offers stand-alone stability services as well as in-process studies with the expertise to guide you from the design of the stability study for each phase of development through the evaluation of the data accruing to ICH Q1E.

HIGHLIGHTS OF ALCAMI'S STABILITY TESTING SERVICES

• Electronic stability protocol generation, inventory control, capacity control, and stability pull calendar

• Paperless, barcode-tracked sample submission to the lab with definitive testing instructions downloaded directly to electronic laboratory notebook (ELN) to ensure first time right testing

• Multiple site storage for disaster mitigation available

• Networked sites working under harmonized SOPs providing backup resources for protocol creation, reporting, etc.

• 24-hour chamber monitoring by multiple sensors in each chamber 

• Limited access facility, on-site off-hours security in addition to electronic security systems

• Approximately 16,000 ft² of stability chamber space across two sites

• Ability to perform studies on Schedule I-V controlled substances

• Multiple building generators

STUDY TYPES

• In-use studies (broaching, reconstituted product stability, multi-use container stability)

• Formulation development studies including stress studies

• Photostability (Options I and II)

• Comparator studies

• Thermal cycling/freeze thaw

• Shipping excursion studies

• Long-term stability studies

• Accelerated stability studies