Stability Storage and Testing

Pharmalytica Services offers the full range of stability storage and testing for shelf-life determination and regulatory submissions. Our stability programs are designed and executed to meet Zones I - IV global submission requirements. Client-specific storage needs can also be accommodated.

All storage chambers, as well as, the laboratories themselves, are continuously monitored by the 21 CFR Part 11 compliant GE Kaye LabWatch™ and Veriteq Monitoring Systems, providing immediate notification in case of divergence. Additionally, all critical chambers are connected to generator back-up in the event of extended power outages.

Standard ICH Storage Chambers
25 ± 2℃/60 ± 5% RH
30 ± 2℃/65 ± 5% RH
40 ± 2℃/75 ± 5% RH

Stressed Condition Chambers
50 ± 2℃/75 ± 5% RH
50℃, 60℃ and 70 ℃

Refrigerated / Frozen Chambers
5 ± 3℃
- 20 ± 5℃
-80 ± 10℃

Photo-stability Chambers
ICH Option 1 and 2 with Temperature Control and Monitor at 25 ± 2℃

Freeze-Thaw Study (To Support Product Shipping)
Three Cycles: -20℃ four days and to 25℃ three days

Monitored Laboratory Temperature Maintained at 20℃ to 25℃