Magellan Pharmaceutical Development provides on-site storage
services in conjunction with our in-house stability
testing, or as a stand-alone service. We offer
standard storage conditions as outlined in the ICH
guidelines, as well as any specialized storage
conditions clients may request.
Magellan offers approximately
20,000 cubic feet of storage area over a broad
range of storage conditions. Each stability chamber
operates independently with its own temperature
and, where applicable, humidity controls. All
storage chambers are continuously monitored by a
computerized Kaye Monitoring System and a hardwired
security system. Temperature and humidity setpoint
windows are ±
2° C and ± 5%RH, respectively, and
failures outside setpoint ranges result in an
immediate alert to the stability staff.
Additionally, all of our storage chambers are on full generator backup in case of power failure. Backup power is fully operational within 6 seconds of power failure.
Please give us a call with any questions or submit a project
to us online.
Click here for a copy of Magellan's sample submission form.
Magellan's storage conditions and equipment include:
| Temperature Control/Ambient: |
| 2° C |
4° C |
| 5° C |
8° C |
| 25° C |
30° C |
| 40° C |
50° C |
| 70° C |
|
|
Controlled Room Temperature (20° -25°)
|
|
Temperature/Humidity Controls: |
| ICH Conditions: |
|
| 25° C/40%RH |
25° C/60%RH |
| 30° C/35%RH |
30° C/60%RH |
| 40° C/20%RH |
40° C/75%RH |
| Other Available Conditions: |
| 25° C/75%RH |
30° C/70%RH |
| 40° C/15%RH |
40° C/85%RH |
| 50° C/20%RH |
|
| Low Temperature: |
| -15° C |
-20° C |
| -70° C |
-76° C |
| Cycle: |
| 2° C/40° C Cycle (1-24 Hour Cycles) |
Photostability
Light Exposure/Temp. Control:
- ICH Option 1 and 2 with Temperature
Control and Monitoring at 25° C
- Fluorescence 200-1000 foot candle
- Room Light/CRT
Chamber Qualifications:
- Kaye Instrument Stability Monitoring System
(Out of range alarms and notification)
- Full Generator Backup
- Hardwired Security System
- Backup Water System
Types of Sample Storage:
- Drug Product
- Drug Substance
- Raw Material
- Placebo/Excipients
- Comparator Drug Product
- Controlled Drugs
* DEA Licensed Facilities for Controlled Drugs Schedules I-V