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GMP Stability Services

The BASi Pharmaceutical Analysis group can handle all aspects of sponsor stability programs. Expertise extends beyond routine sample analysis to the development and validation of stability-indicating methods. BASi will develop a complete package, generating a protocol to client requirements, store samples, perform analytical testing, make stability calculations, prepare interim and final reports and maintain stability tables. All aspects of studies are completely monitored, whether testing is done in our lab or yours.

  • Stability storage at typical ICH conditions
  • Custom storage conditions
  • Photostability
  • Sample management during study
  • Stability study protocol development
  • Stability table preparation and maintenance
  • In-house stability testing

Storage Conditions (typical ICH conditions)

  • 25°C/60% RH
  • 30°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 5°C
  • Custom conditions (-10 to 70°C and 10 to 96% RH)
  • Photostability: cool white fluorescent and UV (Option II)

Facilities

  • 13 reach-in chambers, 2 walk-in rooms, 1 reach-in freezer
  • Kaye LabWatch data-logging
  • Emergency back-up power to all units
  • Comprehensive 24-hour security system

Chamber Monitoring
Temperature and humidity are monitored by a validated Kaye LabWatch software system and by analog chart recorders. An alarm is activated when the temperature or humidity goes out of range, in turn triggering automated telephone call sequences and 24-hour pagers. Temperature is held at ±2°C and humidity is held to ±5% RH. The software allows BASi to calculate mean kinetic temperature, as recently mandated by the FDA, and all chambers are completely mapped and validated. A natural gas generator supplies power to all stability storage units in the event of a power outage.

The stability room security system maintains a complete 24-hour lock-down. Limited access is obtained via a two-level electronic card reader system. The room is secured by motion detectors, a designated alarm system, and an off-site security monitoring system.