Stability Testing & Storage

Customized services for all commercial and premarket drug products

From placebos to controlled drugs, our scientists have years of experience in performing stability testing for all types of commercial and premarket drug products.    
  
   
 
     

    Catalent Services

• Analytical
  • Protocol design
    • Long-term stability test
    • Drug substance stability testing
    • Comparator stability testing
    • Formulation evaluation stability testing
    • Statistical analysis and data trending
    • Forced degradation studies
    • Photostability
    • Temperature cycling
• Storage
  • Catalent offers approximately 22,000 cubic feet of storage area over a broad range of storage conditions.
  • Locations
    • Facility in Research Triangle Park, NC has 37 chambers, which includes 16 walk-in chambers.
    • Facility in Somerset, NJ has 19 chambers, which includes 4 walk-in chambers
      • DEA Licensed Facilities for Controlled Drugs Schedules I-V
  • General stats
    • Each stability chamber operates independently with its own temperature and, where applicable, humidity controls. 
    • All storage chambers are continuously monitored by a Kaye System. 
    • Temperature and humidity set point windows are +/- 2 degrees C and +/- 5% RH, respectively.
    • 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.
  • Photostability
    • Light exposure/temperature control
    • ICH Option with Temperature Control and Monitoring at 25° C
    • Fluorescence 200-1000 foot candle
    • Room Light/CRT
    • Chamber qualifications
    • Kaye Monitoring System (out-of-range alarms and notification)
    • Full generator backup
    • Security system
    • Backup water system
  • Types of sample storage
    • Drug product
    • Drug substance
    • Placebo
    • Comparator drug product
    • Controlled drugs

Facilities

• RTP, North Carolina, U.S.A. - Center for Development and Analytical 
  • General stats
    • Over 330+ personnel in 200,000 sq. ft. of laboratory space
    • 9,500+ sq. ft. of GMP manufacturing for CTMs
  • Project director based work teams
    • Effective resource design including: 
      • Project management
      • Project directors
      • QA
      • Scientific staff supported with administrative assistants
  • Special material handling
    • DEA-controlled substances
    • Cytoxics
    • High potency
    • Light- moisture- and oxygen-sensitive compounds
    • Cephalosporin/penicillin
    • BSL 2/3
    • Hormonals
    • Radioactive licenses
  • Laboratory facilities
    • 6 buildings in Southport Business Park
    • 200,000 sq. ft. laboratory space
    • 22,750 cu. ft. ICH stability
  • cGMP manufacturing
    • 9,500 sq. ft. 
    • Respiratory
    • Sterile (liquid/lyo)
    • Phase I/II scale
  • Operational excellence
    • Visual management of workload 
    • Metrics driven
    • Value-stream approach