Stability Testing & Storage

Customized service that meets the highest standards of quality 

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 testing
  • Drug substance stability testing
  • Comparator stability testing
  • Formulation evaluation stability testing
  • Statistical analysis and data trending
  • Forced degradation studies
  • Photostability
  • Temperature cycling
• Storage
  • 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
  • DEA Licensed Facilities for Controlled Drugs Schedules I-V

Facilities

• RTP, North Carolina, U.S.A. - Center for Development and Analytical
  •  General stats
    • 37 chambers, including 16 walk-in chambers
    • 22,000+ cubic feet of varied condition storage
    • 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
• Swindon, United Kingdom
  • 158,000sq
  • EMEA, FDA, ANVISA, Turnkey MOH & AEO Approved; CT-PAT approval for Catalent US
  • Featured Technologies:
    • Zydis® fast-dissolve technology
    • Development and clinical technologies
    • Regulatory consulting services
  • Analytical Testing Services:
    • Raw material and finished product release testing
    • QP Release
    • Method Development and Validation
    • Compendial testing
    • Stability testing and storage