Stability Services

Stability Operations at Dow Pharmaceutical Sciences

The Stability Operations – part of the Analytical Sciences Department - has many years of experience providing high-quality stability support in protocol development, management of stability studies, and analytical support. While we specialize in topical product development, we support all dosage forms. Our operations have been developed in conformance with FDA and ICH Guidelines. We provide stability services for all stages of drug development, from early research and development to full CGMP/FDA/ICH studies, including large-scale Phase 3/NDA supporting studies to commercial/post approval studies. With the expertise and experience at Dow, we can create a stability program that supports all stages of your product development program.

Stability Storage – Validated, Temperature-mapped, Controlled Environmental Chambers

Storage capabilities include 24 chambers under ICH Guidelines. Twenty are reach-in chambers, including one photostability chamber, two explosive resistant chambers, and two freezers. Four are walk-in chambers. Supported conditions are listed below. ICH photostability studies are performed with a custom-built light chamber, calibrated with a NIS light meter for the UV-A and cool-white fluorescent source exposure levels. All storage equipment is validated, temperature-mapped, continuously monitored, alarmed, and automatically backed-up in case of power failure.

Monitoring and Alarms

A validated Rees Series II™ PC computer-based monitoring system and daily verification of calibrated digital unit displays are used to monitor the chambers. The alarm capabilities of the Rees system activate a call-out phone list if an internal response is not obtained. A natural gas-powered back-up generator provides for continuous electrical supply in case of a power failure along with 24-hour monitoring with a paging system and audible alarm.

Study Management

Stability Operations is a full service department offering stability protocol design and preparation, coordination and execution of stability testing, sample storage, preparation of data reports and stability tables, and data trending and extrapolation for support of product shelf-life predictions. Stability programs can be created to meet regulatory requirements or to help gain other information necessary for successful product development.

Regulatory Compliance

Studies can be performed under GMP regulatory compliance or for research and development purposes.

Reporting

Dow provides high-quality, scientifically-sound, timely technical reports to expedite your management decisions, clinical program support, and regulatory submissions. Statistical stability expiration dating predictions are performed using 95% confidence levels.

Supported Conditions

  • Ultra Freezer, -80°C
  • Freezer, -20°C
  • Refrigerator, 5°C (reach in and walk in space)
  • Controlled Room Temperature
  • 25°C / 60% RH
  • 25°C / 40% RH ( walk in space)
  • 30°C / 65% RH
  • 40°C / 75% RH
  • 40°C /NMT 25% RH
  • Photostability
<< Back to Analytical Sciences