Keyword Search
 

 

Home

Search Proceedings

About NCSL

Contact Us

Help

View Paper

Session Topic: 4E, Pharmaceutical Metrology

   

Paper Title: Issues to Consider When Complying with ICH Guidelines Involving Temperature and Relative Humidity Conditions

   

Date & Time: TUESDAY, August 6, 2002

 

10:45am - 12:15pm PARALLEL SESSIONS - SESSION 4

   

Speaker: Clay Hile Parameter Generation & Control, Inc.

Email: c.hile@humidiycontrol.com

   

ICH publication “Stability Testing of New Drug Substances and Products” prescribes several temperature and humidity conditions to maintain during stability testing. Typically the environment specification stipulates a specific temperature with a ± 2.0°C tolerance and a relative humidity with a ± 5.0% tolerance (example: 25°C ± 2°C/60% RH ± 5% RH). To properly achieve these specifications, three parameters must be considered. They are: sensor accuracy, single point control constancy, and entire chamber uniformity or stratification. The product tested will be at the proper condition when the sum of these parameters are within the prescribed tolerance. This prescribed tolerance applies to both temperature and relative humidity.

NCSL International © 1996-2002 All Content.
1800 30th Street, Suite 305, Boulder, Colorado 80301-1026
Tel: (303) 440-3339 Fax: (303) 440-3384
info@ncsli.org

CD-ROM produced by X-CD Business Solutions