Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

Importancia y uso:

3.1 This practice deals with recommended best practices for freeze dryer instrumentation, particularly which is used for monitoring the status of the product during freeze drying and perhaps for equipment capability testing. Temperature and pressure are both critical variables affecting heat transfer, mass transfer, process efficiency, and product quality. For this reason, particular emphasis is placed on product temperature and pressure measurement within the freeze dryer. The methods discussed in this guide are limited to techniques that are equally applicable at both laboratory and production scale.

3.2 Finally, it is recognized that “best practice” changes over time as new technology matures and process understanding deepens.

Subcomité:

E55.05

Volúmen:

14.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

best practices; freeze drying; pressure measurement; process analytical technology; process instrumentation; temperature measurement;