ABSTRACT

Dry heat is one of the most commonly used methods to

sterilize and/or depyrogenate pharmaceutical com-

ponents and products. Dry heat sterilization is often

used for heat-stable oils, ointments and powders. Most

often, depyrogenation of parenteral containers is

performed utilizing a dry heat oven. The depyrogenation

process is also utilized on certain heat-stabile com-

ponents, glass containers, metal equipment, etc. to

render the item and final parenteral product free of

pyrogens. The equipment utilized to provide the dry

heat medium must be validated to ensure that the

system is able to provide sterile and/or depyrogenated

components, on a reproducible basis.