Abstract
Tunnel sterilizers are being applied increasingly for the continuous sterilization and depyrogenation of glass containers used for parenteral medications. They impose validation parameters quite different from batch sterilizers. This study delineates a program and the results obtained in the validation of an infrared tunnel, encompassing thermal consistency and reproducibility, heat penetration of different-sized glass containers, measurement of air and container particulate matter, microbial lethality, and pyrogen destruction measured with the Limulus Amebocyte Lysate test.
- Received February 18, 1980.
- Accepted March 19, 1980.
- Copyright © Parenteral Drug Association. All rights reserved.
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