RT Journal Article
SR Electronic
T1 Validation Studies of the Fostoria Infrared Tunnel Sterilizer
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 330
OP 347
VO 34
IS 5
A1 Akers, Michael J.
A1 Avis, Kenneth E.
A1 Thompson, Barbara
YR 1980
UL http://journal.pda.org/content/34/5/330.abstract
AB 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.