PT  - JOURNAL ARTICLE
AU  - Henry L. Avallone
TI  - Inspectional Guidelines for Sterile Bulk Antibiotics
DP  - 1980 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 447--451
VI  - 34
IP  - 6
4099  - http://journal.pda.org/content/34/6/447.short
4100  - http://journal.pda.org/content/34/6/447.full
SO  - PDA J Pharm Sci Technol1980 Nov 01; 34
AB  - The sterilization of antibiotic powders and subsequent processing prior to filling represents one of the more challenging operations in the pharmaceutical industry. The processing of sterile bulk antibiotic powders involves some aseptic processing procedures not generally utilized in the production of a parenteral dosage form. The general processing procedures associated with sterile bulk production are discussed. Examples pertaining to agency regulatory philosophy are given.