PT  - JOURNAL ARTICLE
AU  - Hofmann, K. L.
TI  - Sterile Powder Filling the Learning Curve
DP  - 1986 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 198--206
VI  - 40
IP  - 5
4099  - http://journal.pda.org/content/40/5/198.short
4100  - http://journal.pda.org/content/40/5/198.full
SO  - PDA J Pharm Sci Technol1986 Sep 01; 40
AB  - This paper reviews various considerations in planning for installation of a state-of-the-art, high-speed powder filler operated in an aseptic environment. It reveals the problems associated with installation qualification and validation, showing the performance improvement associated with the learning curve. Detailed knowledge of the product’s physical characteristics, a close working relationship with the equipment vendor to facilitate customized modifications, and careful process monitoring to ensure quality is not compromised are required.