RT Journal Article
SR Electronic
T1 Sterile Powder Filling the Learning Curve
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 198
OP 206
VO 40
IS 5
A1 Hofmann, K. L.
YR 1986
UL http://journal.pda.org/content/40/5/198.abstract
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.