RT Journal Article
SR Electronic
T1 Development of a Non-Viable Particulate Monitoring System for Drugs Manufactured in an Aseptic Environment
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 260
OP 265
VO 45
IS 6
A1 Nate Morgan
YR 1991
UL http://journal.pda.org/content/45/6/260.abstract
AB Automated non-viable particulate monitoring systems can significantly reduce sampling costs while providing increased assurance that pharmaceutical products are free of microbial contamination. The need for consistently reliable data in the batch release process requires incorporating adequate fail-safes to detect operator error and hardware malfunction. Use of the “Life Cycle Approach “ in system design and validation is also needed to provide assurance that the system will continue to meet its specifications. The author has collaborated with an instrument vendor to design, install and validate a data gathering and reporting system. Test function design is also discussed.