RT Journal Article
SR Electronic
T1 Continuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical Methodologies
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 446
OP 455
DO 10.5731/pdajpst.2019.010181
VO 74
IS 4
A1 Dalmaso, Gilberto
A1 Campanella, Anna
A1 Lazzeri, Paola
YR 2020
UL http://journal.pda.org/content/74/4/446.abstract
AB Manufacture of sterile products must strictly follow carefully established and validated analytical methods of manufacture and control. Based on this consideration, we evaluated scientific literature describing settle plates and active air sampler monitoring effectiveness. A contamination control strategy should be implemented by pharma manufacturers, especially for aseptic productions, to assess the effectiveness of environmental monitoring and demonstrate that the process is under statistical control. It is of key importance for microbiological monitoring data to correlate as best as possible with total particle monitoring data so that each batch release is reliably supported.