RT Journal Article
SR Electronic
T1 Continuous And Effective Microbiological Air Monitoring In Critical Environments
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.010181
DO 10.5731/pdajpst.2019.010181
A1 Gilberto Dalmaso
A1 Anna Campanella
A1 Paola Lazzeri
YR 2020
UL http://journal.pda.org/content/early/2020/02/14/pdajpst.2019.010181.abstract
AB Manufacture of sterile products must strictly follow carefully established and validated analytical methods of manufacture and control. Based on this consideration, we evaluate scientific literature describing settle plates and active air sampler monitoring effectiveness. A contamination control strategy should be implemented by pharma manufacturers, especially aseptic productions, to assess the effectiveness of environmental monitoring and demonstrate 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 each batch release is reliably supported.