PT  - JOURNAL ARTICLE
AU  - Gilberto Dalmaso
AU  - Anna Campanella
AU  - Paola Lazzeri
TI  - Continuous And Effective Microbiological Air Monitoring In Critical Environments
AID  - 10.5731/pdajpst.2019.010181
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.010181
4099  - http://journal.pda.org/content/early/2020/02/14/pdajpst.2019.010181.short
4100  - http://journal.pda.org/content/early/2020/02/14/pdajpst.2019.010181.full
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.