our present approach for HVAC validation for our aseptic processing area , incudes monitoring of velocites .DOP and in situ air flow analysis and additonally
monitroring of aseptic processing area for 3 continous day for viable count, physical parameters and nonviable particle count to prove prodcution area is providing sufficent SAL
is it necessary to go with this approach of monitoring area for 3 days inspite these parameter are being daily checked as a part of Enviorement management program ?
pleae give u comments on our approach or is there any alternate approach to thes3 day monitoring ?
Microbes are not educated and enlighted like us.They can be present any where at any situation and at any time.
If you have to prove Assurance for sterile production it is always necessary to carry out microbial monitoring in aspectic area, procedures, people and in core class 100 area daily during the process.
The main reason is it will be a valuable tool which guides you about the failures of the product during the route cause analysis and also let you know how your HVAC is behaving, how good your staff are trained to work in sterile areas with proper systems and cleanliness.
-Clean daily
-Swab garmets daily
-Monitor microbes in sterile areas daily
-Monitor LAF --filling zone daily.
-Look the results carefully and make necessary corrective actions where you have repeated higher counts at places, corner zones, entry zones, LAF and also on people especially on garmets and gloves.
This is a group excericise. It cannot be commanded or programmed and executed by one individual.Make sure every one knows and understands the importance of this procedure.