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NVPC



NVPC

Online NVPC: Make= Beckman; Model= Met one 6015P; Capacity= 1CFM
SOFTWARE= EnVigil

Critical alarm: Critical alarms are those alarms when generated indicate excursion which may impact the product quality. Alarm generated in location where the NVPC probe is in close proximity to the product/ sterile container closure/ product contact path.

Location for critical alarms includes grade A location - Filling station, Bunging station, Bunging Hopper station, Portable cart, IOS station, AGV station, Near lyophilizer door open, between lyophilizers (near Lyo) and Lyo LAF (rigid barrier transfer conveyor).

Critical alarms include the following-

1.    Particle count excursion beyond the acceptance criteria at a particular location.
2.    Sensor Failure, Counter Flow Failure, ERROR or SKIPPED message.

Ensure and verify the status of counter flow to meet the below set limit-
Target Counter flow – 1.0 CFM.
Minimum counter flow: 0.9 CFM.
Maximum counter flow: 1.1 CFM.

“0” states counter ‘OFF’ condition.
“1” states counter ‘ON’ condition.

 GRADE- A (On Line)
0.5 Micron= 100 (Cubic feet/min) and 3520 (Cubic meter/35.31 minutes)
5 Micron= 0 (Cubic feet/min) and 20 (Cubic meter/35.31 minutes)

GRADE- B
0.5 Micron= 352000 (Cubic meter)
5 Micron= 2900 (Cubic meter)

GRADE- C
0.5 Micron= 3520000 (Cubic meter)
5 Micron= 29000 (Cubic meter)

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