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Former Member
Aug 02, 2016 at 02:11 PM

In process record in PI sheet

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Hi....

We are using PI sheet as eBatch record in pharmaceutical manufacturing unit as a replacement for BMR / BPR. While creating Process order, control recipe are generated. During execution of manufacturing, observations are recorded in the PI sheet. PI sheet has a provision for calling a transaction "Result Recording" . Inprocess observations are recorded in the resulting recording.

Is there any other way for resulting the results like provision for "Excel sheet" where results can be recorded.

A screen shot for an In process is attached

Process Parameters Record : Drug Layering

Parameters

Target*

Range*

Observation

Time

Date

Inlet Temp. (°C)

43

32 - 55

Product Temp. (°C)

32

28 - 36

Exhaust Temp. (°C)

25 - 35

Air flow (CFM)

700 - 1500

Blower Drive (%)

15 - 45

Spray rate (g/min)

50 - 600

Pump Speed (RPM)

2 - 30

  1. Atm. Air pres. (Bar)
  2. 1.0 – 3.0

Dew point (°C)

7 - 14

Inlet RH (%)

NMT 20

Column Height (mm)

15 - 30

Weight of dispersion Consumed (kg)

To be recorded

Spray time (min)

To be recorded

Bag shaking/

pause time

5-8 / 250-350