Raw Data Report of Tablet

Raw Data Report
Product Name: Batch No.: Batch Size:

1.0 Sifting of Material: Date:
Acceptance Quantity
Process parameters Sieve ID Checked By
Criteria Sifted
Sifting through
Sifting through
Sifting through
Mesh Sifting through
size Sifting through
Sifting through
Sifting through
Sifting through
2.0 Binder Preparation Date:

Operation Sieve /Muslin Cloth
Batch A.R. No. of Isopropyl
time Sieve ID Integrity Checked By
No. alcohol
From To Before After
3.0 Dry Mixing: Date:

Mixing Total
Mixing
Process Set Started Mixing Compiled
Range Observations Completed
Parameters Parameters at Time By
at (Hours)
(Hours) (min.)
04 Min.
Mixing
---- 06 Min.
Time
08 Min.
Chopper
(Slow/Fast/Off) --
speed
Impeller
(Slow/Fast/Off) --
speed
4.0 Binding & Wet Mixing: Date:

Binder Binder Total Binding time (in min.)
Process Set Para- Obser- Addition Addition Binder
Range
Parameters meters vations Started at Completed Addition 1 2 3 4 5 6 7
(Hours) at (Hours) time (min.)
(Slow/
Chopper
Fast/ ----
Speed*
Off)
(Slow/
Impeller
Fast/ ----
Speed*
Off)
Binder
Addition ----
Time
Raw Data Report
Binder Binder Total Binding time (in min.)
Process Set Para- Obser- Addition Addition Binder
Range
Parameters meters vations Started at Completed Addition 1 2 3 4 5 6 7
(Hours) at (Hours) time (min.)
Impeller
Ampere ----
Load
Chopper To be
Ampere recorde ----
Load d
Total
Binding
Time
Compiled
By
5.0 Drying Date:

Drying Started at: _____________ Completed at: _____________
Set Time (in Minutes)
Parameters Range
Parameters Initial* 10 20 30 40 50 60 70 80
Damper 70-
-- -- -- -- -- --
opening 100%
Inlet
Temp. at Air -- -- -- -- -- --
Drying-I
Outlet Temp.
at Air -- -- -- -- -- --
Drying-I
Bag Shaking 10
-- -- -- -- -- -- --
Interval Min.
Bag Shaking 10-30
-- -- -- -- -- -- --
Time Sec.
Raking 10
-- -- -- -- -- -- --
Interval Min.
1-2
Raking Time -- -- -- -- -- -- --
Min.
Damper 70-
--
opening 100%
Inlet
Temp. at Air --
Drying-II#
Outlet Temp.
at Air --
Drying-II#
Bag Shaking 10
-- --
Interval Min.
Bag Shaking 10-30
-- --
Time Sec.
Raw Data Report
Set Time (in Minutes)
Parameters Range
Parameters Initial* 10 20 30 40 50 60 70 80
Raking 10
-- --
Interval Min.
1-2
Raking Time -- --
Min.
LOD at __°C -- -- --
LOD at __°C T1 T2 M3 B4 B5 Composite
from
different --
locations of
FBD bowl.
Compiled
By
*Details shall be recorded after 02 minutes of starting the FBD.
#30 Min. or till LOD achieved
6.0 Sizing & sifting

Batch Time Mesh Mesh Sieve integrity
Screen No Screen ID Compiled by
No. Start End No. ID Before After
7.0 Blending Date:

Blending Time Blend Sample
Blending Time
Blend uniformity Composite
From To (in min) Collected by
sample sample
8.0 Lubrication Date:

Lubrication Time Sampling Location
Lubrication Collected
Date Blend uniformity Composite
From To Time (in min) by
sample sample
Raw Data Report
9.0 Compression: Date:
9.1 Initial Setting Parameter:
Compression force Hardness
Thickness Weight
9.2 Tablet Parameters:

LHS
DT Thickness Hardness
Tablets weight: Target Wt. _____mg (Lt. (Lt.__________) Friability
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.3 Speed challenge study

9.3.1 Minimum Speed: _____________RPM.
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
Tablets weight: Target Wt. _____mg (Lt (Lt.__________) Friability
(Lt.__________)
.___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.3.2 Optimum Speed: _____________RPM.

LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.3.3 Maximum Speed: _____________RPM.

LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.4 Hopper challenge study

9.4.1 Minimum Hopper Speed: _____________.
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.4.2 Optimum Hopper Speed: _____________.

LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.4.3 Maximum Hopper Speed: _____________.

LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
.___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.5 Thickness challenge study

9.5.1 Low thickness
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.5.2 High Thickness

LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.6 Different stages of compression

9.6.1 Initial
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.6.2 Middle
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.6.3 End
LHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
Raw Data Report
RHS
(Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
9.7 Coating: Check and record the observations initially and after every 30 minutes
Initial weight of uncoated tablets: __________mg, Target weight gain: _______.
Observation
Setting Acceptance
Time
Parameters: criteria
No. of guns
Spray gun nozzle
diameter
Atomizing Air
Pressure
Inlet Air Temp
Tablet Bed Temp.
Outlet Temp.
Gun to Tablet Bed
Distance
Coating Pan RPM
Peristaltic Pump
RPM
Exhaust Blower
Tablet weight*
Weight gain*
Drying started at
Observed by
* To be checked after 50% coating solution consumption.

Raw Data Report
9.7.1 Coated tablet parameters
LHS
Tablets weight: Target Wt. _____mg (Lt. (Lt.__________) (Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:
RHS
Tablets weight: Target Wt. _____mg (Lt. (Lt.__________) (Lt.__________)
___min)
Avg. Wt.:
Min.:_______, Max._______
Appearance:

Raw Data Report of Tablet

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Raw Data Report

Product Name: Batch No.: Batch Size:

2.0 Binder Preparation Date:

3.0 Dry Mixing: Date:

4.0 Binding & Wet Mixing: Date:

5.0 Drying Date:

6.0 Sizing & sifting

7.0 Blending Date:

8.0 Lubrication Date:

9.2 Tablet Parameters:

9.3 Speed challenge study

9.3.2 Optimum Speed: _____________RPM.

9.3.3 Maximum Speed: _____________RPM.

9.4 Hopper challenge study

9.4.2 Optimum Hopper Speed: _____________.

9.4.3 Maximum Hopper Speed: _____________.

9.5 Thickness challenge study

9.5.2 High Thickness

9.6 Different stages of compression

* To be checked after 50% coating solution consumption.

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