PERFORMANCE QUALIFICATION

Application Date
REPORT OF THE PAM AF 40T
CAPSULE FILLING MACHINE
Site Oued Tlelat –Oran PQR-004-01 Page 1 / 8

SUMMARY

1. OBJECTIVE …………………………………………………………………....……...2
2. CONTENT………………………………………….………………………….…….....2
3. CONCLUSION……………..…………………………………………..……….….......7

Name & Designation Date & Visa

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1. OBJECTIVE

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REPORT OF THE PAM AF 40T
CAPSULE FILLING MACHINE
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To ensure that the PAM AF 40T capsule machine is suitable for consistently filling and
closing powder and pills capsules within the specified range of weight variation and filling
speed at set operating parameters.

2. CONTENT

The content below holds the test parameters and the results of each test during the
performance qualification of PAM AF 40T capsule machine.
2.1. CYCLE DETAILS
Date of study

Equipment ID

Study Name

2.2. PARAMETERS

Description UOM Value Observed during cycle

Compressed air pressure Bar

Vacuum required (Bush cleaning) mm Hg

Vacuum required (Capsule Separation) mm Hg

Vacuum required (Powder bed) mm Hg

Remarks :

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Date : Date : Date :

Visa : Visa : Visa :

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Capsule size/type: Machine Speed: Fill weight: Accepted weight variation%:

Run 1 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC

Start
Middle
End
weight variation %:
Run 2 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC
Start
Middle
End
weight variation %:
Run 3 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC
Start
Middle
End
weight variation %:
Remark:

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Date & Visa : Date & Visa : Date & Visa :

2.3. Weight variation:

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Capsule size/type: Machine Speed: Fill weight: Accepted weight variation%:

Run 1 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC

Start
Middle
End
weight variation %:
Run 2 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC
Start
Middle
End
weight variation %:
Run 3 1 2 3 4 5 6 7 8 9 10 Min Max Avg % C/NC
Start
Middle
End
weight variation %:
Remark:

Done by : Verified by : Approved by :

Date & Visa : Date & Visa : Date & Visa :

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CAPSULE FILLING MACHINE
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2.4. Production speed and performance :

Capsule size : Max speed : Min speed :

Runs Run 1 Run 2 Run 3 Run 1 Run 2 Run 3
Start time

End time

Total Qt produced

Total Qt rejected

Observation

Rejection rate (%)

C / NC
Specification: Rejection rate no more than 1%
Remark :

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Date & Visa : Date & Visa : Date & Visa :

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2.5. Machine capability Cm :

Capsule size : Max speed : Min speed :

Runs Run 1 Run 2 Run 3 Run 1 Run 2 Run 3
TI

Average

Standard insert

CM

Specifications >1, >1,33 >1, >1,33 >1, >1,33 >1, >1,33 >1, >1,33 >1, >1,33
C / NC

Specification : Cm>1,33  machine capable Cm>1  machine just able

Remark :

Machine capable Machine just able Not Capable

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3. CONCLUSION

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□ Compliance □ Non-
Compliance

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CAPSULE FILLING MACHINE
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Date : Date : Date :

Visa : Visa : Visa :

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