ORIGINAL Confidential

PERFORMANCE QUALIFICATION REPORT

Document Number : VAL-EV/PQR/OC/035 Revision : 00

System : BINDER CLIMATIC CHAMBER #1

Model / Type: KBF 720 Identity Number : 09-16711

VALIDATION /
Department /
Facility: ONCOLOGY PLANT

Location Area: CHEMICAL LAB. Room Number: 467

Prepared By:
Function Name/Title Signature Date
Bagus Irawan / Equipment Validation
Validation
Mukti Wibowo / Qualification Engineer

Reviewed & Approved by:

Function Name/Title Signature Date

Rakhman Hakim
Validation
/ Validation Manager

Lisa Noveni Astuti

QC Manager
/ QC Manager
Reviewed by:
Andriyana
Plant Manager
/ Plant Manager
Agung S. Widodo
EPD Manager /
/ EPD Manager /
Project Manager
Project Manager
Utami Sulistyowati
Approved by : QA Manager
/ QA Manager

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SUMMARY

Climatic Chamber KBF 720 is used to store the retained sample product in PT. Sanbe Farma Unit
Oncology.

The Performance Qualification of that machine has been carried out concurrently based on the
protocol No. VAL-EV/PQP/ OC/035. There was no deviation during PQ execution.

The Performance Qualification was performed by verifying the temperature and humidity
distribution in chamber. The results are as follows:

1. The distribution temperature and humidity in empty chamber results are as follows:

No. TEMPERATURE
Average (∆t)
test Coldest Hottest
1 23.7 °C 25.6 °C 0.9 °C
2 24.0 °C 25.6 °C 0.9 °C
3 23.6 °C 25.0 °C 1.0 °C

No. HUMIDITY
Average (∆t)
test Lowest Highest
1 56.4 % 63.8 % 3.4 %
2 57.9 % 64.3 % 3.4 %
3 57.8 % 63.9 % 3.0 %

2. The distribution temperature and humidity in loading pattern results are as follows:

No. TEMPERATURE
Average (∆t)
test Coldest Hottest
1 24.0 oC 24.9 oC 0.3 oC
2 24.0 oC 24.6 oC 0.2 oC
o
3 24.1 C 24.7 oC 0.2 oC

No. HUMIDITY
Average (∆t)
test Lowest Highest
1 56.8 % 64.7 % 2.0 %
2 56.3 % 64.4 % 2.0 %
3 55.9 % 63.9 % 2.8 %

The acceptance criteria are range limit hottest & coldest temperature is 23 - 27 oC and the lowest
& highest humidity is 55 – 65 %. The all above result meet the acceptance criteria.

Based on the above Performance Qualification results, all items meet the predetermine acceptance
criteria and it is concluded that the Performance Qualification is pass.
It is recommended that the Climatic Chamber KBF 720 can be used for routine keeping the
retained sample for stability testing.

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TABLE OF CONTENTS

SUMMARY......................................................................................................................................2
1. OBJECTIVE...............................................................................................................................4
2. SCOPE.......................................................................................................................................4
3. VALIDATION TEAM...............................................................................................................4
4. VERIFICATION OF COMPLIANCE.......................................................................................4
5. CRITICAL PARAMETER FOR PQ.........................................................................................5
6. PERFORMANCE VERIFICATION.........................................................................................5
6.1. GENERAL PROCEDURE.................................................................................................5
6.2. LOGGER PLACEMENT....................................................................................................6
6.3. TEMPERATURE AND RELATIVE HUMIDITY DISTRIBUTION...............................7
6.3.1. Test Objective................................................................................................................7
6.3.2. Acceptance Criteria........................................................................................................7
6.3.3. Method...........................................................................................................................7
6.3.4. Data logger specification...............................................................................................8
6.3.5. Temperature Distribution Study Data Reduction...........................................................8
7. DEVIATION AND FAILURE INVESTIGATION..................................................................9
8. CONCLUSION AND QUALIFICATION STATUS................................................................9
9. REVISION HISTORY...............................................................................................................9
10. LIST OF ENCLOSURE.............................................................................................................9

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1. OBJECTIVE

The objective of this PQ is to demonstrate that Climatic Chamber with ICH-light facility KBF
720 operates consistently according to the specification during routine use.

2. SCOPE

The scope of this PQ includes the verification of product stability in specific temperature and
humidity with microprocessor temperature control, ICH comfortable light facility, and
microprocessor controlled humidifying and dehumidifying system with loads pattern that will
be validated.

Validation Status:
The Performance Qualification for validation will be conducted concurrently.

3. VALIDATION TEAM

Team Leader : Andriyana

Coordinator Production Equipment : - Mukti Wibowo
- Bagus Irawan
Team Member : - Rakhman Hakim
- Lisa Noveni Astuti
- Agung S Widodo
- Utami Sulistyowati

4. VERIFICATION OF COMPLIANCE

Pass /
Expected Conditions Actual
Fail
The IQ and OQ report has been reviewed and approved
by supplier and owner
IQ Approval Date : 02 – 03 – 2011
OQ Approval Date : 02 – 03 – 2011
Operating Procedures are in place
Major instruments and controls are properly calibrated
Alarms, safety and warning devices are operating
accurately
The normal sequence of operation is functioning
All challenge test results are satisfactory
All deviations are recorded and explained or corrected
A preliminary facility cleaning has been carried out to
remove dust / debris from the facility.

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5. CRITICAL PARAMETER FOR PQ

For Performance Qualification, the parameter critical to the operation of BINDER KBF-720
Climatic Chamber are detailed in the following table.

DESCRIPTION OF PASS/
NO RANGE/LIMIT ACTUAL REMARK
PARAMETER FAIL
1 Chamber temperature 25°C ± 2°C

2 Chamber Humidity 60% ± 5%

6. PERFORMANCE VERIFICATION

6.1. GENERAL PROCEDURE

1. Conduct pre-run data loggers/sensor described in Calibration

2. Place the loggers at the predetermined points

3. Prepare commodities or equipment in the manner proposed for inclusion into the cycle
description form (e.g. wrapped, in boxes, etc.)

4. For process qualification studies (validation of a loading pattern cycle), set the climatic
chamber temperature and relative humidity to proposed set point. (see acceptance
criteria, conformance to climatic chamber operating specification, for acceptable range)

5. Complete the section on the Storage Temperature Validation Data Summary Form
(Validation Protocol). Which describe the cycle parameters, load description,
monitoring instrumentation, control settings, and operational check list. Starts the
Climatic Chamber cycle.

6. Set the recorder to records the temperature and relative humidity on the recorder/monitor
output at the following intervals during the timed climatic phase of the cycle:

Duration of Cycle (min) Observation Intervals (min)

0 – 180 15
> 180 60 ( 1 hour )

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6.2. LOGGER PLACEMENT

No. Logger Logger Position

1 Selves 1, center

2 Selves 3, center

3 Selves 5, center (sensor)

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6.3. TEMPERATURE AND RELATIVE HUMIDITY DISTRIBUTION

6.3.1. Test Objective

To demonstrate temperature and relative humidity distribution inside chamber area.
The temperature and relative humidity distribution should be within specification.

6.3.2. Acceptance Criteria

Range limits hottest temperature and highest relative humidity distribution and
coldest temperature and lowest relative humidity distribution logger:

- Temperature not more than 25 °C ± 2°C and

- Relative humidity not more than 60 % ± 5%

DESCRIPTION OF PASS/
NO RANGE/LIMIT ACTUAL REMARKS
PARAMETER FAIL
1 Temperature Difference between hottest
Distribution and coldest temperature
distribution not more than
25 °C ± 2°C
2 Relative humidity Difference between Lowest
Distribution and highest humidity
distribution not more than 60
% ± 5%

6.3.3. Method

1. Perform initial empty chamber temperature and relative humidity distribution

studies during operational qualification of equipment.

2. Perform subsequent empty chamber temperature and relative humidity

distribution studies only when significant changes have been made to the
climatic chamber which could potentially alter the temperature distribution.

3. Conduct at least one maximum load temperature and humidity distribution study
for each new process qualification. Use the coolest loading pattern defined for
the load description. The study may be performed in conjunction with any
maximum load study.

4. Complete the study following the format described in the general procedure for
all incubation validation studies.

5. Perform all procedure tree times, for each loading pattern.

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6.3.4. Data logger specification

Specification
Brand Testo 177 - H1
Parameter Humidity (% RH) Temperature ( oC / oF)
Sensor Humidity sensor / NTC
Number of measuring channels 2 x internal
Measuring range  0 to 100 %RH ( no condensation )
 - 20 to + 70 oC
Accuracy ± 0.5 oC
± 3 %RH at rated temperature + 25 oC
Resolution 0.1 oC
0.1 % RH
Measuring rate 10s to 24h (freely selectable)
Storage temperature - 40 to + 85 oC
Operating temperature - 20 to + 70 oC
Operating temperature/Display - 20 to + 65 oC
Memory capacity 16.000 readings
Housing ABS/TPE
Dimensions in mm (l x w x h ) 82 x 52 x 30
Weight 84 g
Battery Lithium

6.3.5. Temperature Distribution Study Data Reduction

Note: Calculate and record the following statistics for each observation taken during
the timed climatic chamber portion of the cycle, omitting the initial
observation to allow for stabilization.
1. Mean temperature of temperature distribution loggers

TMEAN = (T1 + T2 +…+ TN) / N

Where,

T = Temperature readings of temperature distribution thermocouples.

N = Total number of loggers used for temperature distribution test

2. Coldest temperature distribution logger temperature

3. Hottest temperature distribution logger temperature

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7. DEVIATION AND FAILURE INVESTIGATION

All deviations from the protocol and the operational checks found during validation execution
and the results of the failure investigations will be documented.

State and explain the impact of these deviations to the validation study
Report Date & No. Nature of Deviation - Impact to the acceptance criteria and whole
study

8. CONCLUSION AND QUALIFICATION STATUS

Based on the above Performance Qualification results, all items meet the predetermine
acceptance criteria and it is concluded that the Performance Qualification is pass.
It is recommended that the Climatic Chamber KBF 720 can be used for routine keeping the
retained sample for stability testing.

9. REVISION HISTORY

Revision
Date Description Originator
No.
00 01 – 08 – 2011 New Documentation Bagus Irawan

10. LIST OF ENCLOSURE

No Title Remark
1 Temperature and Relative Humidity Distribution Data

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