Revalidation Report Page:1/9

Machine : Autoclave Fedegari Code No. : PIAT 3

Report No. : Model : FOW 8 / EA

HOLDI Pharma. Co.

Customer: El-Nasr Pharmaceutical Chemicals
Company

Abu Zabaal El Khanka – Egypt

Tel.: (002) 44604258, Fax: (002) 44604227

INSTALLATION QUALIFICATION
(IQR)
OPERATION QUALIFICATION
(OQR)
Performance QUALIFICATION
(PQR)
Equipment Name : Autoclave Fedegari
Equipment No. : PLAT3
Equipment Dept. : Sterilization
El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)

INSTALLATION , OPERATIONAL AND PERFORMANCE QUALIFICATION Page :- 2/9

Machine: Autoclave Fedegari Code No. : PLAT3
Report No : SR.NO.:
- DOCUMENT REVIWED AND APPROVAL:
This document is signed by the following:-

Prepared by:-
Name Title Company Date Signature

Reviewed by:-
Name Title Company Date Signature

Tested by:-

Name Title Company Date Signature

Blank protocol of this validation is the joint functional responsibility of the following:
Functional
Name Designation Date Signature
department
Engineering

Production
Quality Assurance

Post approval of this validation is the joint functional responsibility of the following:

Functional
Name Designation Date Signature
department
Engineering

Production
Quality Assurance
El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)

Installation Qualification report ( IQR ) Page :- 3/9

Machine: Autoclave Fedegari Code No. : PLAT3
Report No : SR.NO.:
Subject: Installation Qualification report (IQR).
Installation qualification check list:
S. NO Item Check
1 Sematic Panel
2 ON/OFF Switch
3 2 Emergency Stop
4 2 doors
5 Temperature Indicator
6 6 Temperature Sensor
7 2 Pressure gauge
8 Sterilization room
9 3 green bush button
10 Pipe for autoclave drain
11 Paper Cycle Roller
12 Valves
13 Heat exchanger
14 Water spray nozzles
15 Pump
16 Rails inside autoclave for loading/unloading
17 (4) Internal trolley

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Installation Qualification report ( IQR ) Page :- 4/9
Machine: Autoclave Fedegari Code No.: PLAT3
Report No : SR.NO.:
Subject: Summary report (IQR)

Summary, Conclusions and Recommendations.

Sr. Comment Signature

Parameter Remarks
No. with Date
Yes No N/A
Did the IQ Protocol
comply with all the
1 parameters laid
down in the
document?
Did the IQ invite
2
any deviation?

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Operation Qualification report ( OQR) Page :- 5/9
Machine: Autoclave Fedegari Code No.: PLAT3
Report No : SR.NO.:
Subject: Operation qualification report (OQR)
Table of Tests
Test
Test description
No Result
Touch screen panel on / off & emergency stop buttons TEST.
1- power ON.
2- Push emergency stop Button.
1 Observe power on when main supply lever and key switch ON
.Each stop button Disable supply Until reset and main lever
turned off then ON again
Connection panel and PLC TEST.
Disconnect cable between touch screen and PLC turn panel key
switch on. Observe No possible run a cycle
2 Reconnect cable between touch screen and PLC turn panel key
switch on. Observe communiction ok between panel and plc

Door safety device TEST.

(safety thermometer alarm 1)
1- Indicate temp above indicated (door cannot be opened).
2- Indicate temp below indicated (door can be opened).
3 (safety pressure device test)
1- Operate manually PRS safety device (the door cannot open)
(Steam and air supply valves)
Start steam and air valves
Observe steam and air valves can not be open if door opens

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Operation Qualification report ( OQR) Page :- 5/9
Machine: Autoclave Fedegari Code No.: PLAT3
Report No : SR.NO.:
Subject: Operation qualification report (OQR)
Table of Tests
Test
Test description
No Result
Off cycle black out (test)
- Press the emergency stop button and verify panel is ON
and all pneumatic valves are close and not possible door is
opened
6 1- Pressing the emergence stop button observe b.o page
disable.
2- Autoclave on secure condition
-all pneumatic valves are close and door not open
Motor alarm TEST.
1-run a test program including a phase that uses a motors.
2-turn off isolator to motor and check corresponding alarm is
7 activated as expected
3-turn isolator back on and check that alarm cancel
Observe alarm CIRC WATER PUMMP ALARM

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Operation Qualification report ( OQR) Page :- 5/9
Machine: Autoclave Fedegari Code No.: PLAT3
Report No : SR.NO.:
Subject: Operation qualification report (OQR)
Table of Tests
Test
Test description
No Result

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Operation Qualification report ( OQR) Page :- 6/9
Machine: Autoclave Fedegari Code No. : PLAT3
Report No : SR.NO.:
Subject: Summary (OQ)
Summary, Conclusions.

Sr. Comment Signature

Parameter Remarks
No. with Date
Yes No N/A
Did the OQ Protocol
comply with all the
1 parameters laid
down in the
document?
Did the OQ invite
2
any deviation?

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)

Summary report Page :- 7/9

Machine: Autoclave Fedegari Code No. : PLAT3
Protocol No. : SR.NO.:
Subject: : Summary, Conclusion and Recommendations :
Review and comment:

Recommendation:

Corrective Action:

Is deviation report required?

□yes
□No

Q.A approval:

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Performance Qualification(PQP) Page :- 8/9
Machine: Autoclave Fedegari Code No : PLAT3
Protocol No. :
Subject: Performance qualification :
1-Productivity test:

Product Name Ringer's solution

Batch No 272/2206/23 A,B 272/2206/23 A,B
Time of Operation 1.55 hour 1.57 hour

Quantity 3965 bottle 4960bottle

Product Name Ringer's solution
Batch No 273/2206/23 A,B 273/2206/23 A,B
Time of Operation 1.58 hour 1.56 hour

Quantity 3965 bottle 4940 bottle

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Performance Qualification(PQP) Page :- 8/9
Machine: Autoclave Fedegari Code No : PLAT3
Protocol No. :
Subject: Performance qualification :
1-Productivity test:

Product Name Ringer's solution

Batch No 274/2206/23 A,B 274/2206/23 A,B
Time of Operation 1.57 hour 2.34 hour

Quantity 3975 bottle 4970 bottle

Performed by : Observed by : Approved by : Date :

El-Nasr Pharmaceutical Chemicals Company
Autoclave Documents for Qualification and Validation (DQV)
Performance Qualification Protocol ( PQP ) Page :- 9/9
Machine: Autoclave Fedegari Code No : PLAT3
Protocol No. :
Subject: Performance qualification (PQ) :
1-Quality characteristic test:
Verify that the product have the quality characteristic:

1-Table of test :

No. Test 272/2206/23 A,B 273/2206/23 A,B 274/2206/23 A,B Result

1 Bacterial count

Performed by : Observed by : Approved by : Date :