Caraway Pharmaceuticals

Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

Installation Qualification
Protocol

Equipment Name AMPOULES WASHING MACHINE

Equipment ID BL/PD-005/CO

Protocol Number BL/QAD/IQP/001/021

Location AMPOULES SECTION

Page 1 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

CONTENTS

S. No: Description Page No

1. Pre-Approval 3

2. Purpose/Objective 4

3. Scope 4

4. Responsibility 4

5. Qualification Study 4

6. Documentation 4

7. Machine Description 5

8. Acceptance Criteria 6

9. Installation Qualification Report 6

10. Checklist 6

11. Facilities 7

12. Tool kit supplied with Automatic AMPOULES FILLING MACHINE. 7

13. Drawings/Reference Documents 7

14. Identification of Documentation 8

15. Observed Deviation 8

16. Recommendation 8

17. Change Control 8

18. Conclusion 8

19. Post Approval 9

Page 2 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

1. Pre-Approval

Prepared By:

Officer Quality Assurance Signature Date

Reviewed By:

Production Manager Signature Date

Reviewed By:

Manager Quality Assurance Signature Date

Approved By:

Head of Quality Operations Signature Date

Page 3 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

2. Purpose/Objective:

Installation Qualification is a systematic method to check the basic requirement for the installation of
AMPOULES FILLING MACHINE. This description includes all important major/ minor components of
installation.

3. Scope:

The scope of activity of installation qualification of AMPOULES FILLING MACHINE. Is to ensure that,
i. The installation site is in accordance with the manufacturer recommendations and as per user
requirement.
ii. To perform systematic check of equipment to be installed against the manufactured
specification and establish during design qualification (if performed).
iii. To ensure that all the required utilities are provided according to specification.
iv. To critically check equipment according to predetermined checking criteria (check list).
v. To establish the installation qualification report including observation, deviation encountered
during qualification study and impact of deviation, corrective action to be taken in response of
any deviation and finally the conclusion either it qualifies its installation or not.

4. Responsibilities:

i. Quality Assurance Officer.

ii. Representative of engineering department.
5. Installation Qualification Study:

i. To check that machine and accessories are supplied as per purchase order requirement.
ii. To check that the machine is installed at its specified location.
iii. To check that the utilities required by the machine is provided.

6. Documentation:

All documentation work shall be completed concurrently during execution of the qualification. However the
protocol does not define the sequence of the test/ documentation to be carried out.
i. Use indelible black ink for the recording.
ii. Fill out complete information in the format provided.
iii. Do not leave any blank space.
iv. Correct the wrong entry by drawing single line through incorrect data, recording the correct data
and then signing and dating the change.
v. Enter “N/A” in space that is not applicable.
vi. During execution of the protocol any deviation must be implemented as per defined procedure.
vii. During protocol execution, report shall be prepared with following details.
 Discussion of all study in observation column
 Qualification is successfully completed or not

Page 4 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020
 Conclusion
 Recommendation, if any
7. Machine Description:
 AMPOULES FILLING MACHINE. Is a high-tech product which is successfully developed and
designed by adopting advanced technology from abroad and strictly meet GMP requirement.

Ideal for
Ampoules Washing
Key features
 Reasonable structure design
 Requirements of materials to washing technology have been fully satisfied
 Multifunctional sealing structure with easy adjustment.
 The operating parts of mechanical hand completely adopt fully enclosed ball bearings, and the
upper and lower sliding shafts on the machine table surface adopt linear bearing and self-
lubricating system so as to avoid pollution
 The automatic filling and sealing machine adopts frequency conversion steeples speed adjusting
system, and the operation implements coordinated linkage control so as to achieve a higher
production speed. The pneumatic control system is provided with precise filter with stable
pressure of certain amount being maintained.
 The movement system is allocated with safety clutch, which can effectively realize protection for
fault overload.
 Beautiful appearance and easy to be cleaned

Supplied with
 Electric Box
 Hopper
 Frame
 Main transmission shaft for sealing
 Profiling lifting head
 Mechanical hand
 Filling nozzle
 Filling volume adjusting hand wheel

Specifications:

Operating Speed 80/min (max)

Filling Range 5-150ml/Injection (adjustable)

Production Speed 1800-3000 Injection/hour

Filling Accuracy < +1%

Aluminum tube diameter 10-32mm

Aluminum tube length 185mm

Air Supply 0.5-0.7 Mpa

Motor power 1.1kw

Machine power 2kw

Overall Dimension(mm) 1900*850*1900mm(L*W*H)

Page 5 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

Machine Weight 850kg

Hopper volume 40L

Power supply 380V

8. Acceptance Criteria:

The AMPOULES FILLING MACHINE. Should be installed as per the specifications given by the
manufacturer.

Page 6 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

Installation Qualification
Report

Equipment Name AMPOULES FILLING MACHINE.

Equipment ID BL/PD-005/CO

Protocol Number BL/QAD/IQR/001/021

Location AMPOULES SECTION

Page 7 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

9. Installation Qualification Report:

Description of Machine AMPOULES FILLING MACHINE.

Location of Equipment AMPOULES FILLING AREA

Equipment Id BL/PD-005/CO

Model LTGR-80A

10. Installation Checklist

S. No: Check Point Yes NO N/A

1 Location of AMPOULES FILLING MACHINE. In Cream & Ointment Area. Y

Ensure that the Manual /Booklet which explains the operator instruction,
3 Y
calibration, maintenance and cleaning procedures, is available.
Is the Manual /Booklet having diagram, fabrication, and maintenance & drawing
4 Y
is available?
5 Check the Engineering drawings, parts Diagram. (If applicable) N
Check the AMPOULES FILLING MACHINE. For any damage or looseness
6 N
caused during transportation.
7 Is proper connection of Wires & Cables? Y

8 Is Power fusing system available? Y

9 Ensure that the SOP for operating instruction is being prepared. Y

10 Are Spare Parts available? N

11 Is Tool Kit available? Y

Ensure that the site should not be exposed to direct sunlight or moisture, the
12 room temperature should be more than 30oC and humidity should not be more Y
than 60%
13 Avoid exposing the Instrument to extreme Electricity fluctuation. Y
Ensure that the installation surface should be sufficiently large to allow easy work
14 i.e. the space for cleaning operation, calibration and for maintenance should be Y
sufficiently large.
15 Ensure that the main components of the Instrument are assembled properly. Y
Ensure that all the supporting utility is provided according to technical
16 Y
requirement.
Ensure that the AMPOULES FILLING MACHINE. Is installed in a dry and clean
17 Y
room with good lighting.
The AMPOULES FILLING MACHINE. Should be installed on firm and level
18 Y
ground.

19 Ensure whether AMPOULES FILLING MACHINE. Properly earthed. Y

Page 8 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

11. Facilities:

The installation qualification of AMPOULES FILLING MACHINE. Was performed in Production

Department of Caraway Pharmaceuticals in Islamabad, Pakistan.

12. Tool kit supplied with Automatic TUBE FILLING & SEALING MACHINE:

NO. Category Name Unit Piece

1 Main Machine Set 1
Technical Documents

2 Use Instructions Copy 1

3 Product Certification Copy 1
4 Packing List Copy 1
5
Acceptance form of installation and debugging Copy 1

6 Cup seat Piece 9

7 Hopper Piece 1
8 Tube Bucket Piece 1
9 Tool Box Piece 1
Accessories

10 Seal Ring Set 1

11 Dead wrench Piece 4
12 Flexible wrench Piece 1
13 Slotted Screwdriver, Philips screwdriver Piece 1 for each
14 Inner hexagon wrench Set 1
15 Code granules Set 1
16 Grease gun Piece 1

13. Drawings/Reference Documents:

[Link] Title Documents # Checked by

14. Identification of Documents:

Description of Document SOP/QF No.

Change control procedure (SOP) CP-QAD-SOP-010

AMPOULES WASHING MACHINE. (Sop) CP-PD-CRE-SOP-004

Page 9 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

15. Observed Deviation:

Not Observed

16. Recommendations:

NIL

17. Change Control:

NIL

18. Conclusions:

 Installation Qualification of AMPOULES FILLING MACHINE. Is done successfully.

Page 10 of 11
 Caraway Pharmaceuticals
Installation Qualification
Document No. BL/QAD/QF/068 Revision No: 00 Effective Date: 01-06-2020

19. Post Approval:

Prepared By:

Officer Quality Assurance Signature Date

Reviewed By:

Production Manager Signature Date

Reviewed By:

Manager Quality Assurance Signature Date

Approved By:

Head of Quality Operations Signature Date

Page 11 of 11