30 ML Moulded Vial Filling OQ

JODAS EXPOIM PVT. LTD.
OPERATIONAL QUALIFICATION
Equipment /System Name Powder Vial Filling & Bunging Machine
Protocol No. CE/PR/OQ/P-005 (S-03) Equipment /System No. CE/PR/VFM/005
Location Ceph. Block-Production Area Page No. 1 of 15
OF
VIAL FILLING & BUNGING MACHINE (30 ML MOULDED VIALS)
EQUIPMENT No.: CE/PR/VFM/005
Format No. : QA009-F02-00

TABLE OF CONTENTS
1.0 OBJECTIVE: ................................................................................................................................ 3

2.0 REASON FOR QUALIFICATION: ............................................................................................... 4
3.0 PERSONNEL RESPONSIBILITIES:............................................................................................. 5

4.0 EXECUTION TEAM: ..................................................................................................................... 6
5.0 PRE REQUISITES: ....................................................................................................................... 6
6.0 EQUIPMENT /SYSTEM QUALIFICATION PROCEDURE: ........................................................... 7
7.0 DEVIATIONS/DISCREPANCIES RECORD: ............................................................................... 12
8.0 REFERENCE DOCUMENTS: ..................................................................................................... 13
9.0 ABBREVIATIONS: ..................................................................................................................... 13
10.0 ANNEXURES: ............................................................................................................................ 13
11.0 ATTACHMENTS ......................................................................................................................... 14
12.0 SUMMARY ................................................................................................................................. 15

1.0 OBJECTIVE:
The objective of this study is to demonstrate that the VIAL FILLING AND BUNGING MACHINE
located at Jodas Expoim Pvt. Ltd., plot No: 55, phase-3, Biotech Park, Karkapatla village is capable
of consistently and effectively filling and stopperring of 30 mL molded glass vials with 20mm rubber
stoppers.
Vial Size:
S.No Vial size & Type Neck size Stopper size
1 30 ml moulded vial 20 mm 20 mm plain rubber stoppers
Ref. CCF No.: CCPR/012-16.

Background: Initially The vial filling and bunging machine was qualified for 20 ml tubular vials and
20 ml moulded vials. ( Protocol No. CE/PR/OQ/P-005 & CE/PR/OQ/P-005(S-01) ). 30 ml moulded
change parts are added to the vial filling and bunging machine. Qualification of vial filling and
bunging machine for 30 ml moulded vials is doing with supplement protocol.
This Qualification includes:
 Closure placement
 Establishment of machine speeds & verification of Vial filling and bunging machine
 Vial output verification

2.0 REASON FOR QUALIFICATION:

Please select the appropriate option by marking with “ " in the box given against each option:
 New Installation (30 ml moulded change parts) 
 Change in location
 Replacement of major component of the equipment with a new component.
 Any major modification in existing equipment
 Other (Please specify)

_______________________________________________________________________________
______________________________________________________________________________

3.0 PERSONNEL RESPONSIBILITIES:

Responsibilities of individual department / personnel while performing the Operational Qualification
of the Vial filling and bunging machine are as under :
Validation
 Responsible for preparation and review of protocol.
 Provision of training to all concerned persons on protocol prior to execution.
 Assist in the investigation of OQ variances if any.
 Execution, monitoring and review of the qualification activities.
 Verifies that the test requirements described in protocol are meeting criteria for the
performed tests and properly documented.
 Prepare the summary and conclusion of the qualification activity.
Production
 Execution of the protocol.
 Operate the equipment as per SOIs.
 Investigation of OQ variances if any.
 Head / Designee shall be responsible for review of the protocol, summary & conclusion and
approval of the completed Qualification protocol.
Engineering
 Execution of the protocol in co-ordination with production (wherever applicable).
 Assists investigation of OQ variances if any.
 Head / Designee shall be responsible for review of the protocol, Summary & conclusion and
approval of the completed Qualification protocol.
Quality Assurance
 Quality Assurance Head/ Designee shall be responsible for Approval of the protocol, review
of summary & conclusion and completed Qualification data and report.

4.0 EXECUTION TEAM:

4.1 Training to the Executors:
The executors shall be trained before the execution of protocol. Fill the details in training
Format as per the Training SOP No: QA006 and attach the training record.
4.2 List of Executors Involved in Qualification Study:
Record the details of the executors involved in the Qualification activity like name,
department, designation and training details with signature and date in the Annexure-1.
5.0 PRE REQUISITES:
Sr. Checked by Verified

Description Yes/No/NA
No. (PR) by (PR)
Installation of the Powder vial filling &

1. bunging machine is completed. (30 ml
moulded vial change parts).
2. All supporting utilities are connected.
Required power/electrical connections are

3.
given to control panel.
Training is imparted to personnel responsible

4.
to execute the study.
5. Others if any _____________.
Note: The above pre-requisites should be verified and if complete the Operational qualification shall
be carried out.
Comments:
Reviewed by (VA): Date:

6.0 EQUIPMENT /SYSTEM QUALIFICATION PROCEDURE:

The Operational qualification of the Vial filling and bunging machine (30ml moulded vials with 20mm
neck) shall be done by verifying / testing following parameters;
1. Closure placement
2. Establishment of machine speeds & verification of Vial filling and bunging machine performance
3. Vial output verification
4. The detailed procedure for execution of each test is provided in step 6.1 of this protocol.
The above-mentioned tests provide documented verification of the intended performance of the Vial
Filling and bunging machine throughout the representative / anticipated operating range.
The below mentioned change parts are made for 30 ml moulded vials.
Sr. No. Details of Change parts Quantity (No.s) Material
1 Turret (PCD 121) 5 Delrin
2 Turret (PCD 181.5) 5 Delrin
5 Turret (Servo) 2 Delrin
6 Turret (Rejection) 1 Delrin
7 Vial guide – I(Conveyor) 1 Delrin
8 Vial guide – II(Conveyor) 1 Delrin
9 Vial guide – III(Conveyor) 1 Delrin
10 Vial guide – IV(Conveyor) 1 Delrin
11 Vial guide – V(Conveyor) 1 Delrin
12 Vial guide – VI(Conveyor) 1 Delrin
13 Vial guide – VII(Conveyor) 1 Delrin
14 Vial guide – VIII(Conveyor) 1 Delrin
15 Vial guide – IX(Conveyor) 1 Delrin

Sr. No. Details of Change parts Quantity (No.s) Material
16 Vial guide – (Track changer - 1 Delrin

small)
17 Vial guide – (Track changer - 1 Delrin
Bigl)
18 Vial guide – X(Outfeed Front) 1 Delrin
19 Vial guide – XI(Outfeed back) 1 Delrin
20 Vial guide – XII(Rejection tray) 1 Delrin
21 Suction pin 12 SS304
22 Int. Guide – I (Front) 1 Delrin
23 Int. Guide – II (Back) 1 Delrin
24 Un scrambler Guide – I 1 Delrin
25 Un scrambler Guide – II 1 Delrin
26 Un scrambler Guide – III 1 Delrin
27 Un scrambler Guide – IV 1 Delrin
28 Bellows 12 Delrin
29 Bracket For Un scrambler Guide 1 Delrin
6.1 Test Data:
The detailed procedure for execution of each test described above is given in the following pages.
 Switch on the main power of Vial filling and bunging machine and enter in the "SCADA / HMI" by
following the SOI.

6.1.1 Closure placement
Objective : The objective of the Height establishment for stopper pressing unit is to
establish the minimum and maximum height for stoppering of 30 ml
moulded vials with 20 mm rubber stoppers
Tools required : 30 mL moulded glass vials & 20 mm Rubber stopper.
Test procedure :  Set the machine at established minimum machine speed for 30 ml
vials.
 Set the Stopper pressing unit to the maximum height in accordance
with the vial size and record the height of pressing unit.
 Run the Vial filling and Stoppering Machine as per SOI and collect
minimum of 1000 no’s.
 Inspect the 500 nos. of vials for proper stoppering at maximum
stoppering height for placing the stopper uniformly & axially without
any gap.
 Carry out the stoppering by decreasing the stopper pressing unit
height at minimum machine speed for applicable vial size & rubber
stopper.
 Inspect the vials 500 no’s of for proper stoppering at minimum
stoppering height for placing the stopper uniformly & axially without
any gap.
 Note: Ensure that the visual defects inspection activity shall be
carried out by visual inspector.
 Repeat the above procedure at established maximum speed
 Record the observations in Annexure-2.
Acceptance criteria :  The minimum & maximum stoppering height should produce acceptable
product such that
- The rubber stoppers shall be placed on vials uniformly without any
gap.
- No popping out of rubber stopper shall be observed.
- Stoppering must be performed correctly, completely and axially to the
vial body and the stopper must not have any scratches, cracks.

6.1.2 Establishment of machine speeds & verification of Vial filling and bunging machine
performance
Objective : The objective is to establish the minimum and maximum machine

speeds for 30 ml moulded vial and to ensure the correct applications like
vial feeding, powder feeding, powder dosing, stopper feeding,
stoppering of vials and vial out feed.
Tools required : 30 mL moulded vials & 20 mm Rubber stopper.
Test procedure :  Set the machine at minimum possible speed and run the machine as
per SOI to verify smooth functioning of machine and establish the
minimum speed for single, double , triple and four doses and record
the observations in Annexure No – 3
 Run the Vial filling and bunging machine for 5 minutes
 Repeat the above step at maximum possible speed and record the
observations in Annexure No – 3
 Set the machine at established minimum speed and target fill weight
as 250 mg for 30ml vials and operate the vial filling and stoppering
machine as per SOI.
 Inspect the vial feeding performance from infeed conveyor to powder
dosing machine.
 Check the vial transport to the track-1 and track-2.
 Observe the operation of gas pre purging station.
 Check the powder dosing from dosing station into vials.
 Observe the operation of gas post purging station.
 Inspect the proper vial traveling from dosing station to stoppering
station.
 Check the stopper feeding to stoppering station and placing of
stoppers from stoppering station onto the vials.
 Check the vial transport on out feed conveyor.
 Check for any unusual observations if any throughout the activity
and record.

 Record all the observations in the Annexure No – 4
Acceptance criteria :  Established machine speeds are for reference purpose only.
 The vial feeding, transport to the track-1 and track-2, powder
dosing, gas purging, stoppering and vial exit from out feed conveyor
should be correctly performed. Machine shall be free from any
unusual observations.
6.1.3 Production Capacities at Minimum and Maximum Set Speed
Objective : The objective of production capacities at minimum and maximum

established speeds is to check and ensure the output characteristics of
the machine w.r.t to minimum and maximum dosing for 30ml Vials.
Tools required : 30 mL moulded glass vials & 20 mm Rubber stopper.
Test procedure :  Set the machine at established minimum speed (with single, double ,
triple and four doses)
 Start filling of test batch using gamma sterilized lactose and stop the
machine after 3 minutes of elapsing time.
 Record the number of units produced as per machine encoder in
HMI and compare with expected output and record the observations
in Annexure No – 5
 Repeat the above procedure at established maximum speed.
 Repeat the procedure for two more times.
Acceptance criteria :  The actual output shall meet ± 4% to the set speed without any
unusual observations.

7.0 DEVIATIONS/DISCREPANCIES RECORD:

List the deviations/discrepancies observed if any during the Operational qualification of the Vial
Filling and bunging machine and evaluate the deviations/discrepancy as per the SOP No.: QA009
and implement the corrective actions for the same and attach the deviations/discrepancy record.
If deviations/discrepancies are resolved satisfactorily the Vial Filling and bunging machine can be
released for performance qualification up on approval of report.
Sr. No. Description of the Deviation/Discrepancy

8.0 REFERENCE DOCUMENTS:

Nil
9.0 ABBREVIATIONS:
Sr. No Abbreviations Description
1. SOI Standard Operating Instruction
2. OQ Operational Qualification
3. VA Validation
4. EN Engineering
5. PR Production
10.0 ANNEXURES:
Annexure-1 : List of executors
Annexure-2 : Closure placement
Annexure-3 : Establishment of maximum and minimum machine speeds
Annexure-4 : Verification of machine performance
Annexure-5 : Production capacity at Maximum and minimum speeds

11.0 ATTACHMENTS
Sr.
Title
No.

12.0 SUMMARY
Checked Verified
Description Yes/No/NA
by (PR) by(PR)
All acceptance criteria set forth in the Operational
qualification were met
All applicable data sheets were signed as checked and
verified.
Deviations if any
Whether acceptable
If not acceptable, action taken
END OF THE DOCUMENT

30 ML Moulded Vial Filling OQ

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

30 ML Moulded Vial Filling OQ

Uploaded by

Copyright:

Available Formats

JODAS EXPOIM PVT. LTD.

Format No. : QA009-F02-00

1.0 OBJECTIVE: ................................................................................................................................ 3

3.0 PERSONNEL RESPONSIBILITIES:............................................................................................. 5

Format No. : QA009-F02-00

S.No Vial size & Type Neck size Stopper size

1 30 ml moulded vial 20 mm 20 mm plain rubber stoppers

Ref. CCF No.: CCPR/012-16.

Format No. : QA009-F02-00

2.0 REASON FOR QUALIFICATION:

 New Installation (30 ml moulded change parts) 

 Replacement of major component of the equipment with a new component.

 Any major modification in existing equipment

 Other (Please specify)

Format No. : QA009-F02-00

3.0 PERSONNEL RESPONSIBILITIES:

Format No. : QA009-F02-00

4.0 EXECUTION TEAM:

Sr. Checked by Verified

Installation of the Powder vial filling &

2. All supporting utilities are connected.

Required power/electrical connections are

Training is imparted to personnel responsible

5. Others if any _____________.

Reviewed by (VA): Date:

Format No. : QA009-F02-00

6.0 EQUIPMENT /SYSTEM QUALIFICATION PROCEDURE:

3. Vial output verification

1 Turret (PCD 121) 5 Delrin

2 Turret (PCD 181.5) 5 Delrin

3 Turret (PCD 211.75) 2 Delrin

4 Turret (PCD 302.5) 1 Delrin

5 Turret (Servo) 2 Delrin

6 Turret (Rejection) 1 Delrin

7 Vial guide – I(Conveyor) 1 Delrin

8 Vial guide – II(Conveyor) 1 Delrin

9 Vial guide – III(Conveyor) 1 Delrin

10 Vial guide – IV(Conveyor) 1 Delrin

11 Vial guide – V(Conveyor) 1 Delrin

12 Vial guide – VI(Conveyor) 1 Delrin

13 Vial guide – VII(Conveyor) 1 Delrin

14 Vial guide – VIII(Conveyor) 1 Delrin

15 Vial guide – IX(Conveyor) 1 Delrin

Format No. : QA009-F02-00

Sr. No. Details of Change parts Quantity (No.s) Material

16 Vial guide – (Track changer - 1 Delrin

19 Vial guide – XI(Outfeed back) 1 Delrin

20 Vial guide – XII(Rejection tray) 1 Delrin

21 Suction pin 12 SS304

22 Int. Guide – I (Front) 1 Delrin

23 Int. Guide – II (Back) 1 Delrin

24 Un scrambler Guide – I 1 Delrin

25 Un scrambler Guide – II 1 Delrin

26 Un scrambler Guide – III 1 Delrin

27 Un scrambler Guide – IV 1 Delrin

29 Bracket For Un scrambler Guide 1 Delrin

6.1 Test Data:

Format No. : QA009-F02-00

6.1.1 Closure placement

Format No. : QA009-F02-00

Objective : The objective is to establish the minimum and maximum machine

Format No. : QA009-F02-00