30 ML Moulded Vial Filling OQ
30 ML Moulded Vial Filling OQ
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
OPERATIONAL QUALIFICATION
OF
VIAL FILLING & BUNGING MACHINE (30 ML MOULDED VIALS)
EQUIPMENT No.: CE/PR/VFM/005
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. 2 of 15
TABLE OF CONTENTS
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. 3 of 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:
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. 4 of 15
Change in location
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. 5 of 15
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.
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. 6 of 15
Note: The above pre-requisites should be verified and if complete the Operational qualification shall
be carried out.
Comments:
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. 7 of 15
1. Closure placement
2. Establishment of machine speeds & verification of Vial filling and bunging machine performance
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
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. 8 of 15
28 Bellows 12 Delrin
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.
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. 9 of 15
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.
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. 10 of 15
6.1.2 Establishment of machine speeds & verification of Vial filling and bunging machine
performance
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.
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. 11 of 15
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.
Acceptance criteria : The actual output shall meet ± 4% to the set speed without any
unusual observations.
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. 12 of 15
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. 13 of 15
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
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. 14 of 15
11.0 ATTACHMENTS
Sr.
Title
No.
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. 15 of 15
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