In this article, we will discuss the Qualification of Semi-automatic Injection filling machine
IQ OQ PQ Overview
Brief:
Correct functionality and performance of equipment to obtain reliable and accurate data therefore equipment qualification should be part of any good manufacturing practice.
The contents of the qualification workbook are as follows.
- Installation Qualification (IQ) for performing and documenting the installation in a location selected by the user.
- Operational Qualification (OQ) for testing of the equipment in the position selected by the user, to ensure that it meets the performance specifications dictated by the manufacturer.
- Performance Qualification (PQ) for testing that the equipment consistently performs as required for the intended application.
Installation Qualification of Semi-automatic Injection filling machine
| Equipment Name: | Semi-automatic Injection Filling Machine
For 10ml to 20ml Vials |
| Equipment Code: | |
| Instrument Description: | Semi-automatic Injection Filling Machine For 10ml
to 20ml bottles · All contact parts are made out of SS316 L quality material. ·Maximum care has been taken to ensure the safe operation of the unit |
| Application | Any type of INJECTION filling.
Solution Suspension |
| Manufacturer: | SM Engineering |
| Service Contact: | Email:[email protected] |
| Serial Number: | NA |
| Condition When Received: | Ok New |
| New | New |
| Used | |
| Reconditioned | |
| Date Received: |
Installation Qualification
Instrument Specification
| Instrument Parameter | Specified Range | Acceptable |
| Equipment type | Semi-automatic Injection filling machine |
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Capacity Filling &sealing |
50-60 vials /minute | |
| Separate
Laminar Flow Hood |
Separate LFH With HEPA Filter Provides Class 100 Area | |
| Fabrication / construction | S.S.316 CLADDING | |
| Contact parts | S.S.316 AS PER REQUIRE | |
| Motor Hp | 7.5 | |
| Load required | 0.6 AMPERE | |
| Control panel and button | Push Button | |
| Nozzle | 2 | |
| Fill Volume | 10-20ML | |
| Accuracy | ±0.5% | |
| Comments:
Maximum care has been taken to ensure the safe operation of the unit. |
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Installation Qualification
Environment and Siting
| Has the instrument been adequately acclimatized since transport or storage?
YES NO |
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| Parameters | Specified Range | Conditions Met | |
| Working environment | Ambient Temperature | Ambient temperature range +5°C to +40°C | |
| Maximum Relative Humidity | Relative humidity not exceeding 40-60% | | |
| Electrical supply | 440V AC 1.H.P 440V AC | | |
| Motor Capacity | 5.5KW | ||
| Dimensions Filling machine
(H x L x W)FEET |
3 Feet 5 inch x 1 Feet 5 inch x 2 feet 5inch | | |
| SPACE REQUIRED | 3 FEET | | |
| Net weight | <1000 Kg | | |
| Comments: THIS EQUIPMENT MUST BE EARTHED | |||
Installation Qualification
Instrument Delivery and Documentation
| Unpack the instrument carefully. Are any items missing against the Packing List?
Yes No If yes, state missing items:_______________________________________ |
| Is there any damage to the instrument or accessories?
Yes No
If yes: Description of damage: _______________________________________
Corrective action: ___________________________________________
The manufacturer informed: Yes No |
Installation Qualification
| Manufacturer’s Safety Recommendations:
Maximum care has been taken to ensure the safe operation of the unit. Safety guards provided with a limit switch to not start the machine when safety guards are not in the proper position. Do not wear loose clothing, loose neckwear, or exposed jewelry while operating machinery. Always keep hands and other body parts a safe distance away from moving machine parts.
Do not attempt to oil, clean, adjust, or repair any machine while it is running. Stop the machine and lock the power switch in the “OFF” position. Do not operate any machine unless authorized to do so by the instructor or under the instructor’s supervision Do not try to stop the machine with your hands or body. Do not talk to others when they are operating a machine. A distraction may lead to an injury. Report defective machinery, equipment, or hand tools to supervisors. |
| Comments:
After installation and before being put into service for the first time, First, ensure that it has been installed correctly and is safe to operate |
Installation Qualification
Assembly and Installation
Assembled and Installed By: User Specialized Engineer
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Installation Procedure: |
Yes | No |
| Unpacking and inspecting up INJECTION Filling Machine | | |
| The unit is complete and the accessories and options are present. | | |
| INJECTION Filling Machine Frame is installed | | |
| A laminar flow hood is installed. | | |
| Heap filters are installed in the laminar flow hood. | | |
| Compressed air Connections | | |
| INJECTION Filling Machine Lubrication | | |
| Make an electrical connection for both LFH and filling machines. | | |
| Caution :
DO NOT connect the motor to the power source until all components are assembled, the filling machine is installed, and all hardware is tightened to the proper torque which is specified in the operation and maintenance Semi-automatics supplied by Manufacturer. |
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Installation Qualification
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Summary Report
| Instrument: |
Manufacturer: SM Engineering |
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| Installation Qualification
_ Verify approved purchase order. _ Verify invoice. _ Check manufacturer and supplier. _ Check for any physical damage. _ Confirm location and installation requirements per the recommendation of Manufacturer. _ Verify that the required utilities are available. _ Electrical drawings _ Mechanical drawings |
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| Assessment of Complete Installation Qualification:
No Deviations Deviations (List below) |
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| Deviation |
Impact on Operation |
Justification for Acceptance |
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| Successful completion of the preceding activities and checks indicates that this instrument has been satisfactorily delivered and installed. The instrument has passed the Installation Qualification procedure and may now be submitted for Operational Qualification. | ||||
| IQ Completed By: | Date : | |||
| Deviations Approved By: | Date: | |||
| IQ Approved By: | Date : | |||
Operational Qualification of Semi-automatic Injection filling machine
During the OQ testing, the actual operating parameters of the equipment are checked. Operational tests are specific to the type of equipment and its function. Several prerequisites must be met before the OQ is performed: completion of the IQ; verification that deficiencies have been resolved and that the protocol has been updated and approved; verification of the availability of OQ support utilities; verification that all calibrations have been completed; identification of test equipment; and verification of the current calibration status.
Safety information
- Safety guards provided with a limit switch to not start the machine when safety guards are not in the proper position.
| Safety Tests
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Not Done
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Pass | Fail | Date | signed |
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Earth continuity |
| | | ||
| Insulation | | | | ||
| Comments:
While operating the machine, allow no one else to touch it. |
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Operational Qualification
| Pre-Run Check
|
OK | No | N / A |
| Ensure manufacturer’s recommendations for installation site requirements | | | |
| Check the site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, environmental conditions such as humidity, temperature, vibration level, and dust). Allow sufficient shelf space for the equipment | | | |
| Before loading the liquid, ensure that the inner and outer surface of the hopper is cleaned as per the standard procedure | | | |
Comments:
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Operational Qualification
| Functional Test | Acceptance Criteria | Pass | Fail |
| Powers up | Connect the main cable of the Q mixer to the main supply. | | |
| Operation check | Operate the equipment at low, medium, and high speed per operations Semi-automatic to verify the operating control. | | |
| Verify that all switches and push buttons are functioning properly. | | | |
| Establish procedures for operation and maintenance. | | | |
| Classification at Filling Point | The particle load should be examined at the location near the filling points with a
particle counter Requirements _ ð 100 particles Š 0.5 m/cft or ð 3000 particles Š 0.5 m/m3 _ 0 particles Š 5 m/cft or m3 |
| |
| Particle Contamination of Ampules and Vials during
Filling Procedure |
vials should be filled with water for injection and afterward be inspected on the contamination with particles (particle classes: ð 10 m and ð 25 m). The inspection can be performed with a particle counter.
Requirements The USP 24 requirements for “particulate matter in injections, small-volume injections” must be fulfilled. The contamination with particles during the filling step should be equivalent to all available machines. |
| |
| Filling Trials (Media Fill Run) | Meets requirements as per sop | | |
| Filling Volume Accuracy | The filling accuracy should be within ± % of the adjusted and desired filling volume
in accordance with the machine specification, etc. Attention limit: ± 0.5% Action limit: ± 1% |
| |
| Comments:
Any work involving opening up the machine electrical parts must only be carried out by a suitably qualified electrician! |
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Operational Qualification
Calibration
| Control of the volume variation | |||||
| Filling Volume Accuracy | |||||
| Test | Requirements | Result | Passed | Failed | Not Done |
| Filling Volume Accuracy | The filling accuracy should be within ± % of the adjusted and desired filling volume
in accordance with the machine specification, etc. Attention limit: ± 0.5% Action limit: ± 1% |
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| Comments: | |||||
Operational Qualification
Training
| Date Instrument Released for Use:
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| Trained Operators |
Read Operator Semi-automatic |
Practical Training |
Authorizing Signature |
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| Comments:
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Operational Qualification
Summary Report
| Instrument: | Manufacturer: SM Engineering | |||
| Assessment of Complete Installation Qualification:
No Deviations Deviations (List below) |
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|
Deviation |
Impact on Operation |
Justification for Acceptance |
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| Successful completion of the preceding activities and checks indicates that this instrument is operating satisfactorily following delivery and installation. The instrument has passed the Operational Qualification procedure and may now be released for use. | ||||
| OQ Completed By:
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Date : | |||
| Deviations Approved By:
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Date: | |||
| OQ Approved By:
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Date : | |||
Performance Qualification of Semi-automatic Injection filling machine
Triggering Factor for Performance Qualification
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PQ Trigger(s):
Recalibration Routine Maintenance
Functional Tests
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Recalibration
| Control of the volume variation | ||||||
| Recalibration Step
Frequency :Annually |
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| Test | Requirements | Batch # | Result | Passed | Failed | Not Done |
| Filling Volume Accuracy
(Process validation batches) |
The filling accuracy should be within ± % of the adjusted and desired filling volume
in accordance with the machine specification, etc. Attention limit: ± 0.5% Action limit: ± 1% |
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Comments: |
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Performance Qualification
| Functional Test | Acceptance Criteria | Not Done | Pass | Fail |
| Powers up | Connect the main cable of the Q mixer to the main supply.
|
| | |
| Operation check | Operate the equipment at low, medium, and high speed per operations Semi automatic to verify the operating control. | | | |
| Verify that all switches and push buttons are functioning properly. | | | | |
| Establish procedures for operation and maintenance. | | | | |
| Classification at Filling Point | The particle load should be examined at the location near the filling points with a
particle counter Requirements _ ð 100 particles Š 0.5 ìm/cft or ð 3000 particles Š 0.5 ìm/m3 _ 0 particles Š 5 ìm/cft or m3 |
| | |
| Particle Contamination of Ampules and Vials during
Filling Procedure |
vials should be filled with water for injection and afterward be inspected on the contamination with particles (particle classes: ð 10 ìm and ð 25 ìm). The inspection can be performed with a particle counter.
Requirements The USP 24 requirements for “particulate matter in injections, small-volume injections”must be fulfilled. The contamination with particles during the filling step should be equivalent at all available machines. |
| | |
| Filling Trials (Media Fill Run) | Meets requirements as per sop | | | |
| Filling Volume Accuracy | The filling accuracy should be within ± % of the adjusted and desired filling volume
in accordance with the machine specification, etc. Attention limit: ± 0.5% Action limit: ± 1% |
| | |
| Comments:
Any work involving opening up the machine electrical parts must only be carried out by a suitably qualified electrician! |
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Performance Qualification
| Routine Maintenance | Scheduled Frequency |
| The equipment should be cleaned before and after every product to product and batch to batch change over | Daily |
| Electrical connection | 6 Month |
| Compressed air connection | 6 Month |
| Volume adjustment parameters | Monthly |
| Comments :
· Follow scheduled maintenance log book
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Performance Qualification
Safety information:
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| Safety Tests | Not Done | Pass | Fail | Date | signed |
| Earth continuity | | | |
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| Insulation | | | |
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Comments:
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Performance Qualification
Post Fault Rectification
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Is this PQ directly following a fault rectification?
Yes No
If yes:
Description of fault: _______________________________________________ ________________________________________________________________ ________________________________________________________________
Rectification: ____________________________________________________ ________________________________________________________________ ________________________________________________________________
Date rectified: ___________________________________________________
Fault rectified by:
User Specialised Engineer Return to Manufacturer
Any measures advised to prevent reoccurrence: ________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________
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Performance Qualification
Summary Report
| Instrument | Manufacturer: SM Engineering | |||
| Assessment of Complete Installation Qualification:
No Deviations Deviations (List below) |
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|
Deviation |
Impact on Operation |
Justification for Acceptance |
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| Successful completion of the preceding activities and tests indicates that this instrument is operating satisfactorily following recalibration, maintenance or functional checks. The instrument has passed the Performance Qualification procedure and may now be returned to use. | ||||
| PQ Completed By: | Date : | |||
| Deviations Approved By: | Date: | |||
| PQ Approved By: | Date : | |||
if you have any question regarding the Qualification of Semi-automatic Injection filling machine then please do write to us
