Qualification of Semi automatic Injection filling machine

QA SOPS

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:sm_engineering@yahoo.com
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  

      

 

 

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.

 

Installation Qualification

 

Environment and Siting

Has the instrument been adequately acclimatized since transport or storage?

YES                                 NO   

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                   

 

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.

 

Installation Qualification        

Equipment  code: SFM-

 

 

Summary Report

Instrument:  

Manufacturer: SM Engineering

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                                                         

Assessment of Complete Installation Qualification:

No Deviations                                              Deviations           (List below)

 Deviation  

Impact on Operation

 

Justification for Acceptance

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

 

Not Done

 

Pass Fail Date signed
 

Earth continuity

Insulation
Comments:

 While operating the machine, allow no one else to touch it.

 

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:

  • Never move or carry the unit when in use or connected to the mains electricity supply.
  • Safety guards provided with a limit switch to not start the machine when the safety guards are not in the proper position.

 

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!

 

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%

   
Comments:

 

Operational Qualification

 

Training

Date Instrument Released for Use:

 

Trained Operators  

Read Operator Semi-automatic

 

Practical Training

 

Authorizing Signature

Comments:

 

 

Operational Qualification        

 

Summary Report

Instrument: Manufacturer: SM Engineering
Assessment of Complete Installation Qualification:

 

No Deviations                                              Deviations           (List below)

 

Deviation

 

Impact on Operation

 

Justification for Acceptance

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:

 

Date :
Deviations Approved By:

 

 

Date:
OQ Approved By:

 

 

Date :

 

Performance Qualification of Semi-automatic Injection filling machine

Triggering Factor for Performance Qualification

 

PQ Trigger(s):

 

Recalibration                                       Routine Maintenance    

 

Functional Tests            

 

 

 

 

Recalibration

Control of the volume variation
Recalibration Step

Frequency :Annually

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%

 

 

 

 

 

 

 
 

 

 

 
 

 

 

 

 

 
 

Comments:

 

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!

 

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

 

 

Performance Qualification

 

Safety information:

  • Safety guards provided with limit switch to not start the machine when safety guards are not in proper position.
Safety Tests Not Done Pass Fail Date signed
Earth continuity  

 

 

 

Insulation  

 

 

 

 

Comments:

  • Do not place the oven on a readily inflammable support surface!

 

  • It is important that the oven is set up accurately horizontally

 

 

Performance Qualification

 

Post Fault Rectification

 

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: ________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

 

 

Performance Qualification   

Summary Report

Instrument Manufacturer: SM Engineering
Assessment of Complete Installation Qualification:

 

No Deviations                                              Deviations           (List below)

 

Deviation

 

Impact on Operation

 

Justification for Acceptance

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 

 

 

Share