Objective for Automatic Capsule Filling Machine PQ:
The documented evidence describing the procedure for qualification of the Automatic Capsule Filling Machine PQ its ancillary system as intended throughout the anticipated operating range to meet the criteria of the equipment and ancillary system for qualification. It includes:
Demonstrate that the procedure for performance test and operating range of the Automatic Capsule Filling Machine is competent for reproducibility and consistently within its full dynamic range of operation according to specifications and as per cGMP guidelines.
Protocol Pre Approval:
Protocol Prepared By:
| Department | Name | Signature | Date |
| Quality Assurance (Officer/ Executive) |
Protocol reviewed by:
| Department | Name | Signature | Date |
| Quality Assurance (Executive/ Manager) | |||
| Production (Executive/ Manager) | |||
| Engineering (Executive/ Manager) | |||
| Quality Control (Executive/ Manager) |
Protocol Approved By:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
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Responsibilities Assigned
| DEPARTMENT | RESPONSIBILITIES |
| Quality Assurance | Initiation, Review, Approval and Compilation of the Performance Qualification Protocol cum Report. Review of Performance Qualification Protocol cum Report after Execution. Coordination with Production and Engineering to carryout Performance Qualification and Monitoring of Performance Qualification Activity. Post approval of Performance Qualification Protocol cum Report after Execution. Approve any change control generated during the Performance Qualification Study. |
| Production | Review & Pre Approval of Performance Qualification Protocol cum Report. To coordinate & support for execution of Qualification Study as per Protocol. Post approval of Performance Qualification Protocol cum Report after Execution. |
| Quality Control | Review & Pre Approval of Performance Qualification Protocol cum Report. Analytical Support. Post approval of Performance Qualification Protocol cum Report after Execution. |
| Engineering | Review & Pre Approval of Performance Qualification Protocol cum Report. Coordination, execution and technical support in Automatic Capsule filling Machine (AF 90T) Performance Qualification Activity. Review of Performance Qualification Protocol cum Report after Execution. |
Scope:
- The Scope of this Qualification Document is limited to the Performance Qualification for Automatic Capsule Filling Machine with cGMP Model procures from approved vendor. installed in the Capsule filling Area.
- This Protocol cum Report defines the responsibilities, procedures, documentation, references, acceptance criteria, change control and qualification criteria to be used during Performance Qualification of the Automatic Capsule Filling Machine.
- This Protocol cum Report provides all the relevant information of performance qualification activity for Automatic Capsule Filling Machine and all the observations of In-Process checks and analytical results of analyzed samples.
Automatic Capsule Filling Machine AF 90T: Machine Description
Automatic Capsule Filling Machine consists of the following units:
Structure Assembly:
This houses the main drive motor, powder drive motor, pneumatic and vacuum piping, all drive elements and electrical control cabinet. The structure is enclosed on all four sides by removable covers. Removing the hand wheel side cover exposes the main motor & drive assembly , the filter regulator for Main air inlet assembly, Pressure, Vacuum gauge , and Pneumatic solenoid valve assembly. Removing the cover below the exit chute exposes the vacuum throttle valve, electrical junction box no- 2 ,
Pneumatic solenoid valve assembly & Encoder assembly. When the cover located below the empty capsule loading area is removed exposed electrical control panel. Removing the cover below the Powder Hopper exposed PMM motor assembly, electrical junction box no-1.
Drive Assembly:
This consists of the main motor, drive shaft, gears, cams, cam followers, bearings, housings and brackets. Rotary indexing motion is given to the turret, dosing disc and a reciprocating motion is given to various sections that move vertically by specially designed cams.
Turret Assembly:
The turret is a cylindrical disc. It has 10 pairs of cap & body bush holder plates with the cap plate located above the body plate. Each pair are radially equidistant around the turret centre. The turret also houses pneumatic cylinder and cams for providing motion to the cap and body bush holder plates.
Empty capsule loader assembly:
This consists of a capsule hopper, capsule reservoir, magazine, rectifier block, horizontal finger assembly, vertical finger assembly and vacuum block. The reservoir has a baffle plate to regulate the flow of capsules in the reservoir. The magazine is mounted on a shaft. The vertical finger assembly and the capsule releasing fingers are fitted on the magazine. A pneumatic cylinder is provided to start or stop the release of capsules to the rectifier block. This pneumatic cylinder is controlled through MMI. The released capsules are pushed by the horizontal finger assembly. A vacuum block located below the body bush holder plate moves up & down.
Powder Filling Device:
This consists of a hopper, powder stirrer, powder Dispensing tube, powder level sensor, powder tub. The powder hopper is a stainless steel container fitted with an acrylic window. A powder stirrer is mounted centrally in the hopper and driven by a separate motor which is fitted inside the Structure. At the delivery end of the hopper, adjustable gate is provided to control the rate of powder flow and to facilitate the removal of powder at the end of shift. The powder level in the powder tub is sensed by a capacitive type proximity sensor.
Pellet filling attachment (Pneumatic & Mechanical):
This is an optional attachment that can be fitted at station 4 for Mechanical & Station 7 for Pneumatic. It is a gravimetric type of filling. It consists of a Hopper, reservoir and dose chamber assembly. The hopper is a stainless steel container with an acrylic window. A manually operated gate is provided at the bottom of the hopper. The hopper is mounted on top of the reservoir. A capacitive type proximity sensor’s is mounted at the bottom of the reservoir. The reservoir is supported on a guide block. The dose chamber assembly consists of guide block, fixed jaw, movable jaws, slide plate top, slide plate bottom, movable jaw & fix jaw. The volume of the dose to be controlled is by the two movable jaws. The slide plate top & slide plate bottom move in & out by the Pneumatic cylinder for Pneumatic Pellet attachment and reciprocating shaft through a bell crank lever for Mechanical attachment. When the top plate moves backwards, the reservoir is connected through the apertures in the top slide plate to the adjustable cavities in dose container and thus all the cavities are filled by pellets.
Tamping station:
The product to be filled is feed from the hopper to the dosing disc. Due to the centrifugal force of the dosing chamber drive the product is carried to the outer edges of the dosing disc to the tamping plungers. The product is then compressed five times before being transferred into the capsule.
There is dust extraction nozzle in tamping part in capsulation zone.
Pin Plate Assembly:
This consists of a plate on which various segments of pins for different applications are fitted. At no.6 unopened capsules are collected in a box which are ejected out by pins. Similarly at station 8, 9 & 10 there are pins for closing of capsules, ejecting the capsules from the exit chute and cleaning of the capsule bushes.
Electrical Control Assembly:
The electrical control panel is mounted inside the structure of the machine. The mains ON / OFF switch is on the cover of the machine. The control OFF / ON, Emergency stop, Drive ON , Speed Potentiometer. & Drive OFF are mounted on the pendant of the machine. Inching facility is provided for easy checking of various settings on the machine. The display screen of the PLC has various selector keys for performing various operations. The control cabinet inside the structure houses the AC drive, the PLC, MCB’s, SMPS, contactors, overload relays.
Group Sampling:
It is a part called Exit chute located on left side of hand wheel of the AF machine. The main purpose of this exit chute is to take group sampling of filled capsules whenever required for weight purpose. This can be activated from MMI.
PLC Description :
The main function of a PLC is to translate the instructions into the digital codes needed to operate the device or machine and to collect data from field instrumentation & display the information on the operator station. The instruments are connected to the system equipment. The collected data will be utilized by the PLC for process control. The user interface, based in an industrial type MMI, will assist the operator to supervise and control the process. Based on the displayed information the operator, by means of the user interface, can provide commands to the PLC. The PLC then executes the operator instructions.
Acceptance criteria and re-qualification criteria:
Acceptance Criteria:
Qualification shall be considered acceptable when all the conditions specified in respective data sheets are completed and optimum process conditions are finalised with simulation of worst case situations.
Any deviation from the acceptance criteria of the specific check point shall be reported and decision will be taken for the rejection, replacement or rectification of the equipment/ component.
Re-Qualification Criteria:
Qualification of the Automatic Capsule Filling Machine is applicable when:
- Modification or any spare parts of the Automatic Capsule Filling Machine are replaced that have a direct impact on the performance of the equipment.
- Automatic Capsule Filling Machine is sent for major repairing or modification.
- Automatic Capsule Filling Machine is transferred from one location to another within the same premises.
- If the trend data of a particular product shows variation in the validated process then the parameters attributed to the smooth operation of Automatic Capsule Filling Machine to qualified and evaluated.
- Periodic Qualification.
Pre-requisites:
Verification of Documents during Machine PQ :
Ensure that, below listed documents are available before the Performance Qualification activities are carried out to check the performance.
| Name of Document | Document No./ SOP No. | Availability Status (YES/NO) | Checked by Engineering (Sign/Date) | Verified by Quality Assurance (Sign/Date) |
| DQ Protocol cum Report | ||||
| IQ Protocol cum Report | ||||
| OQ Protocol cum Report | ||||
| SOP for Operation and Cleaning of Automatic Capsule Filling Machine (AF 90T) | ||||
| SOP for Preventive Maintenance of Automatic Capsule Filling Machine (AF 90T) |
Calibration Status of Test Instruments for Automatic Capsule Filling Machine PQ:
| Name of Instrument | Purpose of Instrument | Instrument ID. No. | Calibration Done On | Calibration Due On | Checked by Engineering (Sign/Date) | Verified by Quality Assurance (Sign/Date) |
Test Product Batch Information for Automatic Capsule Filling Machine PQ:
Ensure that, below listed, required product is available before the qualification activities are carried out:
| Product Name | Batch No. | Batch Size | Mfg. Date | Exp. Date |
Performance qualification evaluation:
Performance evaluation using placebo formulation:
- To verify the performance of equipment in the range of operational parameters establish in the operational qualification activity.
- To establish the performance based range of operating parameters for performance qualification activity using Placebo Formulation.
Checks:
This test is to ascertain the uniformity of the quality decisive physical characteristics of the capsule throughout the capsule filling process.
Method:
The Performance Qualification shall be carried out, by simulating actual Production conditions and varying minimum & maximum critical process variables conditions.
Empty hard gelatin capsules & Granules/Powder shall be charged in hopper of the Capsule Filling Machine. The capsule filling is processed with approved parameters, in accordance with Standard Operating Procedures as defined in Dummy Batch Manufacturing Record.
Samples shall be collected at Low, Optimum & Fast Speed during capsules filling.
Qualification methodology shall include:
- Weight of empty capsule
- Average fill weight
- Uniformity of fill weight
- Average Weight of Filled Capsule
- Weight of 20 Filled Capsules
- Locking Length of Filled Capsules
- Disintegration Time
Tests & Checks (In Process) for Automatic Capsule Filling Machine PQ:
Locking length of Filled Capsule (Limit: ………….. ± ……… mm (…….… mm to ………. mm):
- Low Speed
| Parameter | Observation |
| Description | |
| Size of Capsule | |
| Machine Speed |
| Capsule No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Locking Length ( mm) | ||||||||||
| Locking Length ( mm) | ||||||||||
Optimum Speed
| Parameter | Observation |
| Description | |
| Size of Capsule | |
| Machine Speed |
| Capsule No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Locking Length ( mm) |
| S. No. | Parameter | Observation |
| Description | ||
| Size of Capsule | ||
| Machine Speed |
| Capsule No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Locking Length ( mm) |
In process checks for Uniformity of weight, Group weight And Disintegration time:
- Low Speed
| Date | |||
| Time | |||
| Capsule No. | Weight of filled capsule—————————- | Weight of empty capsule————————— | Fill weight of capsule——————————– |
| 1. | |||
| 2. | |||
| 3. | |||
| 4. | |||
| 5. | |||
| 6. | |||
| 7. | |||
| 8. | |||
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| 12. | |||
| 13. | |||
| 14. | |||
| 15. | |||
| 16. | |||
| 17. | |||
| 18. | |||
| 19. | |||
| 20. | |||
| Total Wt. g | |||
| Avg. Wt. mg | |||
| Max. Wt. mg | |||
| Min. Wt. mg | |||
| DT (NMT 15min.) | |||
- Optimum Speed
| Date | |||
| Time | |||
| Capsule No. | Weight of filled capsule—————————- | Weight of empty capsule————————— | Fill weight of capsule——————————– |
| 1. | |||
| 2. | |||
| 3. | |||
| 4. | |||
| 5. | |||
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| 15. | |||
| 16. | |||
| 17. | |||
| 18. | |||
| 19. | |||
| 20. | |||
| Total Wt. g | |||
| Avg. Wt. mg | |||
| Max. Wt. mg | |||
| Min. Wt. mg | |||
| DT (NMT 15min.) | |||
- High Speed
| Date | |||
| Time | |||
| Capsule No. | Weight of filled capsule—————————- | Weight of empty capsule————————— | Fill weight of capsule——————————– |
| 1. | |||
| 2. | |||
| 3. | |||
| 4. | |||
| 5. | |||
| 6. | |||
| 7. | |||
| 8. | |||
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| 15. | |||
| 16. | |||
| 17. | |||
| 18. | |||
| 19. | |||
| 20. | |||
| Total Wt. g | |||
| Avg. Wt. mg | |||
| Max. Wt. mg | |||
| Min. Wt. mg | |||
| DT (NMT 15min.) | |||
DEVIATION, CHANGE CONTROL AND CORRECTIVE ACTIONS:
Any deviation or modifications in to the equipment should be performed in accordance with the appropriate change control procedure. A separate assessment shall be made, if any changes or modifications are requested, and shall be done either by vendor and approved by company
Deviation: Any deviation or modification to the Performance Qualification shall be recorded.
Corrective Action: Corrective Actions to be taken up as per approved Change Control and record the Corrective Action.
| S. No. | Deviation | Corrective actions | Action taken by Vendor | Checked by | Verified by |
SUMMARY, CONCLUSION AND RECOMMENDATION:
After completion of Performance Qualification activity, record the summary, conclusion and recommendation for further action.
Summary:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Conclusion:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Recommendation:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
References
- WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Volume- 2, Good Manufacturing Practices and Inspection.
Protocol post approval:
Approved By:
| Department | Name | Signature | Date |
| Production (Head) | |||
| Engineering (Head) | |||
| Quality Control (Head) | |||
| Quality Assurance (Head) |
Acronyms Used:
| Abbreviation | Full form |
| cGEP | Current Good Engineering Practices |
| cGMP | Current Good Manufacturing Practices |
| CFM | Capsule Filling Machine |
| DQ | Design Qualification |
| ID. | Identification |
| IQ | Installation Qualification |
| mg | Milligram |
| mm | Millimeter |
| NMT | Not More Than |
| No. | Number |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| Sr. | Serial |
| w/w | Weight by Weight |
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