NAME OF EQUIPMENT |
: | Auto coater 36 “ |
| MAKE | : | Samarika Pharma |
| MODEL NO. | : | |
| EQUIPMENT ID. NO. | : | |
| DEPARTMENT | : | Production |
| LOCATION / ROOM ID.NO. | : | Coating Room |
| PROTOCOL REFERENCE No. | : | |
| EFFECTIVE DATE | : |
TABLE OF CONTENTS
| SR. No. | CONTENT | PAGE No. |
| 1.0 | Qualification Report Pre-approval | |
| 2.0 | Objective & scope | |
| 3.0 | Responsibilities | |
| 4.0 | qualification test carried out | |
| 5.0 | VALIDATION PLAN AND METHODOLOGY | |
| 6.0 | PERFORMANCE QUALIFICATIONS PROCEDURE | |
| 7.0 | RE-VALIDATION CRITERIA | |
| 8.0 | Acceptance criteria | |
| 9.0 | Observation of results | |
| 10.0 | Evaluation of results | |
| 11.0 | Recommendations (if any) | |
| 12.0 | deficiency and corrective action report | |
| 13.0 | conclusion | |
| 14.0 | certification | |
| 15.0 | qualification report post approval |
1.0 QUALIFICATION REPORT PRE-APPROVAL
| Prepared By | ||
| Name | Designation | Sign and Date |
| Executive-Quality Assurance | ||
| Checked By | ||
| Name | Designation | Sign and Date |
| Manager – Quality Control | ||
| Manager – Engg. & Utility | ||
| Manager – Production | ||
| Approved By | ||
| Name | Designation | Sign and Date |
| Sr. Executive – Quality Assurance | ||
| Authorized By | ||
| Name | Designation | Sign and Date |
| QA Manager | ||
2.0 |
OBJECTIVE & SCOPE |
|
3. RESPONSIBILITIES
| The Qualification group consisting of Qualification, QA, Production, Engineering and Quality Control department and shall be responsible for overall compliance with this report. Their specific duties are as followed:
· Monitoring of report completeness, accuracy, technical excellence and applicability. · Scheduling of Qualification. · Conducting of Qualification test. · Data compilation and review. · Qualification reports preparation and recommendation thereafter (if required). REPORT DEVELOPMENT: Validation department & representative of vendor in co-ordination with validation team and shall take the pre-approval prior to carry out the qualification. QUALIFICATION PROGRAMME: This has been jointly carried out by representative of the equipment in close supervision of validation team. REPORT POST APPROVAL: Head of the user department, Head of Engineering department and Quality Assurance Head will authorize to approve the equipment qualification. |
4.0 VALIDATION TEST CARRIED OUT
The Protocol of Performance qualification shall be initiated and Checked by Production Department. The report shall be finally authorized by Assurance head.
System Description:
Process Equipment Description
The purpose of Tablet Coating System is to uniformly coat tablets by spraying them
- Inlet Air Handling Unit
- Pan Housing (Inlet Air Plenum, Exhaust Air Plenum, Pan & Spraying System)
- Exhaust Air Handling System
Inlet Air Handling Unit
It consists of pre air filters, HEPA filters, Air heating unit and airflow & temperature measuring devices. Inlet air handling unit draws air, with the help of a blower, from the environment and processes the inlet air and controls the inlet airflow. It also contains the Dehumidification section. Dehumidification coils are provided in AHU for RH control.
Pan Housing (36” Pan)
The pan housing consists of a rotating pan, with perforation on its periphery. This perforated surface allows the hot air to pass through. The pan is rotated via a motor gearbox drive with suitable sealing. Temperature measuring device is also mounted to measure the temperature of the bed in the pan.
The pan has baffles that help the tablets to move in a very uniform pattern, thereby receive a uniform from the solution vessel to the spray nozzle, via the peristaltic pump.
The atomization of the spray solution is achieved by providing high pressure compressed air to the atomizing spray nozzles. The spray rate & the atomizing pressure can be controlled separately. The Spray rate can be controlled by varying the RPM of the Peristaltic Pump.
Auto coater is an automated tablet coating system for efficient film coating of the tablets with cGMP Compliance in closed condition.
The main Pan unit consists of a cylindrical perforated pan with conical ends in a SS double –walled enclosure. Tablets to be coated are charged in to the Pan. During the coating process, coating fluid are sprayed (Film Coating) through multiple air borne sprays Gun (s) mounted with in the pan.
A Peristaltic pump is employed for precise delivery of coating fluid. The Tablet bed is gently and efficiently mixed during pan rotation with the aid of mixing baffles attached internally, with in pan.
The coated tablet cores dried with heated, air supplied from inlet AHU which contain a heating system as well as Sequential battery of EU-7, EU-9 & EU-13 µ filters. As a result, applied coating is dried with non-chilled water coil & heating through steam coil. Heating air is conveyed through the discrete filter cabinet containing 5µ secondary filters.
Exhaust air is passed through wet scrubbing system, for minimizing expulsion of dust & coating resins from coating systems, comprises MS scrubber with inlet and outlet connections, fed through suitable piping by pump from water holding tank.
Electrically operated peristaltic pump is incorporated outside the unit. The silicon tubing passes through the pump, of which one end is dipped into the solution tank and the other end is connected to coating/or dosing manifold.
W.I.P System consisting strategically mounted high capacity spray nozzles fed through pipe network from pump with solenoid. Strong jets are provided diagonally opposite on left & right side of the perforation area of the pan. Nozzles are also provided for washing front and back cones.
4.1 Equipment Identification
| Model No. | : | GMP Model |
| Serial No. | : | |
| Tag No. | : | |
| Name of the Supplier | : | |
| Purchase Order Number / Date | : |
4.2 Description of Operation:
Film coating Machine consists of Cylindrical-horizontally placed pan having a tablet bed in an enclosed system controlled with a variable speed motor. It is provided with a wide round mouth to incorporate the Triple spray gun assembly for spraying the coating solution by means of peristaltic pump and PLC system.
4.3 Standard Operating Procedure established during Operation Qualification Cleaning of Auto Coater -Preventive maintenance of Auto Coater.
5.0 Validation Plan and Methodology:
Performance of Tablet Coating Auto Coater 36’’ GMP Model shall be tested at extreme and optimum operational conditions, which are identified as Critical Process Variables.
| Critical Process Variables are: | |
| Gun distance from tablet bed, | |
| Pan Rate , | |
| Inlet Temperature | |
| Atomizing air pressure | |
Equipment Performance Qualification shall be carried out, simulating actual production conditions and varying minimum & maximum critical process variable condition.
No Pharmaceutical Active Ingredients shall be used for the qualification purpose. Place to tablets and film coating
Excipients used for manufacturing of routine products using aq. coating method shall be used for the study.
Composition of placebo and method for film coating is described in an Approved Batch Production Record attached as Attachment #01
In-process testing shall be carried out for verification of physical appearance (Sticking, picking, capping, shade variation), shape, embossing/engraving.
Minimum three trials shall be carried out for each process variable at three points, to verify the consistency and reproducibility of the equipment performance.
| Process Variable | Observed Parameters for qualification | Number of trials | Quality Parameters to be tested | Sampling frequency | |
| Gun distance from (CM ) | 18 | 1 | Appearance of tablet surface during coating | 20 tablets from the 6 location pan | |
| 22 | 1 | ||||
| 24 | 1 | ||||
| Spray gun
(g/min ) |
75 | 1 | Appearance of tablet surface during coating | Tablets from the 6 location of the pan | |
| 100 | 1 | ||||
| 125
|
1 | ||||
| Pan loadoC | 35
|
1 | Appearance of tablet surface during coating | Tablets from the 6 location of the pan | |
| 40 | 1 | ||||
| 45 | 1 | ||||
| Atomizing Air pressure(Kg. / cm2)
|
2.0 | 1 | Appearance of tablet surface during coating | Tablets from the 6 location of the pan | |
| 2.5 | 1 | ||||
| 3.0 | 1 | ||||
| Negative pressure in pan(mm)
|
6 | 1 | Appearance of tablet surface during coating | Tablets from the 6 location of the pan | |
| 8 | 1 | ||||
| 12 | 1 | ||||
| PAN RPM | 4.0 | 1 | Appearance of tablet surface during coating | Tablets from the 6 location of the pan | |
| 5.0 | 1 | ||||
| 6.0 | 1 | ||||
| PUMP | 18 | 1 | Appearance of tablet surface during coating | Tablet surface during coating | |
| 22 | 1 | ||||
| 26 | 1 | ||||
6.0 Performance Qualification Procedure:
Test Data Sheet
Date:
Time:
6.1 Gun Distance from Bed
| Gun Distance from Tablet Bed (cms)
|
Appearance of Tablet Surface | Bed Temp |
| Remarks (if any): | ||
Data Entered By:
Verified By:
6.2
| RPM of peristaltic pump
|
Observed Spray Rate
(g / Min.)
|
Appearance of Tablet Surface | Bed Temperature (°C)
|
| 18 | |||
| 22 | |||
| 24 | |||
Data Entered By:
Verified By:
6.3 Effect Pan Load
| Pan load (kgs ) | Appearance of Tablet Surface | Bed Temp (oc ) |
Remarks (if any):
Data Entered By:
Verified By:
- Effect of Inlet Temperature
Test Data Sheet
Temperature (°C)
|
Appearance of Tablet Surface | Temperature (°C)
|
Remarks (if any):
Data Entered By:
Verified By:
6.5 Effect of Atomizing Pressure
Test Data Sheet
Date Time
| Atomizing Pressure | Appearance of Tablet Surface | Bed Temperature |
Remarks (if any):
Data Entered By:
Verified By
6.6 Negative Pressure in Pan:
Test Data Sheet
| Negative Pressure in Pan | Appearance of Tablet Surface | Bed Temperature |
Remarks (if any):
Data Entered By:
Verified By
6.7 Pan RPM
Test Data Sheet
| Pan RPM | Appearance of Tablet Surface | Bed Temperature |
7 .0 Re-Validation Criteria
Performance Qualification of Auto Coater to be re-qualified on: Substitution of existing Auto Coater with a new Auto Coater.
Replacement of existing instrument/component with a new one, which can have a direct impact on the performance of the Auto Coater.
Any major modification to the existing Auto Coater which can effect the performance of the equipment. If the Auto Coater is found to be malfunctioning during performance qualification.
8.0 ACCEPTANCE CRITERIA
Performance 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 actual production condition and varying minimum & maximum critical process variable conditions.
9.0 OBSERVATION OF RESULTS
10.0 |
EVALUTION OF RESULT |
11.0 |
RECOMMENDATIONS (IF ANY) |
12.0 DEFICIENCY AND CORRECTIVE ACTION REPORT
Description of deficiency and date observed _____________________________________
Person responsible for corrective action and date assigned:_________________________
Corrective actions taken and date conducted:____________________________________
SIGNATURE
Conducted By : __________________________________Date : _________________
Certified By : __________________________________ Date : _________________
Reviewed &
Inspected By : __________________________________ Date : _________________
13.0CONCLUSION
14.0 CERTIFICATION
13. QUALIFICATION REPORT POST-APPROVAL
| Prepared By | ||
| Name | Designation | Sign and Date |
| Executive -Quality Assurance |
|
|
| Checked By | ||
| Name | Designation | Sign and Date |
| Manager – Quality Control | ||
| Manager – Engg. & Utility | ||
| Manager – Production | ||
| Approved By | ||
| Name | Designation | Sign and Date |
| Sr. Executive – Quality Assurance |
|
|
| Authorized By | ||
| Name | Designation | Sign and Date |
| QA Manager |
|
|