Terms and Conditions

PERFORMANCE QUALIFICATION OF AUTO COATER

ByReshma Verma

Jan 2, 2021 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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

 

The objective of this report is to provide the stepwise guidelines for the equipment qualification and establish documented evidence that Auto coater Machine is to qualify as per the Design specifications, Manufacturer’s recommendations and Process requirements complies with Standard operating procedures and cGMP requirements at pharmaceutical company ).

The scope of this Report is to provide an outline for the performance of the equipment for static attributes to verify that:

Objective of this protocol is to collect sufficient data to establish that Performance Qualification for Auto Coater 36’’ supplied by                                                                                                    . Performs to meet the desired Product Quality in consistent manner, when operated as per Standard Operating Procedure.

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