SOP for Performance Qualification for Auto Coater 48’’ GMP Model

SOP for Performance Qualification for Auto Coater 48’’ GMP Model

TABLE OF CONTENTS

1.0Approval
2.0Objective
3.0Responsibility
4.0System Description
4.1Equipment Identification
4.2Description of Operation
4.3Standard Operating Procedure Established During Operation Qualification
5.0Validation Plan and Methodology
6.0Performance Qualification Procedure
6.1Gun Distance from Bed
6.2RPM of Peristaltic pump and Spray Rate
6.3Effect Of Pan Load
6.4Effect Of Inlet Temperature
6.5Effect Of Atomizing Pressure
6.6Negative Pressure in PAN
6.7Effect of PAN R.P.M
6.8Uniformity of Weight Build Up
7.0Deviation and Corrective Action
8.0Change Control Proposal
9.0Revalidation Criteria
10.0Acceptance Criteria
11.0Evaluation of Result
12.0Conclusion
13.0Appendix
13.1Abbreviations
13.2Reference
13.3Annexures

1.0        Approval

 2.0        Objective:

Objective of this protocol is to collect sufficient data to establish that Performance Qualification for Auto Coater 48’’  supplied by supplied by  ____________________. Performs to meet the desired Product Quality in a consistent manner, when operated as per Standard Operating Procedure.

Performance Qualification Protocol shall provide the Methodology of qualification studies, formats for recording the observation, Criteria of Qualification and a guideline for documentation of the study.

3.0        Responsibility:

The validation group comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:

  • Production Department
  • Quality Assurance Department
  • Quality Control Department

The Production department shall be responsible for checking the operations and recording data as per the procedures outlined in the data sheets of this protocol. The Quality control department shall be responsible for testing of samples wherever required.

The Protocol of Performance qualification shall be initiated and Checked by Production Department. The report shall be finally authorized by GM operation and Quality Assurance head.

4.0        System Description:

Process Equipment Description

The purpose of Tablet Coating System is to uniformly coat tablets by spraying them with coating materials in controlled environment & on a moving tablet bed. The hot air entering this equipment will enable efficient drying of tablets, while they are being coated.

Complete system can be divided in following sub sections:

➢ 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 (48” 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 coating.

The spray system consists of a Solution vessel with Pneumatic stirrer, a Peristaltic Pump

& the spray nozzle assembly. Silicone tubes (Food Grade) are used to transfer material

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-contaminated, dust free and optimized volumes of air, for producing uniformly coated tablet cores.

Air handling system is modularly constructed to allow quick and easy removal of sub-assembly for maintenance and repairs. Pre –clarified air is drawn through inlet blower for dehumidification through 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

The subjected equipment is identified as Auto Coater

The Equipment is identified as:Auto Coater 48’’ GMP MODEL
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

  • Title: Auto Coater (Eq. ID.
  • Operation of Auto Coater
  • Cleaning of Auto Coater
  • Preventive maintenance of Auto Coater

5.0        Validation Plan and Methodology:

Performance of Tablet Coating Auto Coater 48’’ 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
  • Spray rate
  • Pan load
  • Inlet Temperature
  • Atomising air pressure
  • Negative pressure in pan
  • Pan RPM
  • RPM of Peristaltic

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. Placebo 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.

Validation Plan is described in the following Matrix.

Process VariableObserved Parameters for qualificationNumber of trialsQuality Parameters to be testedSampling frequency
Gun distance from tablet bed (cm)181Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
221
241
Spray rate

(g/min.)

751Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
1001
1251
Pan load

(Kg)

401Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
601
801
Inlet Temperature (°C)501Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
551
601
Atomising Air pressure

(Kg. / cm2)

2.01Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
2.51
3.01
Negative pressure in pan (mm)61Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
81
121
Pan RPM

 

4.01Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
5.01
6.01
RPM of Peristaltic pump181Appearance of tablet surface during coating.20 tablets from 6 locations of the pan.
221
261

 6.0 Performance Qualification Procedure:

Test Data Sheet

Date: …………….. Time: ……………..

6.1 Gun Distance from Bed                  

Gun Distance from Tablet Bed (cms)The appearance of the Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

18Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
22Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
24Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

 

6.2 RPM of Peristaltic pump and Spray Rate.:

Test Data Sheet

     Date: ……………..                                                                                            Time: ……………..

RPM of peristaltic pumpObserved Spray Rate

(g / Min.)

The appearance of Tablet Surface

(Tick ü whichever is applicable)

Bed Temperature (°C)
18Gun1Picking
Sticking
Gun2TotalSurface Roughness
=Non Uniformity of Colour
Gun3Uniform Coating
22Gun1Picking
Sticking
Gun2TotalSurface Roughness
=Non Uniformity of Colour
Gun3Uniform Coating
26Gun1Picking
Sticking
Gun2TotalSurface Roughness
=Non Uniformity of Colour
Gun3Uniform Coating

6.3 Effect Pan Load

Test Data Sheet

Date: ……………..                                                                                               Time: ……………..

Pan Load

(Kg.)

Appearance of Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

40.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
60.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
80.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

 6.4 Effect of Inlet Temperature

Test Data Sheet

      Date: ……………..                                                                                                                     Time: ……………..

Inlet Temperature

( °C )

Appearance of Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

50Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
55Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
60Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

 Remarks (if any):

6.5 Effect of Atomising Pressure

Test Data Sheet

       Date: ……………..                                                                                                                      Time: ……………..

Atomising Pressure

(Kg. / cm2)

Appearance of Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

2.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
2.5Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
3.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

6.6 Negative Pressure in Pan:

Test Data Sheet

 Date: ……………..                                                                                                                      Time: ……………..

Negative Pressure in Pan

(mm)

Appearance of Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

6.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
8.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
12.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

 6.7 Effect of Pan R.P.M:

Test Data Sheet

  Date: ……………..                                                                                                                    Time: ……………..

Pan RPMAppearance of Tablet Surface

(Tick ü whichever is applicable)

Bed

Temperature (°C)

4.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
5.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating
6.0Picking
Sticking
Surface Roughness
Non Uniformity of Colour
Uniform Coating

6.8 Uniformity of Weight Build-Up:

Test Data Sheet

  Date: ……………..                                                                                                                     Time: ……………..

Initial Pre Warm Average Weight of core: ( 100 Tablets)

Sampling Locations in PanWeight Observed (gm.)

100 Tablets

Average Weight

(mg.)

% Actual Weight Build Up
A
B
C
D
E
F
Average :-

  % Actual Weight Build Up 

Film Coating Efficiency:————————-  X   100 =  % Theoretical Weight Build Up  

 Sampling Locations are shown diagrammatically below

A 7 -

7.0       Deviation and Corrective Action  

Description of deviation and date observed

The person responsible for corrective action and date assigned

Corrective action taken and date conducted

Checked/Date by:   __________________ Verified/Date by:   ___________________                      

8.0      Change Control Proposal

Sr.Change Observed / MadeReason Verified By (Production)

Sign & Date

Approved By (Q.A.)

Sign & Date

9.0        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.

10.0      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.

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.

11.0      Evaluation of Result:

Results shall be documented in Test Data Sheets based on the observations recorded in Performance Qualification. Evaluation of results shall be carried out by finalising the operational range of equipments for processing of products.

All test results meeting the Acceptance Criteria shall establish the satisfactory performance of Auto Coater ,when operated as per SOP No. _______________________

12.0      Conclusion:

A summary report shall be prepared to summarize the results of PQ test .On the basis of results and evaluation, a conclusion shall be drawn to state the adequacy of the equipment to produce the Quality Products meeting the desired Product Quality in consistent manner, when operated as per Standard Operating Procedure.

13.0      Appendix  

13.1      Abbreviations

Min             –    Minutes
RSD           –    Relative Standard Deviation
SOP            –    Standard Operating Procedure
PQ              –    Performance Qualification
RPM           –    Rotations Per Minute
QA             –    Quality Assurance
G               –    Grams
FDA           –    Food & Drug Administration

13.2      References

13.2.1   Protocol Format and style guide – FDA guidelines

13.3      Annexure

13.3.1   Q.C. Test report

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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