Tablet Machine Qualification Protocol

DESIGN, INSTALLATION, OPERATION AND PERFORMANCE
QUALIFICATION PROTOCOL FOR THE GEI COURTOY HIGH SPEED

ROTARY TABLETING MACHINE, BELONGING TO FARMACÉUTICA
PLUSPHARM S.A. DE C.V.
PLUSPHARM Date of issue: Protocol code Equipment code Pages

31-Oct-2021 TAB-001 STC-21 1 of 7
Name Date Signature
Elaborated: QFI. Lorenzana Guarneros 26-Oct-2021

Ma. Fernanda
Reviewed: QFI.Medina Lerma Monica 28-Oct-2021
Approved: QFI.Hernandez Cendejas 30-Oct-2021

Estefany
1. OBJECTIVE
Demonstrate documentarily based on the design, installation, operation and

performance qualification performed on the High Speed Rotary Tableting Machine,
Gei Courtoy brand, code STC-21, that the requirements of the qualifications are met.
Determine based on the qualification if the High Speed Rotary Tablet Press, brand
Gei Courtoy, code STC-21, located at PLUSPHARM S.A de C.V., complies with the
functionality specifications described by the supplier.
2. SCOPE
Elaborated: Reviewed: Authorized:

Date: 26-Oct-2021 Date: 28-Oct-2021 Date: 30-Oct- 2021
Signature: Signature:
Signature:
Name: Y. War Name: R. Romero
Name: M. Ramirez
Position: Health Manager Position: Health Manager
Position: Analytical
Chemist

31-Oct-2021 TAB-001 STC-21 2 of 7
This protocol applies to the qualification of design, installation, operation and

performance of the High Speed Rotary Tablet Press, Gei Courtoy brand, code STC-
21, located at PLUSPHARM S.A. de C.V., with address L109 Parque Toreo Central,
Perif. Blvd. Manuel Ávila Camacho 5, Residencial Lomas de Sotelo, 53390
Naucalpan de Juárez, Méx. It is used for the manufacture of tablets.
3. RESPONSIBILITIES
3.1. It is the responsibility of the Health Officer:

3.1.1. Authorize and sign the protocol for the qualification of the High Speed
Rotary Tablet Press, Gei Courtoy brand, code STC-21.
3.1.2. To supervise the protocol for the calibration of a High Speed Rotary Tablet
Press, Gei Courtoy brand, code STC-21.
3.2. Rating Department - Validation.

3.2.1. Coordinate all testing activities and verify that the necessary requirements
are met.
3.2.2. Develop the Design, Installation, Operation and Performance qualification
protocol prior to execution.
3.2.3. Prepare the Design, Installation, Operation, and Performance qualification
report and confirm that the results
3.2.4. Prepare, issue and sign the final protocol.
3.2.5. Document deviations observed during the appraisal process.
3.3. Subject matter specialist as supervisor, coordinator or manufacturing

operator.
3.3.1. Review the test results obtained and the data obtained against the
acceptance criteria.
3.4. It is the responsibility of the Quality Assurance Unit.

3.4.1. Verify compliance with the acceptance criteria established for the High
Speed Rotary Tablet Press, Gei Courtoy brand, code STC-21.

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 3 of 7
3.4.2. Monitor compliance with the qualification program

3.4.3. Review rating protocol to be issued and corresponding reports.
3.5. To introduce the protocol to the personnel in charge of calibrating a High

Speed Rotary Tablet Press.
4. DEFINITIONS
4.1. Qualification: The performance of specific tests based on scientific knowledge,
to demonstrate that the equipment, critical systems, facilities, personnel and
suppliers comply with the previously established requirements, which must be
concluded before validating the processes.
4.2. Platen or plate: Platform where the matrix that will give the shape and size to
the tablet is located (the matrix is interchangeable).
4.3. Die: Circular piece whose cavity is filled with the powder or granulate to be
compressed, into which the punches enter.
4.4. Lower punch: Cylindrical piece whose upper face forms, together with the
walls of the matrix, a cavity that regulates the size and weight of the tablets.
4.5. Upper punch: Cylindrical piece that penetrates the die from the top and whose
upper face exerts pressure on the powder, sufficient to form the tablet. During
compression, the lower punch retains its position and the upper punch
penetrates the die exerting the necessary pressure to form the tablet.
4.6. Feeding hopper: Feeding piece for powder or granules, in which any of these
is placed; it is provided with a device that facilitates the sliding of the powder
in the matrix.
4.7. Distributor or shoe: Metal part that receives the powder or granules from the
hopper and distributes it to the dies during the compression process. This
accessory is placed on the platen, but without touching it, i.e. at a sufficient
distance to scrape off the powder or granules.
4.8. Turret or revolver: Metal part that holds the tooling system for the manufacture
of the tablet.

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 4 of 7
4.9. Tablet exit guide: Part through which the tablets slide out once compressed.
5. MATERIAL AND DOCUMENTATION

● Standard Operating Procedure for equipment qualification
● Mexican Official StandardNOM-059-SSA1-2015, Good manufacturing
practices for medicines.
● High speed rotary tableting machine operation manual, Gei Courtoy brand,
code STC-21, belonging to PLUS PHARM S.A. de C.V. Pharmaceuticals.
● Work computer
● Tape measure
● Camera
● Stopwatch
● Durometer
● Vernier
● Friabilizer
● Balance
6. DESCRIPTION OF THE EQUIPMENT TO BE QUALIFIED
High Speed Rotary Tableting Machine, Gei Courtoy brand, code STC-21,
belonging to the pharmaceutical company PLUSPHARM S.A. de C.V, made
of stainless steel, weight 2500 Kg, 36 Punches, Maximum pressure/pre-
pressure force: 80/ 10 kN, Maximum tablet diameter: 13 mm, Maximum tablet
thickness 19mm, Rotary vane fillers, Double stainless steel powder hoppers,
Dual force feeders. 2 precompression stations, 2 main compression stations,
Touch screen panel, Safety guards, Controller Type: PLC (Programmable
Logic Controller)

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 5 of 7
Figure 1. Gei Courtoy R190F/36 High Speed Tableting Machine.
7. PROCEDURE
7.1. Design qualification
7.1.1. To make a description or check list where the characteristics
that the high speed rotary tablet press should have with
respectto its design are mentioned.
7.1.2. Acceptance Criteria: The High Speed Rotary Tableting Machine,
belonging to PLUSPHARM SA Pharmaceuticals. de C.V., shall
comply with the necessary specifications according to the
required design (Annex B).
7.2. Installation Qualification

7.2.1. Make a description including the installation characteristics and
dimensions of the equipment with respect to the designated
area.
7.2.2. Acceptance Criteria: The High Speed Rotary Tableting Machine,
belonging to PLUSPHARM S.A. de C.V. Pharmaceuticals, shall
be in the required location complying with the necessary

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 6 of 7
dimensions to allow the free flow of materials, equipment and

personnel (Annex C).
7.2.3. Services
7.2.3.1. To carry out an inspection of the access to facilities, the
conditions of electric current, temperature, humidity,
pressure required for the High Speed Rotary Tableting
Machine, belonging to PLUSPHARM S.A. de C.V.
Pharmaceuticals.
7.2.3.2. Acceptance Criteria: The High Speed Rotary Tableting
Machine, belonging to PLUSPHARM Pharmaceuticals.
S.A. de C.V., must have the minimum environmental
conditions necessary for its installation (Annex C), review
these conditions in the installation manual (Annex A).
7.3. Operation Qualification

7.3.1. Check that all the elements or parts that make up the High
Speed Rotary Tablet Press, belonging to PLUSPHARM S.A. de
C.V. Pharmaceuticals, such as turret, shoe, punches, navigation
panel, equipment controls, safety devices, etc., are working.
7.3.2. Acceptance criteria: All parts of the High Speed Rotary Tablet
Press, belonging to PLUSPHARM S.A. de C.V.
Pharmaceuticals, fulfill their intended function (Annex D).
7.4. Performance Rating

7.4.1. To test the performance of the High Speed Rotary Tablet
Machine, belonging to the pharmaceutical company
PLUSPHARM S.A. de C.V., where it must comply with all the
specifications required for its correct operation.

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 7 of 7
7.4.2. Acceptance Criteria, The High Speed Rotary Tableting Machine,

belonging to PLUSPHARM S.A. de C.V. Pharmaceuticals, shall
operate in accordance with the needs that were notified from the
design qualification (Annex E).
8. RISK ASSESSMENT
By means of a visual inspection, identify possible failures that have a direct
impact on the correct performance of the main components of the equipment,
in case of identifying any failure, the corresponding corrective actions should
be recorded and if any preventive action is considered. (Annex F)
9. DEVIATIONS
If a discrepancy, modification or failure is found or observed, it should be
recorded in Annex G.
And the qualification or validation coordinator must be notified of the deviation
observed within a period not to exceed 24 hours, the coordinator must record
the reported deviation noting the data of the person who observed the
deviation and the day. You should confirm the deviation and perform a risk
analysis based on the impact it has on the product. The coordinator together
with the area expert must make the analysis to establish the corrective actions
within 24 hours after the deviation was notified and must follow up until the
deviation has been corrected.
10. DOCUMENTATION
In the case of modifications to the protocol with code TAB-001, these should
be recorded in Annex H.
All documents related to the qualification of the High Speed Rotary Tablet
Press, belonging to PLUSPHARM S.A. de C.V. Pharmaceuticals, such as
calibration reports or qualification reports, will be included .

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 8 of 7
11. REFERENCES
Fonseca, A. C. J. (2015). Evaluation of the effect of the compression process

on dissolution kinetics in immediate release furosemide tablets.
https://intellectum.unisabana.edu.co/bitstream/handle/10818/22336/EFECTO
%20DEL%20PROCESO%20DE%20COMPRESI%C3%93N%20EN%20DISOLUCI
%C3%93N%20DE%20LAS%20TABLETAS%20DE%20FUROSEMIDA.pdf?
sequence=4&isAllowed=y. Date of consultation: October 14, 2021.
Lopez, G. J. A. (2001). Qualification of a rotary tablet press.
http://132.248.9.195/pd2001/297242/297242.pdf. Date of consultation: October 15,
2021.
Makinate. (2021). Conditioning and processing.
https://makinate.es/tableteadora-courtoy-r190f-36-usada-m2003698170/?
filtercategory=747. Date of consultation: October 10, 2021.
Mexican Official Standard NOM-059-SSA1-2013 Good Manufacturing
Practices for Medicines.
Standard Operating Procedure for Equipment Qualification with code PNO-
002-CE21
Standard Operating Procedure to carry out Standard Operating Procedures
with code PNO-001-PNO11

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 9 of 7
12. ANNEX
A. Rotary Tablet Press Installation Manual

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 10 of 7
B. Design Qualification
No. test Test Complies Remarks
Yes No NA
1 The number of tablets is

maximum 264,000/h.
2 Contains at least 36 punches
3 The maximum pressure/pre-

pressure force is between
880/10 kN.
4 The maximum reproducible

diameter of the tablets is 13
mm.
5 The fillers are rotary vane
6 Maximum tablet thickness is

19 mm.
7 Tableting machine features

dual force feeders

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 11 of 7
8 It has two precompression

and two compression
stations.
9 Has a PLC controller

(Programmable Logic
Controller)
10 The weight of the product is

approximately 2500 Kg.
11 The tablet press can work up

to 21568 h.
12 The maximum measurements

are Length x Width x Height:
1.1 x 1.05 X 2 m
13 The turret must be easily

removable
14 Punches have an end or

mouth with a sharp tip
15 The touch screen panel (the

panel must have a memory
option of conditions)
16 Steel punches made of high

hardness steel (S1) .
The tests described in this format are not limitative.

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 12 of 7
C. Installation Qualification
No. test Test Criteria Complies
Yes No NA
1 Power supply voltage 220V
2 Pneumatic compressed 6 to 8 ba
air supply
3 Ambient conditions: Temperature: 15 to 40 ° C

Temperature and Relative Humidity: < 80 %.
relative humidity
4 Minimum space Length x Width x Height: 1.1 x

1.05 X 2 m
D. Operation Qualification
No. test Test Criteria Complies

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 13 of 7
Yes No NA
1 Touch screen Functions are turned on and

off by touching the buttons
on the screen
2 Equipment controls. Controls turn on and off or

buttons work.
3 Equipment memory Memory works when a

function is programmed
4 Automatic equipment control Automatic mode is activated

system.
5 Safety devices The safety devices are

activated.
6 Pre-compression and The stations precompress

compression stations and compress
7 Feeder Allows bulk product flow
8 Fin fillers Giran
9 Punching movements The punches go up and

down at the moment in
10 Turret Rota
11 Shoes They have movement


Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 14 of 7
E. Performance Rating
No. test Test Parameter Complies
Yes No NA
1 Weight 500.0 g

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 15 of 7
2 Weight variation: ± 5.0 %
3 Hardness: Not less than 3.0 KN
4 Thickness 3.6 ± 0.2 mm
5 Diameter 12.0 ± 0.2 mm
6 Equipment operation in
automatic mode for 30 minutes
7 Production speed 264, 000 tablets/h
8 Filling height Thickness: 3.6 ± 0.2 mm
9 Force and distance uniform adjustment of tablet

between punches for weight and hardness
pre and compression
F. Risk Analysis

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 16 of 7
G. Deviations
H. umentation

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 17 of 7

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 18 of 7

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 19 of 7

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 20 of 7

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 21 of 7
H. Documentation
Acceptance criteria:
1. All drawings and diagrams, operation manuals, calculation memory and other documents must be
correlated, approved, registered, current, available, complete and correspond to the design.
2. All documentation must indicate all the characteristics of the same.
3. All Standard Operating Procedures for cleaning, sanitizing, operation and maintenance of the
Facility must be in place and in force, and must specify the normal operating parameters for the
Facility.
Tipo de documento:_____________________________________________________________
Titulo:___________________________________________________________________________________
_______________________________________________________________________________________
Código:__________________
Issued/reviewed:________________________________ Date: _____________________________
Discrepancia del original:__________________________________________________________________
_______________________________________________________________________________________
Original location:____________________________ Copy attached (Y/N):_________________________
Is the document current?____ __________________ Is the document up to date?__________
Observaciones:____________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________

Signature:
Name: M. Ramirez
Chemist

31-Oct-2021 TAB-001 STC-21 22 of 7
Tipo de documento:_____________________________________________________________
Titulo:___________________________________________________________________________________
_______________________________________________________________________________________
Código:__________________
Issued/reviewed:________________________________ Date: _____________________________
Discrepancia del original:__________________________________________________________________
_______________________________________________________________________________________
Original location:____________________________ Copy attached (Y/N):_________________________
Is the document current?____ __________________ Is the document up to date?__________
Observaciones:____________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
If necessary, use additional sheets that should be numbered consecutively.
Prepared by: ______________________________ Fecha:_______________
Reviewed by: ________________________________ Date: _______________

Signature:
Name: M. Ramirez
Chemist

Tablet Machine Qualification Protocol

Uploaded by

Copyright:

Available Formats

You might also like

Tablet Machine Qualification Protocol

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Tablet Machine Qualification Protocol

Uploaded by

Copyright:

Available Formats

DESIGN, INSTALLATION, OPERATION AND PERFORMANCE

QUALIFICATION PROTOCOL FOR THE GEI COURTOY HIGH SPEED

PLUSPHARM Date of issue: Protocol code Equipment code Pages

Name Date Signature

Elaborated: QFI. Lorenzana Guarneros 26-Oct-2021

Reviewed: QFI.Medina Lerma Monica 28-Oct-2021

Approved: QFI.Hernandez Cendejas 30-Oct-2021

Demonstrate documentarily based on the design, installation, operation and

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

This protocol applies to the qualification of design, installation, operation and

3.1. It is the responsibility of the Health Officer:

3.2. Rating Department - Validation.

3.3. Subject matter specialist as supervisor, coordinator or manufacturing

3.4. It is the responsibility of the Quality Assurance Unit.

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

3.4.2. Monitor compliance with the qualification program

3.5. To introduce the protocol to the personnel in charge of calibrating a High

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

5. MATERIAL AND DOCUMENTATION

6. DESCRIPTION OF THE EQUIPMENT TO BE QUALIFIED

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

Figure 1. Gei Courtoy R190F/36 High Speed Tableting Machine.

7.2. Installation Qualification

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

dimensions to allow the free flow of materials, equipment and

7.3. Operation Qualification

7.4. Performance Rating

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

7.4.2. Acceptance Criteria, The High Speed Rotary Tableting Machine,

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

Fonseca, A. C. J. (2015). Evaluation of the effect of the compression process

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

1 The number of tablets is

2 Contains at least 36 punches

3 The maximum pressure/pre-

4 The maximum reproducible

5 The fillers are rotary vane

6 Maximum tablet thickness is

7 Tableting machine features

Elaborated: Reviewed: Authorized:

PLUSPHARM Date of issue: Protocol code Equipment code Pages

8 It has two precompression

9 Has a PLC controller

10 The weight of the product is

11 The tablet press can work up

12 The maximum measurements

13 The turret must be easily

Issued/reviewed:____ Date: _

Original location:____ Copy attached (Y/N):_

Is the document current? ____ Is the document up to date?

Issued/reviewed:____ Date: _

Original location:____ Copy attached (Y/N):_

Is the document current? ____ Is the document up to date?

Prepared by: ________________ Fecha:_

Reviewed by: __________________ Date: _