Disintegration Tester

Disintegration Tester is designed for the accurate estimation of disintegration time of

tablets and capsules as per IP/USP standards. The instrument is designed to test two
batches of six tablets, simultaneously. The unit is extremely useful for pharmaceutical
industries. It is used in quality control and R & D to determine compliance with the
disintegration requirement of the tablet and capsule as per USP/BP/IP standards.

This disintegration tester measure the amount of time required for a tablet (sample) to
totally disintegrate inside a liquid medium. The liquid used in the disintegration tester
vessel is often an acidic mixture, designed to replicate the inside of the human stomach.
Disintegration testers allow researchers and QC technicians to ascertain if a tablet does
indeed breakdown inside the human body, and how long it takes to do so. This can provide
information useful to improving and manufacturing pharmaceutical drugs and also confirm
that standards of compliance and regulation are being maintained.

Fig. 1: IP/USP Disintegration test apparatus

Instrument uses the
latest
microprocessor technology and advanced engineering techniques so as to give enhanced
accuracy and reproducibility. This disintegration Tester is equipped with 4 line
alphanumeric LCD display with backlit for displaying various test parameters and 15 soft
touch membrane type keys with full numeric keypad that provides a convenient interface
for entering numeric values.
The unit is provided with two glass beakers having capacity of 1000ml & each basket
consists of 6 cylindrical glass tubes (3 inches long) with arrangement to hold temperature
sensor placed in the sturdy, acrylic water bath. The large spread out stainless steel heater
ensures perfectly uniform heating. The instrument has dual channel temperature system
with sensors to monitor the test temperature of disintegration beaker as well as water bath
temperature. The temperature of the water bath and beaker is accurately maintained at 37
± 0.2°C. The temperature of the water bath and vessels are accurately maintained using
highly accurate sensors and microcontroller technology. The basket speed is accurately
controlled and maintained as per IP, USP specifications.

Disintegration testers work by raising and lowering a ‘basket’ in and out of the test medium,
for a set period of time, to see if the tablet disintegrate or not. The time required for the
upward stroke is equal to the time required for the downward stroke, and the change in
stroke direction should be smooth and not abrupt. The disintegration testers raise and
lower the basket in an attempt to create movement, similar to the conditions inside the
human stomach, so that the tablet can move about and the test medium circulate around it
in a manner similar to inside the body. During the test basket doesn’t raise itself completely
out of the test medium, so the tablet is always submerged throughout the disintegration
tester’s operation. The baskets are automatically positioned at the top when the test is
over.
DESIGN QUALIFICATION OF
DISINTEGRATION TESTER
 Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &
RESEARCH, PIMPRI
DESIGN QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No.DYPIPSR/PCEU/INS/024 )
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 1 of 5
NO.

• INSTRUMENT DETAILS:
Name of Equipment DISINTEGRATION TESTER
Name of Department Pharmaceutics
Location of equipment Pharmaceutics UG Laboratory 404
Model no. DT-2D
Year of Purchase 2008

• TABLE OF CONTENTS

1.0 Objective 2.0 Scope 3.0 Responsibility 4.0 User requirement specification 5.0 FAT
Procedure 6.0 Design qualification approval 7.0 Reference documents

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &

RESEARCH, PIMPRI
DESIGN QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024 )
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 2 of 5
NO.

1.0 Objective:
• This instrument is designed for accurate estimation of disintegration time of tablets as
per IP/USP standards. This disintegration tester measure the amount of time required
for a tablet (sample) to totally disintegrate inside a liquid medium under the specific
experimental conditions. The instrument is designed to test two batches of six tablets,
simultaneously.
• This sophisticated microprocessor based programmable instrument is having many
unique features. Instrument uses the latest microprocessor technology and advanced
engineering techniques, to give enhanced accuracy and reproducibility. It is equipped
with 4 line alphanumeric LCD display with backlit for displaying various test parameters.
The temperature of the water bath and vessels are accurately maintained using highly
accurate sensors and microcontroller technology.

2.0 Scope:

• The scope of this qualification document is limited to the design qualification of

Disintegration apparatus
• The equipment shall be used for disintegration study of different tablets and capsules.
• The equipment shall operate under dust free environment and conditions as per GMP.

3.0 Responsibility:

Roll No.
Name:
Class and department:
Prepared By Checked By Approved BY
Name & Designation
Sign & Date
 Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &
RESEARCH, PIMPRI
DESIGN QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL NO.
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 3 of 5
 4.0 User Requirement Specifications:

DESCRIPTION SPECIFICATION OBSERVATION

Equipment Specification It should comply with USP, IP specifications

Stations 2 stations with easy Snap-Fit shafts for baskets.

Water bath Highly accurate sensors and microcontroller

technology provides uniform and constant
temperature to water bath.
Basket Two baskets with 6 tubes move up and down
with each stroke in the vessels (beakers).
Temperature Accuracy 37 ± 0.2 °C
Glass tubes, guided discs 6 cylindrical glass tubes(3 inch long), guided
discs as per IP/USP specifications
Stroke length Stroke length is set as per IP specifications
(5060mm).
Design Microprocessor based unit with, user friendly
design.
Reaction Beaker Reaction beaker of sufficient capacity (1 L).
LCD Display 20 x 4 line alphanumeric LCD display with
backlit
Pause-key Pause is unique facility.
Alarm facility The apparatus will stop automatically with audio
alarm.
Cleaning It should be easy to clean in place
Calibration All components that require calibration shall be
identified and calibrated.
Calibration certificates to be provided at the
time of IQ.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &

RESEARCH, PIMPRI
 DESIGN QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 4 of 5
NO.

5.0 FAT Procedure:

After the completion of the erection work of the machine, client shall be informed to perform the
FAT.

Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT
document as per details given below

1. Test criteria
2. Design verification check list
3. Deficiency and corrective action report
4. Pre-installation requirement
5. Final report

6.0 Design qualification approval:

According to the data collected as a result of this study, the equipment has been properly
designed & qualified in accordance with standards and is now available for process
qualification.
Suppliers name Position Signature Date

Customer

Student name Roll No. Signature Date

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES
&
RESEARCH, PIMPRI
 DESIGN QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No.
DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 5 of 5
NO.

7.0 Reference documents

1. Manufacturer brochure:
2. DQ Protocol No.:

Written By Signature Date

Checked By Signature Date

Approved By Signature Date

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 INSTALLATION
QUALIFICATION OF
DISINTEGRATION TESTER

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
 REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 1of 6
NO.

• INSTRUMENT DETAILS

Name of Equipment DISINTEGRATION TEST APPARATUS

Name of department Pharmaceutics
Location of equipment Pharmaceutics UG Laboratory 404
Model no. DT-2D
Date of Purchase 2008

• TABLE OF CONTENTS
1.0 Pre- Approval 2.0 Purpose 3.0 Scope 4.0 Responsibility 5.0 System
Description 6.0 Critical parameters consider during installation 7.0 Installation
Qualification Procedure 8.0 Requalification 9.0 Conclusion 10.0 Appendix

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &

RESEARCH, PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 2of 6
NO.

1.0 Pre- Approval :

 Signing of this approval page of Installation Qualification Protocol No.
DYP/QAT/PV/IQ/PC010/2016-17 indicates agreement with the installation qualification
approach described in this document. If modifications to the installation qualification
become necessary, an addendum will be prepared and approved.

Written by Signature Date

Checked by Signature Date

Approved by Signature Date

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &

RESEARCH, PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 3 of 6
NO.

2.0 Purpose :
2.1 To verify the proper installation of equipment.
2.2 To demonstrate that all the critical components of process equipment installed appropriately
2.3 To provide record of the key features of the equipment and components as currently installed.
2.4 To ensure that there is sufficient information available to enable the equipment to be
operated and maintained safely, effectively and consistently.
 2.5 To verify the installation attributes of the DISINTEGRATION TESTER critical to serve the intended
purpose of the equipment.
2.6 To establish the suitability of the draft SOP prepared for the operations of equipments.
2.7 To document the observation for future reference.

3.0 Scope:
The scope of this qualification protocol is limited to the installation qualification of
DISINTEGRATION TESTER. This qualification protocol is part of a validation activity.

4.0 Responsibility:
Roll No.
Name:
Class and department:

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES &

RESEARCH, PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 4 of 6
NO.

5.0 System Description: Parts Of Disintegration Tester

Sr.No. PARTS / COMPONENTS
1 Stations: 2 stations with easy Snap-Fit shafts for baskets
2 Water bath: Large spread out stainless steel heater ensures uniform heating.
3 Basket: The basket move up and down with each stroke in the beakers.
4 Temperature Sensing And Control System: Programmable wake-up for temperature
control.
5 Glass tubes, guided discs: Glass tubes, guided discs as per IP/USP specifications
6 Reaction Beaker: Reaction beaker of sufficient capacity(1000ml).
 7 LCD Display: LCD Display to indicate temperature, time duration.
8 Pause-key: Pause is unique facility.
9 Alarm facility: The apparatus will stop automatically with audio alarm.

6.0 Few critical parameters consider during installation:

 Room Temperature : 15-30 °C

• RH : 20-70%
• Table Strength : Should have sufficient strength to place
the equipment
• Base / surface : Smooth and leveled steady base
• Voltage : 220V ± 10 %
• Earthing : Less than 3 V between neutral & earth

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 5 of 6
NO.

7.0 Installation Qualification Procedure :

1. Verify the approved purchase order.

2. Verify invoice.
3. Check the manufacturer and supplier.
4. Verify the model no. and serial no.
5. Prepare a checklist for all the components and parts, including the spare parts according
to the purchase order and manufacturer’s specifications.
6. Record the information for each part, component, auxiliary equipment, supporting facilities
and compare to manufacturer’s specifications.
7. Installation should be done as per the instructions provided in the manual.
 8. Record any deviations.
9. Prepare a deviation report including the justification of acceptance and impact on the
function.
10. Prepare an IQ report.

8.0 Reqalification :
Installation qualification to be repeated in case of :

 Replacement of any major component/ instrument.

 Major modification in the existing equipment.
 During monitoring, if equipment is found to be malfunctioning.
 Shifting of equipment from one location to another.

 Requalification: ensures that the equipment is still in the qualified state after a change &
periodical assessment of eqipment within defined time intervals

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
INSTALLATION QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 6 of 6
NO.

9.0 Conclusion:
The DISINTEGRATION TESTER is qualifying the installation qualification test as per the
guidelines described in this Protocol No. DYP/QAT/PV/IQ/PC010/2016-17. The operation
qualification can be followed now.

POST APPROVAL :
NAME SIGNATURE DATE
Written By :
Checked By:
Approved By:
 10.0 Appendix:

Abbrevations And Definitions :

1. SOP : Standard Operating Procedure

2. IQ : Installation Qualification
3. QA : Quality Assurance
4. GMP : Good Manufacturing Practices
5. Acceptance criteria : The product , equipment, and / or process specifications and limits,
such as acceptable quality level and unacceptable quality level, that are necessary for
making a decision to accept or reject.
6. Installation Qualification : Documented verification that the system or subsystem is
installed satisfactorily as per the recommendations of the manufacturers.
7. Validation : Establishing documented evidence that is system does what it purports to do.
8. Revalidation : Repetition of the validation process or a specific portion of it .

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 OPERATIONAL
QUALIFICATION OF
DISINTEGRATION TESTER

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 1 of 13
NO.

• INSTRUMENT DETAILS
Name of Equipment Disintegration test apparatus
Name of department Pharmaceutics
Location of equipment Pharmaceutics UG Laboratory 404
Model no. DT-2D
Date of Purchase 2008
 • TABLE OF CONTENTS

1.0 Pre- Approval 2.0 Purpose 3.0 Responsibility 4.0 Requalification 5.0 System Description
6.0 Operational Qualification Procedure 6.1 Training 6.2 Key Functionality 6.3 Sop Verification
6.4 Deficiency (If Any)And Corrective Action Report 7.0 Acceptance Criteria 8.0 Conclusion

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 2 of 13
NO.

1.0 Pre-approval:
Signing of this approval page of Operation Qualification Protocol No.
DYP/QAT/PV/OQ/PC010/2016-17, indicates agreement with the operation qualification approach
described in this document. If modifications to the operation qualification become necessary, an
addendum will be prepared and approved.
Written by Signature Date

Checked by Signature Date

Approved by Signature Date

 2.0 Purpose:

2.1 To verify the proper functioning of a Disintegration tester.

2.2 To verify the operational attributes of the Disintegration tester critical to serve the intended
purpose of the equipment.
2.3 To define the testing to be performed and the expected results.
2.4 To establish the suitability of the draft SOP prepared for the operations of equipments.
2.5 To document the observation for future reference.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 3 of 13
NO.

3.0 Responsibility:
Roll No.
Name:
Class and department:

4.0 Requalifucation :

• Operation qualification to be repeated in case of :

 Replacement of any major component/ instrument.
 Major modification in the existing equipment.
 During monitoring, if equipment is found to be malfunctioning.
 Shifting of equipment from one location to another.
 • Requalification: ensures that the equipment is still in the qualified state after a change &
periodical assessment of eqipment within defined time intervals

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 4 of 13
NO.

5.0 SYSTEM DESCRIPTION:

PARTS OF DISINTEGRATION TEST APPARATUS

Sr. PARTS / COMPONENTS
No.
1 Stations: 2 stations with easy Snap-Fit shafts for baskets
2 Water bath: Large spread out stainless steel heater ensures uniform
heating.
3 Basket: The basket move up and down with each stroke in the beakers.
4 Temperature Sensing And Control System: Programmable wake-up for
temperature control.
5 Glass tubes, guided disks: Glass tubes, guided disks as per IP/USP
specifications
6 Reaction Beaker: Reaction beaker of sufficient capacity.
7 LCD Display: LCD Display to indicate temperature, time duration.
 8 Pause-key: Pause is unique facility.
9 Alarm facility: The apparatus will stop automatically with audio alarm.

LOCATION : Pharmaceutics lab

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 5 of 13
NO.

6.1 Operational Qualification Procedure:

6.2 A draft SOP should be prepared on the basis of supplier guide / manual for operation
before the qualification testing.
6.3 Prior to the qualification test, the personnel shall be trained by the Engineer from the
supplier on the operational features of the equipment/ system.
6.4 The trained personnel shall carry out the operational qualification following the
procedure mentioned under section 6.2 for key functionality and 6.3 for safety features.
Record the observations of qualification test in test data sheet of section 6.2.1 and 6.3.
6.5 Operate the equipment/ system as per the draft SOP. Record the change if any and
confirm the SOP. Report the confirmation of SOP in section 6.4
6.6 Report the deficiency from the specified function in any section 6.5

Operating Procedure:
5.1 Check installation of machine for heater, basket
5.2 Check all displays on panel are identified.
5.3 Turn on the power from the electrical panel.
5.4 Set the controls on panel.
 5.5 Fill the water bath , start the heater, display, start the sturdy motor, to drive
disintegration baskets ‘UP & DOWN’, at constant speed, setup the stroke length.
5.6 Operate LCD display to indicate test parameters like temperature, time duration, and
alarm.
5.7 Status of the tablets can be checked with the help of ‘PAUSE KEY’ provided without
disturbing the test parameters. Verify functionality of each component on control panel
against its specified functions.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 6 of 13
NO.

 Number of Cycles per minute

Start End Time Side A (Left hand side of the Side B (Right hand side of
Time (Mins.) operator). the operator).
(Mins.)
No. Of cycles No. Cycles No. of No. Of cycles
(A) per min. cycles per min.
(A / 5) (B) (B / 5)
0 5

15 20

30 35

45 50

60 65
i. Record the frequency of moving up and down of the Basket rack assembly, in a given
time as shown below.
ii. Record the frequency (of moving up and down) manually with respect to time. iii.
Do not stop the instrument in between the operation.
 iv.
Measure the frequency initially and after each 15 minutes interval from the start, for
5 minutes each.
v. Record five readings. vi. Divide the observed reading by five & note the frequency of
moving up & down per minute. vii. Perform the test for both the basket rack
assembly positions (side A & side B) individually.
Acceptance criteria: The No. of cycles per minute should be within the following limit (as per
IP/USP/BP) throughout the period of operation.
For Tablet: As per I.P. - 28-32 cycles/min.
For Capsule: As per I.P. - 28-32 Cycles/min.
As per USP/B.P. - 29-32 Cycles/min.
Prepared By Checked By Approved BY
Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 7 of 13
NO.

 Calibration for Temperature Maintenance:

Time Temperature (In °C)

(In Mins.) Side A (Left hand side of the Side B (Right hand side of the
operator) operator)
Initial
After 15
After 30
After 45
After 60
After 75
After 90
After 105
After 120

i. Set the temperature to 37°C. ii.

Fill the beaker with water.
iii. Attach the basket rack assembly & start the constant frequency of moving up & down.
 iv. Insert the calibrated thermometer in one of the tubes of the basket rack assembly.
v. Wait till temperature reaches between 36°C to 38°C.
vi. Start recording the readings.
vii. Record the temperature readings initially & after each 15 minutes interval up to 120
minutes from the start.
viii. Perform the test for both the basket rack assembly positions (side A & side B) individually.
ix. While performing the test, do not keep thermometer inside the basket rack assembly
constantly, but insert 2 to 3 minutes prior to the measurement to give stable reading.
Acceptance criteria: As per IP/USP, the temperature should remain within 37 ±2 °C,
throughout the operation.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 6.1 Training:

Title: Date:

Name of the Trainer:

Sr .no Name of the Trainee Employee number Signature
1.
2.
3.
4.

Signature of the Trainer: Date :

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 9 of 13
NO.
6.2 Key Functionality : A. Purpose:

The purpose of this procedure is to demonstrate that the control panel and other manual
operations of Disintegration Tester.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 6.3 SOP Verification:

Title: DISINEGRATION TESTER

Operate the equipment as per the draft SOP and record the details given below:

Operated By :

Checked By:

The operating personnel understand and follow the SOP description (Yes / No):

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 11 of 13
NO.
Changes required in draft SOP ( if any):

SOP to be revised (Yes / No):

If yes, Review No.

Remarks : SOP Confirmed / Not Confirmed

Verified By:

Signature:

Date:

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
 REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 12 of 13
NO.

6.4 Deficiency (If Any)And Corrective Action Report:

Description of deficiency and date observed:

Person, responsible for corrective action and date assigned:

Corrective actions taken and date conducted:

Conducted By: Approved By:

Date : Date:

Comments (if any):

Verified by :
Signature:
Date:
Prepared By Checked By Approved BY
Name & Designation
Sign & Date
 Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
OPERATIONAL QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 13 of 13
NO.

6.0 Acceptance Criteria:

Operational qualification should be considered acceptable when all the conditions specified in
various data sheets under section 6.0 have been met.

Any deviation from the acceptance criteria of the specific check point should be reported and
decision should be taken for rejection, replacement or rectification of equipment/ component.

7.0 Conclusion:

The disintegration test apparatus is qualifying the operational qualification test as per the
guidelines described in this Protocol No. DYP/QAT/PV/OQ/PC010/2016-17 The disintegration test
apparatus can be tested for its Performance Qualification as per the Protocol No.
DYP/QAT/PV/OQ/PC010/2016-17

Prepared By Checked By Approved BY

Name & Designation
Sign & Date
 PERFORMANCE
QUALIFICATION OF
DISINTEGRATION TESTER
 • INSTRUMENT DETAILS

Name of Equipment Disintegration test apparatus

Name of department Pharmaceutics
Location of equipment Pharmaceutics UG Laboratory 404
Model no. DT-2D
Date of Purchase 2008

• TABLE OF CONTENTS
Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
PERFOEMANCE QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. of 4
NO.
1.0 Pre- Approval 2.0 Objective 3.0 Responsibility 4.0 Performance Qualification Test:
Procedure 5.0 Performance Qualification Test Results 6.0 Requalification

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

1.0 Pre- Approval:

Signing of this approval page of Performance Qualification Protocol No.
 DYP/QAT/PV/PQ/PC010/2016-17, indicates agreement with the performance qualification approach
described in this document. If modifications to the performance qualification become necessary, an
addendum will be prepared and approved.

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
PERFOEMANCE QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 2of 4
NO.

Written by Signature Date

Checked by Signature Date

Approved by Signature Date

Prepared By Checked By Approved BY

Name & Designation
Sign & Date

Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,

PIMPRI
PERFOEMANCE QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
 REF.PROTOCOL
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 3 of 4
NO.

2.0 Objective:
The objective of this protocol is to collect sufficient data to establish that disintegration
test apparatus performs to meet the desired product quality in the 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:
Roll No.
Name:
Class and department:

4.0 Performance Qualification test: Procedure-

 For this process, it is necessary that disintegration test basket be fitted with wire mesh, six
glass tubes and six guided disks, with stainless steel nut.  Main instrument with acrylic
tank Beaker 1000 ml  Basket holder for holding basket.
 Aluminium cover for acrylic tank with beaker holding stands.
 Make all the necessary arrangements as per the SOP.
 Place 1 tablet in each of the six tubes of the basket and, if prescribed, add a disc.
 Operate the apparatus, using water maintained at 37 ± 0.2 °C as the immersion fluid unless
otherwise specified in the individual monograph. At the end of the time limit specified in
the monograph.
 Lift the basket from the fluid, and observe the tablets: all of the tablets have disintegrated
completely, record the disintegration time.
Prepared By Checked By Approved BY
Name & Designation
Sign & Date
 Dr. D. Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES & RESEARCH,
PIMPRI
PERFOEMANCE QUALIFICATION REPORT
Instrument: DISINTEGRATION TESTER (Instrument No. DYPIPSR/PCEU/INS/024)
REPORT NO. DYP/QAT/PV/IQ/RP010/2021-22 EFFECTIVE DATE
REF.PROTOCOL NO.
DYP/QAT/PV/IQ/PC010/2021-22 PAGE NO. 4 of 4
 5.0 Performance Qualification Test Results:

1. DISINTEGRATION TIME

Sr. No Time of disintegration

1. 3.51 min.

2. 2.40 min.
3. 2.46 min.

4. 4.30 min.
5. 3.10 min.

6. 4.25 min.

6.0 Requalification :
Performance qualification to be repeated in case of :

 Replacement of any major component/ instrument.

 Major modification in the existing equipment.
 During monitoring, if equipment is found to be malfunctioning.
 Shifting of equipment from one location to another.

Prepared By Checked By Approved BY

Name & Designation
Sign & Date