URS mainly includes:

 FDA requirement

 Technical and economic demand

A. FDA Requirement:
FDA requirements are fulfilled by URS which is the key feature to develop detailing document for all the technical
system. The URS is an important document require for the authorizing phase as well. It provides the foundation for
an offer to the suppliers.

B. Technical and Economic demand:

Technical as well as economic requirements are documented in the URS for the technological organization. As URS
is not collected merely for the validation it covers more aspects than only the FDA requirement7.

1.2 Factory Acceptance Test (FAT):

Factory Acceptance Test (FAT) is an official test and the inspection work process that performed at the
manufacturer when the system or facility is fully fabricated and assembled prior to the delivery. The FAT is to test
the function and capacity of the products and system at the factory8.

1.3 Site Acceptance Test (SAT):

Site Acceptance Test (SAT) is performed at the site, before the system is installed at the permanent operating
position. The SAT is to test and check functions with other interfaces on the site9.

1.4 Installation Qualification (IQ):

The installation and configuration of a system is verified by Installation Qualification Protocol. IQ Protocol is the
documented evidence that the equipment has been installed properly adhering to all key aspects of the installation,
approved design intentions and manufacturers recommendation. When Installation of equipment has been done,
approval of the necessary procedures, or the training of apposite personnel have to be done. IQ protocols must be
accepted before protocol execution. The validation package retains a transcript of the unexecuted protocol. The
System Owner and Quality Assurance must favour the unexecuted convention, while executed a convention must be
marked by the analyser and checked on by the System Owner and Quality Assurance10.

1.5 Operational Qualification (OQ):

The Operational Qualification in simple terms means that the operation of the system meets the requirements as in
URS. The OQ Protocol is the document which includes test cases in order to confirm the proper operation of the
system. The URS mention the test requirements OQ. OQ is a crucial step which is performed before the system is
ready for use. OQ can be linked to IQ and PQ based on complexity of the system10.

1.6 Performance Qualification (PQ):

Building confidence through suitable testing that the completed product or process made by a predefined procedure
meets all release requirements for functionality and safety and that operations are compelling and predictable. The
PQ protocol is a document that proves that a system qualifies that a system gratifies the defined requirements in the
production environment10.

2. METHODOLOGY:
2.1 User Requirement Specification (URS):
URS for the tray dryer was prepared according to cGMP and FDA guidelines. URS was prepared according to the in
house requirement.

1. Name of the Equipment: Tray Dryer

2. Equipment Make / Model: cGMP

3. Purpose of the Equipment:

Drying of wet granules, Uniform dried granules formation, Remove the moisture from the Powders.

4. Capacity / Output:

Gross volume: 229500 cm3

Working volume: 8400 cm3 each; 8400 cm3 X 5 Trays

5. Process Requirements:

 Occupancy hours: 10 hours

 Material of construction

SS316 – Product contact part

SS304 – Non-contact part

 Number of Trays:

Trays with dimensions 80 x 42 cm: 5

Trays spare of same dimensions: 2

 Vent:

On the top at the left side of the equipment

 Preferable method of cleaning:

Clean in place and manual

 Available area for installation:

It will be positioned in the provided area of size 105 x 70 x 102 cm

 Environmental conditions:

Operating temperature: 50°C to 100°C

6. Automation and Control system:

Table 1:Automation and Control system

S. No Component (s) Required Description
(yes / no)
1. Motor Yes ½ HP
2. Fan Yes 1 fan with 500rpm
3. Heating coil Yes 3 Coil, 1 left 1 right and 1
 middle
4. Temperature sensors Yes 2 sensors
5. Alarms and Warning Yes After attending the given
temperature or complete
drying, interlocking with
product temperature sensors
6. MMI / HMI and PLC Detail Yes Auto / Manual / Recipe /
s Maintenance / WIP modes
required.
7. Powder Button Yes Button with red colour and
light indicating when it ON
MMI: Man-Machine Interface; HMI: Human Machine Interface; PLC: Programmable Logic Controller; WIP: Work in Process / Progress

7. Other Requirements:

Table 2: Other Requirements

S. No Description Purpose
1. Two Spare trays Standby in case of damage
2. Meshes cover for the To protect the working
motor person
3. Stainless steel 304 Door To open
Handle
4. Silicone covering around To prevent the airflow and
the Door maintain temperature.
5. Ammeter and Voltmeter To access the current flow
on electrical panel door

8. Safety features:

Table 3: Safety features

S. Safety Required Description
No features (yes / no)
2. Earthing Yes
3. Noise level Yes Sound reduction 70 to 75
dB

9. Documentation:

Table 4: Documentation
S. Title Required Description
No (yes / no)
1. Material of Yes Certificate shall be
construction provided for contact,
Certificate Non-contact pants
(MOC)
2. Performance Test Yes No load running trials
Certificates and load trials required
at site
3. Qualification Yes Provide the
Document (DQ, qualification
IQ, OQ and PQ documents like IQ OQ
documents) PQ
4. Operation and Yes Required 2 sets
Maintenance
Manual
5. Drawing
GA Drawing Yes
P and ID Drawing Yes Required 2 sets
Electrical Yes
6. Others Any other if there is
 value addition to that
other than stated in
this URS

10. Other requireents:

Table 5: Other requirements

S. Title Require Description
No d (yes /
no)
1. Training Yes Required on operation and
maintenance of PLC
2. Inspection at Yes Allow to inspect at your site
Vendor’s end before dispatch of equipment
(FAT)
3. Technical Yes Required for trouble shooting
support and spares list
4. Others Yes Required warranty certificate
of equipment

11. URS Acceptance by the vendor:

The User Requirement Specification has been discussed and agreed upon. We hereby declare that we will supply the
equipment as per above laid down specification

Name of the Vendor Signature / Date

Prepared by Approved Authorized by

by
Designation
Name
Sign and date

2.2 Installation Qualification (IQ)11:

Installation Qualification was prepared as per the protocol mentioned in URS. Installation Qualification is
conformity with installation specification, equipment manuals schematics and engineering drawing ensuring that all
major processes of the equipment. IQ is done to check that the equipment has been introduced as per makers
suggestion in an appropriate way and put in a situation reasonable for its planned reason5.

2.2.1 Objective:
To demonstrate that the Tray Dryer installed in the Department of Pharmaceutics, PG Lab 2, conforms to the
purchase specification and the manufacturers literature, and to document the information that the equipment meets
specifications.

2.2.2 Scope:
For Installation and Qualification of a New Laboratory Tray Dryer

2.2.3 Responsibility:
Supervisor of the department where the Tray Dryer is located is responsible for writing the protocol, supervising the
performance of the IQ, verifying the data and writing the IQ report.

QA department for approving the protocol, reviewing, approving the date and providing conclusions.

2.2.4 Systems / Equipment:

i. Name of the Equipment: - Tray Dryer

 ii. Equipment Make / Model: - cGMP

iii. Purpose of the Equipment: -

Drying of wet granules, Uniform dried granules formation, Remove the moisture from the Powders.

iv. Material of construction of product: -

 SS316 – Product contact part

 SS304 – Non-contact part

v. Number of Trays: -

Trays with dimensions 80 x 42 cm: - 5

Trays spare of same dimensions: - 2

vi. Number of Motor: - 1 Motor ½ HP

vii. Number of fan: - one fan

viii. Temperature sensors: - 3

ix. Heating coil: - 2

x. MMI / HMI / PLC: - controlling system

xi. Power button

xii. Alarm

xiii. Ammeter and Voltmeter

xiv. Earthing

xv. Silicone covering around the Door

xvi. Meshes cover for the motor

2.3 Operational Qualification (OQ) [11]:

2.3.1 Objective:
To determine that the Tray Dryer installed in building of Manipal College of Pharmaceutical Science (Department
of Pharmaceutics PG Lab 2), operates according to specifications

2.3.2 Equipment and Documents:

This is done to give a high level of affirmation that the gear capacities as proposed. Operational Qualification ought
to be directed in three phases:

 Component Operational Qualification, of which adjustment can be viewed as a large part.

 System Operational Qualification to decide whether the whole framework works as a coordinated entirety.

 Process Performance Qualification: This checks the framework is repeatable and is reliably creating a quality
item5.

2.3.3 Procedure:
Preparation of the granules (without drug) by using the following formula
Table 6: Formula
Ingredient Quantity (g)
HPMC 4.4
MCC 13.3
Lactose 0.8
Talc 0.4
Mg. Stearate 0.8

Granules prepared for performing the OQ Studies.

2.4 Performance Qualification (PQ) [11]:
2.4.1 Objective:
To determine that the Tray Dryer installed in building of Manipal College of Pharmaceutical Science (Department
of Pharmaceutics PG Lab 2), executes as proposed by over and again running the equipment on its expected
schedules and recording all pertinent data and information for temperature distribution studies and load setups which
will be tried and tested. Results must show that execution reliably meets pre-determined under ordinary conditions,
and where proper for worst circumstances.

2.4.2 Equipment and Documents:

Before beginning the performance validation, SOPs for every test method, the data to be recorded, and the criteria
for acceptance should be prepared and approved. Thermocouple location Diagrams for each trial. Charts for the time
and temperature recording.

2.3.3 Procedure:
Preparation of the granules by using the following formula
Table7: Formula
Ingredient Quantity (mg)
Diclofenac Sodium 50
Microcrystalline Cellulose 40
Sodium Starch Glycolate 20
Lactose 80
Talc 2
Mg. Stearate 1.6
Colloidal Silicon dioxide 2

Granules prepared with the drug (actual batch) for performing the PQ Studies.

Figure 2: Granules

Loss on Drying (LOD)

Formula:

Inital weight of sample – Weight of sample after stying

LOD = ---------------------------------------------------------------------------
Inital weight of sample

The experiment was carried out at 700c for 1 hour 30 min at three different places in the equipment i.e. top, middle
and bottom as show below
Figure 3: Tray Dryer

3. RESULT AND DISCUSSION:

3.1 Installation Qualification (IQ):
Installation Qualification of tray dyer was done by preparing a check list of the parts and functions as specified in
URS. The equipment was inspected and accordingly Yes or No was selected in the check list.
Tick Yes / No for the following:

Table 8: Procedure
i. Equipment Model cGMP  Yes □ No
ii. Material of construction of product
Product contact part - SS316  Yes □ No
Non-contact part - SS304  Yes □ No
iii. Number of Trays
Trays with dimensions 80 x 42 cm 5  Yes □ No
Trays spare of same dimensions 2  Yes □ No
iv. One motor ½ HP  Yes □ No
v. One fan  Yes □ No
vi. Temperature sensors 3  Yes □ No
vii. Heating coil 2  Yes □ No
viii. MMI / HMI / PLC controlling  Yes □ No
system
ix. Power button  Yes □ No
x. Alarm □ Yes  No
xi. Ammeter and Voltmeter  Yes □ No
xii. Earthing  Yes □ No
xiii. Silicone covering around the Door  Yes □ No
xiv. Meshes cover for the motor  Yes □ No
xv. Noise level 70-75 dB  Yes □ No
xvi. Material of construction Certificate  Yes □ No
(MOC)
xvii. Inspection at Vendor’s end (FAT)  Yes □ No
xviii. Drawing 2 sets  Yes □ No

Report:
Installation Qualification was carried out successfully and the equipmenst is now ready for Operational
Qualification.

3.2 Operational Qualification (OQ):

Operational Qualification of tray dryer was done by performing following studies

 Challenge test for set Temperature: In this study, the equipment was set at different temperature, a calibrated
thermometer was used to carry out three trials to confirm the set temperature of the equipment. Obtained results
are tabulated as shown in Table 9.

Table 9: Challenge test for set Temperature

Set Temperature Actual Observed Temperature (°C)
(°C) Trial 1 Trial 2 Trial 3
50 49 49 48
55 55 53 54
60 59 58 58
65 63 63 64
70 71 69 70
75 77 75 76
80 82 80 80
85 84 83 84
 Time required to reach temperature: In this study, the time was noted down after reaching the temperature
and the results were tabulated as shown in Table 10.

Table 10: Time required to reach set temperature

Temperature (°C) Time
50 -55 1 min 30sec
55 -60 2 min 00sec
60 -65 2 min 15 sec
65 -70 2 min 40 sec
70 -75 2 min 53 sec
75 -80 5 min 12 sec
80 -85 1 min 42 sec

 Temperature distribution study: In this study, the temperature of the equipment was set at three different
temperature, at three different position and a calibrated thermometer was used to carry out three trials to confirm
the set temperature of the equipment and the results were tabulated as shown in Table 11.

Table 11: Temperature Distribution Study

Trial Set Temperature Actual Observed
Number (°C) Temperature (°C)
Top Middle Bottom
Trial 1 50 48 50 50
70 68 69 70
80 79 80 80
Trial 2 50 48 50 50
70 69 70 69
80 78 79 80
Trial 3 50 49 49 50
70 68 70 70
80 79 80 79

Calibration of Temperature: In this study, the temperature was checked by used calibrated thermometer as showed in
below fig. 4 and 5 for 70°C both on the equipment as well as thermometer showed the same temperature.

Figure 4: Thermometer

Figure 5: Tray Dryer Temperature indicater

Report:
Operational Qualification carried out successfully and the equipmenst is now ready for Performance Qualification.

3.3 Performance Qualification (PQ):

Performance Qualification of tray dryer was done by performing following study. Prepared granules were used to
determine the Percentage Loss on Drying. Granules were weighed with the dish and calculated the weight of
granules (i.e. W3). This weight is before the drying, granules were kept for drying in the tray dryer and the weight of
granules was noted after drying. The following calculation were done, one of the calculation is given below.

Calculation:
Weight of the Dish (W1): 30.168 g
Weight of the Dish and Granules (W2): 32.168 g
Weight of the Granules (W3): W2 – W1; 32.168 g – 30.168 g = 2 g
Weight of the Dish and Granules After drying (W4): 32.135 g
Weight of the dried Granules (W5): W4 – W1; 32.135 g – 30.168 g = 1.967 g
LOD % = X 100; X 100 = 1.65

Table 12: Loss on Drying

LOD (%) Top Middle Bottom
A 1.65 1.85 1.95
B 1.55 1.95 1.95
C 1.7 1.9 1.95

Reporting:
The equipment performed satisfactorily, Tray dryer is thus qualified and can be used for regular experimental or
research activities.

4. CONCLUSION:
Qualification of the equipment is a regulatory requirement so that medicinal products manufactured using these
equipment shall produce a product always meeting predetermined specifications. Therefore, the study was carried
out on New Laboratory Tray Dryer which was fabricated according to the URS document. Equipment qualified all
the process steps successfully such as FAT, SAT, IQ, OQ and PQ. The New Laboratory Tray Dryer qualifies and
ready to use for the manufacturing process or experimental purpose.

Installation, Operational and

Performance Qualification Report of
Vacuum Tray Dryer (VTD)
8 Votes

Equipment Name : Vacuum Tray Dryer

Equipment Model No.: XYZ

Equipment Sr. No.: XYZ

Equipment ID No.: VTD/XYZ

Equipment Area : Drying room

Equipment Manufacturer Name :

Equipment Application : For drying of wet granules and pellets

Report Date :

REPORT APPROVAL:

Prepared by Checked by Approved by

Signature

Date

Name

Department Maintenance Quality Assurance Production Head -Maintenance Head – Quality Assu

Corporate Office: – XYZ Factory:-

Sr. No. Title Page N

Report approval ……………………………………………………… 1

Table of contents ……………………………………………………… 2

Abbreviations…………………………………………………………… 3

Objective ……………………………………………………………… 4

Scope ………………………………………………………………… 4

Responsibilities ………………………………………………………… 4

Equipment description ………………………………………………… 4

Procedure ……………………………………………………………… 4

Installation verification report ………………………………………… 4–5

Technical specification verification report …………………………… 6–8

Sub components specification verification report …………………… 8–9

Measuring Device Calibration Verification Report…………………… 10

Utility verification report…….………………………………………… 10

Safety features verification report …………………………………… 10 – 1

 Material of construction (MOC) verification report …………………. 11 – 1

Test /inspection certificate verification report ………………………. 12 – 1

Operational functionality verification Report………………………… 13 – 1

Temperature verification report……………………………………… 15 – 1

Performance verification report……………………………………… 16 – 1

Deviation report ……………………………………………………… 18

Change control……………………………………………………… 18

List of annexure ………………………………………………………. 18

Summary and conclusion of qualification……………………………… 19

Certification of qualification…………………………………………… 19

Abbreviations:

Sr. No. Abbreviation Full Form

°C Degree centigrade

% Percentage

± Plus minus
Sr. No. Abbreviation Full Form

AC Alternative current

cm2 Square centimetre

Dist. District

DQ Design qualification

H Height

Hz Hertz

ID Identification

i.e. That is

IQ Installation qualification

kg Kilogram

L Length

MIDC Maharashtra state industrial development corporation

 Sr. No. Abbreviation Full Form

MOC Material of construction

No. Number

OQ Operational qualification

PQ Performance qualification

PR Production

QA Quality assurance

Qty. Quantity

Sr. Serial

SS Stainless steel

V Voltage

VTD Vacuum tray dryer

W Width

1. OBJECTIVE:
1. To record the findings of installation, operational and performance qualification of
vacuum tray dryer having ID. No. VTD/XYZ.
 2.0 SCOPE:

 The scope of this report is limited to vacuum tray dryer having ID. No. P/PR/VTD/001.

 3.0 RESPONSIBILITIES:
 Maintenance Officer/Executive:To prepare qualification report and co-ordinate the
entire qualification activity.
 Quality Assurance Officer/Executive: To witness the qualification study and ascertain
that the study is conducted as per the protocol.
 Production Officer/Executive: To execute qualification study in co-ordination with
other departments.
 Head Maintenance: To review the qualification documents.
 Head Quality Assurance: To review and approve the qualification documents.

 4.0 EQUIPMENT DESCRIPTION:

 AS per installation qualification protocol No.: XYZ/IQ/OQ/PQ/XYZ.

 5.0 PROCEDURE:

Qualification of the equipment should meet the acceptance criteria outlined in the
following steps.

 5.1 Installation Verification Report

Check
Sr.
Check point Acceptance Criteria (Specification) Observations by
No.
Sign/D

Visually there should not be any

1.0 Visual inspection of the equipment.
abnormality.

Area of installation should have

Check the area of installation (Dryer
2.0 sufficient space for operation and
area cubicle).
servicing of the equipment.

Check the levelling of the machine Air bubble shall be at centre position
3.0
using level indicator. of level indicator.

4.0 Check the major components and Major components and their electrical
their electrical cables for housing and cables shall be securely housed and
 Check
Sr.
Check point Acceptance Criteria (Specification) Observations by
No.
Sign/D

anchoring. anchored.

5.0 Check the electrical ports. All electrical ports shall be cleaned.

All electrical connections shall be

Check the electrical circuit found connected as per electrical
6.0
diagram. circuit drawing (reference No. DW-
CE010)

 Technical Specification Verification Report

Sr. Checke
Check point Acceptance Criteria (Specification) Observations
No. Sign/D

1.0 Loading capacity 96 trays with approx 2 – 3 kg material in each trays

2.0 Dimension Approximate 2750 (L) x 1900 x 2400 (H)

mm

Heating shelf’s shall be provided for holding and

heating the trays.Sufficient distance shall be
3.0 Heating shelfs
provided between two trays after mounting the
trays on the shelfs.

Door bolts shall be provided to lock the vacuum

4.0 Door bolts
chamber door.

5.0 Vacuum pump Vacuum pump facility shall be provided to

Sr. Checke
Check point Acceptance Criteria (Specification) Observations
No. Sign/D

generate the vacuum in the chamber.

Condenser facility shall be provided for

6.0 Condenser condensing the vapors drawn from vacuum
chamber.

Receiver shall be provided to collect the

7.0 Receiver condensate solvent and to draw vapour through
vacuum pump.

Digital temperature Digital temperature indicator cum controller shall

8.0 indicator cum be provided to control the incoming hot water
controller temperature.

Digital temperature indicator shall be provided to

Digital temperature
9.0 display the inlet temperature and product
indicator
temperature of dryer.

Circulation pump shall be provided to circulate the

10.0 Circulation pump
hot water through drying equipment and tank.

Vacuum break valve shall be provided in front of

11.0 Vacuum break valve
equipment for easy access.

Nitrogen purging Nitrogen purging valve shall be provided in front

12.0
valve of equipment for easy access.

View glass shall be provided in front of equipment

13.0 View glass
to view the indoor material.
 Sr. Checke
Check point Acceptance Criteria (Specification) Observations
No. Sign/D

Driving/electrical
14.0
parts

Driving and electrical parts shall be covered with

Driving and electrical SS304 material.There shall be separate cabinet for
14.1
parts electrical parts to avoid pollutions from driving
parts.

15.0 Operating panel

Operating panel shall be installed in front of

15.1 Operating panel
equipment for easy access.

Emergency stop button shall be provided on

Emergency stop
15.2 operating panel to stop the equipment in
button
emergency.

 Sub Components Specification Verification Report

Sr. Acceptance Checked by

Check point Observations
No. Criteria (Specification) Sign/Date

1.0 Condenser Qty.: 1 No.

2.0 Receiver Qty.: 1 No.

3.0 Vacuum pump Qty.: 1 Set.

 Sr. Acceptance Checked by
Check point Observations
No. Criteria (Specification) Sign/Date

4.0 Circulation pump Qty.: 1 Set.

5.0 Motor Qty.: 1 No.

6.0 Sensor details

Incoming hot water

6.1 Qty.: 1 No.
temperature sensor

6.2 Inlet temperature sensor Qty.: 1 No.

6.3 Product temperature sensor Qty.: 1 No.

7.0 Electrical parts

7.1 Rupture disc/ Explosion vent Qty.: 1 No.

8.0 Pneumatic parts

8.1 Inlet control solenoid valve Qty.: 1 Set

8.2 Steam inlet control valve Qty.: 1 Set

8.3 Vacuum gauge Qty.: 1 Set

 5.3 Measuring Device Calibration Verification Report

 ID. Calibration Done On
Sr. Measuring Acceptance Observatio Checke
No./ Sr. and Calibration Due
No. Device Criteria n Sign/Da
No. Date

It shall be within
Multimeter its calibration
period.

 5.4 Utility Verification Report

Sr. Utility Checked by

Acceptance Criteria (Specification) Observations
No. parameter Sign/Date

Three phase 415 V AC ± 10% and 50 Hz ±

1.0 Electrical
5%.

2.0 Steam supply NLT 6.0 kg/cm2

 5.5 Safety Features Verification Report

Sr. Checked b
Safety features Acceptance Criteria (Specification) Observations
No. Sign/Date

1.0 Edges Edges of construction shall be rounded.

2.0 Electricity The equipment shall be earthed.

3.0 Driving part Driving part shall be covered.

4.0 Emergency stop button Emergency stop switch shall be provided.

 Sr. Checked b
Safety features Acceptance Criteria (Specification) Observations
No. Sign/Date

The equipment shall consist of inflatable

5.0 Sealing system
gaskets.

Vacuum relief Rupture disc provision shall be provided to

6.0
plate/explosion disk opens at a pressure of 0.25 bar.

7.0 Control panel Control panel shall be flameproof.

 5.6 Material of Construction (MOC) Verification Report

Sr. Acceptance Criteria (Specification) Checked by

Component Observations
No. for MOC Sign/Date

1.0 Chamber SS 316

2.0 Tray SS 316

3.0 Heating shelfs SS 316

4.0 Condenser SS 316

5.0 Receiver SS 316

6.0 Support columns/legs SS 304

Hot water distribution

7.0 SS 304
headers
 Sr. Acceptance Criteria (Specification) Checked by
Component Observations
No. for MOC Sign/Date

8.0 Tank SS 304

9.0 Steam inlet control valve SS 304

10.0 Silicone rubber gaskets Food grade

 5.7 Test/Inspection Certificate Verification Report

Sr. Checked by
Check point Acceptance Criteria (Specification) Observations
No. Sign/Date

It shall be tested/inspected for its

1.0 Motor
performance.

It shall be tested/inspected for its

2.0 Vacuum pump
performance.

It shall be tested/inspected for its

3.0 Circulation pump
performance.

It shall be tested/inspected for its

4.0 Sensor
performance.

It shall be tested/inspected for its

5.0 Vacuum gauge
performance.

Control panel flame It shall be tested/inspected for its

6.0
proof performance.
 Sr. Checked by
Check point Acceptance Criteria (Specification) Observations
No. Sign/Date

It shall be tested/inspected for its

7.0 Rupture disc
performance.

Steam inlet control It shall be tested/inspected for its

8.0
valve performance.

Wall panel insulation It shall be tested/inspected for its

9.0
material performance.

Guarantee/Warrantee certificate shall be

10.0 Vacuum tray dryer
provided.

Note: Whether component is tested /inspected of its performance shall be verified

based on the test/inspection certificate provided by the manufacturer.

 5.8 Operational Functionality Verification Report

Sr. Checked b
Operation Acceptance Criteria Observations
No. Sign/Date

Turn the main switch panel (red)

1.0 Main panel shall turn ON.
ON/OFF button to ON position.

Turn the main switch panel (red)

2.0 Main panel shall turn OFF.
ON/OFF button to OFF position.

Press (green) ON button of hot water

3.0 Hot water pump shall turn ON.
pump

4.0 Press (red) OFF button of hot water Hot water pump shall turn
 Sr. Checked b
Operation Acceptance Criteria Observations
No. Sign/Date

pump OFF.

Press (green) ON button of vacuum

5.0 Vacuum pump shall turn ON.
pump

Press (red) OFF button of hot water

6.0 Vacuum pump shall turn OFF.
pump

By pressing temp set (green) button set Hot water temperature shall be
7.0
the hot water temperature at 90°C. entered successfully.

By pressing up (green) button increase Set hot water temperature shall

8.0
the set hot water temperature. increase successfully.

By pressing down (green) button Set hot water temperature shall

9.0
decrease the set hot water temperature. decrease successfully.

 5.9 Temperature Verification Report

Sr. Acceptance Checked

Operation Observations
No. Criteria Sign/Dat

Set the hot water system temperature at 40°C and record For
1.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only

Set the hot water system temperature at 50°C and record For
2.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only
 Sr. Acceptance Checked
Operation Observations
No. Criteria Sign/Dat

Set the hot water system temperature at 60°C and record For
3.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only

Set the hot water system temperature at 70°C and record For
4.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only

Set the hot water system temperature at 80°C and record For
5.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only

Set the hot water system temperature at 90°C and record For
6.0 the hot water inlet temperature and product temperature information
from temperature controller panel. only

 5.10 Performance Verification Report

 5.10.1 LOD Report:

Minimum capacity of VTD:

Product Name : Batch No.:

Batch Size :

Sr. No. Sample Location LOD Result at Initial LOD Result at End Checked by sign/d

1.0 Top Centre Tray

2.0 Middle Centre Tray

 3.0 Bottom Centre Tray

 5.10.2 LOD Report:

Maximum capacity of VTD:

Batch No.:
Product Name :

Batch Size :

Sr. No. Sample Location LOD Result at Initial LOD Result at End Checked by sign/d

Top Centre Tray

Middle Centre Tray

Bottom Centre Tray

 5.10.3 Temperature mapping study report:

Temperature mapping study is carried out with maximum batch size (i.e. by loading 96
trays with approximately 2 to 3 kg material in each tray) with data recording interval of
15 min.

Batch No.:
Product Name :

Batch Size :
 Minimum temperature location:
 Highest fluctuation location:
 Maximum temperature location:

 6.0 DEVIATION REPORT:

Deviation Justification for acceptance Impact on installation, operation and

Sr. No.
(s) criteria performance

 7.0 CHANGE CONTROL:

 8.0 LIST OF ANNEX:

 9.0 SUMMARY AND CONCLUSION OF QUALIFICATION:

 10.0 CERTIFICATION OF QUALIFICATION: