Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.
Summary and conclusion of qualification………………………………
19
Certification of qualification……………………………………………
19
Abbreviations:
Sr. No.
Abbreviation
Full Form
°C
Degree centigrade
%
Percentage
±
Plus minus
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
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
OBJECTIVE:
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.
3.0RESPONSIBILITIES:
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.
4.0EQUIPMENT 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
Sr. No.
Check point
Acceptance Criteria (Specification)
Observations
Checked by Sign/Date
1.0
Visual inspection of the equipment.
Visually there should not be any abnormality.
2.0
Check the area of installation (Dryer area cubicle).
Area of installation should have sufficient space for operation and servicing of the equipment.
3.0
Check the levelling of the machine using level indicator.
Air bubble shall be at centre position of level indicator.
4.0
Check the major components and their electrical cables for housing and anchoring.
Major components and their electrical cables shall be securely housed and anchored.
5.0
Check the electrical ports.
All electrical ports shall be cleaned.
6.0
Check the electrical circuit diagram.
All electrical connections shall be found connected as per electrical circuit drawing (reference No. DW-CE010)
Technical Specification Verification Report
Sr. No.
Check point
Acceptance Criteria (Specification)
Observations
Checked by Sign/Date
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
3.0
Heating shelfs
Heating shelf’s shall be provided for holding and heating the trays.Sufficient distance shall be provided between two trays after mounting the trays on the shelfs.
4.0
Door bolts
Door bolts shall be provided to lock the vacuum chamber door.
5.0
Vacuum pump
Vacuum pump facility shall be provided to generate the vacuum in the chamber.
6.0
Condenser
Condenser facility shall be provided for condensing the vapors drawn from vacuum chamber.
7.0
Receiver
Receiver shall be provided to collect the condensate solvent and to draw vapour through vacuum pump.
8.0
Digital temperature indicator cum controller
Digital temperature indicator cum controller shall be provided to control the incoming hot water temperature.
9.0
Digital temperature indicator
Digital temperature indicator shall be provided to display the inlet temperature and product temperature of dryer.
10.0
Circulation pump
Circulation pump shall be provided to circulate the hot water through drying equipment and tank.
11.0
Vacuum break valve
Vacuum break valve shall be provided in front of equipment for easy access.
12.0
Nitrogen purging valve
Nitrogen purging valve shall be provided in front of equipment for easy access.
13.0
View glass
View glass shall be provided in front of equipment to view the indoor material.
14.0
Driving/electrical parts
14.1
Driving and electrical parts
Driving and electrical parts shall be covered with SS304 material.There shall be separate cabinet for electrical parts to avoid pollutions from driving parts.
15.0
Operating panel
15.1
Operating panel
Operating panel shall be installed in front of equipment for easy access.
15.2
Emergency stop button
Emergency stop button shall be provided on operating panel to stop the equipment in emergency.
Guarantee/Warrantee certificate shall be 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. No.
Operation
Acceptance Criteria
Observations
Checked by Sign/Date
1.0
Turn the main switch panel (red) ON/OFF button to ON position.
Main panel shall turn ON.
2.0
Turn the main switch panel (red) ON/OFF button to OFF position.
Main panel shall turn OFF.
3.0
Press (green) ON button of hot water pump
Hot water pump shall turn ON.
4.0
Press (red) OFF button of hot water pump
Hot water pump shall turn OFF.
5.0
Press (green) ON button of vacuum pump
Vacuum pump shall turn ON.
6.0
Press (red) OFF button of hot water pump
Vacuum pump shall turn OFF.
7.0
By pressing temp set (green) button set the hot water temperature at 90°C.
Hot water temperature shall be entered successfully.
8.0
By pressing up (green) button increase the set hot water temperature.
Set hot water temperature shall increase successfully.
9.0
By pressing down (green) button decrease the set hot water temperature.
Set hot water temperature shall decrease successfully.
5.9 Temperature Verification Report
Sr. No.
Operation
Acceptance Criteria
Observations
Checked by Sign/Date
1.0
Set the hot water system temperature at 40°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information only
2.0
Set the hot water system temperature at 50°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information only
3.0
Set the hot water system temperature at 60°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information only
4.0
Set the hot water system temperature at 70°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information only
5.0
Set the hot water system temperature at 80°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information only
6.0
Set the hot water system temperature at 90°C and record the hot water inlet temperature and product temperature from temperature controller panel.
For information 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/date
1.0
Top Centre Tray
2.0
Middle Centre Tray
3.0
Bottom Centre Tray
5.10.2 LOD Report:
Maximum capacity of VTD:
Product Name :
Batch No.:
Batch Size :
Sr. No.
Sample Location
LOD Result at Initial
LOD Result at End
Checked by sign/date
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.
Product Name :
Batch No.:
Batch Size :
Minimum temperature location:
Highest fluctuation location:
Maximum temperature location:
6.0DEVIATION REPORT:
Sr.No.
Deviation (s)
Justification for acceptance criteria
Impact on installation, operation and performance
7.0 CHANGE CONTROL:
8.0LIST OF ANNEX:
9.0 SUMMARY AND CONCLUSION OF QUALIFICATION:
10.0 CERTIFICATION OF QUALIFICATION:
Qualification is satisfactory. Yes/No
Hence equipment can be used for routine use. Yes/No
x 2400 (H) mm
Pharmaceutical Updates 