Title: Users Requirement Brief

URS Deviation List

Machine: Fette PKB system

Requirements

No. Requirement
A PROCESS/PRODUCT REQUIREMENTS
1.0 Description of the equipment
As peripheral device for a tablet press the PKB 3 is connectionable depending upon interpretation at single , double or triple
--rotary press.
PKB 3 transports powdery lubricant to a tablet press to coat the press chambers.
This prevents the product from adhering to the die wall and pressing surface of the punch and avoids any damage to the
finished tablet when it is lifted out with the lower punch

2.0 Purpose of the equipment / facility / system

PKB 3 transports powdery lubricant to a tablet press to coat the press chambers.
This prevents the product from adhering to the die wall and pressing surface of the punch and avoids any damage to the
finished tablet when it is lifted out with the lower punch.

3.0 Product dosage type : Solid oral

4.0 Suggested suppliers name : Fette
5.0 Requirements for any power failure backups or other utilities : N.A
6.0 Any other specific requirements : NA
The high---precision weigher constantly monitors the set dose of lubricant and adjusts the lubricant flow where necessary

An agitator in the lubricant storage tank ensures that the dosing screws are filled to a constant
level. The dosing screws bring the lubricant to a down pipe. The dosing screw and agitator are driven by a gear motor. A
single user interface to allow an operator to perform IPC and NIR testing from the same operator interface

A pressure--- or time monitoring function informs the operator when the injector needs to be
cleaned via the control panel (Schematic Panel, panel for operating the unit) by an optical and acoustic signal

B OPERATIONAL REQUIREMENTS
1.0 Technical Specification:
Nameplate : in the switchboard
Operating voltage: 230 V, 50 / 60
Current consumption 3 A
Power consumption 0.7 KW
Compressed air connection: 5 --- 6 bar dried air maximum 10 bar
Capacity storage tank: 12 dm3
Dosing range: 0.2 ... 2 kg/h
Dimensions of the unit:
Width: 1000 mm
Depth: 600 mm
Height: 1600 mm
Total weight: 269 kg
 Title: Users Requirement Brief Version: Nil
Doc.-No.:UR/FD/338
URS Deviation List Date: 08.05.2018

Customer: Torrent Pharma ltd (R&D)- Bhat

Deviations/Remarks Status Quotation Reference

H33f, H33e, H32

H33f, H33e, H32

This is internal evaluation for Torrent.

This is internal evaluation for Torrent.
This is internal evaluation for Torrent.

"A single user interface to allow an operator to perform IPC and NIR testing
from the same operator interface" This points is not related to PKB
 Title: Users Requirement Brief

URS Deviation List

Machine: Fette PKB system

Requirements

No. Requirement
C Documentation requirements :
Instrument operating SOP
SOP for creation of calibration model and data analysis.
Procedure for replacing the source lamp for NIR
User manual for hardware and software
Warranty certificate

DQ, IQ and OQ protocol (Softcopy)

GA drawing
Instrument calibration certificate
Installation, Operational (With screen shot and details of operation with principle) and
maintenance manual.
List of spares parts and change parts.
Technical details
Material of construction certificate for contact and non contact parts.
Software validation certificate

Food grade certificate for oil and silicon tubing and gasket (If applicable)
Bought out items certificate and its manual

Re qualification criteria and check point to be perform during re qualification

Draft operating procedure with screen shot

Maintenance manual with exploded view of each assly and sub assly for the machine.
FAT Protocol

Vendor recommendation checklist for performing periodic preventive checks at our end
D Safety requirements
Instrument to be enclosed by some shock absorber to have protection against any collision
impact while processing.
Password protection for alternation.
 Title: Users Requirement Brief Version: Nil
Doc.-No.:UR/FD/338
URS Deviation List Date: 08.05.2018

Customer: Torrent Pharma ltd (R&D)- Bhat

Deviations/Remarks Status Quotation Reference

Available in O&M manual

This point is not related to PKB system.
This point is not related to PKB system.
O&M manual for PKB will be provided.
12 months from date of Installation or 15 months from
B/L date whichever is earlier
IQ, OQ and DQ Protocol is not available for PKB
Fette will provide the same.
These certificates are not available
Available in O&M manual

Fette will provide the same.

MOC certificates are not provided

This certificates are not applicable as it is controlled from Fette machine

These certificates are not available

These certificates are not available
This depends upon TPL qualification protocol. If it is mandatory to requalify
after every change then it is required to do so. Few pneumatic connection
will be added and few parameters settings will be required.

Available in O&M manual

Available in O&M manual
FAT is not applicable. Test will be carried out during Installation and
commissioning
Available in O&M manual

PKB will be shipped in seaworthy packing

Existing password policy of the machine is applicable. There is no separate

policy required.