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Project Name :

HVAC System

Page No.

Page 1 of 3

URS Reference No:

URS/GPF-2/MFG/XXX

Version No:

01

Issue Date:

Dec 2015

Superseded Version

NA

BEACON PHARMACEUTICALS LIMITED


Bhaluka, Mymensingh, Bangladesh

USER REQUIREMENT SPECIFICATIONS


FOR
HVAC SYSTEM AT GENERAL PRODUCTION FACILITY-2

URS Approval:
Name
Prepared by:
Md. Shahadat Hossain
Asst. Manager, Production
Checked by:
Md. Saiful Islam
Sr. Manager, Production
Checked by:
Md. Abdullah Ibn Taskin
Deputy Manager, Engineering
Authorized by:
Md. Shahidur Rahman
SVP, Factory Operations
Approved by:
Md. Iqbal Hossain
Deputy Manager, Quality Compliance

Signature:

Date:

Project Name :

HVAC System

Page No.

Page 2 of 3

URS Reference No:

URS/GPF-2/MFG/XXX

Version No:

01

Issue Date:

Dec 2015

Superseded Version

NA

BEACON PHARMACEUTICALS LIMITED


Bhaluka, Mymensingh, Bangladesh

Basic Requirement
Capacity
Power Supply
Room Condition

Materials of Construction (MOC)

Process Requirement

Process Control

Beacon Pharmaceuticals Limited is looking for HVAC system for Solid and Liquid
facility at General Production Facility-2
These Specifications will cover the details design, supply, Installation, testing and
commissioning. This design must meet all cGMP guidelines and legislation.
415 10 Volts, 50 HZ, 3 Phase
Relative Humidity of equipment room: 455%
Temperature of room:
222C
Grade of equipment room:
Grade D
The product contact part of the machine will be made of SS AISI 316L and other
Parts will be SS AISI 304
Surface finish will be at product contact side Ra0.3 m and for non contact side
Ra0.8 m.
This HVAC system should be applicable for General Production Facility-2 solid and
liquid products of Beacon Pharmaceuticals Limited plant. Facility comprises air
handling systems which provide heating, ventilation and air conditioning. This is
achieved by controlling the pressure, temperature, humidity, flow rate, flow pattern
and cleanliness of the various areas. Monitoring and controlling systems are
employed to ensure optimum conditions are maintained.
The air conditioning system has been designed and installed to provide air
conditioned particulate controlled air to all rooms within the facility. Air conditioning
systems should be located in the roof of building and the position of AHU will be 8ft
above the room ceiling above the production area.
1. Air exhaust system including dust extraction system should be incorporated
2. Removal for waste water should have adequate drainage facility.
3. Lighting should be sufficient.
4. During operation if spray nozzle get clogged the machine should have a
cleaning system of nozzle in place.
5. There should be an automatic alarm system if there is any malfunctioning

Emergency Stop
Sound level
Cleaning
Control System and Automation

and a reset button shall be provided.


The E-Stop mechanism shall be located in easily accessible areas around the
equipment as required by national and local safety standards.
Not more than 75db
Automatic CIP system with PW should be provided.
The machine should be PLC controlled with color touch HMI
In order to avoid operating errors, the user software will be designed to operate in
four clearly separated operation modes, i.e.
Manual operation
Automatic operation
Cleaning
Maintenance
The access to each operation mode has to be controlled by password protection.
The system will allow the following identifications:
Date
Product name
Batch Number

Project Name :

HVAC System

Page No.

Page 3 of 3

URS Reference No:

URS/GPF-2/MFG/XXX

Version No:

01

Issue Date:

Dec 2015

Superseded Version

NA

BEACON PHARMACEUTICALS LIMITED


Bhaluka, Mymensingh, Bangladesh

Drawings & Protocols

Factory Acceptance Test (FAT)

Site Acceptance Test (SAT)


Spares

Operator I.D.
Time setting to start and end of a cycle.
Language requirement is English.
(i) DQ, IQ & OQ protocols will supply by vendor and executed by Beacon
Pharmaceuticals Limited & Vendor.
(ii) Vendor is to provide all necessary protocols which will be approved by
Beacon Pharmaceuticals Limited.
(iii) Following documents will be supplied by vendor:
a. Installation Manual (2 Copies)
b. Operational Manual (2 Copies)
c. Service Manual (2 Copies)
d. Routine maintenance schedule and recommended change parts list.
e. All necessary drawings (i.e. P&I diagram, Electrical and pneumatic Wiring
diagram, Equipment Layout, Assembly and disassembling drawings etc.
f.
Complete component lists including origin.
g. Instrument calibration certificate with manual
h. All materials Certificate
i. Spares parts list.
Note: All documents have to comply with the cGMP standard.
(i) Beacon personals and vendor jointly execute the Factory Acceptance Test
at vendors site. The Supplier shall notify the BPL 4 weeks prior to FAT.
(ii) FAT protocol shall be submitted to the user for review and approval
minimum 2 (two) weeks ahead of the FAT.
SAT shall be executed by the vendor jointly with BPL personals at BPL site.
Frequently degradable change parts for two years.

Warranty

12 months support service ensuring smooth running of the machine.

Document History
Version No

Date

01

Dec 2014

Reason for Version


1. New Document