User Requirements Specification

for
Drum Mixer Machine

1. INTRODUCTION
1.1 Description
The technical specification specifies the requirements of drum mixer machine for Pharmaceuticals Ltd. Bangladesh
(Unit-1).
All information in this document must remain confidential.
Suppliers must separately list out all non-compliance in their quotation with the requirements of this
specification.
1.2 Scope
The purpose of this document is to specify the requirements of drum mixer machine at Gazipur plant (Unit-1).
This specification must not be seen as exhaustive. The supplier may propose any useful addition in consideration
to the betterment of the system for safety and operability aspects.
1.3 Purpose
The purpose of Blending equipment is to produce a uniform mixture of granules/powders coming from the
granulation suit & additives/excipients that are additionally added in the blender.

2. ENVIRONMENT AND UTILITIES TO BE USED

2.1 Layout
This equipment is to be installed in:
Factory ……………………Kaliakair, Gazipur
Area …………………… Ground Floor
Available space…………… 70 Sqft.
2.2 Utilities and Technical Specification:
Requirements for utilities and Technical to be specified by the supplier.

Criteria Description
Capacity 15 Kg & 30 Kg.
Dimension For 30 Kg:Dia-420mm,Height:650mm; For 15 Kg: Dia-380mm, Height:450mm.
MOC All product contact parts should be SS 316.
Sheet Thickness: 1.5mm.
Power Available 400±10V, 3 Phase, ground, 50 Hz
Main Motor 400±10V, 3 Phase, ground, 50 Hz
Inverter LS, Korea
Baffle As per machine capacity. Should be SS 316.
Machine Frame SS 304 frame structure.
Speed Variable Control by inverter.
Electric panel board Separate with MCCB and IPS4 graded.
Control Box Start switch, Stop switch, Emergency Stop switch, Lamp & other electrical
components. All lining is numbered in order.
Metal All product contact parts must be AISI 316. Others should be SS 304.
Polish Mirror polish.

3. Cleaning
The machine should have designed to have easy accessibility to all parts to ensure easy maintenance and cleaning
for changeover.
The equipment shall be easily accessible for manual cleaning of the surfaces.

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4. Instrumentation
All doors and hatches giving an access to moving parts shall be equipped with safety switches, which stop the
machine immediately.
5. Emergency stop
Emergency stop switch must stop the complete machine immediately in a safe way. Emergency stop buttons must
be positioned so that operator can reach the stop from all sides of the machine.
6. Material specification
All contact parts shall be made of stainless steel AISI 316L or compatible. Stainless steel AISI SS-304 or equivalent
shall be used in surfaces (out side of machine body) that are not in contact with the product. All metallic and non-
metallic materials used in the equipment must withstand cleaning with water, 70% IPA and detergents. All nut-bolts
should be SS-304.
7. GENERAL REQUIREMENTS
The machine must belong to standard GMP design (enclosed from all possible ends). The machine shall be
equipped with safety guards for avoiding human injury.
8. Noise level
Noise level of the equipment, shall be as low as possible, and must not exceed 40dB (A) measured at operator
working places.
9. Maintenance
The machine shall be built with intention for quick and easy access for service and maintenance.
10. INSTALLATION & COMMISSIONING
Installation & Commissioning will be done by the supplier at Gazipur Site (Unit-1)
11. TRAINING
The supplier should train at least One Production Officer, one operator and one engineering people to operate and
maintain the machine.
12. SITE ACCEPTANCE TESTING (SAT)
Site acceptance testing will be done jointly by the supplier and the site team to check that the equipment operates
satisfactorily under production conditions. Testing will be carried out jointly by the supplier and GPL nominated
team, once the equipment has been fully installed and commissioned by the supplier. The protocols are to be
approved by both parties as planned in the project schedule.

Prepared by: Signature:

Md. Islam Date:
(Sr. Production Officer)
Checked by: Signature:
Md. Abul Date:
(Deputy Manager, Production)
Checked by: Signature:
Date:
(Deputy Manager,Engineering)
Approved by: Signature:
Date:
(Factory Manager-unit 1)

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