1.0 Approval

The user requirement specification for Rapid Mixer Granulator (RMG) for Mixing, Wet Binding & Size reduction which is to be used in Granulation Area have been prepared, reviewed, approved & authorized by concerns personnel from Production, Engineering and QA.

Working and Principle of Rapid Mixer Granulator (RMG)

2.0     Scope:

The URS document is generated by the User to provide details of structural, functional, cGMP and statutory requirements for the Rapid Mixer Granulator (RMG) machine in order to obtain information and Technical offer from different vendors.

To provide a written document to vendor with respect to correct design of equipment as per requirement.

This specification covers the design, manufacturer, inspection, testing and commissioning of Rapid Mixer Granulator (RMG), together with supporting documents of the equipment to be used in Granulation area (for Mixing, Wet Binding & Size reduction). This design must comply with cGMP requirements.

This URS will be recognized as an integral part of the procurement agreement with the selected equipment Manufacturer. The equipment shall operate under controlled environment (ISO-8) and conditions as per the GMP requirements.

3.0    Process / Product Requirement:

3.1    Name of the equipment: 

         Rapid Mixer Granulator (RMG)            

3.2  Purpose of Equipment:

The purpose of Rapid Mixer Granulator is to do Granulation (Mixing, Wet Binding & Size reduction).

3.3 Chemical/Physical Characteristics of the Process Material:

Not Applicable.

3.4 Suggested Capacity:                     

Equipment Capacity- 150 liters

4.0   Operational Requirement:

4.1    Equipment Description 

This Rapid mixer Granulator is used in pharmaceutical Formulation industries for the mixing & granulation of powders. The mixing is done by bottom agitator/ impeller blades & side wall-mounted chopper is used to break the large lumps which are formed during the wet granulation process. The charging of powder in the rapid mixing granulator is by a pneumatic delivery system & after granulation the wet mill will be used to reduce the particle size of wet mass & can be delivered to Fluid Bed Dryer (FBD) which can be done with Optional attachment by using transfer pipes & suction delivery system.

4.2    Technical Requirements:

Equipment Name

Rapid Mixing Granulator

Equipment Capacity- 150 liters

Working volume (Ltr.)- ~ 120

Working volume (kgs)-30 to 60

Impeller Motor HP- Around 15

Impeller Blade RPM-Around 150

Chopper Motor HP-3

Chopper Motor RPM-Around 2800

Sr. No.	Item	Specifications
1	Granulation Area Dimension	8.80 x 6.10 x 2.70 ( LxWxH) mts
2	Temperature	20 to 30 °C
3	Pressure	Atmospheric
4	Humidity	40 – 60 %
5	Motor & Drive	Explosion Proof
6	Electricals	Explosion Proof
7	HMI	Water Proof

Vacuum  Pump :

Shall be Flour mounted vacuum system of water ring vacuum pump to install vacuum pump at service floor to avoid biological contamination from seal water.

Control valve shall be provided to save loss of seal water when pump is not in operation.

Interconnecting piping, wiring & pneumatic tubing from battery limit to vacuum pump has to be installed.

Standard major components :

Spare parts/other accessories requirements	Specification
Control valve	On – off type Ball valve Pneumatically actuated
Simplex temperature sensor	PT 100  at drain
Pressure switch for Air	Range : 0.5 to 7 bar g MOC : Brass, Diaphragm type
Gasket Vacuum Switch	Range : 750 to 100 mm of  Hg MOC : Brass, Diaphragm type
Pressure transmitter	Range : -1 to 3 bar g
Pressure gauges Jacket	4” dial size, 0 – 4 kg/cm2
Compound Gauge for Chamber	4” dial size, – 1 to 4  kg/cm2
Safety valve	¾” BSP, SS 316L
Pneumatic components	Should meet the requirements
PLC	Should meet the requirements
MMI	Two Line display , MMI – E1012
Air Pressure Regulator	FRL – ¼”

General Requirements For Components

• In compliance with cGMP guidelines.

• Effective seating
• Machine with best- Safety/ Cleaning / Operating and maintenance features.
• Fully automatic operation through programmable.
• Logic controller (Required as optional)
• Binder addition system (Required as optional)
• Easy fast wet granulation system.

Product Bowl

• Made of SS 316.
• Flat bottom, smooth rounded edges.
• All internal surfaces must have a smooth mirror polished.
• Side wall-mounted chopper.
• Bottom-installed agitator/impeller.
• Air purging from the bottom to prevent the entry of water or product into the motor shaft.
• No entry of water/powder to the chopper compartment.
• No chances of particle generation by impeller or chopper seals.

Lid Over Bowl

• Port for material charging through a pneumatic system.
• Port for Binder addition through transfer pump.(As optional)
• Hopper for manual addition of binder.
• Air sealing lid having manual clamps with a sensor.
• Lid opening, vertical or horizontal (To be specified)
• Small viewport for observing the inside operation. (Open & close option)
• Light lamp.
• Breathing filter/dedusting system

Agitator & Chopper:

• Smooth finish.
• Mixer and chopper blades.
• Totally leak proof seal for both impeller and chopper.

• No chances of seal damage during operation.
• No chance of powder/water entry to the motor shaft.
• Easy to assemble & dismantle.
• Independent working of Agitator & Chopper.
• Agitator speed Minimum 5 RPM maximum 150 RPM.
• Chopper speed minimum 300 RPM Maximum 3000 RPM.
• Directly installed motor for Chopper.

• Discharge through the side-mounted gate.
• Control of discharge opening from HMI gate till levels 25%, 50%, and 75% to full opening.
• Install a discharge hinged for opening & cleaning.
• Height must be according to the FBD charging point.
• Electro-Pneumatic operated discharge.
• Automated discharge interlocked and interfaced with pneumatically operated cylinder.

Wet Mill (Required as Option)

• A wet Mill should be installed below the discharge opening.
• Mesh size for wet mill 7 mm.
• No choking of the mill during operation.
• The Mill load must be displayed on HMI.
• Connected with a transfer pipe to deliver products to FBD.

Transfer Pipes (Required as Optional)

• Pharmaceutical grade transfer pipes.
• Diameter suitable for smooth transferring of the product without blockage.
• Non-collapsible due to suction.
• Easy to clean, no product adherence to the walls after cleaning.

WIP System

• WIP/CIP system with raw water, hot water & purified water supply.
• Cleaning spray balls should be installed for bowl cleaning, discharge port & wet mill cleaning.

Mounting Stand.

• SS 304 mounting Stand to support entire equipment.
• Platform space for easy movement.
• Smooth finish, no chance of product or water retention.
• Platform & stairs with side support.
• No slippery surfaces.

HMI & PLC

• HMI of leading Brand.
• PLC of Leading Brand.
• Large Color screen with a highly sensitive touch system.
• Waterproof HMI & PLC.
• Software installation for PLC & HMI.
• PLC with HMI/ SCADA with 21CFR Compliance, Auto Powder loading.

 4.3  Material of Construction:

Sr. No.	Component	Specification
1	All Product Contact Parts	SS 316
2	Non-Contact Exposed Parts. Non-Contact Internal Parts.	SS 304 covered with SS 304
3	Elastomers in contact with the product	Silicone/Teflon
4	Elastomers not in contact with the product	Food grade

4.4    Details of Utilities :

• Electric Power Supply:  0.3HP /440V / 3Phase / 50Hz
• Compressed Air Pressure:  6 bar

4.5 Software and Hardware

 As per the GMP designed.

4.6    Preferable Method of Cleaning:

 Easily accessible for cleaning.

 Product contact parts shall be easily dismantable and cleanable

 All contact parts to be cleaned with water.

The equipment shall be compatible to different cleaning agents

 Parts which are required for cleaning should be provided with quick fixing arrangement.

5.0 Safety Requirement:

5.1  Process Safety  Systems/Alarm and safety features :

• Overload alarm indication on HMI for chopper, agitator & wet mill.
• “Lid not sealed” alarm indication.
• Lid sealing air pressure alarm.
• The chopper & agitator should not start if the lid is open.
• The wet mill should not start if the hinged lid is open.
• Limit switches installed.
• Earth wire installation.
• No sharp edges.
• Noise level according to guidelines.

6.0    FAT Procedure :  When the equipment is ready the FAT team of XYZ Company will go and perform FAT on the direction of manufacturer.

7.0   Documentation Requirement:

Documentation – Supplier shall provide the following documents in English language.

Operational and maintenance manual

Certificate of calibrations and MOC

Food grade certificate for all gaskets

Other drawing such as PID, electrical, instrumentation and as built final drawing

Schematic drawing of equipment.

Installation and operational protocols

Calibration certificates and trace ability to NFL standards

8.0  Compliance & Data Recording

• Must be compliant with all drug regulatory bodies, especially with 21 CFR.
• HMI Must be able to store data up to minimum 100 product recipes.
• Printed data availability option.
• Data backup functionality must be available.
• Data transfer option using USB.
• Three-layer password protection & audit trail.

9.0  Scope of Training :

• The Manufacturer shall provide operator training at site. This shall include, but not limited to, making available the services of a qualified representative to train the operators.
• The training of the personnel shall include a minimum of the following:
• Start-up and shut-down procedures
• Typical operations
• Emergency shutdown
• Safety training
• Troubleshooting procedure
• The Manufacturer shall ensure that the operation manual is available at site for reference. The Manufacturer shall issue certificates to the persons trained by them after successful completion of training at no extra cost      

10.0 Abbreviations:

DQ             Design Qualification

cGMP        Current Good Manufacturing Practice

IQ               Installation Qualification

MOC          Material of Construction

OQ             Operational Qualification

SOP          Standard Operating Procedure

SS              Stainless Steel

FAT            Factory Acceptance Test

11.0  Discussions/ Reviews/ Comments:

The user requirements specification is prepared for communicating the user expectation for the subjected equipment manufacturer/supplier with respect to the subjected equipment. The requirements specified are the basic requirement based on the available information for the process, operation, safety and cGMP requirements. The vendor is encouraged to suggest and/or quote for the latest developments to increase/improve the productivity, product quality, process control, safety etc.

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