1.0 Approval

The user requirement specification for Compression Machine for Compression of Blend which is to be used in Production Area have been prepared, reviewed, approved & authorized by concerns from the following area.

2.0     Scope:

The URS document is generated by the User to provide details of structural, functional, cGMP and statutory requirements for the Tablet compression 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 Tablet compression machine along with deduster and Metal detector, with supporting documents of the equipment to be used in Compression area. 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: 

Compression Machine

3.2 Purpose of Equipment:

The purpose of Compression Machine is to do Compression of Blend.

3.3 Chemical/Physical Characteristics of the Process Material:

Not Applicable.

3.4 Suggested Capacity:                     

Output minimum 50,000 to 1,00, 000 tablets per hour for monolayer.

4.0  Operational Requirement:

4.1    Equipment Description 

A tablet compression machine is used to compress powders or granules into tablets by using punches & dies. The powder is filled in hoppers from where it is supplied to dies & compressed into tablets with the help of upper & lower punches by applying pressure through compression rollers. After compression tablets are passed through the metal detector and deduster and are collected into a container.

4.2    Technical Requirements:

Equipment Name

Compression Machine, (Single rotary), 27 station

D tooling

Sr. No	Item	Specifications
1	Room Dimension	3.8×3.0×2.7 (W×D×H)
2	Machine Dimension	To sit comfortably along with metal detector and deduster keeping at least one container of blend and compressed tablets in the area with ease of working.
3	Tablet dimension	Rounded capsule shape of 5 to 25mm
4	Temperature	15 to 30 °C
5	Pressure	Atmospheric
6	Humidity	40-60 %
7	Motor	3.7/5 (kW/hp)
8	Power supply	220/380/415/480V±10%, 3 Ph., 50/60 Hz
9	HMI	Water Proof

Standard major components

Sr. No	Operation	Description
1	Charging of Product	Charging of product to Tablet Compression Machine’s hopper can be through a pneumatic system.
2	Discharging	Collected manually in containers.
3	Cleaning	Manual
4	Speed/rpm	As per design
5	Metal Detector & Deduster	High-sensitive metal detector with challenge test tablets set. Deduster & metal detector in combined model.

General Requirements for Components

Hoppers 

• Hopper with agitator assembly & ACVFD.
• Made of SS 316L.
• All internal surfaces must have a smooth mirror polished.

Punches & Dies

• MOC according to current pharma standards.
• Upper punch penetration (mm) – 3 to 6.
• Lower punch spray lubrication system.
•    Lower punch key way.

Dust Collector

• A high-efficiency dust collector should be installed along with the machine.

Deduster & Metal Detector

• Made of 316L.
• No seals should be present below the Deduster installation.
• Efficiently remove powder from tablets.
• Metal detectors should be of high sensitivity.
• Capable of removing any type of metal.
• Challenge test tablets set should be provided.

Transfer Pipes (Required as Optional)

• Pharmaceutical grade transfer pipes.
• Ensure trouble free transferring 
• Easy to clean.

WIP System:

NA

HMI & PLC

• PLC control with HMI & printing facility
• HMI of Required brand.
• PLC of Required brand.
• Waterproof HMI & PLC.
• Software installation for PLC & HMI.

4.3 Material of Construction:

Sr. No	Components	Specifications
1	All Contact Parts	SS 316L
2	Non-Contact Exposed Parts.	SS 304L
3	Inflatable Tubes	Pharmaceutical grade
4	Elastomers (Seals) in contact with the product	Silicone
5	Elastomers not in contact with the product	Food Grade

4.4    Details of Utilities:

• Electric Power Supply:  3.7kW/5.0hp

4.5 Software and Hardware

 As per the GMP designed.

4.6 Additional features

Electromagnetic clause

Force feeding system

Tablet output required to show in PLC

Powder level sensing for hopper (Optional)

4.7    Preferable Method of Cleaning:

 Easily accessible for cleaning.

 Product contact parts shall be easily dismantalable 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:

• Punches overload alarm.
• Open door alarm.
• Dust collector not connected alarm.
• Metal detector not attached alarm.

6.0    FAT Procedure:

 When the equipment is ready the FAT team will go and perform FAT on the consultation of manufacturer.

7.0   Documentation Requirement:

The manufacturer will provide all the documents required for qualification including the following,

• Design Qualification Document 
• Installation Qualification Document
• Operational Qualification Document
• Performance Qualification Document 
• Operational Manual for Equipment
• Maintenance Manual
• Instructions
• MOC certificate 
• Electric wires & panel diagrams.
• List of all parts & spare parts.

8.0  Compliance & Data Recording

• Compliant with 21 CFR.
• The machine has the capacity to store data for 150 products.
• Printed data availability option.
• Data backup functionality must be available.
• Data transfer by USB with 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

ACVFD       Air Condition Variable Frequency Drive

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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