URS For Compression Machine

If you want to purchase a compression machine for tablet manufacturing then first of all you will have to generate a URS or user requirement specifications for that compression machine.

If you don’t know how to generate a URS then read the following article.

How To Write a URS 

A sample URS for the compression machine is given below.


Pharmainform Pharmaceutical Pakistan 


Tablet Compression Machine (B Type)


Pharmainform Consultant Lahore

Compression Machine URS

Table Of Content 

  1.    Objective  
  2.    Scope      
  3.    Responsibilities 
  4.    Equipment Description 
  5.    Technical Requirements 
  6.     Utilities Details 
  7.     Calibration Components 
  8.     Alarm & Safety Features    
  9.     Procedure For FAT
  10.     Documents Requirement.
  11.      Compliance & Data   Recording 
  12.       Training 
  13.       Guarantee 
  14.       FAT Approval

 1.0 Objective

The objective of this URS is to clearly define the requirements of the user for Tablet Compression Machine design,

manufacturing of Tablet Compression Machine according to cGMP guidelines & provide a high level of assurance that the equipment is manufactured according to the requirements of the user.

2.0 Scope 

The scope of this URS includes the following 

  • Design & Construction of Tablet Compression Machine.
  • Installation & Commissioning Of Tablet Compression Machine.
  • Training of personnel regarding Compression machine  operation, Its cleaning procedures & maintenance.


3.0 Responsibilities

Responsibilities will be as follow,

3.1 Client 

It will be the responsibility of the client to perform the (FAT).

3.2 Manufacturer

3.2.1 Manufacturer of the equipment will be responsible to design, engineer & to give initial demonstration on the following,

  • Tablet Compression Machine Overview
  • Drawings
  • Equipment Dimensions
  • Specifications of sub-components
  • Details description of Utilities
  • Calibration Components
  • Material Of Construction (MOC )
  • Short Working Description
  • Safety features
  • Requirements for installation

3.2.2 Manufacturer will facilitate the user for FAT.

3.2.3 Manufacturer will be responsible for the safe delivery of equipment to the client site.

3.2.3 Manufacturer will be responsible for installation, equipment commissioning, and staff training.

4.0 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 by a pneumatic system 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.

5.0 Technical Requirements

Equipment Name

Tablet Compression Machine


Compression of Powders & Granules

Equipment Capacity

35 Station Rotary Compression Machine (B Type)

5.1 Material Of Construction (MOC)

S. No




All Contact Parts

According to standard 


Non Contact Exposed Parts.

According to standard 


Elastomers in contact with the product



Elastomers not in contact with the product

Food Grade 

5.2 Working Conditions & Safety 

S. No





Ambient 120 °C






Less than 55 %


Motor & Drive 

Explosion Proof 



Explosion Proof 



Water Proof 

5.3 Operational Requirements





Charging Of Product 

Charging of product to Tablet Compression Machine’s hopper should be through a pneumatic system.



Collected manually in containers.






As per design 


Metal Detector & Deduster

High-sensitive metal detector with challenge test tablets set.Deduster & metal detector in combined model.

5.4 General Requirements For Components

5.4.1 Hoppers 

  • Made of SS 316L.
  • All internal surfaces must have a smooth mirror polished.
  • The side wall has a glass window.
  • butterfly valve to control flow.

5.4.2 Punches & Dies

  • MOC according to current pharma standards.
  • The tolling list will be provided at the time of DQ.

5.4.3 Dust Collector

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

5.4.4 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.

5.4.5 Transfer Pipes 

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

5.4.6 HMI & PLC

  • HMI of  Required brand.
  • PLC of Required brand.
  • Waterproof HMI & PLC.
  • Software installation for PLC & HMI.

6.0 Details of Utilities


3 phase (To be discussed)


To be discussed 

7.0 Calibration Components

Calibration required components should be mentioned.

8.0 Alarm & Safety Features

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

9.0 FAT 

When the equipment is ready, the manufacturer will inform the user/client to perform FAT.

10.0 Documents Required 

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.

11.0 Compliance & Data Recording 

  • Compliant with 21 CFR.
  • The machine has the capacity to store data for 150 product.
  • Printed data availability option.
  • Data backup functionality must be available.
  • Data transfer by USB with three-layer password protection & audit trail.

12.0 Training

Manufacturer-trained staff will provide training to the user/client staff for operating, and cleaning the Tablet Compression Machine. 

13.0 Guarantee 

The vendor will provide a one-year guarantee for each component of the Compression machine after the successful commissioning of the equipment.

14.0 URS Approval

Prepared By

Reviewed By

Approved By