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.
A sample URS for the compression machine is given below.
Pharmainform Pharmaceutical Pakistan
Tablet Compression Machine (B Type)
Pharmainform Consultant Lahore
Table Of Content
- Equipment Description
- Technical Requirements
- Utilities Details
- Calibration Components
- Alarm & Safety Features
- Procedure For FAT
- Documents Requirement.
- Compliance & Data Recording
- FAT Approval
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.
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.
Responsibilities will be as follow,
It will be the responsibility of the client to perform the (FAT).
3.2.1 Manufacturer of the equipment will be responsible to design, engineer & to give initial demonstration on the following,
- Tablet Compression Machine Overview
- 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
Tablet Compression Machine
Compression of Powders & Granules
35 Station Rotary Compression Machine (B Type)
5.1 Material Of Construction (MOC)
5.2 Working Conditions & Safety
5.3 Operational Requirements
5.4 General Requirements For Components
- 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.
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
- 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.
Manufacturer-trained staff will provide training to the user/client staff for operating, and cleaning the Tablet Compression Machine.
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