URS is an abbreviation for user requirement specifications & is an important document that is generated in pharmaceutical industries for purchasing any equipment, instrument, or device.
URS is generated by the user or client for the manufacturer so that the equipment is designed & manufactured according to the recommendations or specifications of the client or user.
Example
To understand the real concept of URS, let’s take a routine life example.
Whenever you want to buy a cell phone, first of all, you make up your mind regarding its various specifications according to your requirements and how & where you want to use that cell phone. Mostly you think about the following,
- Storage capacity
- RAM
- Color
- Different sensors e.g fingerprint
- Resolution of camera etc.
All the above specifications are usually in your mind before purchasing the cell phone & you always demand the shopkeeper to provide you with a cell phone according to your choice.
In the same manner, whenever any client wants to purchase equipment, instrument, or device according to his requirements, he always writes down all the requirements & specifications on a document which is known as URS.
Importance of URS
Following are some main points that represent the importance of the URS document
- It is the written evidence for the manufacturer to manufacture and design equipment.
- URS is the document that summarizes all the requirements of the client for the manufacturer.
- It binds the manufacturer to provide the same equipment as mentioned in the specifications.
- it is a sort of agreement between the user and client or manufacturer to manufacture the same equipment as described in the URS.
- During the FAT test, the user or client verifies all the specifications which he or she already has mentioned in the URS.
Important Point
One of the most important points to remember during the generation of User Requirement Specifications (URS) is that it must be generated by the end-user mean if you are in the pharmaceutical industry and you want to purchase or buy equipment, do not ask to generate URS to any person who is not aware of that equipment & its usage.
Always ask the person to generate the User Requirement Specifications (URS) who is directly involved in the use of that equipment or has full knowledge regarding that equipment.
If the person who is going to generate URS is not aware of that equipment he must discuss and consult all the requirements & specifications with the person who is the end user of that equipment.
Also Discuss all the requirements with various departments like operations, compliance, Engineering & safety.
How To Generate URS
In this article, I will give you a Practical example of how to generate URS for a Rapid Mixing Granulator (RMG). I will try my best to explain all the requirements for RMG as a sample so that you may be able to generate a URS according to your requirements.
You will learn following
- How To Write a URS?
- Components of URS
- How Each Component explanation is described in detail
Sample URS
User Requirement Specifications For RMG.
USER
Pharmainform Pharmaceutical Industries Pakistan.
EQUIPMENT
RAPID MIXING GRANULATOR (RMG)
PREPARED BY
Pharmainform Consultant Lahore
Table Of Content
A good URS has the following components & all are explained in detail for your understanding.
- Objective
- Scope
- Responsibilities
- Equipment Description
- Technical Requirements
- Details of Utilities
- Components For Calibration
- Alarm & Safety Features
- FAT Procedure
- Required Documents
- Compliance & Data Recording
- Training
- Guarantee
- FAT Approval
1.0 Objective
The objective of this URS is to clearly define the requirements of the user for Rapid Mixing Granulator design,
manufacturing of Rapid Mixing Granulator according to cGMP guidelines & to 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 covers the following,
- Design & Construction of RMG.
- Installation & Commissioning Of RMG.
- Training of personnel regarding equipment operation, It’s cleaning procedures & maintenance.
3.0 Responsibilities
Client & Manufacturer responsibilities will be as follow,
3.1 Client
It will be the responsibility of the client to perform the Factory Acceptance Test (FAT).
3.2 Manufacturer
3.2.1 Manufacturer will be responsible to design, engineer & to give pre-training on the following,
- Equipment 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.
3.2.4 Manufacturer will be responsible for installation, equipment commissioning and staff training.
3.2.5 Manufacturer will provide all tools required for dismantling & assembling with a compliant toolbox.
4.0 Equipment Description
This rapid-mixing granulator is used in pharmaceutical 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 granulation process. The charging of powder in the rapid mixing granulator is by a pneumatic delivery system & after granulation the wet mill is used to reduce the particle size of wet mass & is delivered to FBD by using transfer pipes & suction delivery system.
5.0 Technical Requirements
Equipment Name
Rapid Mixing Granulator
Purpose
Mixing & Granulation
Equipment Capacity
Volume
600 Liter Brimful.
Working capacity 450 Liter.
kilogram Capacity
225 kg at 0.5 gm/ml bulk density of powders.
5.1 Material Of Construction (MOC)
5.2 Working Conditions & Safety
5.3 Operational Requirements
5.4 General Requirements For Components
5.4.1 Product Bowl
- Made of SS 316L.
- 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.
5.4.2 Lid Over Bowl
- Port for material charging through a pneumatic system.
- Port for Binder addition through transfer pump.
- Hopper for manual addition of binder.
- Air sealing lid having manual clamps with a sensor.
- Lid opening, vertical or horizontal (To be discussed)
- Small viewport for observing the inside operation. (Open & close option)
- Light lamp installed.
- Breathing filter/dedusting system.
5.4.3 Agitator & Chopper
- Smooth finish.
- 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.
5.4.4 Discharge System
- 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.
5.4.5 Wet Mill
- 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.
5.4.6 Transfer Pipes
- 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.
5.4.7 WIP System
- WIP/CIP system with raw water, hot water & purified water supply along with detergent supply system.
- Cleaning spray balls should be installed for bowl cleaning, discharge port & wet mill cleaning.
5.4.8 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.
5.4.9 HMI & PLC
- HMI of Siemens brand.
- PLC of Siemens brand.
- Large Color screen with a highly sensitive touch system.
- Waterproof HMI & PLC.
- Software installation for PLC & HMI.
6.0 Details of Utilities
Power
3 phase (To be discussed)
Compressed air
As per requirements.
Footprints
To be discussed
7.0 Calibration Components
All the components should be identified which require Calibration at the user site e.g
- Pressure gauges
- Voltmeter
- Ammeter
8.0 Alarm & 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.
9.0 FAT
When the equipment is ready, the manufacturer will inform the user/client to perform FAT.
The user/client FAT team will go & perform FAT at the manufacturer’s cost.
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
- Make & model information of every fitted component.
- Electric wires & panel diagrams.
- List of all parts & spare parts.
11.0 Compliance & Data Recording
- Must be compliant with all drug regulatory bodies, especially with 21 CFR.
- HMI Must be able to store data for 150 product recipes.
- Printed data availability option.
- Data backup functionality must be available.
- Data transfer option using USB.
- 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 Rapid Mixing Granulator. Will also guide regarding maintenance & later on will provide services in case of any critical process.
13.0 Guarantee
The manufacturer will provide a one-year guarantee for each component of equipment after the successful commissioning of the equipment. In case of any part replacement, the manufacturer will deliver it at its own cost.
14.0 URS Approval
Prepared By
Reviewed By (Production)
Reviewed By ( Safety Engineer)
Checked By (Engineering Head )
Approved By (Director Technical Operations)