Pharmaceutical User Requirement Specification Of Equipment

The User Requirement Specification or URS is a document that is drawn up by a buyer of equipment to describe precisely the required attributes of the equipment. In the case of a large pharmaceutical company it may be the equipment user department that prepares the URS and then sends it to the equipment manufacturer to follow. Below is a suggested format for the URS and some key points to consider when drawing up a document for pharmaceutical companies.

Introduction

This provides a brief introduction to the equipment and the purchaser.

Overview

This section should describe:

• The intended user of the equipment
• Capacity of the equipment
• Space availability at the facility – allow for both the required space during operation and that required to install the equipment, e.g. allow for fork-lift trucks or lifting gear.
• Required accuracy of the equipment
• Cleaning requirements – specifications on how the equipment should be cleaned
• Specific Equipment Requirements
• Specify the required quality of the stainless steel if applicable
• Indicate the specific requirement of the equipment e.g. tablet speed, revolutions/minute, number of baffles etc.

Operational Requirements

This section should list:

• All functional technical requirements
• Operational requirements
• Control System. Specify equipment needs, interfaces, output forms (e.g. USB)
• Power requirements (voltage and power). Auto or Manual Start
• Safety. Safety guards and MCB trips if overload or short circuit
• Environmental conditions. Include the temperature and humidity of the area where the equipment is to be installed
• Other requirements. Indicate other requirements such as of non-contact and specifics on seals and tubing

Compatibility and Support

• Utilities. Indicate type of power supply to use for the equipment, requirement of UPS or other utility requirement. Include water supply quality or compressed air, if required.
• Availability. Limitation of operation time for the equipment
• Supporting Documents. Operating manuals, warranty, parts, spare parts, circuit diagrams

Abbreviations

List all the abbreviations used in the document and the full meaning of the abbreviations used.

References

Include references to appropriate regulatory guidelines or reference manuals.

Purchasing plant machinery for your company is often a major capital investment and commitment, which is why documents such as a Unser Requirement Specification are so important to ensure that the right machinery is purchased and it is delivered installed and operates in the manner that your business requires and expects.

At LFA we understand the importance of committing to capital equipment purchase. That is what we have a template URS that your team can use. Feel free to get in contact with us and we will send it over. That way if you are buying a rotary pill press or a handheld tablet press you can define precisely the equipment you need.