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Cleanrooms are perhaps the most critical zones you’ll find within a medical or pharmaceutical facility. For cleanrooms to operate optimally, they need to be clean and sterile at all times. But constantly keeping up with all the compliance requirements can be tedious for anybody. Well, this is where cleanroom environmental monitoring comes in.


A monitoring system is basically an automated system that records or documents a number of physical parameters (like humidity and temperature) within the cleanroom. By doing so, it reduces the need for manual intervention in measuring and recording. Experts will tell you that the best way to establish cleanroom environmental monitoring is by first defining a user requirement specification (URS). Some might even say that it is the single most crucial step in the Good Automated Manufacturing Practice (GAMP).


Your URS will act as a detailed plan to ensure that all the cleanroom environmental monitoring objectives are met and satisfy all the requirements by the end-user. In this article, we shall look at what a URS is, what it includes, and how you can establish a comprehensive URS for your cleanroom monitoring system.



What is the Goal of the User Requirement Specification?


A user requirement specification is basically a description of what users need from a system. This includes any relevant compliance requirements, as well as any technical, operational, and business needs. For this reason, a user requirement specification should be one of the first things to consider before purchasing any new equipment for a process-related organization.


In the case of a cleanroom monitoring system, for instance, your typical URS would also state the good manufacturing practice (GMP) regulations to be followed and the cleanliness grades which are required. The most commonly referred regulations governing cleanroom systems are EU GMP and FDA current GMP (cGMP) requirements.



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Components of a URS for Cleanroom Monitoring

A basic URS usually constitutes a few fundamental sections. Let’s take a look.


1. Introduction

It’s a good practice to begin with a brief introduction defining the equipment in question.


2. Overview

The overview section mainly defines the dimensions of the equipment in question and any related parameters. It includes:

  • The intended use – Here, you should specify what you would use the equipment for. For instance, in this case, it would be to monitor the cleanroom.

  • Capacity – State the capacity of the equipment that you require, in either liters or kilograms.

  • Availability of space – State the amount of space you have available in the cleanroom for installing the monitoring equipment in all dimensions (height, width, and length).

  • The instrument’s accuracy – Include the accuracy you want in the instrument. If applicable, use the decimal system.

  • Cleaning requirement – Capture any cleaning requirements you may have. Naturally, you want an instrument that is easy to clean.

  • Equipment specifics requirement – Here, you can include every requirement you need the device to satisfy. For instance, it can be a particular quality of stainless steel.

3. Operational Requirements

For your cleanroom monitoring system to properly align with your quality management system and ensure compliance, there are a few basic requirements you can list within your URS.


These sections are fundamental to the functions of a typical central monitor system (CMS): sensors, network, utilities, infrastructure, security, alarm functions, period of renewal arrangements, maintenance, support, and warranties. 


4. Compatibility and Support Regulations

As the name suggests, these are the requirements that fulfill regulations and compatibility with your facilities. They include:

  • Utilities – This includes the power supply required to operate the instrument. Other utilities that can come into play include uninterrupted power supply (UPS) units, among others.

  • Availability – Here, you specify the intended operating time of the instrument, in hours or working shifts.

  • Supporting documents – This includes everything from the operating manual: warranty letter, circuit diagrams, spare part list, and change part list, among others.

5. Abbreviations

List each abbreviation you've used in your URS document for easy reference.


6. References

Make sure to include titles of any guidelines and reference books.


7. Approval

This is where you sign off. State the names of people actively involved in the making of the document and their respective departments.


When you are defining your URS requirements, be sure to abide by the SMART criteria. This means that they should be Specific, Measurable, Attainable, Relevant, and Testable. Let’s break it down:

  • Specific – The URS should be clear, unambiguous, self-contained, and precise enough for checking and testing.
  • Measurable – You should be able to measure progress towards the achievement of the requirement.
  • Attainable – The requirement should be possible to achieve.
  • Realistic – The requirements must be both relevant to the cause and are within reach.
  • Testable – Testability plays a huge role when choosing system requirements. In most cases, a system that isn’t testable will cause problems later on. By testing, you are able to ensure the accuracy of the requirement before incorporating it into the system.

All your objectives should be complete and measurable. You can start by defining whether your requirements are high priority, medium priority, or low priority. Try to make them as specific, objective, and complete as possible. For instance, instead of stating “the room will be regulated at 30˚C,” it would be better to state that “the room will be regulated at 30˚C ± 2˚C.”



How to Prepare the URS: Who Builds it?


Ideally, no one individual creates the whole URS. Usually, it is composed of a committee of stakeholders and experts. Each individual introduces their area of specialization to the discussion. For best results, try and incorporate all the key departments in your institution, including production, quality, engineering, IT, management, and HR.


Overall, selecting requirements based on the needs of a number of individuals before shopping for the system will increase the probability of getting the best match for your particular application. When you actively involve stakeholders in the process, stakeholders are more likely to approve the system requirements.


Also, it is important to note that by involving all these different parties, there are likely to be more requirements than the system can meet adequately. And for this reason, you might need to leave some of them out. However, for easy traceability, you can note down any requirements that have not been satisfied. This will allow you to come up with workaround solutions to meet the unfulfilled requirements.


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Remember, at the end of the day, each company is different and has different needs. Your best bet would be to develop your requirements while addressing your facility's individual needs and respective GxP applications instead of basing them on what can be found in the market. This way, you’ll be sure to acquire the most utility from the system.




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