What is a Pharmaceutical Cleanroom and How to Create It?

Without a controlled space to carry out testing in, the process of pharmaceutical development and manufacturing is simply impossible. This is why cleanrooms are so critical to the pharma industry.

What is a pharmaceutical clean room?

Well, it’s a straightforward question with a straightforward answer. A pharma clean room is simply an especially clean space, with no contamination or infiltration, for use in the development of medicine or medical processes.

Or is it? As with many things, especially in the pharma field, the answer is not quite so clean cut.

Yes, a clean room is space that has been cleaned of and safeguarded against contaminants. But are all clean rooms equal? No, they are not.

Let’s take a look at some of the different classifications of clean rooms to help you get to grips with what the concept can really mean. This will help you ensure the safety and hygiene of your pharma manufacturing and testing equipment.

The ISO Scale

In the USA and Canada, clean rooms are assessed according to the ISO scale.

In 1999, the ISO-14644-1 scale was introduced, and is now the de facto measurement of how “clean” a clean room really is.

The classes on this scale are as follows:

• ISO 1 (The cleanest end of the scale)
• ISO 2
• ISO 3
• ISO 4
• ISO 5
• ISO 6
• ISO 7
• ISO 8
• ISO 9 (The dirtiest end of the scale)

It is worth mentioning that, while ISO 9 is the “dirtiest” of all the clean room classifications, it is still considerably cleaner than a standard space! It is still worth knowing how your clean room ranks so you can achieve the best results with your equipment, though.

What the ISO Scale Classifications Actually Mean

The different classifications are defined according to the amount of particles found in the air in each space. However, each classification also takes into account the size of each particle.

In order for a clean room to be considered ISO 1, it must have:

• 10 or fewer particles of 0.1 µm (microns) or less in size
• 2 or fewer particles between 0.1. µm and 0.2 µm

Take a look at the table below to learn more about these classifications.

*Please note that any values not filled in above are simply not required for classification at that level. For example, particles of 0.3 µm and above cannot be present in a clean room of ISO 1 classification. Any trace of a particle of that size will automatically move the clean room up to the next ISO class.

**Similarly, filtration for particles of 0.3 µm or less is considered too precise for ISO classes 7, 8 and 9, and particles of this size will simply not be taken into account.

Clean Rooms and Air Recirculation

Clean room classifications relate to the amount of particles found in the air within the space. As long as the particle levels listed above are achieved, there are no hard and fast rules regarding how this is done.

However, most spaces classed as clean rooms will meet certain standards regarding air recirculation. This is because air that is not recirculated or is left unchanged for a long period of time is unfiltered, and therefore may carry contaminants.

Generally, the air in an ISO 5 class clean room will be changed and filtered between 240 and 360 times per hour. For an ISO 6 class space, this drops to between 90 and 180 times per hour, 30 to 60 times per hour for ISO 7, and 10 to 15 times per hour for the ISO 8 category.

By comparison, a conventional building with an HVAC system undergoes two to four complete changes of its air each hour.

How to Create the Ideal Pharma Cleanroom: Checklist & Best Practices

How do you set one of these spaces up in your own facility? How do you make sure that your cleanroom is up to the job, and able to give you the accurate results you truly need? These are the factors that you need to pay attention to:

Temperature control

The temperature of your cleanroom is something you need complete control of. When crafting your cleanroom, make sure that you can adequately and accurately regulate the temperature with gauges and controls. Ventilation is a big part of this, and you will need generators and ventilators that can provide this temperature regulation.

Humidity control is also important as varying levels of moisture in the air can create discrepancies during testing.

Air quality

You cannot afford any contamination within your cleanroom. With this in mind, install filters with extreme levels of efficacy – filtering out particles as small as 0.3. microns – to keep the air clean and free from contamination. Keeping the space pressurized above atmospheric pressure also prevents outside airflow into the chamber, while airlocks provide easily controlled access.

Air flow

Air flow needs to be consistent throughout the whole chamber. This means you need to consider the internal architecture and how this permits the flow of air through the space. For larger spaces, internal fans can also help to achieve consistent flow.

Electrostatic discharge conduction

Electrostatic discharge is a natural phenomenon, as anyone who has ever rubbed their hand against a balloon and put it near their hair will attest. However, in a cleanroom, it can be dangerous or damaging. Different materials and types of clothing cause different levels of electrostatic discharge, and you need to make sure that your space is set up to deal with this. Install features that can conduct this discharge and safely get rid of any excess electricity.

Instruments

What are you going to be testing? How will you be testing this? To what degree of accuracy do you want to test? Answer these questions and then make sure you have the right instruments to achieve this.

Integrity of materials

As you may have noticed up to now, the elimination of contamination is one of the primary concerns when building a cleanroom. With this in mind, you need to be ultra-careful when it comes to working with different materials. All of the materials you use need to have a high level of structural integrity so they do not degrade and contribute their own particles into the atmosphere.

This goes for all materials used to craft the interior, as well as all materials used in the clothing of your team.

Treatment of hazardous substances

It is likely that you are going to have to deal with some hazardous substances, so know in advance how you are going to do this. There will be laws and regulations regarding the treatment of such substances in your area, so make sure that you are always in compliance with this.

Get your protocols in place for dealing with these substances, and make sure that your facility has all the equipment needed to do this safely.

External decontamination

You will need decontamination areas outside of your cleanroom to allow team members to wash and disinfect clothes and hands. This provides an additional level of defense against contamination.

We stock a range of different pieces of equipment to help you build a safe materials handling space within your facility, including vial trays and soft gel trays. Check out our product range today or reach out to our team!