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.
But 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? Take a look at the following checklist and make sure your cleanroom is full up to scratch.
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.
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 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.
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.
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.
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