Cleanroom Best Practice – a User’s Guide

When we discuss Cleanroom Best Practice, we really need to start with first principles: Why is it important to keep cleanrooms clean?

SImple: To ensure that no important and sensitive equipment, organisms or pharmaceuticals become contaminated and to ensure the health and welfare of everyone working in the cleanroom.

Contaminants reduce the effectiveness of medicines, vaccines, chemicals or microorganisms and could, potentially, make them dangerous. This is why cleanrooms are used – to isolate valuable and important products from the dangers of contamination and ensure their high quality and safety.

Contaminants can include everything from microorganisms carried in by people or through dust particles or other poo=llutants brought in on the air. The truth is that the vast majority of contamination is introduced into a cleanroom by the humans working within it, which is why there must be policies and procedures in place to guide and protect staff.

It is important to note that specific regulations and guidelines may vary depending on the country and the type of bioprocessing taking place in your cleanroom. Therefore, it is important for all relevant personnel to be familiar with the regulations that apply to your facility and follow the guidelines accordingly.

That said, here are some examples of the type of cleanroom best practice you may need to observe:

1 – Provide training for all personnel

The principal way to ensure that a cleanroom remains clean is to ensure that everyone who works in and around it has been properly trained. That’s basic. No reputable manufacturing firm should allow untrained people anywhere near its factory floor, no matter what it is producing. Training should cover all proper cleanroom procedures and protocols, including:

• Understanding of and experience in cleanroom protocols and procedures
• Proper gowning techniques (more on that in a mo)
• Proper use and maintenance of cleanroom equipment
• Understanding of particle and microbial contamination control
• Understanding of and experience in emergency procedures
• Familiarity with good manufacturing practices (GMP) and good laboratory practices (GLP)
• Basic understanding of what is being produced in the cleanroom.

An easily-overlooked training need is to include all of the service personnel (such as maintenance crews or cleaners) who will spend time in the cleanroom – they need to employ the same strict protocols as the scientists and technicians.

2 – Restrict access to authorised personnel only

Something that takes place outside the cleanroom which very much affects what goes on in the cleanroom is authorisation. As well as ensuring that everyone in the cleanroom is trained in how to behave, you need to  make sure that the only people who get in there are authorised to be in there.

Restricting access to a cleanroom is important because:

• Authorised people should understand the importance of hygiene and have proper training, that cannot be expected of everyone.
• Unauthorised personnel may be unaware of the potential risks of cross-contamination and may, therefore, inadvertently spoil a batch.
• Some cleanrooms may contain confidential or proprietary information or materials that should only be accessible to authorised personnel.

Maintaining the integrity of your products through authorisation can be achieved by implementing a system of badges, access cards or biometric identification and, in extremely sensitive cases, through monitoring the access to the cleanroom with cameras or security personnel.

3 – Strict gowning protocols

We’ve written before about whether you can have a beard in a cleanroom. Well, this is all part of cleanroom best practice. As is ensuring that everyone is wearing the correct outer clothing.

Strict gowning protocols for all personnel are important because they help to prevent the introduction of contaminants into the cleanroom. People may inadvertently bring particles in on their clothing, hair, or skin.

Wearing the correct coveralls can help to maintain the cleanliness of the environment and, therefore, protect the products or materials being handled within the cleanroom.

A strict gowning protocol typically includes the following steps:

• Personnel should be sure to visit the toilet and take care of any other personal needs they may have – such as being hungry or thirsty – before entering the gowning area. If they have to leave the cleanroom to go to the loo, they will have to go through the full gowning procedure again before returning.
• As well as coveralls, personnel should wear a hairnet, beard cover (if necessary) and shoe covers of some kind.
• Personnel should also wear gloves made of a material that does not produce particles.
• Before leaving the cleanroom, personnel should remove gloves and shoe covers and place them in designated containers for disposal.
• Personnel should shower before leaving the gowning area and put on clean street clothes.

Of course, the very strictest application of this cleanroom best practice may not be required in all instances – the level of cleanliness required may be dependent on the type of cleanroom and the nature of the materials being handled.

4 – Regularly clean and disinfect all surfaces & tools in the cleanroom

Regularly ensuring that all tools and work surfaces in a cleanroom are hygienic and fit for purpose is important for a few reasons:

• To ensure the environment remains free of particle and microorganism contaminants.
• To prevent cross-contamination. As equipment is moved around in the cleanroom, they can transfer contamination to the hands of the people carrying them and to other surfaces or objects.
• Cleanrooms are designed to eliminate microorganisms, but some hardy specimens can still grow on surfaces if not cleaned and disinfected regularly.
• Pharmaceutical products are sensitive to any kind of contamination, which could spoil a batch or even make it dangerous – so regular cleaning and disinfecting of surfaces and equipment is crucial to maintaining the integrity of the final product.

As with any of the rules and regulations that control the use and production of sensitive pharmaceuticals – constant vigilance is necessary to ensure that , at all times, the conditions in the cleanroom are fit for purpose.

5 – Use air filters

It’s important that the air in the cleanroom is as pure as the people and the surfaces. 

Air filters remove particles from the air that can come from a variety of sources, such as personnel, equipment, and even the surrounding environment. These particles can become harmful contaminants if they find their way into the bioprocess workflow. 

HEPA (High Efficiency Particulate Air) filters are typically used in cleanrooms and are rated by IEST (the Institute of Environmental Sciences and Technology) to trap 99.97% of particulates 0.3 microns or larger.

This means they will trap most bacteria, mold spores and many other contaminants.

Aligned with this – it’s an important part of cleanroom best practice to not interrupt laminar airflow. This creates a flow of filtered air into a cleanroom in a specific direction, usually parallel to the work surfaces in the room.

This airflow helps to remove particles that may have settled on surfaces or equipment and ensure that they travel out of the cleanroom, rather than floating around and settling elsewhere within it.

6 – Use tools rather than hands

One of the defining characteristics of we homo sapiens is our use of tools. If we can’t do something ourselves, we can typically design a tool that will do it for us. Well, part of cleanroom best practice is to use tools when we shouldn’t use our hands.

Not using tools like forceps and tweezers in a cleanroom can lead to several potential dangers:

• Increased risk of contamination: Forceps and tweezers are used to handle small items without directly touching them with the hands. If the tools themselves are hygienic, this greatly reduces the chance of contaminants being introduced or transferred.
• Damage to products or materials: If the equipment is sensitive, fragile or particularly small, handling it may damage it. Also, personnel may be more likely to drop or mishandle equipment.
• Increased risk of injury: If a staff member uses their hands, there is an increased danger of injury from needles or sharp edges with the accompanying danger to the staff member themselves, as well as the danger of contamination within the cleanroom.

In summary, using tools minimises the risk of contamination, protects the products, protects the personnel and increases efficiency.

7 – Establish procedures for disposing of contaminated materials

The proper disposal of contaminated materials is crucial to maintaining the integrity of the cleanroom and the products therein. Cleanroom best practice for handling and disposing of contaminated materials includes:

• Personnel handling contaminated materials should be fully trained so they understand the risks involved and they need to wear appropriate PPE.
• Proper documentation should be maintained, including the date of disposal, method of decontamination, and the name of the person responsible.
• All contaminated materials must be clearly labelled and identified as such to prevent accidental handling or improper disposal by untrained personnel.
• Contaminated materials should be segregated and handled separately to prevent cross-contamination.
• Contaminated materials should be decontaminated using appropriate methods such as autoclaving, chemical treatment or, ultimately, incineration before disposal.
• Contaminated materials should then be disposed of in accordance with local regulations.
• Emergency response plans should be in place and all staff should be familiar with them, in case of an accidental release or exposure to contaminated materials.

Stay safe in there

However strict some of these regulations may seem, they are all designed to do two things – protect the valuable bioprocess products and protect the valuable people creating them.

As with any regulatory infrastructure, principles will be applied differently from industry to industry, company to company and county to country, but the rule remains consistent throughout – that cleanroom best practice is in everyone’s best interest.

It’s also worth mentioning that regularly reviewing and updating cleanroom best practice is a must. This helps to ensure processes are current and effective and also refreshes them in the minds of personnel whose health and welfare may depend upon them.

Author

ALLpaQ

Packaging

ALLpaQ is the market leader in the design of innovative pharma containers and fluid management solutions.

Follow me