Training Staff in Cleanroom Behaviour and Best Practices

Strict Personal Conduct in a cleanroom and airlock environment is the most important part of maintaining cleanroom integrity and controlling contamination. Training staff in the correct cleanroom behaviours is most successful when the reasons for each rule are clear. Together with practical examples, this increases willingness to comply and remember best practices.

Why do cleanroom personnel need training?

After the high investment of a cleanroom installation, it’s important not to act in ways that compromise the environment created. Cleanroom training and best practices must be understood before entering the cleanroom at all, as attempting to ‘learn on the job’ would introduce contaminants.

Following cleanroom best practices in sterile environments, such as pharmaceutical cleanrooms, is critical to create safe, effective products. Best practices include preventative and protective steps, such as wearing protective gear and acting correctly within the cleanroom.

Who needs training?

Anyone entering the cleanroom is a potential source of contamination, no matter how long they are inside. Even an observer requires contamination training and gowning to enter a cleanroom, regardless of their position.

More specific training is available for different roles. For example, an operator will need the highest level of training in a clean room.

Core Areas of Cleanroom Training for Staff

Basics:

No smoking, eating or drinking (including lozenges, chewing gum or medication).
No unnecessary personal items (necessary items include glasses, hearing aids, etc.)
Illustrated posters help everyone remember the rules.
Regular training of all persons entering the cleanroom, however briefly, is mandatory.
Do not cross your arms, touch your face or hair. Gloves & gowns will need changing.
Minimise unnecessary movements by maintaining neutral posture and using the most appropriate tools.
The rules apply to everyone without exception.

Personal hygiene

Regular Handwashing before entering the cleanroom is extremely important. Contaminants are most frequently brought into cleanrooms by people, so making sure hands are clean before beginning the gowning process is step one.

The only part of the body that is exposed in the cleanroom is the face, so personal hygiene also applies to keeping the face clear of any products or debris. This includes makeup and products such as eyelash extensions.

Finally, do not scratch, even if you have an itch. Scratching exposed areas causes skin particles to dislodge into the air, and oils from skin to adhere to gloves, which can then transfer to the product. However, satisfying an itch on an area covered by protective clothing is also a risk, as the friction can loosen fibres and particles from the gown.

Gowning Procedures

There is a strict order of gowning to follow to prevent contamination. This differs depending on the cleanroom classification, but the core steps are as follows.

Before Entering:

Hair Net/Bouffant: make sure all strands of hair are contained. Beard covers should also be provided.
Shoe covers: containing all laces and tassels.

In the Gowning Area:

Wash hands thoroughly up to the elbows
Gowning Gloves: recommended for ISO Class 5 (GMP Grade A-B) or cleaner
Mask: Bend the nosepiece to ensure a tight fit across the face. Wear over or under the hood.
Hood: Tighten around face/neck with strings.
Coverall: step into coverall legs, making certain that the sleeves and upper garment do not touch the floor or bench. Tuck the hood’s shoulder panels inside the coverall before zipping to the top.
Boots and boot covers: wear boots over shoes and pull the boot covers up over the coverall legs. Some facilities use a cross-over bench – transfer each foot to the clean side of the bench after applying the boot cover to avoid it touching the floor on the non-clean side.
Goggles: Safety goggles are optional for some cleanrooms, but can be worn when extra protection is required.
Cleanroom gloves: either replacing or over the gowning gloves, put the hem of the glove over the cuff of the sleeve.

Gowning Removal

Remove protective garments in reverse order and either discard or contain them properly. Gloves, shoe & boot covers, masks and hair nets are single-use, and should be discarded after each change. Goggles, overalls, boots and hoods can be hung up in the gowning area or prepared for decontamination before storage. In sterile cleanrooms, all items must be discarded.

No Jewellery in cleanrooms

Most facilities enforce rules against visible jewellery, as most precious metals attract particles and microorganisms. Even under gowns and gloves, movement while working causes friction that can abrade material and skin, generating particles. Rings, necklaces, earrings and bracelets should be stored safely before applying the first pair of gloves.

Maintaining Designed Airflow in the clean room

Cleanroom ventilation requires that clean air enters the space via the ceiling and leaves as close as possible to the floor, removing any particulate as it changes the air. This pushes contaminants towards the floor, keeping work areas as clean as possible..

Activities and equipment should not influence the designed airflow. A common mistake is obstructing exhaust ventilation to any extent, temporarily or permanently. If, for example, a trolley is placed in front of a floor vent, contaminants cannot be vented and will build up in the room.

Personnel should move slowly and in a controlled manner. Fast movements impact airflow more than one would imagine and can lead to product contamination. Even walking too quickly will stir up the contaminants that have been pushed towards the floor.

Coughs & Sneezes – Worst Case Scenario

Ideally, nobody would enter a cleanroom if there was a risk of them coughing or sneezing. Anyone with a cold or cough should stay away from the cleanroom. However, we can’t always predict when a sneeze is coming, and they are not always possible to suppress. Coughs and sneezes are reflexive actions that expel cell remains, bacteria, viruses and glycoproteins from our airways, up to 8 metres away – so what can we do?

In some cases, operators may be near enough to the personnel airlock to be able to exit the cleanroom before the cough or sneeze occurs. This keeps the aerosol from entering the cleanroom at all.

If this is not possible, hold cleanroom wipes over the mouth and nose. All droplets should be caught in the wipes, which can then be disposed of outside the airlock. Then, change all cleanroom clothing, including masks, gowns, hoods and gloves.

Maximum Number of Personnel in the Cleanroom

As people are the most common source of contamination in cleanrooms, it makes sense to minimise the number of personnel working inside at one time. A maximum number is up to the cleanroom manager to decide, and must be communicated clearly to all staff. The maximum can be indicated with clear signage outside the cleanroom gowning area to prevent accidental overstaffing.

Tools and Resources to Support Training

All training you offer to cleanroom staff should include a variety of materials to support learning and memorisation of the requirements. Demonstrating best practices is advisable, but demonstrating poor practice is not, as you should keep the cleanroom as sterile as possible.

Videos to highlight common mistakes are preferable, and keep training away from live equipment. We also advise placing simple but eye-catching graphics and checklists around the gowning area to remind staff of best practices.

Monitoring and Measuring Training Effectiveness

Once you are sure of what must be included in your cleanroom training, decide how to test your staff on what they have learnt. Many cleanroom training courses use small quizzes, repeated regularly, to make sure key information is retained.

To provide cleanroom training, it’s worth inspecting the workflows within each cleanroom thoroughly to make sure the training covers all eventualities. Test equipment and emergency systems to be certain there will be no accidents during training. A facility walk-through is also advisable to check that each step is documented and visual cues are clear. Provide additional materials in printed handouts and a link to online copies so that they are always available to staff.

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