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Cleanroom Gowning

Cleanroom Gowning

Cleanroom Gowning

This is a guide to help you in the setting up of your SOP (standard operating procedures) for your cleanroom. The choice of PPE will depend on the classification of your cleanroom but there are a lot of common does and don’ts.
Published: 20 July 2021

Firstly, you need to select the right PPE for your cleanroom. In all classification of cleanrooms, the garments should produce little or no particulate emission. This requires the fabric or material to be stable, possessing a high ability to resist breakdown.

  • Your choice of PPE can be manufactured of woven and non-woven materials.
  • Garments should have a minimum of seams; seams must firmly envelop the raw edge of the material. Sewing threads should be of a non-fi lament materials and resist linting.
  • The PPE should be loose-fitting to eliminate abrasion against the clothing underneath.
  • Garments should not have pockets, belts, or pleats.

There are a number of actions which should be actively avoided in a cleanroom as they will add particulate into the controlled area.

  • Before entering the gowning room, remove all make up such as lipstick, blush, eye shadow, eye liner, mascara, powder, and any other cosmetic that is applied on the face or neck area.
  • Fake eyelashes, hair extensions or nail extensions are not permitted in a cleanroom.
  • No personnel wearing perfumes or aftershaves should be allowed in to the cleanroom.
  • Hair combing should not be allowed in the gowning room.
  • Personnel should wash their hands – and face if required. Hot air or lint-less wipes shall be used for drying. Do not use paper towels.
  • No eating, drinking or smoking in the gowning room, including chewing gum
  • Remove all jewellery before entering the gowning room.
  • Do not enter cleanroom without complete cleanroom attire.
  • Do not rub any exposed part of the face with a gloved hand. If this occurs, gloves must be changed.
  • Movements such as scratching the head, rubbing hands, or similar type actions are to be avoided.

This is a suggested gowning sequence for an ISO 6 and ISO 5 cleanroom.

  • Walk on a sticky mat to remove contaminants from street shoes.
  • Street shoes are to be removed outside the gowning room.
  • Put on slipper and enter into the gowning room.
  • Remove slipper in gowning room.
  • Put on hair net or hood to assure that all hair is tucked under head covering.
  • Secure the face mask. Pull the bottom of the face mask down completely under chin and make sure it is covering the nose.
  • Remove coverall from sealed packaging. Assure the upper part of the jumpsuit does not touch the floor. Put on the coverall, feet first and finally arms. NB. This is a tricky procedure and will need practice as part of the training.
  • If you are using a separate hood, ensure that it is tucked underneath the coverall before zipping up the jumpsuit.
  • Take the cleanroom footware (shoe cover or cleanroom boots) from the storage racks and put on as you move over the step over bench.
  • If you are wearing boots ensure the legs of the jumpsuit are tucked in.

It is good practice to now perform a series of checks before entering the cleanroom

  • Check to make sure that you have no hair exposed.
  • Check that the face mask covers the nose and chin.
  • Check to make sure that the hood is tucked underneath the jumpsuit collar.

Gloves

Some cleanrooms require double groves in which case the first set would have been put on as you enter the gowning room. You can now take one glove at a time from the glove bin. Handle gloves only by the cuffs. Pull glove cuff toward upper arm. Cover cuff of sleeve with gloves.

You are now ready to enter the Cleanroom it is worth reminding your operators as they enter to walk slowly and avoid creating air turbulence while in the cleanroom.

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Peter Phillips

I knew of Toni and her team from around 2003 and the days of their Clean Tent business. With a small new business that needed a clean room, I went straight back. Very helpful discussion with Toni led me to choosing a custom lamina flow hood (cheaper!) which was delivered bang on time, immediately passed an ISO 1385 audit and has been cheerfully maintained ever since. I'd go back to ISOClean because they know their stuff and do what they say.

Sharjil

ISO Cleanroom were very easy and practical to work with. Both Toni and Amaleed were knowledgeable and very flexible - looking forward to working with them in for future projects.

Siobhan Carey

I recently contracted Iso Cleanroom to design and build two modular ISO Class 6 cleanrooms so that our small orthobiologics company could implement in-house manufacture. They delivered on all of their commitments on cost, schedule and quality with no fuss. They showed up they day they said the would and finished up the day they said they would. They were extremely organised and meticulous, and helped us to address some unforeseen issues that cropped up during the installation.

Gareth Evans

We contracted ISO Cleanroom to design, build and validate a large cleanroom in our new facility. Toni really knows her business, and was very helpful through the design process, enabling us to make the most of the available space. When it came to installation, Anthony and his team did an exceptional job, keeping the install to schedule. We are very happy with the professional service we have had from ISO Cleanroom and would not hesitate in recommending others to use them for any cleanroom requirements.