Cleanroom Gowning Work Instruction Example

What gowning involves

People are a major source of particles and microorganisms in a cleanroom. Skin flakes, hair, cosmetics and fibers from street clothes all shed, and they shed more with movement. Cleanroom garments act as a filter between the person and the room, but only if they go on in a way that keeps their outside surfaces from touching the floor, street clothes or bare hands.

That is why gowning is done top to bottom and dirty to clean. Hair and face are covered first so nothing falls onto the coverall. The coverall goes on before boots so the legs can be tucked in. The step-over bench divides the less clean side of the gowning room from the clean side, and gloves go on last, over the sleeves, so the hands that touched everything else are covered. The details vary with the cleanroom class and the product, which is why each facility writes its own instruction.

Where the requirements come from

ISO 14644-1 classifies cleanrooms by airborne particle concentration, and ISO 14644-5 covers cleanroom operations including clothing. IEST-RP-CC003 gives detailed guidance on garment systems. Sterile pharmaceutical manufacturing in Europe follows EU GMP Annex 1, which has its own gowning expectations. Medical device makers also need their gowning controls to fit their QMS, as covered in the FDA QMSR guide. Read the documents that apply to your room; this page does not restate them.

Example: Gowning for Entry to the Assembly Cleanroom

Example This work instruction is for Example Manufacturing Co., a fictional maker of medical device subassemblies with an ISO Class 7 assembly room (example value). The garment list, hand-washing time and disinfectant are example values, not recommendations. Use the values in your own cleanroom procedures and garment supplier’s instructions.

Download this example (.docx)

Tools, materials and PPE

• Locker for personal items
• Hand-washing sink with soap and paper towels; hand sanitizer
• Hair cover, beard cover where needed, face mask
• Cleanroom hood, coverall and boots in the correct size
• Safety glasses or goggles
• Cleanroom gloves; 70% isopropyl alcohol spray for gloves (example value)
• Full-length mirror

Steps

1. Prepare before the gowning room. Remove jewelry, watches and phones and put them in your locker with outerwear. Remove makeup. Report any illness, rash or sunburn to the supervisor.
   Key point: Nothing goes into the cleanroom that is not on the approved list.
   Reason: Jewelry and cosmetics shed particles and can tear gloves or garments; illness raises shedding.
2. Wash your hands. Wash hands and forearms with soap for at least 20 seconds (example value), rinse, and dry with a paper towel.
   Key point: Turn off the tap with the towel, not your clean hand.
   Reason: Clean hands carry fewer particles and microorganisms onto the garments you are about to handle.
3. Cover hair and face. Put on the hair cover so all hair is inside, then a beard cover if you have facial hair, then the face mask.
   Key point: No hair visible at the forehead, ears or neck. Mask over the nose.
   Reason: Covering the head first stops hair and skin falling onto the coverall as you put it on.
4. Put on the hood. Take the hood from its pack touching only the inside. Put it on and fasten it so it covers the hair cover, ears and neck.
   Key point: Handle garments by the inside wherever possible.
   Reason: The outside of the garment faces the room and must stay clean.
5. Put on the coverall. Unfold the coverall without letting it touch the floor. Step in one leg at a time, pull it up, put your arms in, tuck the hood skirt inside the collar and zip up.
   Key point: If any part of the coverall touches the floor, discard it and take a new one.
   Reason: The floor on the less clean side of the gowning room is the dirtiest surface in the area.Safety: Sit or hold the rail while stepping into the legs to keep your balance.
6. Put on boots across the bench. Sit on the step-over bench. Put on one boot, tuck the coverall leg inside, fasten it and swing that leg over to the clean side. Repeat with the other leg.
   Key point: A booted foot only ever touches the clean side.
   Reason: The bench is the line between less clean and clean; crossing it with an unbooted foot carries dirt across.Safety: Swing your legs over slowly and keep a hand on the bench. Gowning room floors can be slippery.
7. Put on eye protection and gloves. Put on safety glasses or goggles. Sanitize your hands, then put on gloves, pulling each cuff over the coverall sleeve.
   Key point: Glove cuffs over the sleeves, no gap at the wrist. Change any glove that tears.
   Reason: Gloves go on last so they cover hands that touched everything else.
8. Sanitize gloves and check in the mirror. Spray gloves with the alcohol and let them dry. Check yourself in the full-length mirror front and back.
   Key point: No skin or hair showing except around the eyes; all fasteners closed; no tears.
   Reason: A mirror check catches gaps you cannot feel.Safety: Isopropyl alcohol is flammable. No ignition sources in the gowning room, and let gloves dry before touching anything electrical.
9. Enter and record. Enter through the airlock, letting one door close before opening the next. Sign the entry log.
   Key point: Never hold both airlock doors open.
   Reason: The airlock keeps the pressure difference that stops less clean air flowing in.

Acceptance criteria

• All garments in the correct order and size, none touched the floor or the less clean side.
• No skin or hair visible except around the eyes.
• Glove cuffs over coverall sleeves, gloves sanitized and dry.
• Mirror check done front and back with no tears or open fasteners.
• Entry recorded in the cleanroom log.

How to adapt this example

Copy the steps into the blank work instruction template, or edit the .docx above. Walk your own gowning room with the people who use it and write down the layout: where the lockers, sink, bench, mirror and airlock are. Then fit the steps to that layout using the method in how to write a work instruction.

• Match the garment list and order to your room class and product. Sterile or higher-class rooms often add steps such as sterile garments, double gloves or a second gowning room.
• Add a degowning section for exit and re-entry, including which garments are reused and how they are stored.
• Post photos of each stage at the point of use. The visual work instruction template is built for that.
• Qualify people on gowning before unescorted entry and record it on a skills matrix; see training effectiveness for checking that training stuck.
• Translate the posted instruction for every language your cleanroom staff read. See multilingual work instructions.
• Mark printed copies as uncontrolled with the PDF watermark tool, and replace posted copies at every revision.

Common mistakes

• Gowning bottom to top. Cover hair and face first and put gloves on last.
• Letting the coverall touch the floor and carrying on. Discard it and take a new one. Make that explicit in the step.
• No defined step-over line. Mark the bench or line clearly and only booted feet cross it.
• Instruction only in a binder. Post it, with photos, at the point of use in the gowning room.
• Same instruction for visitors with no escort rule. State who may enter unescorted and how visitors are gowned and supervised.

Frequently asked questions

Sources

1. ISO 14644-1, Cleanrooms and associated controlled environments — Classification of air cleanliness by particle concentration, ISO
2. ISO 14644-5, Cleanrooms and associated controlled environments — Operations, ISO
3. IEST-RP-CC003, Garment System Considerations for Cleanrooms and Other Controlled Environments, IEST
4. EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products, European Commission

See also

• How to write a work instruction (Work Instructions pillar)
• Blank work instruction template (.docx)
• Visual work instruction template
• Training skills matrix template
• PDF watermark tool
• CNC machine setup work instruction example
• Torque sequence work instruction example
• MIG welding setup work instruction example
• Packaging and labeling work instruction example