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Clean Room Gowning Procedure Step by Step

The document discusses cleanroom gowning procedures and requirements. It provides a table showing the recommended protective garments for different ISO cleanroom classes. These include face masks, beard covers, hair nets, shoe covers, gloves, frocks, hoods, and coveralls. It then provides a basic 12-step cleanroom gowning procedure and discusses the purpose of cleanroom gloves.

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0% found this document useful (0 votes)

144 views8 pages

Clean Room Gowning Procedure Step by Step

Uploaded by

nataarajan praveen

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Step By Step
Cleanroom gowning procedures, and the extent to which one needs to gown up, differ depending
on clean room class and application. For example in ISO Class 7 or ISO Class 8 clean rooms,
frocks are often acceptable. However in ISO Class 5 or ISO Class 6 (or cleaner) clean rooms:
coveralls, hoods, gloves, and shoe covers (also known as booties) are required. Precaution
should be observed to assure that no sterile surfaces contact non-sterile surfaces during
gowning, processing, or cleaning.

The following table indicates which garment elements are recommended for each specific class
of clean room.

Table 1: ISO Level Requirement Table

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ISO 8 ISO 7 ISO 6 ISO 4
ISO 5
Product Image Class Class Class Class
Class 100
100,000 10,000 1,000 10

Face Suggested Suggested Suggested Yes Yes

Masks /
Veils

Beard Yes Yes Yes Yes Yes

Covers

Hair Nets Yes Yes Yes Yes Yes

Shoe Suggested Yes Yes Yes Yes

Covers

Gloves Suggested Suggested Yes Yes Yes

Frock Yes Yes SD SD SD

Hood SD SD SD Yes Yes

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ISO 8 ISO 7 ISO 6 ISO 4
ISO 5
Product Image Class Class Class Class
Class 100
100,000 10,000 1,000 10

Coverall SD SD SD Yes Yes

Suit

1. Yes – Recommended (per IEST standards)

2. NR – Not recommended (per IEST standards)
3. SD – Situation dependent / Application specific (per IEST standards)
4. Suggested – Suggested based on the collective experience by the working group

Here Is A Basic Gowning Procedure

1. Wash and dry hands thoroughly; remove all jewelry.
2. Bouffant Cap – Use a bouffant cap to completely cover your hair.
3. Cleanroom Sticky Mat – Walk on the mat to remove dirt from your shoes, and roll any carts
entering the cleanroom over the mat.
4. Shoe Covers – Place your shoe cover over your entire shoe and cover your laces.
5. Cleanroom Gloves – Some cleanrooms require that you use gloves while dressing. If that is
required, then this will be the first of two sets.
Face
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7. Hood – Put a hood over your mask and ensure that your face/neck seal is not exposed
8. Coverall – Step into your coverall, making sure that your sleeves and upper garment do not
touch the floor or walls. Tuck your hood panels inside your coverall before zipping up
9. Boot Covers – Place the first boot cover over the leg of your coveralls. Put on your boot, and
step that foot into the “clean” side of the gowning area. Place the other boot cover over your
other leg before completely entering the “clean” side.
10. Eye Protection – Put on goggles if your cleanroom requires eye protection.
11. Cleanroom Gloves – If the second set of gloves are required, put on over the first set of gloves
or remove first set and then put on cleanroom gloves. Make sure gloves cover the cuff of the
sleeve.

Clean room gloves are worn for one of two reasons: to protect the wearer from exposure to
dangerous or irritative substances, and/or to protect cleanroom products from contaminants
introduced through operators, equipment, or airborne particles.

Pharmaceutical manufacturers will generally require sterile gloves with clean room designated
packaging. Clean room glove packaging features a polyethylene, easy open packaging which is
washed with deionized water, assembled, and then packaged for delivery inside a cleanroom.

Categories: Cleanroom Gowning, Cleanroom Solutions

Tags: clean room gowning requirements, clean room procedures, cleanroom gowning, gown room

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