ISO 7 Cleanroom Gowning Requirements
01 February 2024

ISO 7 Cleanroom Gowning Requirements

Proper cleaning procedures and maintenance are crucial to preserving the cleanliness, contamination control, and efficiency of cleanroom processes. Each cleanroom receives a different cleanliness classification based on the industrial application that the cleanroom operates in, as well as other environmental considerations. Each cleanroom class has a slightly different protocol when it comes to gowning, protocol, and supplies. For ISO 7 (Formerly Class 10,000) cleanrooms, these gowning requirements need careful consideration.

What Is a Cleanroom?

A cleanroom is a controlled environment where workers perform certain industrial activities. Usually, employees pack, manufacture, and assemble products such as medical devices, semiconductors, touch screens, and implantable devices. Aerospace, pharmaceuticals, electronics and medical equipment manufacturers may all use cleanrooms to package their products.

In a cleanroom, the regulations eliminate airborne contamination from people, equipment, facilities, and industrial processes. The more stringent the cleanroom classification, the more sterile the air will be within the cleanroom. Lower ISO classifications, such as ISO 4 or 5, have a higher level of cleanliness than higher ISO classifications, such as ISO 7 or 8. Nevertheless, each classification has a set of requirements that every employee must adhere to. These regulations include gowning requirements.

Why Is Proper Gowning Important in Cleanrooms?

Gowning refers to a set of personnel protective clothing and cleanroom supplies that workers must wear whenever they are in a cleanroom. These gowning requirements can cover any of the following body parts:

  • Face
  • Legs and pants
  • Hands
  • Head and hair
  • Beard and mustache
  • Feet and shoes
  • Torso and upper body

By utilizing proper gowning procedures, cleanroom employees can cover all parts of their body that have a potential for contamination. Particles coming from hair, skin cells and clothing fibers can easily become airborne and shed in the cleanroom environment. This could lead to contamination of the environment and the product. If the product risks contamination, the whole operation is at risk.

What are the ISO 7 Cleanroom Gowning Requirements?

If you are entering an ISO 7 cleanroom, it is vital to follow the facility’s gowning requirements. In most ISO 7 facilities, you and anyone else entering the cleanroom must completely cover your hair using a bouffant. You should also cover your ears using the bouffant. If you have any facial hair, you will have to don a beard cover as well. You will also need to cover your shoes with shoe covers. ESD shoe covers are available for grounding when working in and around sensitive electronics  In some cleanrooms, you may also have to wear gloves.

In addition, you will have to wear a protective frock or cleanroom suits. Using a cleanroom-approved stainless steel gowning rack and hanger can help you avoid contamination of the frock during the gowning process. To carefully place the frock on your body, zip the frock all the way up or snap all applicable snaps.  If you have to wear gloves, make sure you pull them over the cuff areas of your gown.

Tips for a Safe Cleanroom Etiquette

You should only allow trained and authorized personnel in your cleanroom. Ensure that all movement is deliberate and slow. Limit all running, horseplay, or contaminating activities. Do not allow any eating, drinking, gum, or tobacco in your cleanroom. If you notice contamination on any of your cleanroom gowns, ensure that the worker changes the gown immediately.

Cleanroom Shoe Covers

High-Tech Conversions makes cleanroom shoe covers that are an essential part of any cleanroom safety program. They help to prevent the introduction of dirt, dust, and other contaminants into the cleanroom environment. Cleanroom shoe covers are typically made from disposable materials, such as Tyvek or SMS fabric. These materials are lint-free and non-shedding, which helps to prevent the spread of contaminants.

Cleanroom shoe covers are available in a variety of sizes and styles to fit most foot sizes. They are typically secured with elastic or Velcro closures, which helps to ensure a snug fit. Cleanroom shoe covers should be worn whenever entering a cleanroom. They should be removed and disposed of properly when leaving the cleanroom.

Here are some of the benefits of wearing cleanroom shoe covers:

  • Prevent the introduction of contaminants into the cleanroom environment
  • Protect sensitive equipment and products from damage
  • Help to create a safe and productive work environment

Cleanroom Wipes

Cleanroom wipes from High-Tech Conversions are an essential tool for maintaining the cleanliness of a cleanroom environment. They are used to remove dirt, dust, and other contaminants from surfaces, equipment, and tools. Cleanroom wipes are typically made from lint-free materials, such as polyester or cellulose. They are available in a variety of sizes and shapes to fit a variety of cleaning needs.

Cleanroom wipes can be used dry or wet. When used dry, they are effective for removing loose dirt and dust. When used wet, they can be used to remove more stubborn contaminants, such as oil and grease. Cleanroom wipes are disposable, so they should be discarded after each use. They should not be reused, as this could introduce contaminants into the cleanroom environment.

Here are some of the benefits of using cleanroom wipes:

  • Remove dirt, dust, and other contaminants from surfaces, equipment, and tools
  • Help to prevent the spread of contamination
  • Disposable, so they do not introduce contaminants into the cleanroom environment
  • Available in a variety of sizes and shapes to fit a variety of cleaning needs