Perhaps the most important aspect of working in a cleanroom and maintaining the cleanliness of the environment is the apparel you wear. Since the goal of a clean room is to minimize any particles, it’s standard to wear cleanroom-approved apparel over your normal clothing and to cover exposed skin and hair. The issue that arises is what type of apparel to wear in your particular cleanroom.
Learn What Apparel To Wear In Your Cleanroom
Cleanroom ISO Classes Explained
Since cleanrooms are categorized by their cleanliness level, the personal protective apparel worn in your cleanroom should be made of materials compatible with your allowed particle shed levels. Below are guidelines as to what cleanroom clothing to wear in each ISO Class cleanroom category.
The most common cleanroom cleanliness levels are ISO4 Class 10, ISO5 Class 100, ISO6 Class 1000, ISO7 Class 10,000 and ISO8 Class 10,000. The higher the ISO Class level number, the less strict the environment. For example, a Class 1000 cleanroom does not require the coverage and apparel cleanliness that a Class 100 would require.
Different industries require different cleanliness and sterility levels. Pharmaceutical and medical device manufacturing cleanrooms are often Class 100 ISO5 which is considered a critical environment requiring complete body coverage and careful donning procedures. Industrial manufacturing like bearings and mechanical components are normally ISO6-8 Class 1000 – 10,000 which does not require the super-strict cleanliness of a pharmaceutical room. Download additional details about cleanroom classifications.
See below for guidance for each cleanroom class to make sure you are wearing the right styles of apparel. Also, we offer guidance for selection of cleanroom wipes for ISO Class cleanrooms.
- Download our Cleanroom Connection Gowning and De-Gowning Poster for Sterile & Non-Sterile Environments
- Review our advice on selecting chemo-rated gloves for your pharmaceutical cleanroom or other healthcare facility.\
- In addition to advising on meeting ISO classes, we can help you with specific applications such as advice on controlling ESD from cleanroom personnel.
Cleanroom Apparel for ISO Classes
Class 100,000 – ISO8 ( Least Strict / Clean )
- Bouffant Cap
- Frock or Lab Coat
- Shoe Cover
- Face Mask
- Gloves
- Recommended Frequency of Change: Twice A Week
Class 10,000 – ISO7
- Bouffant Cap
- Frock or Lab Coat
- Shoe Cover
- Face Mask
- Gloves
- Recommended Frequency of Change: Twice A Week
Class 1000 – ISO6
- Bouffant Cap
- Coverall or Lab Coat
- Boot or Shoe Covers
- Face Mask
- Gloves
- Recommended Frequency of Change: Three Times A Week
Class 100 – ISO5
- Hood
- Bouffant Cap
- Coverall
- Boot Covers
- Face Mask
- Goggles
- Gloves
- Recommended Frequency Of Change: Daily
- Additional Note : Make Sure All Products Introduced to Environment Are Labeled Class 100 Compatible
Class 10 – ISO4
- Hood
- Bouffant Cap
- Coverall
- Intersuit Under Coverall
- Boot Covers
- Face Mask
- Goggles
- Gloves
- Recommended Frequency Of Change: Each Entry
- Additional Note : Make Sure All Products Introduced to the Environment Are Labeled Class 10 Compatible
Class 1 – ISO3 ( Most Strict / Cleanest )
- Hood
- Bouffant Cap
- Coverall
- Intersuit Under Coverall
- Boot Covers
- Goggles
- Face Mask
- Gloves
- Recommended Frequency Of Change: Each Entry
- Additional Note : Make Sure All Products Introduced to the Environment Are Labeled Class 1-10 Compatible
USP Cleanroom Apparel
Compounding pharmacies and similar cleanrooms in hospitals, labs, and other institutions must follow guidelines outlined by the US Pharmacopoeia. For your convenience, we have collected the best products that help our cleanroom clients achieve compliance and remain compliant. Let our cleanroom experts help you with samples.