Pharmacy Courses

Rules for Cleanroom Personnel in Pharma Industry


The biggest problem with Cleanrooms is people since they carry contaminants and microorganisms on their skin. There are several steps that companies take in an attempt to control the amount of contaminants released by personnel. The first rule is the use of specially designed clothing produced by cleanroom suppliers.


The ISO class of a Cleanroom determines the type of clothing that personnel are required to wear. OSHA has guidelines for Cleanrooms but does not have standards for protective clothing.


Clothing Requirements for Cleanrooms.

  • Hood /Bouffant hat/Coverall/Inner suit worn underneath coveralls
  • Boot covers/Goggles/Facemask/
  • Gloves


Cleanroom Clothing Factors

1. Must match the cleanroom‘s risk and hazard analysis

2. Sturdy to avoid rips or tears

3. Disposable

4. Non-disposable when proper laundry is available

5.  Sized to fit worker measurements

6. Delivered in individually vacuum sealed packaging and stored in a cleanroom environment


Disposable clothing is the most common option for Cleanroom clothing, which is disposed of in designated bins. The image below is of a "bunny suit" that is normally white and covers the whole body. All of the labeled items are disposable.


Every company has their own set of rules for Cleanroom use. The list below:

Entering and exiting – thoroughly wash and dry hands. Put on protective clothing. When exiting, dispose of all clothing and wash up a second time.


Cleaning – walls, floors, and work surfaces must be completely wiped down using SDS (Safety Data Sheet) chemicals. Also, anything that is brought in from the outside needs to be wiped down to remove potential contaminants /particle is a general overview


Hygiene – personal hygiene must include a daily shower, washing of hair, brushing of teeth, and approved skin care products. Workers should also avoid wearing cosmetics.


Clothing – personnel may be required to completely change from their street clothing prior to entering the cleanroom. Wool is often prohibited due to the static electricity that it produces.


Work pace – personnel must move slowly at an even pace to avoid air turbulence.


Dropped items – items dropped or have fallen on the floor, they are not to be picked up.


Tools and supplies – are organized and stored in properly labeled containers and cabinets. In addition, items that generate particles are avoided, such as wood, paper, cartons, pencils, etc.


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Resource Person: Ch/Ahmed Mahmoud

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