Introduction to Cleanrooms Basic principles and protocols

Purpose of Clean Protocol Promote Successful Cleanroom Operations Promote Successful Cleanroom Operations Ensure Safety in the Clean Environment Ensure Safety in the Clean Environment Provide Operational Conditions that Meet Process & User Needs Provide Operational Conditions that Meet Process & User Needs

Perspective The protocol provides basic awareness and general guidelines for cleanroom users. Successful cleanroom operation relies on each user’s understanding, participation and self discipline. The success of each user relies on trust, understanding and shared responsibility among all users.

What is a Cleanroom? A clean environment designed to reduce the contamination of processes and materials. This is accomplished by removing or reducing contamination sources.

Principles of the Clean Environment Air is highly (HEPA) filtered 0.3  ) Air is highly (HEPA) filtered 0.3  ) Layout should minimize particle sources in filtered air stream Layout should minimize particle sources in filtered air stream Air flow should remove most particles generated by process Air flow should remove most particles generated by process

Types of Contamination Particulate Dust, skin, hair, makeup… Particulate Dust, skin, hair, makeup… Chemical Oil, grease, metal ions, perfume… Chemical Oil, grease, metal ions, perfume… Biological Bacteria, fungi, rodents??? Biological Bacteria, fungi, rodents??? Radiation Ultraviolet light… Radiation Ultraviolet light…

Particle Characteristics 50 micron particles are visible 50 micron particles are visible Average human hair is about 100 microns Average human hair is about 100 microns Time to fall 1 meter in still air Time to fall 1 meter in still air 33 seconds for 10 micron particle 33 seconds for 10 micron particle 48 minutes for 1 micron particle 48 minutes for 1 micron particle Humans generate >1x10 5 particles per minute when motionless (fully gowned) Humans generate >1x10 5 particles per minute when motionless (fully gowned) Humans can generate >1x10 6 particles when walking in the cleanroom Humans can generate >1x10 6 particles when walking in the cleanroom

Contamination Sources People ~75% People ~75% Ventilation ~15% Ventilation ~15% Room Structure ~5% Room Structure ~5% Equipment ~5% Equipment ~5%

Contamination Control Personnel Control Personnel Control Dress code Dress code Personal Hygiene Personal Hygiene Gowning Gowning Environmental Control Environmental Control Entrance and exit Entrance and exit Materials and supplies Materials and supplies Cleaning and maintenance Cleaning and maintenance Atmospheric Atmospheric

Dress code No sleeveless shirts No sleeveless shirts No shorts or skirts No shorts or skirts No slippers or sandals No slippers or sandals No jewelry that can puncture garments or gloves No jewelry that can puncture garments or gloves Avoid clothing that sheds Avoid clothing that sheds

Personal Hygiene Shower each day before entry Shower each day before entry Control Dermatitis & Dandruff Control Dermatitis & Dandruff Do not smoke before entry Do not smoke before entry No chewing gum or tobacco No chewing gum or tobacco No Cosmetics should be worn No Cosmetics should be worn Facial hair will need to be covered Facial hair will need to be covered

Gowning Proper gowning order Proper gowning order Hair cover Hair cover Hood Hood Shoe covers Shoe covers Coverall Coverall Gloves Gloves Face mask Face mask Safety Glasses Safety Glasses

Gowning Basics Garments should not be removed from cleanroom unless in approved container Garments should not be removed from cleanroom unless in approved container Don’t walk out of the cleanroom with your garments on Don’t walk out of the cleanroom with your garments on Change garments when soiled or showing any visible signs of wear Change garments when soiled or showing any visible signs of wear Don’t reach inside your garment while in the cleanroom Don’t reach inside your garment while in the cleanroom

Garment Reuse and Storage Reusable – Store in Gown bin or zip lock bag Reusable – Store in Gown bin or zip lock bag Coveralls Coveralls Hood Hood Knee-high Booties (not the blue disposables) Knee-high Booties (not the blue disposables) Safety Glasses Safety Glasses Not Reusable – Throw in trash Not Reusable – Throw in trash Hair nets & Beard covers Hair nets & Beard covers Blue disposable shoe covers Blue disposable shoe covers Gloves Gloves Face mask Face mask

Entry & Exit Enter and exit quickly Enter and exit quickly Only one person may enter at a time Only one person may enter at a time Each user must use their own access card Each user must use their own access card Pass from the gowning area to the clean area slowly to reduce migration of particles between areas Pass from the gowning area to the clean area slowly to reduce migration of particles between areas

Materials and Supplies Do Not carry non-cleanroom items into the cleanroom Do Not carry non-cleanroom items into the cleanroom Do not carry cleanroom items out of the cleanroom Do not carry cleanroom items out of the cleanroom Do not use pencils or erasers Do not use pencils or erasers Paper should be kept in a plastic sleeve Paper should be kept in a plastic sleeve Do Not cut the cleanroom wipers Do Not cut the cleanroom wipers Clean everything you carry into the cleanroom Clean everything you carry into the cleanroom

Chemicals Do not take new chemicals into the cleanroom without permission Do not take new chemicals into the cleanroom without permission Always read MSDS for every chemical you use Always read MSDS for every chemical you use Large quantities of chemicals must be stored outside the cleanroom Large quantities of chemicals must be stored outside the cleanroom Chemicals inside the cleanroom should be properly stored Chemicals inside the cleanroom should be properly stored All chemical containers should be clearly labeled with their contents and Hazard Classification All chemical containers should be clearly labeled with their contents and Hazard Classification Unattended chemicals and experiments should be labeled with the owners name, immediate contact number, list of all chemicals involved, and estimated time of return or completion. Unattended chemicals and experiments should be labeled with the owners name, immediate contact number, list of all chemicals involved, and estimated time of return or completion.

Chemical Handling Always use safety carriers with glass bottles 2L and larger Always use safety carriers with glass bottles 2L and larger Do not transport chemicals in open containers Do not transport chemicals in open containers Chemicals should be used inside approved hoods or under properly positioned snorkel extractors Chemicals should be used inside approved hoods or under properly positioned snorkel extractors Full apron, Trionic gloves and full face shield are required for using all acids Full apron, Trionic gloves and full face shield are required for using all acids Gloves, lab coat, and safety glasses are considered minimum personal protective equipment when handling ANY chemical Gloves, lab coat, and safety glasses are considered minimum personal protective equipment when handling ANY chemical

Chemical Handling In case of a small spill In case of a small spill Inform all users in the cleanroom Inform all users in the cleanroom Clearly mark the affected area Clearly mark the affected area Use appropriate absorbent material to clean up the spill Use appropriate absorbent material to clean up the spill In case of large spill In case of large spill Inform all users in the cleanroom Inform all users in the cleanroom Clearly mark the affected area and evacuate Clearly mark the affected area and evacuate Contact VEH&S and cleanroom staff immediately Contact VEH&S and cleanroom staff immediately

Chemical Handling Chemical waste should be properly disposed of as outlined by VEH&S Chemical waste should be properly disposed of as outlined by VEH&S No chemicals may be poured down the drains No chemicals may be poured down the drains Waste containers should be properly marked as such and have a pink Hazardous Waste tag tied to them at all times Waste containers should be properly marked as such and have a pink Hazardous Waste tag tied to them at all times If you have questions about disposal contact a staff member If you have questions about disposal contact a staff member

In Case of Emergency Always follow the rules set forth by VEH&S Always follow the rules set forth by VEH&S If an emergency requires evacuation, leave the cleanroom immediately, do not stop to un-gown If an emergency requires evacuation, leave the cleanroom immediately, do not stop to un-gown Inform other users before leaving Inform other users before leaving

Equipment use All users must be trained before using any equipment All users must be trained before using any equipment All equipment use should be scheduled All equipment use should be scheduled If you are unable to use scheduled time please delete your reservation If you are unable to use scheduled time please delete your reservation It is every users responsibility to report damaged or malfunctioning equipment It is every users responsibility to report damaged or malfunctioning equipment It is every users responsibility to properly operate and clean each piece of equipment that they use It is every users responsibility to properly operate and clean each piece of equipment that they use

Housekeeping Every user is responsible for keeping the cleanrooms clean Every user is responsible for keeping the cleanrooms clean Always clean your workspace before leaving Always clean your workspace before leaving Don’t leave or store items on or in equipment Don’t leave or store items on or in equipment Do not set liquids on any equipment Do not set liquids on any equipment Properly store all materials before leaving the cleanroom Properly store all materials before leaving the cleanroom Last one out should make sure the room is in a safe idle mode Last one out should make sure the room is in a safe idle mode

Violations of Rules First time First time Warning Warning Report to Advisor Report to Advisor Second time Second time Suspension of access Suspension of access Report to Advisor Report to Advisor Retraining may be required Retraining may be required Third Offense Third Offense Suspension of access Suspension of access Report to Advisor Report to Advisor Access will not be renewed until an acceptable resolution is reached between Advisor and Cleanroom Manager Access will not be renewed until an acceptable resolution is reached between Advisor and Cleanroom Manager Cleanroom Protocol re-training will be required Cleanroom Protocol re-training will be required