QUALITY MANUAL

7. PRODUCT REALIZATION
7.3 CLEANROOM PROCESS

Last Revision:

2012

A cleanroom is a controlled environment where Fruth Custom Plastics products are manufactured. It is a room in which the concentration of airborne particles are controlled to specified limits. These contaminants are generated by people, process, facilities and equipment.

7.3.1 Classes (Cleanning Levels) Typical office building air contains from 500,000 to 1,000,000 particles (0.5 microns or larger) per cubic foot of air. A Class 100 cleanroom is designed to never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000 and Class 10,000 cleanrooms are designed to limit particles to 1000 and 10,000 respectively. 7.3.2 Key Elements of Contamination Control These are the things that need to be considered when providing an effective contamination control program. HEPA (High Efficiency Particulate Air Filter) - These filters are extremely important for maintaining contamination control. They filter particles as small as 0.3 microns with a 99.97% minimum particle-collective efficiency. Cleanroom Architecture - Cleanrooms are designed to achieve and maintain a airflow in which essentially the entire body of air within a confined area moves with uniform velocity along parellel flow lines. This air flow is called laminar flow. The more restriction of air flow the more turbulence. Turbulence can cause particle movement. Filtration - In addition to the HEPA filters commonly used in cleanrooms, there are a number of other filtration mechanisms used to remove particles from gases and liquids. These filters are essential for providing effective contamination control. Cleaning - Cleaning is an essential element of contamination control. Decisions need to made about the details of cleanroom maintenance and cleaning.

7.3.3 Cleanroom Garments The requirements for cleanroom garments are very important in Fruth Custom Plastics, Gloves, face masks, head covers, special shoes are need it to use in a cleanroom environment.

7.3.4 Cleaning Procedures for Cleanrooms The following procedures listed here are routine cleaning tasks in Fruth Custom Plastics . It is important for all employees review all cleaning procedures to be used in a cleanroom. A detailed cleaning schedule should be prepared for every cleanroom.

QUALITY MANUAL
7. PRODUCT REALIZATION

Last Revision:

2012

7.3.4.1 Cleaning Procedure for a Class 10,000 Cleanroom 1. Housekeeping maintenance of the cleanroom and restricted areas is essential to assure quality. 2. Cleaning of a cleanroom should be performed on a daily basis. 3. Improper cleaning of the cleanroom can lead to contamination and a loss in end user product quality. 4. Proper selection of equipment and materials is important for proper cleaning. 5. Only products that have proven cleanroom performance records should be considered for use in cleanrooms.. List of Some of Equipment and Supplies Needed to Clean the Cleanroom (All supplies must meet the Class 10,000 minimum requirements) 1. 2. 3. 4. 5. Cleaning and disinfecting solutions Cleanroom mops Cleanroom vacuum cleaner (if allowed) Cleanroom wipers Cleanroom mop bucket and wringer

List of Cleaning Tasks to be Completed in the Cleanroom (Frequency may vary depending upon local requirements) 1. 2. 3. Cleaning of all work surfaces in the controlled environment. Vacuuming (if allowed) of the floors and work surfaces. Emptying of appropriate trash and waste.

4. Cleaning of the doors, door frames and lockers in the pre-stagin area and gowning areas using the approved cleaning solution. 5. Mop gowning and cleanroom floors.

QUALITY MANUAL
7. PRODUCT REALIZATION

Last Revision:

2012

7.3.4.2 Cleaning Procedure for a Class 1000 Cleanroom Description of Work Wet mop with approved mop, cleaner & DI water Remove trash, clean walls Vacuum entry mats, sweep and mop floors Vacuum floor (When is necessary) Frequency 2 times per shift 1 time per shift 1 time per shift 2 times per week

7.3.4.3 Cleaning Procedure for a Class 100 Cleanroom Procedure Trash removal Mop walkways Wipe down horizontal surfaces Pull tacky mats Mop and trash removal Wipe down walls and trim Mop and trash removal Wipe walls and trim Mop Wipe walls and trim Vacuum Mop and trash removal Frequency Once daily Once a week Once monthly Every 2 hours Once daily Once a week Once daily Once a week Twice a shift Once a week Once monthly Once per shift

7.3.4.4 Cleanroom Regulations Below is a list of regulations that Fruth Custom Plastics use as a minimum for the successful operation of a cleanroom. All employees should be aware and follow these regulations at all times.

QUALITY MANUAL
7. PRODUCT REALIZATION

Last Revision:

2012

1. All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room. 2. Valuable personal Items such as wallets may be permitted in the cleanroom provided they are NEVER removed from beneath the cleanroom garments. 3. 4. NO eating, smoking or gum chewing allowed inside the cleanroom. Only garments approved for the cleanroom should be worn when entering.

5. NO cosmetics shall be worn in the cleanrooms. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eye liner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes. 6. Only approved cleanroom paper shall be allowed in the cleanroom.

7. Gloves or finger cots should not be allowed to touch any item or surface that has not been thoroughly cleaned. 8. Approved skin lotions or lanolin based soaps are sometimes allowed. These can reduce skin flaking.

9. All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the cleanroom surfaces. All of these items are a source of contamination. 10. NO tool should be allowed to rest on the surface of a bench or table. It should be place on a cleanroom wiper. 11. ALL equipment, materials and containers introduced into a sterile facility must be subjected to stringent sterilization prior to entrance. 12. NO ONE who is physically ill, especially with respiratory or stomach disorders, may enter a sterile room. This is a good practice in any cleanroom environment.