ABSTRACT
Introduction ..................................................................................................103 A Short Course in Particulation .................................................................104 Facility Design ..............................................................................................104 Protecting Cleanrooms from Human Contamination ............................106 Behavior .........................................................................................................107 Cleanroom Garments ..................................................................................108 Evaluation of Fabrics Using ASTM and AATCC Test Methods at 1×, 50×, and 100× • Evaluation of Seams and Components via RP-3 Recommendations • Evaluation of Ability of Garment System to Entrain Particles Using Body Box Testing at 1×, 50×, and 100× • Evaluation of the Cleaning of the Garment System • Validating a Cleanroom Garment System Supplier • Validation of Gamma Radiation Sterilization of Cleanroom Apparel • Gamma Subcontractor Quali©cation Routine Monitoring of Sterilization Process............................................. 111 Certi©cate of Sterility Gowning for the Cleanroom .......................................................................112 Sterile Gowning Procedure Housekeeping ................................................................................................ 114 Ongoing Assessments ..................................................................................115 Summary ....................................................................................................... 116 References ...................................................................................................... 116 Standards and Recommended Practices • Journal Articles
¢e implementation of a cleanroom management program compliant with current good manufacturing practices (cGMP) includes the following:
• Validation of the design of the cleanroom • Designation of linear ¬ow of product and personnel • Written procedures and document control • Change control • Training and auditing for compliance
A balanced cleanroom management program is a comprehensive set of standard operating procedures (SOPs) that outline the requirements necessary to maintain the cleanroom environment successfully. ¢e program is de©ned as “balanced” because if one component of the cleanroom management program is not working properly, the entire program is disrupted, thereby allowing for possible contamination of the cleanroom. A balanced cleanroom management program takes into account the following requirements:
• Reducing potential contamination by designing a facility and cleanroom with a low-risk ¬oor plan
• Creating linear ¬ow of both product and personnel • Protecting from human contamination by choosing the right uniform program, requiring adher-
ence to gowning procedures, and setting guidelines for personnel behavior • Utilizing the correct types of cleanroom supplies for each application • Creating housekeeping procedures that maintain a consistent level of cleanliness • Requiring continuous improvement through ongoing assessments of the cleanroom environment
and auditing and trending of test results
¢e size of particles that are a contamination hazard to the cleanroom environment is measured in micrometers. A micrometer is one millionth of a meter. Some common cleanroom contaminants and their micrometer sizes are
Human hair: 70-100 μm Human skin ¬akes: 0.4-10 μm Pollen: 5-100 μm Mold: 2-20 μm Smoke: 0.01-1 μm Household dust: 0.05-100 μm Bacteria: 0.25-10 μm
¢ere are many sources of contamination to the cleanroom environment. Equipment generates particles through friction, heat, and exhaust. Additionally, equipment generates static electricity, which causes unwanted particle migration due to electro-inductive forces. Cleanroom processes can cause contamination by generating by-products (outgassing) that are exposed to the cleanroom surfaces and air. Incoming components used in production may also contain contaminants that will compromise the integrity of the cleanroom environment.
