Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the cleanroom from the people working in the cleanroom. Whereas contamination may be due to the product, processes, or equipment in the cleanroom, the people working in the cleanroom exercise the greatest control over the cause of and elimination of contamination. Therefore, all protocol programs address the functionality of the cleanroom, the behavior of the people working in the cleanroom, and the cleaning and maintenance of the cleanroom.
The basic components of a balanced cleanroom protocol program are:
- The facility design and cleanroom floor-plan
- Cleanroom gowning requirements and procedures
- Personnel behavior within the cleanroom environment
- Cleanroom supplies – correct types and usage
- Cleanroom housekeeping
- Continuous improvement and assessments (audits and trending test results)
Facility Design
Initially, one must understand the design, layout, and certification of the cleanroom. IEST-RP-CC012.2, “Considerations in Cleanroom Design” is an excellent document to reference for understanding the design and functions of various components in cleanrooms (i.e., air flow, room pressures and particle management, etc.).
Cleanroom Gowning Procedures
After the cleanroom has passed certification, cleanroom personnel must don the required cleanroom apparel applicable to the classification of the cleanroom. Many cleanroom operations require the cleanroom personnel to change from street clothes to 100% polyester building suits or tech suits to reduce the amount of particle contamination in the cleanroom environment. The garment system selected must meet the specifications for the cleanroom applications. Facility requirements for changing areas, lockers, in-use garment storage, soiled garment storage, garment inventory storage, and internal inventory transit must be defined. Additionally cleanroom garment laundering and other garment management services must be defined and subcontracted.
Gowning procedures begin at home with daily bathing or showering, shaving, brushing of teeth and hair, and application of non-silicone containing skin moisturizers to reduce skin flakes. All make-up, hair gels, hair sprays, perfumes, aromatic after-shave lotions, or body lotions are not cleanroom compatible and therefore unacceptable to wear to work. At work, all employees must wash hands before entering the cleanroom and after eating and/or using the toilet. Cleanroom compatible hand cream may be applied prior to gowning.
Personnel Behavior
Meticulous hiring practices for cleanroom personnel include screening potential operators for physical characteristics such as: smoker hiring policy, overweight or obese personnel, facial hair, sensitivity to heat, cold and humidity, and seasonal allergies including skin allergies. Also, when evaluating personal skills and language skills, the human resources department must also evaluate potential cleanroom candidates for mental characteristics such as claustrophobia.
Cleanroom Supplies and Storage
Garments may be stored inside the cleanroom gowning area as well as the many cleanroom consumable supplies to support the cleanroom operators and the processes inside the cleanroom. Cleanroom supplies should be stored in cleanroom packaging until use. All chemicals and supplies used to clean the cleanroom should also be stored in original cleanroom packaging until use. Used mops and mop heads should be properly disposed after use. It is recommended that the cleanroom supplies storage area be ventilated under vertical unidirectional air flow. Prior to introduction of any supplies into the cleanroom storage areas, proper wipe down of the exterior packaging should be performed.
Cleanroom Housekeeping
An integral piece of the cleanroom management program is cleaning of the cleanroom. A documented and controlled cleanroom cleaning program should be established and maintained to ensure the integrity of the cleanroom environment. Selection of cleanroom cleaning materials, equipment, and cleaning agents should be appropriate to the type of cleaning required (i.e., aseptic versus non-aseptic cleanrooms). All cleaning agents and subsequent cleaning protocols should be validated to assure efficacy of cleaning.
Continuous Monitoring for Efficacy
Monitoring and auditing the cleanroom management program assures that the documented procedures and protocols are understood, implemented and effective at all levels within the cleanroom manufacturing process. The audit program should provide documented and impartial evidence that the cleanroom management program is robust and reproducible. Tracking and trending this data will show shifts in the program which can be addressed prior to compromising the entire cleanroom protocol program.
From: “Ask Jan: Basic Cleanroom Protocol”
