Cleanroom Procedure Bundle

The Cleanroom Procedure Bundle includes Cleanroom Design and Validation Procedure to provide instruction on the design, build, and validation of a cleanroom to ensure the environment complies with user requirement specifications, applicable standards, and regulations, and to ensure the facility is fit for its intended purpose.; Environmental Controls Procedure to establish a monitoring plan that considers surface and air particulate (viable and non-viable), bioburden, temperature and humidity, differential pressure, contamination of product, and cleanroom attributes that affect cleanroom performance.; and our Cleanroom Cleaning Procedure to define the cleaning practices for cleanrooms and controlled manufacturing environments. The cleanroom procedure bundle provides valuable guidance on cleanroom installation, validation, monitoring and controls, and routine cleanroom cleaning practices. The Cleanroom Procedure Bundle complies with ISO 14644, ISO 13485, and FDA QSR requirements.