AS ONE Clean Room File, 9-5647-01 Set of 20 Piece

As One 9-5647-01 A "clean room file" typically refers to a document, record, or set of documents that pertain to activities or processes within a clean room environment. Clean rooms are controlled environments with strict standards for cleanliness and air quality, often used in industries like pharmaceuticals, electronics manufacturing, biotechnology, and aerospace. Clean room files are essential for documenting and maintaining compliance with these standards. Here's what you might find in a clean room file: Operating Procedures: Detailed documentation of standard operating procedures (SOPs) for clean room activities, including gowning procedures, equipment usage, and maintenance protocols. Environmental Monitoring Records: Records of environmental monitoring, including air quality, temperature, humidity, and particle counts. These records are crucial for demonstrating compliance with clean room classifications (e.g., ISO Class 5, ISO Class 7). Calibration and Maintenance Records: Documentation of equipment calibration and maintenance activities to ensure that instruments and systems within the clean room are functioning correctly and accurately. Material and Equipment Records: Information about the materials, chemicals, and equipment used within the clean room, including their specifications, sources, and usage guidelines. Gowning and Personnel Records: Documentation of personnel training, qualifications, and gowning procedures. This may include records of clean room personnel and their certification. Change Control and Deviation Records: Records of any changes made to clean room processes, equipment, or procedures, as well as deviations from standard protocols. These records help track and manage any variations from normal operations. Cleaning and Sanitization Records: Documentation of cleaning and sanitization procedures for the clean room, including schedules, cleaning agents used, and results of cleaning checks. Validation and Qualification Records: Records of equipment and process validation and qualification, demonstrating that the clean room and its equipment consistently meet required standards. Material Safety Data Sheets (MSDS): Safety data sheets for chemicals and substances used within the clean room, providing information on their properties, hazards, and safe handling procedures. Audit and Inspection Reports: Reports from internal and external audits or inspections, along with corrective and preventive action (CAPA) plans. Compliance Documentation: Records that demonstrate compliance with industry-specific standards and regulations, such as Good Manufacturing Practices (GMP) or ISO standards.

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