Specimen Storage Facility Standard Operating Procedures

Administration and Quality Oversight

• Writing, Reviewing and Maintaining SOPs
• Facility Overview and Scope of Charge
• Organization: Directorship, Staffing, Oversight Committee
• Managing Storage Space
• Personnel Training
• Controlled Document Management
• Personnel Safety
• Quality Management
• Deviation Management
• Out of Specification Response and Notification Management
• Regulatory and Client/User Audit
• Facility Commissioning and Validation/Revalidation
• Housing Good Laboratory Practices Collections
• SSF Managed Specimens Intake and Release

Facility

• Mechanical Refrigeration Units Storage Room Operations
• LN₂ System and LN₂ Freezer Room Operations
• Controlled Access Operations
• Alarm Systems Management and Response

Equipment

• Refrigerators and Freezers
• LN₂ Freezers
• Sensit P100 Personal O₂ Monitors
• Timers
• Thermometers
• Drager Quick Air Emergency Escape Breathing Apparatus
• Scott ELSA Emergency Escape Breathing Device
• Drager Pac 5500 Personal O₂ Monitors
• -80°C LN₂ Freezer Units