Infrastructure

Having the correct infrastructure within any Biostorage facility is essential. Continuous improvement to plan for any eventuality is a constant for all team members at SciSafe. Our world leading facilities are focused on the specific and oftentimes unique requirements in controlled temperature storage. Oversized and redundant systems are the backbone of any Biostorage facility this includes abundant power, redundant power, oversized and redundant HVAC sytems.

Sample security is controlled by facility access control, building security systems and CCTV, 21cfr part sample management and monitoring and redundant chambers for all storage conditions.

SciSafe does not just maintain strong written facility procedures, it has directly applied these systems during Hurricane Sandy where it ran on backup power for a period of 6 days with no storage Out of Condition effect to any sample.

A brief listing of our infrastructure highlights are listed below:

  1. Oversize power supply with redundant systems including transformers
  2. Backup power throughout all facilities with automatic transfer switch units. Power outage monitoring with Sensaphone CELL Sentinel Monitoring system
  3. Redundant HVAC systems for extreme weather conditions and emergency situations
  4. Controlled card scanning access to building and sample suite with audit log
  5. Closed Circuit Television throughout facilities
  6. DEA Schedule 2 compliant alarm system with cellular backup
  7. Sample Monitoring System (21 CFR Part 11 compliant) that constantly monitors chamber and room temperatures and notify in different ways if there is an out of condition alarm
    • Automated dial out alarm that will continue to call until the alarm is acknowledged (multiple team members on the “On Call” list)
    • Emailed notification to multiple team members with follow up emails until system is acknowledged
    • Facility alarm company (ADT) will notify team member in the event of an out of condition alarm
  8. A robust cGMP validation and calibration program for all controlled temperature chambers and rooms
  9. A comprehensive preventative maintenance program for all controlled temperature chambers and rooms
  10. A comprehensive cGMP validation and calibration program for all controlled temperature chambers and rooms
  11. Backup chambers and rooms including units specifically dedicated to customer inventory so that customer samples can be inventoried at the temperature that they are to be stored
  12. Experienced staff on call at all facilities 24/7/365 and robust contingency planning