Biorepository & Cryogenic Storage, Salient Features


Bio-Repository Facility and Infra-Structure of KTI has been established with a provision to accommodate additional growth of adding new freezers with relative ease.

KamTek uses a number of Structural and Functional Backup Systems that makes its operation most desirable for current and future Bio-Repository Projects. For example,

 

TWO UNITS OF HVAC SYSTEM (50-ton capacity) serve the repository section of the facility to maintain constant temperature of 71-73°F in addition to HVAC for the lab and office area.

 

STANDBY EMERGENCY DIESEL POWER GENERATOR of 300KW capacity (800-Amp power at 480V-240V-110V) with automatic switch and 800 gallon fuel supply for 96 hours of operation. The generator is connected to all cryo-storage equipment, monitoring systems, vital components of labs (incubator, bio-safety hood etc).

 

UNINTERRUPTED AUTOMATIC LN2 SUPPLY from 3000-gallon on-site LN2 Feeding Storage tank for a minimum of 7 days supply through vacuum pipe using auto-fill LN2 system with low level alarm.

IN-HOUSE BACKUP FREEZER OPTION in case of freezer breakdown and a provision for quarantine freezer space.

FACILITY SECURITY

i) Electronic Controlled Access to the facility as well as to the doorway entries to the bio-repository area.

ii) Environmental Sensors in place to detect high temperature and flooding condition.

iii) Video-surveillance system in place for repository area.

iv) Auto “System Testing” feature to ensure that all important communicating connections are secure.

v) All critical equipment items (Power Generator, ATS, Fuel Tank, and LN2 Supply Tank) are fenced in and locked.

vi) Locked walk-in closet to house master key boxes & controls for our facility security system, as well as all other electronic controls.

FREEZER TEMPERATURE 24/7 MONITORING AND RECORDING by Rees Centron Monitoring System (CMS)

i) any fluctuations beyond the set temperature limits of freezers,

ii) startup of the backup generator

iii) of total electric outage,

iv) any anomaly in its own wireless communication system

v) test for Plain Old Telephone (POT) line communication

vi) Automatic data storage and backup vii System can be accessed remotely

POT LINES USED FOR TELECOMMUNICATION of REES and ASG monitoring systems to stay independent of any commercial power.

CELLULAR BACK-UP OF INTERNET SERVICES is also available for critical communications.

SECURE MULTI LAYERED DATA BACK UPS of operational and corporate data (onsite servers and cloud) and inventory database management system (secure off site server & cloud).

A variety of Facility Management practices are exercised to constantly monitor the performance of each component of the facility infra-structure at regular time intervals. These measures have been adopted to effectively use the bio-repository facility to its optimal capability under cGMP conditions. The focus is always to preserve the integrity of Bio-Specimens at every stage of Bio-repository operation, namely Sample acquisition, storage, inventory, processing, testing, shipments and Sample tracking through a CFR21 part 11 validated database management system.

 

Salient Features of Repository facility

 

The Bio_repository Facility was designed to Promote:

  • the safe handling
  • receipt,
  • processing
  • storage
  • inventory
  • packaging and distribution for all type od infectious and
  • non-infectious biological specimens and rodents

The Facility houses:

  • Ultra-low mechaical freezers (-50deg C)
  • vapor-phase liquid nitrogen freezers (-150deg C to -169deg C)
  • mechanical walk-in freezer room(-20deg C)
  • Mechanical walk-in Cold rooms (4deg C)

The Facility Provides:

  • Unintrerruted Power supply
  • Uninterrupted LN2 Supply
  • Uninterrypted and remote monitoring system

Has Multi-layered Computerized Security System

  • provides around-th-clock secure access,
  • intrusion, temperature and dlooding detection, and
  • electronics monitoring of all freezers and critical facility functions