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Biotechnology Services
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Cell Bank Storage
Safe and reliable storage is of paramount importance in ensuring the security of your product throughout its development and commercial production. Covance has a fully GMP compliant liquid nitrogen storage system to provide primary or secondary site storage facilities for clients' cell banks. The facility has state-of-the-art automated cryogenic refrigeration equipment based on Statebourne Biosystem 10 liquid nitrogen refrigerators. The level of liquid nitrogen is automatically maintained from Statebourne Cryostor 240 pressurized liquid nitrogen tanks. The liquid nitrogen refrigerators also have an automatic quick chill facility to ensure temperature maintenance following lid opening and the prevention of temperature gradient formation.
Access to the facility is strictly limited to authorized staff who have undergone appropriate training in the use of the equipment and procedures for handling cell banks. All operations performed within the facility are routinely witnessed and checked by a second analyst. Cells can be stored in dedicated vessels or in shared storage vessels as required. Only cell banks that have been adequately characterized will be accepted for storage in shared vessels. Full cell bank characterization services are available.
The liquid nitrogen refrigerators possess integral controllers for the supply of liquid nitrogen, ensuring that a stable level is maintained. Temperature, fill time and lid open time of the refrigerators are also monitored. Local and remote alarms are activated if any of the above parameters are outside specified ranges.
Topics discussed below include:
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Tolerance limits
- Temperature — alarm activated if temperature is higher than -150°C
- Filling time — alarm activated if filling to normal operating level takes longer than 20 minutes
- High and low nitrogen levels — alarms activated if the liquid nitrogen level falls below 55 mm or rises above 110 mm
- Lid open — alarm activated if the lid is left open for longer than 10 minutes.
All of the above alarm functions also sound remotely via the Building Management System alarm network, and qualified members of staff are on 24-hour, 365-day call out to rectify any alarm event.
On a daily basis, all equipment is checked to ensure that the refrigerators are within specification and that there is no build-up of ice on the lid seals. |
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Calibration
The temperature inside the refrigerators is monitored using calibrated temperature probes that are located near the top of the vessels. Temperature probes are calibrated annually when the refrigerators are serviced. Following the annual service the refrigerators are also temperature mapped to ensure that the temperature measured by the probe is representative of the temperature throughout the vessel and that there are no significant temperature gradients. |
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Disaster recovery arrangements
In the event of leakage of nitrogen from a supplied vessel, the time out on filling alarm will sound. If this situation should arise, the refrigerators will be stable at 150°C for at least 72 hours if unopened. In the event of leakage of nitrogen from a refrigerator, cell banks will be transferred to a second vessel. In the event of equipment failure, Statebourne Cryogenics will supply replacements within 24 hours of the fault being reported. Liquid nitrogen deliveries can be arranged at any time. |
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Viability, stability and adventitious agent testing
At the start of a contract, cell bank viability and stability testing requirements are discussed with the client. Adventitious agent testing is also considered at this time. Initial testing is carried out followed by further testing at agreed timepoints. |
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Features of the service
- Full documentation of storage arrangements in a Quality Assurance audited protocol signed by both Covance and the client
- Storage of cell banks in refrigerators that house only well-characterized cell banks
- Controlled and logged access to the facility and individual refrigerators
- All manipulations witnessed by a second analyst
- Temperature monitoring is automatic using Biosystem 10 controllers at 5-minute intervals
- Liquid nitrogen levels outside preset limits are recorded automatically
- Daily metrology checks (manual) of temperature, liquid nitrogen levels and condition of lid seals
- Viability testing is offered routinely by the Covance Biotechnology Division; the frequency and extent of testing is agreed in the storage conditions protocol
- Notification of out of specification temperature events
- Quarterly summary report of any out of specification events and inventory
- Annual report of storage parameters, including full inventory, summary of out of specification events, and a summary of PQ testing
- Access to all SOPs, IQ/OQ/PQ documentation, training records, at any time.
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