ECACC has established a cGMP Safe Deposit storage facility offering customers secure second site storage for their valuable cGMP cell lines
Material produced in accordance with the requirements of cGMP is required to be stored under controlled conditions.
The guidance states that cGMP products and seed stocks are required to be segregated from non-cGMP material.
In addition, the guidance advises that seed stocks and cell banks are required to be stored in more than one secure location to minimise the risk of total loss of resources in the event of a disaster.
ECACC is able to accept cell lines produced according to the requirements of cGMP for cryo-storage.
The cell lines must be accompanied by a certificate to confirm they have been produced in accordance with the requirements of cGMP and that they have been tested for freedom from mycoplasma, bacteria or fungi.
The ECACC cGMP Safe Deposit Service enables customers to comply with the requirements of cGMP by providing secure second site storage.
The service is not designed to be used as the sole or primary site of storage.
The cGMP dedicated storage tank is monitored continuously by a chart recorder linked to a telemetry alarm system.
ECACC monitor cell lines stored in the same vessel are periodically resuscitated and cultured to further confirm that conditions favourable for preserving cell lines are maintained.
Cell lines are stored in vapour phase above a liquid nitrogen reservoir.
The ampoules are placed within an aluminum cryo-box that can hold up to 100 ampoules.
The depositor can request to have separate cryo-boxes for each cell line deposited or multiple deposits in one cryo-box.
Cryo-boxes are exclusive to each customer.
The cGMP dedicated storage vessel is housed in a purpose built ultra low storage facility which is one of the largest liquid nitrogen repositories in Europe.
The facility can accommodate 50 liquid nitrogen storage vessels each containing up to 25,000 ampoules.
The purpose built ultra low storage facility has been validated by installation qualification (IQ).
The dedicated cGMP storage vessel has been subjected to a formal IQ/operational qualification (OQ)/performance qualification (PQ) validation exercise.
The chart recorder has been tested to IQ/OQ The site benefits from the high level of security that applies to the Centre for Emergency Preparedness and Response, Health Protection Agency, Porton Down, UK.
Security staff are present on site 24 hours a day and access to the ultra low storage facility is restricted to authorised personnel only.
All the inventory storage vessels are configured for automatic liquid nitrogen replenishment and each vessel is alarmed and monitored by an electronic telemetry system.
