cGMP Deposit Terms and Conditions

Safe Deposit Terms and Conditions

Storage Conditions: ATCC makes all reasonable efforts to preserve living culture material submitted frozen for safekeeping by maintaining the material in the vapor phase of liquid nitrogen tanks at -145°C or lower. The depositor is responsible for ensuring that preserved material submitted to ATCC is viable. To verify that culture material arrives at ATCC in a viable condition we will maintain the material under the storage conditions described above for 1-2 weeks and return one vial to the depositor for viability testing. This service is not automatic and must be requested by the depositor. Handling, dry ice charges and shipping are additional. In order to avoid any potential concerns about unauthorized use of the proprietary material, ATCC does not perform viability testing on safe deposit cultures except by special request .

ATCC accepts no responsibility for material that is found to be nonviable after storage in our facility. Viability testing of material stored at ATCC for safekeeping is the responsibility of the depositor. We will maintain culture material in our facility under the same stringent conditions as ATCC collection material to assure that the physical properties remain unchanged. However, ATCC is not responsible for damage to material, including, but not limited to, damage due to circumstances beyond ATCC's control such as fire, flood, or other natural disasters. Therefore, we strongly recommend that valuable culture material always be maintained in two locations, and that the only purpose for storing culture material at ATCC be for redundant back-up in the event of loss of the primary source.

Insurance: ATCC has no way of assessing the commercial value of cultures deposited for safekeeping. Therefore, the determination of economic value for strains deposited with ATCC for safekeeping and the responsibility for insurance or other financial protection remain the sole responsibility of the depositor. ATCC arbitrarily assigns a value of $1.00 per strain or cell line for insurance purposes and assumes no other liability for loss of or damage to any culture deposited for safekeeping.

Maintenance of Records: Written records are maintained on each culture submitted for safekeeping. The records consist of correspondence, information on the type of material, designation of ownership, and inventory. These records, with the exception of locator codes, are the property of the depositor, and copies may be obtained or originals inspected at the ATCC facility after prior written notification of intent to do so. Records on cultures removed from safekeeping for return to the depositor or discard are maintained for a period of ten (10) years after termination of the deposit. After this ten-year period the records will be forwarded to the depositor or destroyed. ATCC assumes no liability for the correctness of the depositors information concerning patent and safe deposits.

Confidentiality: Information received by ATCC on cultures submitted for safe deposit will be maintained in confidence to the extent possible. Access to this information, as well as the locator codes for the stored culture material, generally is limited to certain individuals on the ATCC staff. Except as provided by law, information will not be released to any third party without prior written permission from the depositor. Under no circumstances will material be released to any party other than the depositor.

The identity of all depositors is held in confidence by ATCC. To ensure that this confidentiality is not breached, we take every precaution when requests for information or culture material are received. All requests should be made in writing on the depositor's stationery and signed by an individual who is familiar to the appropriate ATCC personnel. Telephone requests are discouraged. Those depositors who do not wish to have ATCC honor telephone requests at all should indicate so. If desired, we will accept authorized signatures to compare with written requests.

Propriety: All material submitted to ATCC for safekeeping remains the property of the depositor. ATCC will not release the material or use it in any way unless specifically requested by the depositor. To ensure ATCC is aware of the ownership of deposited material a "Request for Safe Deposit" form must accompany each deposit. The depositor's name, as well as the name of the individual or institution on whose behalf the deposit is being made, must appear on the form. Material will be released only in response to written authorization from the depositor or the depositor's institution.

Security: In order to ensure the safety and security of the ATCC facility containing the safe deposit liquid nitrogen repository, a security staff is on duty 24 hours a day, 7 days a week. In addition, access to the liquid nitrogen repository is limited to authorized individuals via a controlled and monitored electronic entrance system. The liquid nitrogen tanks containing the safe deposit culture material are locked and accessed only by authorized inventory staff. All tanks are equipped with alarm systems, which monitor temperature and liquid nitrogen levels. When one or both deviate from established parameters, an audible alarm sounds and the security staff on the premises is alerted as well as an outside monitoring firm. Both the security staff and the monitoring firm maintain a redundant call list that includes the repository supervisor.

All safe deposit culture material is assigned inventory control numbers, the identities of which are known only to depositors and ATCC employees responsible for the safe deposits. Access to inventory records is limited to authorized personnel.

Renewal of Maintenance Agreements: On the anniversary of the deposit ATCC will automatically issue a request for renewal for any material requiring annual renewal, unless other instructions are provided by the depositor prior to the anniversary date. Requests for renewal of multiple-year arrangements will consist of submission of a new draft contract by ATCC to the depositor with the same terms as the previous agreement, unless other arrangements have been made prior to the end of the agreement period. An invoice is not automatic. We usually request a purchase order number or credit card authorization.

Termination of Maintenance: Depositors may request termination of their deposit at any time. Requests for termination should include instructions on disposition of the stored material. ATCC will destroy the material at ATCC's facilities for an additional fee upon receiving written instructions from the depositor. Alternatively, material can be shipped back to the depositor for shipping and handling fees. No portion of the deposit fee will be returned for early termination of a deposit.

Abandonment: Not responding to ATCC's requests for renewal of maintenance agreements will be considered abandonment of the stored material. ATCC will make a good faith effort to contact the depositor by all available means, including registered mail. Final notification will be given by registered mail of the date on which the depositor's material will be removed from storage and destroyed, if no response has been received. ATCC accepts no responsibility for loss of material destroyed by ATCC because of abandonment by the depositor.

Quality Assurance: All safe deposit material is handled by select ATCC repository staff. Upon arrival at ATCC a chain-of-custody is established for each package, and when the final destination is reached documentation is generated on receipt and location. This documentation is provided to ATCC Services. All safe deposit inventory is maintained in secure locked tanks that are accessible only to the repository supervisor and the select repository staff.

Safe deposit inventory is housed in liquid nitrogen tanks that are designed for vapor phase storage such as MVE models LZ-100, 1830 and 1830-2T. The tank temperature is established by adjusting the liquid nitrogen level to ensure a temperature of -145ºC or lower at the top of the inventory space. This is validated by measuring the temperature in the inventory space under actual working conditions.

All tanks are equipped with liquid level sensors. The electronic controllers provide audio and visual alarm signals for low-level alert, fill needed, fill completed, and high-level alert. All units have controls for manual and automatic filling. Manual filling is performed at least twice each week before the low-level indicator is reached, and all tanks are manually isolated from the liquid nitrogen source when not in use to prevent accidental overfilling.

Individual tank temperatures are monitored and logged using a PC-based program that signals the facility-wide alarm system when temperatures are out of range. The alarm system is monitored by designated ATCC staff and the ATCC security staff 24 hours a day. The alarms are also monitored by an off-site central service, and redundancy includes several levels of staff equipped with pagers and cell phones that are on call for immediate response to any alarm conditions. All alarm conditions and any action taken are logged. Back-up tanks are available if tank failure necessitates relocation of the inventory.

All tanks are connected to the emergency electrical power system provided by an on-site generator maintained by ATCC staff. Emergency response procedures are in place for handling facility emergencies such as fire. There is no redundant back-up of safe deposit material. ATCC's safe deposit service is offered as a redundant back-up to the client's own inventory. Therefore, we strongly encourage depositors not to utilize ATCC's safe deposit service as their sole source of banked material.

Vials are either placed on aluminum canes for storage in a vertical array of six vials each or are maintained in storage boxes in an inventory racking system. All safe deposit material is located in the vapor phase of the tank. For a variety of reasons, including safety, we do not maintain vials directly in the liquid nitrogen.

All tanks are located in secure areas of the ATCC facility, accessible only by authorized personnel. Inventory staff assigned to those areas are trained in the proper handling of material stored at cryogenic temperatures to ensure the integrity of the sample at all times, and in good inventory practices for storage, retrieval and maintenance of these items.

cGMP Safe Deposits

For those materials entrusted to ATCC for safe deposit under cGMP conditions all of the above terms and conditions apply. The following additional quality conditions are part of the cGMP service.

All ATCC staff who handle deposits submitted for cGMP storage and who process the documentation associated with them are trained in cGMP regulations and in the specific SOPs for their activities, including how to make process changes and initiate corrective actions. In addition all support staff who maintain the tanks and alarm systems and who perform equipment validations are trained in cGMP compliance.

Prior arrangements are required before material can be sent to ATCC for cGMP safe deposit. A tracking label is provided for placement on the shipping container to allow segregation of the cGMP material immediately upon arrival at ATCC. In addition, the inventory identification number for each item deposited is assigned prior to receipt of the material to ensure control through the entire process.

Dedicated tanks are used exclusively for cGMP safe deposit material, and mammalian cell banks are segregated from microbial cell banks. The tanks are physically separated from other tanks in the repository and are accessible only by cGMP-trained repository staff. The tanks are fully validated under cGMP conditions. Quality assurance staff are present at all times during stocking and retrieval activities or anytime the tank is opened.

There is a quality plan for the service, SOPs for all activities associated with the service, and training documentation for all participating staff.

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