CellSeal®

Frequently Asked Questions

The CellSeal line of lab products offers aseptic fill, finish, and storage options that scale to suit your bioprocessing project — all tailored for CellSeal Closed-System Cryogenic Vials.

COMPATIBILITY

Q: Are CellSeal Vials compatible with cryopreservation in liquid nitrogen?

A: CellSeal Vials are validated in actual conditions. CellSeal Vials were subjected to freezing, storage in liquid nitrogen, a drop test, frozen transportation, and thawing. Following thawing, a series of container integrity tests were performed, including dye and bacterial immersion studies. All vials met the defined criteria for each test.

COMPLIANCE

Q: Are the component materials suitable for use with biological products?

A: All specimen contacting materials are manufactured from USP Class VI compliant materials, and have been subjected to biological safety testing that included genotoxicity, cytotoxicity, sensitization, irritation, hemocompatibility, and acute systemic toxicity. All tests conducted met the requirements as specified in ISO 10993-1 with no adverse results.

Q: Is a Certificate of Compliance provided with the CellSeal Vial?

A: Yes. A Certificate of Compliance per lot number is provided to the customer with each purchase.

Q: Is a Certificate of Compliance provided with the CellSeal Vial?

A: A CE marked CellSeal medical device may be available in some regions. Please speak with your product representative for additional details.

COMPLETED STUDIES

Q: Has an extractable/leachable study been completed on CellSeal Vials?

A: CellSeal Vials have demonstrated low levels of extractables and leachables in evaluations.*
*E&L data is available

ESTABLISHED STANDARDS

Q: What are the current established standards that have been adopted by the cell therapy industry for particulates?

A: CellSeal Vials are manufactured in a way to support products that need to meet the visible particulates requirements specified in United States Pharmacopeia (USP) <1>, Injections and sub-visible particulate requirements in USP <788>, Particulate Matter in Injections.

EXPIRATION

Q: What is the expiration date of the CellSeal Vial?

A: The CellSeal Vial has an expiration date of three years from date of manufacture.

INSTRUCTIONS FOR USE

Q: How do I use the CellSeal Vial?

A: Please refer to the corresponding recommended instructions for guidance (IFU) below on how to use the CellSeal Vial.
CellSeal needle user guide (PDF)
CellSeal needleless user guide (PDF)

Disclaimer

Unless otherwise noted, CellSeal products are intended for laboratory research, bioprocessing, or manufacturing use only. Any use for diagnostic purposes, direct transfusion, or in the production of therapeutic product(s) or vaccine(s) may require advance regulatory review or approval. Determining the need for and seeking regulatory approval is the sole responsibility of the CellSeal product user. Cook Regentec will provide support in the form of testing data or Master File cross reference authorization as available and upon request. If you have any questions, please contact us at CellSealReg@CookRegentec.com.