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Version 7.60.1 of the ISBT 128 Product Description Code Database is Now Available

Version 7.60.1 of the ISBT 128 Product Description Code Database is now available and can be downloaded from the Product Description Code Database page.

ICCBBA is currently in the process of transitioning to a new website.The Database and Product Lookup Tools have now been redirected to the new website.

To receive access to the password-protected areas of the new website, users must have a new website account. If you do not have an account, please use this link for instructions on how to register for a password account on our website. https://www.isbt128.org/website-registration.

Below are some helpful links on the new website to help you access ISBT 128 Product Codes:

Database 

Product Lookup Program

Product Requests

[01 June 2022]


Public Comment Period for IG-002 US Consensus Standard for Blood v4.0.0 Draft

ICCBBA and the ATAG (Americas Technical Advisory Group) are seeking public comment on a new version 4.0.0 of the document IG-002 United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128.  The significant changes made to the document are captured in the version control table found in section 1.7.  Some of the changes include: 

  • Table 5 - New class-modifier combinations were added to the table.
  • Section 4.2.1.2 and Section 4.3.1.4 - The use of the “D” collection type in the Product Code for Directed, Eligible for Crossover units will not required to be used and will remain optional.
  • Table 7 - New attributes were added to the table.
  • Section 7.5 - The lower left quadrant Product Code label examples from section 7.5 were omitted and added to an addendum. It is also being suggested that some of the upper right quadrant ABO/Rh label examples be added to the addendum, in particular those that do not have accompanying text with the example.
  • Section 7.8.2 - Guidance on Reconstituted Red Blood Cells were expanded.
  • Section 7.8.11 – The Technical Bulletin document TB-015 (Bacterial Testing Strategies for Platelets - US Guidance) was incorporated into the section. TB-015 will be retired in the future when IG-002 v4.0.0 has been published.
  • Section 7.8.12 - The Technical Bulletin document TB-003 (Apheresis Platelets - US Guidance) was incorporated into the section. TB-003 will be retired in the future when IG-002 v4.0.0 has been published.
  • Updated CFR references throughout the document.
  • The labeling guidance for bacterially monitored Pooled Platelets has been revised.   

There were many other minor changes made throughout the document and reviewers are encouraged to comment on the entire draft document. All public comments will be reviewed by ICCBBA and ATAG prior to acceptance. 

The draft for IG-002 v4.0.0 can be found here. A mark-up version of the draft document is available upon request. 

Please submit comments to ig002.comments@isbt128.org by May 31, 2022.

[15 April 2022]


Version 6.1.0 of the Technical Specification is available now.

This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules. 

Version 6.1.0: ST-001 ISBT 128 Standard Technical Specification – PDF (2 MB)

*ICCBBA is currently in the process of transitioning to a new website.The ISBT 128 Standard Technical Specification and other webpages/documents have now been redirected to the new website.

[20 December 2021]


A new Standard, Labeling of Collection Products for Cellular Therapy Manufacturing, has now been published

ST-018 - ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing 

The new standard was designed to address inconsistencies in labeling apheresis collection products that are being used in cellular therapy manufacturing and was developed in collaboration with industry partners including bluebird bio, GlaxoSmithKline, Gilead Sciences, Johnson & Johnson, Juno Therapeutics, Kite Pharma, Legend Biotech, National Marrow Donor Program (NMDP/Be The Match), Deloitte, AABB, FACT, Standards Coordinating Body for Regenerative Medicine, TrakCel, Vineti, and subject matter experts in apheresis nursing and quality assurance. The standard aims to reduce the risk of misinterpretation of patient data while providing consistency in labeling requirements to collection centers.

This builds on the existing ISBT 128 standards for cellular therapy and is a supplement to the ISBT 128 Standard Technical Specification (ST-001). Essential ISBT 128 traceability information is retained, while also accommodating sponsor/manufacturer information in a standardized manner. It defines the labeling requirements for cellular therapy apheresis collection products for further manufacturing into clinical trials products or approved products. It is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label. While designed for apheresis collection products, the use of the label on collection products for further processing from other sources is not prohibited. Future versions of this standard may be extended to cover other sources of collection products.

Comments and questions about the new Standard should be directed to iccbba@iccbba.org.

[17 December 2020]