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AABB > Press Room > Comments

Joint Comments on Exceptions to FDA Sterility Testing Requirements (21 CFR 610.12) – 9/16/11 

September 16, 2011

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

Re: Docket No. 2011-N-0080 Amendments to Sterility Test Requirements for Biological Products

Dear FDA Dockets Manager:

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

Founded in 1962, America's Blood Centers is North America's largest network of community-based blood programs. Seventy-five blood centers operate more than 600 collection sites in 45 U.S. states and Canada, providing half of the United States, and all of Canada's volunteer donor blood supply. These blood centers serve more than 180 million people and provide blood products and services to more than 4,200 hospitals and health care facilities across North America. ABC's U.S. members are licensed and regulated by the U.S. Food & Drug Administration. Canadian members are regulated by Health Canada.

The American Red Cross, through its 36 Blood Services Regions and five National Testing Laboratories, supplies more than 40% of the nation's blood supply. Over six million units of whole blood were collected from nearly four million Red Cross volunteer donors, separated into 9.5 million components, and supplied to approximately 3,000 hospitals and transfusion centers to meet the needs of patients last year.

We appreciate the opportunity to provide comments to the Proposed Rule "Amendments to Sterility Test Requirements for Biological Products" published 21 June 2011. The amendments proposed by the Food and Drug Administration to the sterility test requirements in 21 CFR 610.12 will provide manufacturers greater flexibility to use the most appropriate and state-of-the-art test methods, and the agency is to be commended for updating the regulations. Separate comments to several of the proposals were filed by AABB in a separate document. These joint comments address the question proposed by FDA (found on page 36024 of the Federal Register Notice) regarding the current exceptions to sterility test requirements and whether the exception for Platelets should be withdrawn.


21CFR 610.12(g)(4)(i) Sterility testing is not required for Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood Cells, Plasma, Source Plasma, Smallpox Vaccine, Reagent Red Blood Cells, Anti-Human Globulin, and Blood Grouping Reagent.


The agency's proposal is to maintain the current exceptions although FDA has asked that comments be submitted on whether to remove the exception for Platelets.


As noted on page 36024 of the Federal Register Notice the blood collection industry has called for and implemented methods to detect and limit or inactivate bacteria in platelet components (Standards for Blood Banks and Transfusion Services, 27th edition, Culture-based methods are in wide use as a quality control tool and more recently a nonculture-based method for use at point of issue has become available. However, early culture-based testing as it is practiced in the blood donor industry is not sterility testing and currently there are no available procedures/tests that will ensure the sterility of platelet products. Therefore if the current exception for Platelets from 21 CFR 610.12 is removed, manufacturers of blood components will not be able to satisfy this new requirement. The only technology that could possibly satisfy this requirement is pathogen inactivation, but these systems are currently not licensed in the US. We therefore recommend that FDA vigorously support applications for pathogen inactivation processes for platelet components. We recommend that FDA continue to exempt Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood Cells, and Plasma from the sterility test requirements in 21 CFR 610.12

Furthermore, any testing requirement tied to a biologics license application (BLA) is too narrow an approach to ensure optimal bacterial testing of platelet products. Platelets distributed as single whole blood-derived components that are pooled by a transfusion service would likely not be subject to the requirements. Any platelet collected or manufactured by a facility that does not have a BLA also would not be subject to the regulation.

We recommend that FDA use a different mechanism to require testing of all platelet products for bacterial contamination (without tying the requirement to a BLA and without requiring that sterility be documented) using a device approved by the FDA for this purpose. 21 CFR 610.12 as it is currently written, and the proposed language, restricts this requirement to a holder of a BLA. A proposed rule from 2007 (Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use) suggested that bacterial culture test results should be negative before products are released. However, the agency should recognize that due to the short shelf-life of platelets, it is required that platelet units be released as "negative to date".

We appreciate the opportunity to comment on the proposed rule. Should you have any questions regarding these comments or would like additional information, please contact me at 919.658.1689 or acarrgreer@aabb.org.


M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs

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