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AABB > Press Room > Comments

Comments on Amendments to FDA Sterility Testing Requirements for Biological Products (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.

AABB appreciates the opportunity to provide comments to the Proposed Rule "Amendments to Sterility Test Requirements for Biological Products" published 21 June 2011. In developing the comments AABB has relied on the expertise of its cellular therapy and transfusion medicine membership.

AABB applauds the FDA for amending the sterility test requirements in 21 CFR 610.12 which will provide manufacturers greater flexibility to use the most appropriate and state-of-the-art test methods. Comments to several of the proposals follow.

Comments to specific sections in the proposed rule are arranged in the following format:

Section – Current regulation and proposed regulation including impact of the proposed change

Comment/Recommendation – comments or recommendations on proposed changes

Section: When is sterility testing required?


21 CFR 610.12 requires that sterility testing must be performed, with certain limited exceptions, on both bulk and final container material for each lot of each biological product prior to release of that lot.


21 CFR 610.12 "The test. Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product's final container material or other material as appropriate and as approved in the biologics license application (BLA) or BLA supplement".

The proposed change will eliminate the sterility test requirement for most bulk materials. For purposes of sterility testing, the most appropriate test material is the final container material. The agency recognizes that due to the nature of some biological products, testing the final container material may not always be feasible or appropriate.


AABB endorses this proposed change. Each cellular therapy product is a lot in and of itself so therefore agrees with the testing of either the final container material or other material, as appropriate, prior to release.

Section: What are the sterility test requirements?

Test Methods


21 CFR 610.12(a), (b), and (e) prescribes the culture-based test method to be used for sterility testing, including the acceptable culture media and incubation conditions (time and temperature) to be used during testing.


21 CFR 610.12 "Test requirements. The sterility test must be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test".

The proposed change eliminates the requirement to use specified test methods and specific culture media for sterility testing. Manufacturers will be required to use a sterility test appropriate to the material being tested and ensure the material does not interfere with or otherwise hinder the test.


AABB agrees with the proposed change. This change allows manufacturers the flexibility to choose the most appropriate test method. The current required methods often require a larger sample volume than the volume of some products. The proposal will allow manufacturers that continue to use media to select media which would be better at detecting certain organisms than the current specific required media.



21 CFR 610.12(e) (2) (ii) stipulates the test organisms, strains, characteristics, identity and verification to be used to test growth-promoting qualities of the required test media.


21 CFR 610.12(e) (1) (2) "Verification. For culture-based test methods, studies must be conducted to demonstrate that the performance of the test organisms and culture media are suitable to consistently detect the presence of viable contaminating microorganisms, including test for each lot of culture media to verify its growth-promoting properties over the shelf-life of the media. For non-culture based test methods, within the test itself, appropriate controls must be used to demonstrate the ability of the test method to continue to consistently detect the presence of viable contaminating microorganisms".

The proposed change will eliminate the requirement to test culture media with specific test organisms and to eliminate the requirement regarding the number of organisms that must be used to demonstrate the growth-promoting qualities of the culture media. This proposal will also allow manufacturers to use sterility test methods that are either culture-based or non-culture based.


AABB recommends that the guidance to accompany the rule include such things as a list of organisms for manufacturers to consider in the development of their verification plan, including examples of when verification is required. This list will also be important in developing a validation plan.

AABB endorses the removal of the required list of specified organisms however providing a list of organisms for manufacturers to consider would be a benefit to facilities that do not have the necessary expertise or staffing.

AABB appreciates 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 +1.337.936.3538 or Bsee@aabb.org.


Becky See, MS, MLS (ASCP)cm, CQA(ASQ)
Deputy Director, Regulatory Affairs

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