§113.26. Detection of viable bacteria and fungi except in live vaccine. — Inbound Citations

(1) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(1) Final container samples of completed product from the first serial or subserial of an autogenous biologic produced from an isolate shall be tested for purity as prescribed in § 113.26, and for safety as prescribed in § 113.33(b) or § 113.38 except that:

(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.

(ii) Serials which are satisfactory after the third day of observation of purity test cultures and of safety test animals may be released for shipment to the customer and the tests continued throughout the required period; and

(iii) Serials released on the basis of satisfactory results of third day observations shall be immediately recalled if evidence of contamination occurs in test cultures or if any of the test animals used to demonstrate product safety, sicken, or die during the observation period.

(iv) Test summaries must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) on a quarterly basis by the 21st day of January, April, July, and October or more often as required by the Administrator.

(a) Final container samples of completed product from each serial and subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(1) Final container samples of completed product from each serial shall be tested as prescribed in § 113.26.

(a) Ingredients for which standards are prescribed in the United States Pharmacopeia, or elsewhere in this part, shall conform to such standards. In lieu of preparing the media from the individual ingredients, they may be made from dehydrated mixtures which, when rehydrated with purified water, have the same or equivalent composition as such media and have growth-promoting buffering, and oxygen tension-controlling properties equal to or better than such media. The formulas for the composition of the culture media prescribed in §§ 113.26 and 113.27 are set forth in the United States Pharmacopeia, 19th Edition.

(1) Final container samples of completed product shall be tested for viable bacteria and fungi as prescribed in § 113.26.

(a) Final container samples of completed product shall be tested for viable bacteria and fungi as prescribed in § 113.26. In addition, each serial shall be free from extraneous organisms as determined by Gram staining and microscopic examination.

(e) The antigen shall be tested for viable bacteria and fungi as prescribed in § 113.26.

(a) Each serial shall be tested for viable bacteria and fungi as prescribed in § 113.26.

(1) Dried products for parenteral administration and liquid products shall be tested as prescribed in § 113.26.

(b) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable).

(d) The MCS and either each subculture used to prepare a biological product or the final pool of harvested material for each serial of such product or final container samples of completed product for each serial of such product shall be tested for bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable). If bacteria or fungi are found in the MCS, the MCS shall not be used. If bacteria or fungi are found in a subculture, the subculture shall not be used.

(b) Samples of each lot of ingredient or animal origin which is not subjected to heat sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26.

(c) Final container samples from each serial shall be tested for bacteria and fungi in accordance with the test provided in § 113.26. Any serial found to be unsatisfactory shall not be released.

(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.