virus harvest pool and control fluid pool shall be tested for the presence of Mycoplasma, as follows: Samples of the virus for this test shall be stored either (1) between 2° and 8° C. for no longer than 24 hours, or (2) at -20° C. or lower if stored for longer than 24 hours. The test shall be performed on samples of the viral harvest pool and on control fluid pool obtained at the time of viral harvest, as follows: No less than 2.0 ml. of each sample shall be inoculated in evenly distributed amounts over the surface of no less than 10 plates of at least two agar media. No less than 1.0 ml. of sample shall be inoculated into each of four tubes containing 10 ml. of a semisolid broth medium. The media shall be such as have been shown to be capable of detecting known Mycoplasma and each test shall include control cultures of at least two known strains of Mycoplasma, one of which must be M. pneumoniae. One half of the plates and two tubes of broth shall be Incubated aerobically at 36° C. ±1° C. and the remaining plates and tubes shall be incubated anaerobically at 36° C. ±1° C. in an environment of 5-10 percent CO2 în N,. Aerobic incubation shall be for a period of no less than 14 days and the broth in the two tubes shall be tested after 3 days and 14 days, at which times 0.5 ml. of broth from each of the two tubes shall be combined and subinoculated on to no less than 4 additional plates and incubated aerobically. Anaerobic incubation shall be for no less than 14 days and the broth in the two tubes shall be tested after 3 days and 14 days, at which times 0.5 ml. of broth from each of the two tubes shall be combined and subinoculated on to no less than four additional plates and incubated anaerobically. All inoculated plates shall be incubated for no less than 14 days, at which time observation for growth of Mycoplasma shall be made at a magnification of no less than 300X. If the Dienes Methylene Blue-Azure dye or an equivalent staining procedure is used, no less than a one square cm. plug of the agar shall be excised from the inoculated area and examined for the presence of Mycoplasma. The presence of the Mycoplasma shall be determined by comparison of the growth obtained from the test samples with that of the control cultures, with respect to typical colonial and microscopic morphology. The virus pool is satisfactory for vaccine manufacture if none of the tests on the samples show evidence of the presence of Mycoplasma. Subpart E-Hepatitis Requirements § 610.40 Test for hepatitis associated (Australia) antigen. (a) General. Each donation of human blood, plasma, or serum to be used in preparing a biological product shall be tested for the presence of hepatitis associated (Australia) antigen. Such test shall be performed on blood, plasma, or serum taken from the donor at the time of donation or, for such material collected prior to the effective date of this section, upon removal from storage by the manufacturer. Only hepatitis associated antibody (anti-Australia antigen) licensed under this subchapter shall be used in performing the test and the test method(s) used shall be that for which the antibody product is specifically designed to be effective as recommended by the manufacturer in the package enclosure. (b) Restrictions on use-(1) Injectable biological products. Blood, plasma, or serum that is reactive when tested for hepatitis associated (Australia) antigen shall not be used in manufacturing injectable biological products. (2) In vitro diagnostic biological products. Blood, plasma, or serum that is reactive when tested for hepatitis associated (Australia) antigen may be used in manufacturing in vitro diagnostic biological products, provided that the package label of the biological products prepared from such blood, plasma, or serum conspicuously indicates that the product was prepared from material that was reactive when tested for hepatitis associated antigen and may transmit viral hepatitis. § 610.41 History of hepatitis associated (Australia) antigen. A person testing positive, or known to have previously tested positive, for hepatitis associated (Australia) antigen may not serve as a donor of human blood, plasma, or serum to be used in preparing any injectable biological product, except that a person known to have previously tested positive for hepatitis associated (Australia) antigen may serve source of hepatitis associated antibody when such antibody is required for the manufacture of a licensed biological product provided such person meets the requirements of § 610.40 at the time of donation. as a Subpart F-Dating Period Limitations § 610.50 Date of manufacture. The date of manufacture shall be determined as follows: (a) For products for which an official standard of potency is prescribed in either § 610.20 or § 610.21, or which are subject to official potency tests, the date of initiation by the manufacturer of the last valid potency test. (b) For products which are not subject to official potency tests, (1) the date of removal from animals, (2) the date of extraction, (3) the date of solution, or (4) the date of cessation of growth, whichever is applicable. § 610.51 Periods of cold storage. Except as otherwise provided in the regulations of this subchapter, products may be held in cold storage by the manufacturer as follows: At a temperature not above 5°C.-1 year. At a temperature not above 0°C.-2 years. § 610.52 Dating period. The dating period for a combination of two or more products shall be no longer than the dating period of the component product with the shortest dating period. The dating period for a product shall begin on the date of manufacture, except that the dating period may begin on the date of issue from the manufacturer's cold storage, provided the product was maintained as prescribed in § 610.51. If held in the manufacturer's cold storage beyond the period prescribed, the dating period shall be reduced by a corresponding period. § 610.53 Dating periods for specific products. The following dating periods are based on data relating to usage, clinical experience or laboratory tests that establish the period beyond which the product cannot be expected beyond reasonable doubt to yield its specific results and retain its safety, purity, and potency, provided the product is maintained at the recommended temperatures. The standards prescribed by the regulations in this subchapter, designed to insure continued safety, purity, and potency of the products, are based on the dating periods set forth below. Cold storage periods and temperatures prescribed in § 610.51 shall apply and outside labels shall recommend storage between 2° C. and 8° C., except when specifially provided otherwise. (Storage temperatures and storage periods are given in parentheses after the dating periods below when they differ from those specified in § 610.51.) Adsorbed Anti-A Serum.. Adenovirus and Influenza Virus Vaccines Combined Aluminum Phosphate Adsorbed. Adenovirus Vaccine... One year. Six months (5° C., six months). Six months (5° C., six months). Six months (5° C., six months). Aggregated Radio-Iodinated (a) Al- Thirty days. § 610.51 does not apply. bumin (Human). Allergenic Extracts.. Allergenic Extracts, Alum Precipitated... Anthrax Vaccine, Adsorbed.. Anti-A Blood Grouping Serum...--- Anti-A, B Blood Grouping Serum. Anti-B Blood Grouping Serum... Anti-Di Serum (Anti-Diego). Anti-Fy Serum (Anti-Duffy). Anti-Fyb Serum... Anti-Gr (Vw) Serum..-. Antihemophilic Factor (Human)__ Anti-Human Chorionic With 50 percent or more glycerin, three years (5° C., three years). With less than 50 percent glycerin, eighteen months (5° C., eighteen months). Products for which cold storage conditions are inappropriate, eighteen months, provided labeling recommends storage at no warmer than 30° C. § 610.51 does not apply. Powders and tablets, five years, provided labeling recommends storage at no warmer than 30° C. § 610.51 does not apply. Freeze dried products, five years (5o C., three years). Eighteen months (5° C., eighteen months). One year (5° C., two years). § 610.51 does not apply. Liquid: One year. Dried: Five years. Liquid: One year. Dried: Five years. Liquid: One year. Dried: Five years. One year. One year. One year. One year. Gonadotropic One year. § 610.51 does not apply. One year. § 610.51 does not apply. One year. Anti-Rh Typing Serum, Anti-hr ́ ́ (Anti- Anti-Rh Typing Serum, Anti-rh' (Anti- Liquid: One year. Anti-Rh Typing Serum, Anti-rh” (Anti- Anti-Rh Typing Serum, Anti-Rh. (Anti- Anti-Rh Typing Serum, Anti-Rho' (Anti- Anti-Rh Typing Serum, Anti-Rh.” (Anti DE). Anti-Rh Typing Serum, Anti-Rh.rh ́rh ́ ́ (Anti-CDE). Dried: Five years. Liquid: One year. One year. One year. Cobra Venom with Silicic and Formic Eighteen months (5o C., one year). Cobra Venom Solution.... Coccidioidin Collagenase Cryoprecipitated Antihemophilic Factor (Human). Diphtheria Antitoxin. Diphtheria and Tetanus Toxoids and Pertussis and Poliomyelitis Vaccines Adsorbed. Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed and Poliomyelitis Vaccine. Eighteen months (5° C., one year). Eighteen months, provided labeling recommends 12 months from the date of collection of source blood, provided labeling recommends storage at not above -18° C. § 610.51 does not apply. Liquid: Five years with an initial 20 percent excess of potency. Dried: Five years with an initial 10 percent excess of potency. Four months (5° C., two months) (a) Four months (5° C., two months). (b) One year, provided the pertussis and poliomyelitis components unmixed when issued (5° C., one year). Diphtheria and Tetanus Toxoids and Per- Eighteen months (5° C., one year). tussis Vaccine. Diphtheria and Tetanus Toxoids and Per- Eighteen months (5° C., one year). tussis Vaccine Adsorbed. Lymphogranuloma Venereum Antigen... Measles, Mumps, and Rubella Virus Vaccine, Live. Measles and Mumps Virus Vaccine, Live__ Mumps Immune Globulin (Human). Mumps Skin Test Antigen.. Mumps Vaccine_ Mumps Virus Vaccine, Live. Normal Horse Serum. Normal Serum Albumin (Human) Two years. One year (5° C., one year). One year (-20 C., one year). Twenty months. § 610.51 does not apply. Eighteen months (5° C., one year). Eighteen months (5° C., one year). Five years. (a) Five years, provided labeling recommends storage between 2° and 10° C. (5° C., three years). or |