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Animal and Plant Health Inspection Service, USDA § 113.31

necessary to perform the test is as fol- (6) Calculate the percentage of mois- lows: ture in the original sample as follows: (1) Cylindrical weighing with (B¥C)/(B¥A) × (100) = Percentage of re- airtight stoppers. sidual moisture, where: (2) Vacuum oven equipped with vali- A = of weighing dated and thermostat. A B¥A = weight of sample before drying suitable air-drying device should be at- B¥C = weight of sample after drying tached to the inlet valve. (3) Balance, accurate to 0.1 mg (rated (7) The results are considered satis- precision ±0.01mg). factory if the percentage of residual (4) equipped with phos- moisture is less than or equal to the phorous pentoxide, silica gel, or equiv- manufacturer’s specification. alent. [68 FR 57608, Oct. 6, 2003] (5) Desiccated vaccine in original sealed . Sample and control should § 113.30 Detection of Salmonella con- be kept at room temperature in their tamination. original airtight until use. The test for detection of Salmonella (b) Test procedure: contamination provided in this section (1) Thoroughly cleaned and labeled shall be conducted when such a test is sample-weighing bottles with stoppers prescribed in an applicable Standard should be allowed to dry at 60 ±3 °C Requirement or in the filed Outline of under vacuum at less than 2.5 kPa. Production for the product. (i) Transfer hot bottles and stoppers (a) Samples shall be collected from into the desiccator and allow to cool to the bulk suspension before room temperature. bacteriostatic or bactericidal agents (ii) After bottles have cooled, insert have been added. When tissue culture stoppers and weigh and record the products are to be tested, 1 ml of tissue weights of the bottles as ‘‘A.’’ extract used as the source of cells or 1 (iii) Return weighing bottles to the ml of the minced tissue per se shall be desiccator. tested. (2) Remove the sample (b) Five ml of the liquid vaccine sus- seal. pension shall be used to inoculate each (i) Using a spatula, break up the sam- 100 ml of liquid broth medium (tryptose ple plug and transfer the required and either selenite F or tetrathionate). amount of sample to the previously The inoculated media shall be incu- tared weighing bottle. bated 18–24 hours at 35–37 °C. (ii) Insert the and weigh and (c) Transfers shall be made to either record the weights of the weighing bot- MacConkey agar or Salmonella- tles as ‘‘B.’’ Shigella agar, incubated for 18–24 hours (3) Place the weighing bottle with the and examined. stopper at an angle in the vacuum (d) If no growth typical of Salmonella oven. Set the vacuum to < 2.5 kPa and is noted, the plates shall be incubated the temperature to 60 ±3 °C. an additional 18–24 hours and again ex- (4) After a minimum of 3 hours of amined. drying time, turn off the vacuum pump (e) If suspicious colonies are ob- and allow dry air to bleed into the oven served, further subculture on suitable until the pressure inside the oven is media shall be made for positive identi- equalized with the prevailing atmos- fication. If Salmonella is found, the pheric pressure. bulk suspension is unsatisfactory. (5) While the bottle is still warm, re- [38 FR 29888, Oct. 30, 1973] place the stopper in its normal position and transfer the weighing bottle to the § 113.31 Detection of avian lymphoid desiccator. leukosis. (i) Allow a minimum of 2 hours for The complement-fixation test for de- the weighing bottle to cool to room tection of avian lymphoid leukosis pro- temperature or for its weight to reach vided in this section shall be conducted equilibrium. on all biological products containing (ii) Weigh, and record the weight as virus which has been propagated in ‘‘C.’’ substrates of chicken origin: Provided,

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