Determination of moisture content in desiccated biological products.

CFR · 2024-01-01 · US · Title 9

Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product. Firms currently using methods other than those provided in this section for determining the moisture content in desiccated biological products have until November 5, 2004 to update their Outlines of Production to be in compliance with this requirement. (a) Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows: (1) Cylindrical weighing bottles with airtight glass stoppers. (2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve. (3) Balance, accurate to 0.1 mg (rated precision ±0.01mg). (4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent. (5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use. (b) Test procedure: (1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa. (i) Transfer hot bottles and stoppers into the desiccat

official document · source cfr-2024 · id 9:§ 113.29