|
|
671
CONTAINERS—PERMEATION
661). As used herein, the term “container” refers to the entire system comprising, usually, the container itself, the liner (if used), the closure in the case of multiple-unit containers, and the lidding and blister in the case of single-unit and unit-dose containers.
for 1 hour, and cool in a desiccator.
. [NOTE—A saturated system of 35 g of sodium chloride with each 100 mL of water placed in the bottom of a desiccator maintains the specified humidity. Other methods may be employed to maintain these conditions.] After 336 ± 1 hours (14 days), record the weight of the individual containers in the same manner. Completely fill 5 empty containers of the same size and type as the containers under test with water or a noncompressible, free-flowing solid such as well-tamped fine glass beads, to the level indicated by the closure surface when in place. Transfer the contents of each to a graduated cylinder, and determine the average container volume, in mL. Calculate the rate of moisture permeability, in mg per day per L, by the formula:
| Closure Diameter1 (mm) | Suggested Tightness Range with Manually Applied Torque;2 (inch-pounds) |
| 8 | 5 |
| 10 | 6 |
| 13 | 8 |
| 15 | 5–9 |
| 18 | 7–10 |
| 20 | 8–12 |
| 22 | 9–14 |
| 24 | 10–18 |
| 28 | 12–21 |
| 30 | 13–23 |
| 33 | 15–25 |
| 38 | 17–26 |
| 43 | 17–27 |
| 48 | 19–30 |
| 53 | 21–36 |
| 58 | 23–40 |
| 63 | 25–43 |
| 66 | 26–45 |
| 70 | 28–50 |
| 83 | 32–65 |
| 86 | 40–65 |
| 89 | 40–70 |
| 100 | 45–70 |
| 110 | 45–70 |
| 120 | 55–95 |
| 132 | 60–95 |
|
1
The torque designated for the next larger closure diameter is to be applied in testing containers having a closure diameter intermediate to the diameters listed.
2
A suitable apparatus is available from Owens-Illinois, Toledo, OH 43666. (Model 25 torque tester is used for testing between 0 and 25; Model 50 for testing between 0 and 50; and Model 100 for testing between 0 and 100 inch-pounds of torque.) The torque values refer to application, not removal, of the closure. For further detail regarding instructions, reference may be made to “Standard Test Method for Application and Removal Torque of Threaded or Lug-Style Closures” ASTM Method D3198-97, published by the American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103.
|
|
for 1 hour prior to use. Use pellets weighing approximately 400 mg each and having a diameter of approximately 8 mm. [NOTE—If necessary due to limited unit-dose container size, pellets weighing less than 400 mg each and having a diameter of less than 8 mm may be used.]
. [NOTE—A saturated system of 35 g of sodium chloride with each 100 mL of water placed in the bottom of a desiccator maintains the specified humidity. Other methods may be employed to maintain these conditions.] After a 24-hour interval, and at each multiple thereof (see Results), remove the containers from the chamber, and allow them to equilibrate for 15 to 60 minutes in the weighing area. Again record the weight of the individual containers and the combined controls in the same manner. [NOTE—If any indicating pellets turn pink during this procedure, or if the pellet weight increase exceeds 10%, terminate the test, and regard only earlier determinations as valid.] Return the containers to the humidity chamber. Calculate the rate of moisture permeation, in mg per day, of each container taken by the formula:
WI) is the difference, in mg, between the final and initial weights of each test container; and (CF CI) is the difference, in mg, between the average final and average initial weights of the controls, the data being calculated to two significant figures. [NOTE—Where the permeations measured are less than 5 mg per day, and where the controls are observed to reach equilibrium within 7 days, the individual permeations may be determined more accurately by using the 7-day test container and control container weights as WI and CI, respectively, in the calculation. In this case, a suitable test interval for Class A (see Results) would be not less than 28 days following the initial 7-day equilibration period (a total of 35 days).]
. [NOTE—A saturated system of 35 g of sodium chloride with each 100 mL of water placed in the bottom of a desiccator maintains the specified humidity. Other methods may be employed to maintain these conditions.] After 24 hours, and at each multiple thereof (see Results), remove the packs from the chamber, and allow them to equilibrate for about 45 minutes. Record the weights of the individual packs, and return them to the chamber. Weigh the control packs as a unit, and divide the total weight by the number of control packs to obtain the average empty pack weight. [NOTE—If any indicating pellets turn pink during the procedure, or if the average pellet weight increase in any pack exceeds 10%, terminate the test, and regard only earlier determinations as valid.] Calculate the average rate of moisture permeation, in mg per day, for each unit-dose container or blister in each pack taken by the formula:
WI) is the difference, in mg, between the final and initial weights of each test pack; and (CF CI) is the difference, in mg, between the average final and average initial weights of the control packs, the rates being calculated to two significant figures.
1176). The use of an analytical balance on which weights can be recorded to 4 or 5 decimal places may permit more precise characterization between containers and/or shorter test periods.