h671i CONTAINERS— PERFORMANCE TESTING - USP-NF

1 &h671iCONTAINERS PERFORMANCE TESTINGIt is the purpose of this chapter to provide standards for the func-tional properties of plastic containers and their components used topackage regulated articles (pharmaceuticals, biologics, dietary sup-plements, and devices). Definitions that apply to this chapter areprovided in thePreservation, Packaging, Storage, and Labelingsection of theGeneral Notices and Requirements. The tests thatfollow are provided to determine the moisture permeability andlight transmission of plastic containers utilized for regulated arti-cles. The sectionMultiple-Unit Containers for Capsules and Tab-letsapplies to multiple-unit containers. The sectionSingle-UnitContainers and Unit-Dose Containers for Capsules and Tabletsapplies to single-unit and unit-dose containers.

2 The sectionMulti-ple-Unit Containers for Capsules and Tablets (Without Closure)applies to polyethylene and polypropylene containers that haveno closures. The sectionMultiple-Unit and Single-Unit Containersfor Liquidsapplies to multiple-unit and single-unit container intended to provide protection from light or offeredas alight-resistantcontainer meets the requirements forLightTransmission, where such protection or resistance is by virtue ofthe specific properties of the material of which the container iscomposed, including any coating applied thereto. A clear and col-orless or a translucent container that is madelight-resistantbymeans of an opaque enclosure (seeGeneral Notices and Require-ments) is exempt from the requirements forLight Transmission.

3 Asused herein, the term container refers to the entire system com-prising, usually, the container itself, the liner (if used), the closurein the case of multiple-unit containers, and the lidding and blister inthe case of unit-dose CONTAINERS FORCAPSULES AND TABLETSD esiccant Place a quantity of 4- to 8-mesh, anhydrous calci-um chloride1in a shallow container, taking care to exclude any finepowder, then dry at 1108for 1 hour, and cool in a Select 12 containers of a uniform size and type,clean the sealing surfaces with a lint-free cloth, and close and openeach container 30 times. Apply the closure firmly and uniformlyeach time the container is closed. Close screw-capped containerswith a torque that is within the range of tightness specified in theaccompanying table.

4 AddDesiccantto 10 of the containers, desig-natedtest containers,filling each to within 13 mm of the closure ifthe container volume is 20 mL or more, or filling each to two-thirdsof capacity if the container volume is less than 20 mL. If the inte-rior of the container is more than 63 mm in depth, an inert filler orspacer may be placed in the bottom to minimize the total weight ofthe container andDesiccant; the layer ofDesiccantin such a con-tainer shall be not less than 5 cm in depth. Close each immediatelyafter addingDesiccant, applying the torque designated in the ac-companying table when closing screw-capped containers. To eachof the remaining 2 containers, designatedcontrols, add a sufficientnumber of glass beads to attain a weight approximately equal tothat of each of thetest containers, and close, applying the torquedesignated in the accompanying table when closing screw-cappedcontainers.

5 Record the weight of the individual containers so pre-pared to the nearest mg if the container volume is less than 20mL; to the nearest mg if the container volume is 20 mL or more butless than 200 mL; or to the nearest centigram (10 mg) if the con-tainer volume is 200 mL or more; and store at 75+3% relativehumidity and a temperature of 23+28. [NOTE A saturated systemof 35 g of sodium chloride with each 100 mL of water placed in thebottom of a desiccator maintains the specified humidity. Othermethods may be employed to maintain these conditions.] After336+1 hours (14 days), record the weight of the individual con-tainers in the same manner. Completely fill 5 empty containers ofthe same size and type as the containers under test with water or anoncompressible, free-flowing solid such as well-tamped fine glassbeads, to the level indicated by the closure surface when in the contents of each to a graduated cylinder, and deter-mine the average container volume, in mL.

6 Calculate the rate ofmoisture permeability, in mg per day per L, by the formula:(1000 / 14V)[(TF TI) (CF CI)]in whichVis the volume, in mL, of the container; (TF TI) is thedifference, in mg, between the final and initial weights of eachtestcontainer;and (CF CI) is the difference, in mg, between the av-erage final and average initial weights of the con-tainers used for drugs being dispensed on prescription, thecontainers so tested aretight containersif not more than 1 of the10test containersexceeds 100 mg per day per L in moisture per-meability, and none exceeds 200 mg per day per containers used for drugs being dispensed on prescription,the containers arewell-closed containersif not more than 1 of the10test containersexceeds 2000 mg per day per L in moisture per-meability, and none exceeds 3000 mg per day per 1.

7 Torque Applicable to Screw-Type ContainerClosure Diametera(mm)Suggested Tightness Range with ManuallyApplied Torque;b(inch-pounds)85106138155 9187 10208 12229 142410 182812 213013 233315 253817 264317 274819 305321 365823 406325 436626 457028 508332 658640 658940 7010045 7011045 701 Suitable 4- to 8-mesh, anhydrous calcium chloride is available commer-cially as Item JT1313-1 from VWR Scientific. Consult the VWR Scientificcatalog for ordering information or call ForumVol. 32(4) [July Aug. 2006]1#2007 The United States Pharmacopeial Convention, Inc. All Rights 1 of 7 Time:15:02 Date:11/30/07 Instance: t:\share\uspnf\printq\out\DGH_2007113015 133_M99430 Template:T:/SHARE/USPNF/PRINTQ/ BulletinOfficial December 1, 2007 Table 1. Torque Applicable to Screw-Type Container(Contin-ued)Closure Diametera(mm)Suggested Tightness Range with ManuallyApplied Torque;b(inch-pounds)12055 9513260 95aThe torque designated for the next larger closure diameter is to beapplied in TESTING containers having a closure diameter intermedi-ate to the diameters suitable apparatus is available from SecurePak, PO Box 1210,Maumee, Ohio 43537-8210.

8 MRA Model with indicators on boththe removal and application sides available in the following ranges:1) 0-25 inch lbs., which reads in 1 inch lb increments, 2) 0-50 inchlbs., which reads in 2 inch lb increments, and 3) 0-100 inch lbs.,which reads in 5 inch lb further detail regarding in-structions, reference may be made to Standard Test Method forApplication and Removal Torque of Threaded or Lug-Style Clo-sures ASTM Method D3198-02,published by the American So-ciety for TESTING and Materials, 100 Barr Harbor Drive, P. O. BoxC700, West Conshohocken, PA CONTAINERS FORCAPSULES AND TABLETS(Without Closure)Polyethylene Container Fit the containers with imperviousseals obtained by heat-sealing the bottles with an aluminum foil polyethylene laminate or other suitable the containers asspecified underMultiple-Unit Containers for Capsules and Tab-lets:the high density polyethylene containers so tested meet therequirements if the moisture permeability exceeds 10 mg per dayper L in not more than 1 of the 10 test containers and exceeds 25mg per day per L in none of them.

9 The low density polyethylenecontainers so tested meet the requirements if the moisture perme-ability exceeds 20 mg per day per L in not more than 1 of the 10test containers and exceeds 30 mg per day per L in none of Containers Fit the containers with impervi-ous seals obtained by heat-sealing the bottles with an aluminumfoil polyethylene laminate or other suitable seal. Test the con-tainers as described underMultiple-Unit Containers for Capsulesand Tablets. The containers meet the requirements if the moisturepermeability exceeds 15 mg per day per L in not more than 1 of the10 test containers and exceeds 25 mg per day per L in none CONTAINERS AND UNIT-DOSECONTAINERS FOR CAPSULES AND TABLETSTo permit an informed judgment regarding the suitability of thepackaging for a particular type of product, the following procedureand classification scheme are provided for evaluating the moisture-permeation characteristics of single-unit and unit-dose as equipment and operator PERFORMANCE may affect themoisture permeation of a container formed or closed, the moisture-permeation characteristics of the packaging system being utilizedshall be Dry suitable desiccant pellets3at 1108for 1 hourprior to use.

10 Use pellets weighing approximately 400 mg eachand having a diameter of approximately 8 mm. [NOTE If necessarydue to limited unit-dose container size, pellets weighing less than400 mg each and having a diameter of less than 8 mm may beused.]Procedure Method I Seal not fewer than 10 unit-dose containers with 1pellet in each, and seal 10 additional, empty unit-dose containersto provide the controls, using finger cots or padded forceps to han-dle the sealed containers. Number the containers, and record theindividual weights4to the nearest mg. Weigh the controls as a unit,and divide the total weight by the number of controls to obtain theaverage. Store all of the containers at 75+3% relative humidityand at a temperature of 23+28. [NOTE A saturated system of 35 gof sodium chloride with each 100 mL of water placed in the bottomof a desiccator maintains the specified humidity.]