Aly Designation: F2054/F2054M - 13 Burst Testing of Flexible Package Seals Using Internal Air 19 Plates" irvA mpc nese ear a eo, Standard Test Method for Pressurization Within Restr ‘tsp ce by de el hrs et es da oN 1. Scope 1.1. These test methods cover the procedure for determining the rinimum burst strength of a seal placed around the Perimeter of a flexible package as itis internally pressurized and enclosed within restraining plat 1.2 The test methods deseribed herein are functionally slmilse to Test Methods F140 with the exception of the use of restraining plates. Test Methods F) 140 deseribes: methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability 10 Withstand pressurization stresses. Under Test Methods 11140 the stresses are aot distributed uniformly to all areas of the package Seal, Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods 1140 may not reliably detect the weakest ste of the seal 1.3 The burst test internally and increasingly pressurizes package until an area ofthe package seal around the perimeter “burs” open in response to pressurization. By placing the package within restraining plas during pressurization, the \timensional stability of the package is maintained in « manner that resulls in stresses applied more uniformly along. the perimeter of the package, where seals are noemally placed, This allows the test to have a higher probability of detecting the weakest area of the seal and provide & measurement of the pressure requized to "bars open the package 1.4 This test only applies to flenible packages with seals placed aroun! the perimeter of a flexible package (often referred to as @ pouch), In particular iis intended as applicable to packages with seals that have a peelable seal feature (peeled ‘pen by end user to remove contents of pockoge). 14.1 Porous barrier materials’ failure to reach adequate pressure to burst the package seals may be de to insufficient volume flow: See Appendix X4 for information. fue gig ns rp Siar 9 “Geneon approved Ape |, 2013, Pulsed Se 2013. Ogi seed 24H Lit prov edoa appre 212 at F2DS4 07 QOD. 1.5 The valves stated in ether SI units or inch-pound units ‘are wo be regatded separacely as standard. ‘The valves stated in each system may not be exact equivalents; therefore, each ‘system shall be used independently of the otber. Combining vals from the two systems may result in non-confacmance with the standard 1.6 This standard does not purport to address all of the safety concerns, if ans, associated with iis ase. It 1 the responsibilty of the user of this standard to establish appro priate safety and health practices and determine the applica bility of regulatory liniuaions prior 1 use, Particular cain \dvised where users of this procedure may be required (© sruning plate Fixtares, Reference Ap pendix X3 for further information regarding calculation of sires felons and structural design considerations, 2. Referenced Documents 2.1 ASTM Standards? E171 Practice for Conditioning and Testing Flexible Barrier Packaging H6)I Practice for Conducting an Intetlaboratory Study to esermine the Prevision of a Test Method F17 Tenminology Relating o Flexible Bartiee Packaging FSS Test Method for Seal Strength of Flexible Barrier Materials F140 Test Methods for Intemal Pressurization Failure Re sistance of Untestained Packages A. Terminology 3.1 Definitions—For dofnitons and terms used in this test ‘method, refer to Terminology FI? for standardized texminol- ‘ogy for flexible burier packaging, 2.2 Definitions of Terms Specific 10 This Standard: 3.2 restraining plates, n—tofers to plates that are rigid in rare and configured 1@ contact and limit the packages ‘expandable surface area asthe package is pressurized. cyt ASTI Cato Sis even, Fo Aaa Rk of AST Conymght hy ASTM (al righ resentQh F0suraosan —13 4, Summary of Test Method 4.1 Packages are tested in an apparatus that internally pressurizes the package until an area of the package ruptures (turst). For most applications the rupuare (burst) will occur at fone oF more areas of the seal. The pneumatic supply and pressurization equipment need the capability to maintain an increasing pressure until the seal area fils. (For porous barrier material, see Appendix X4.) During pressurization, the pack age shall he encloxed between two rigid and parallel plates (Festraining plates) that limit the expansion and dimensional distortion of the package but allow the seal perimeter area to be tunrestricted. A sensor inside the package detects the internal pressure at the point at which the package ruptures (burst) Dependent on the application, two configurations of restraining plates are i 4.1.1 Open Package Configuration —An open package configuration is used where there is a seal placed around three sides of the package perimeter and the fourth side is open. This ‘configuration is generally use inthe original package man- facture, Se Fig. 1 for an illustration of the configuration used, 4.1.2 Closed Package Conjiguration —A closed package configuration is used where there is a seal placed around all {our sides of the package. This configuration generally is used in operations where the purpose is to test the seal in i's finished, fully-sealed state. See Fig. 2 for an illustration of the configuration used. S. Significance and Use 5.1. This test provides a rapid means of evaluating tenden: «es for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation, This test method provides an indicator of the burst strength of a package, where the burst will normally oeeur in oae or more freas of the seal, An indicator of the minimum burst stength muy be of importance wo the package manufacturer and ond user in ensuring adequate package integrity. This test method «eannot provide a measure of package seal uniformity. This test ‘Clamping Jaws 19 ‘Seal Open End of Pack Upper Restraining Plate ETE Split Plate Restrainit Top 5" Restraining Port | ESR TT Bottom Restraining Plate FIG. 2 Restraining Plates, Closed Package Configuration ‘method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that ‘contact the surface of the restraining plates used, This test ‘method should be combined with other methods of evaluating ‘overall package integrity, uniformity of the package seal, or ‘opening functionality if so require. 5.2 This test frequently is used to quickly evahuste pack: seal strength during the manufacturing process and at various stages of the package's life eyele. 53 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be ‘equivalent. Typical parameters can include, but are not limited to the package size, material, type and configuration af sea, rate of air flow into the package, pressure deteetion sensing mechanism and sensitivity (machine response to. pressure ‘drop), position of test ancl rigidity of restraining plates, and distance between restmining plates. See Appendix X2 for further information Flexible Package LLL LLL LLL Lower: Restraining Plate Pressurizaton and Sensor Nozzle (Open End Package Test) Extending Through Sealing Clamp Seal Area Perimeter Mechanism and Open End of Package FIG. 1 Restraining Piates, Open Package Configuration ‘Copyih by ASTM Lath al is resend:yy F205ar2054m - 13 54 This test may not necessarily provide correlation with package seal strength as typically measured using Test Meth- ‘ods F1140 or F88 (or equivalents) 6. Apparatus 6.1 Packages are tested under conditions described as f lows: 6.1 Open-Package Tester—Open-package test fixtures are used to test flenible packages with one of the four sides ofthe package open (nonseaed) The package is pressurized with an inflaion nozzle and pressure seasing mechanism inserted ito the open end of the package. The open end then is sealed by a clamping mechanism forthe duration of the ex (see Fig. 1) 6.12 Closed Package Tester—Closed-package test ixtres fare_uced to test packages with all four sides of the package sealed. The closed package tesier intermlly pressurizes the package ullizing a pressure nozzle and sensing mechanism that is connected though a puncture in the package (see Fig. 2. 6.2 The test apparatus for both open and closed package testing shall include the following: {62.1 An ir supply and pressure regulating mechanism that ca prxdace sufcint air low to pressurize the package tothe point of package failure (burs); For porous arrer materials, see Appendix X4: 622 A means of detecting a rapid pressure drop inside the package that signals that an aa of the package i stressed 10 failure thurs 62.3 A means of measuring the internal pressure at the point in which a rapid pressure drop cccurs asthe result of seal ‘Or other package fale (burs) 6.24 Two esraining pats that are configured similar w as stow in Fis. | or Fig. 2 is rigid to movement and lex, and contact the expandable surfce area of the package for the duration ofthe tes. 625 The following depending on type of test conducted. 625.1 Open-package test fixtures shall have a pressuriza- tion nozzle and sensor that is insevied ito the open end ofthe package, and clamping mechanism that seals the open end of the package, as well as creates an airtight seal around the pressurization norrie and sensor: at 62.52 Closed-package test fnures shall havea pressuriza- tion nozzle and sencor tat insects into a punetare of the body ofthe sealed package while mainiining am ai tight seal around those mechanisms 7. Sampling 7.1 Sampling—Choose the number of test specimens to permit an adequate determination of representative perfor- 8 Conditioning 8.1 Stancdend Test Conditions —Condition the packages for minimum of 72 h before performing test. Reference Specifi- cation E171 for further information on standard conditioning. 8.2 Effeats ofenvironmental conditions other than the above standards bave aot been determined as they relate tothe results (of this test method and may depend on packaging materials (Copy by ASTM In all igh reseed: used. Where comparisons or corelation's of test results may be ‘a requirement, and the testis conducted in other than standard test conditions, record the conditioning factory and the tem- perature and relative humidity atthe ime of test. 9, Procedure 9.1. Package Preparation—The package may be tesed with, if the package can fit within the restraining plates, or without product enclosed inside the package. Record the package test Preparation, if applicable. 9.2 Open-Package Test 1 Insert the package in a manner in which the body of the package is enclosed beiwcen the restraining plates. Place the package between the restraining plates in a manner which ‘minimizes the unrestrained areas ofthe package during the test It is advised to use some type of markings or fituring that ‘ensures consistent placement for all packages tsted. Ensure plate gap dimension is set to appropriate pap setting. See ‘Appendix X1 for recommendations on determining appropriate plate gap dimension settings {9.22 Inset or otherwise place the pressurization and sensor nozale inside the open end of the package 9.2. Close the clamping mechanism to produce an ai tight seal around the open end of the package including the area around the pressurization and sensor nozzle 9.3 Closed-Package Test: 9.3.1 Insert the body of the package within the restraining plates and close the plates i applicable, to the required plate fp dinensn. See Appendix XI for reommendaions on ing appropriate plate gap dimension settings. Sys] Cally en te preaaon an ser node entry device, and affix tothe package so as to create an at tight seal. The center of the package is the preferred point of entry and may be fixtured as an attachment tothe restraining plates (see Fig. 2). 9A Set the rate of pressurization and sensor sensitivity, if user selectable. Set the pressure failure sensor readout, if user selectable, 10 the desired units of measure, usually set 10 readout in pascal (Pa) kilopascal KPa) or inches of water units ‘of measure for most package tes resolutions requite. 9 Begin test by initiating inflation process. Continue pressurization until failure occurs, A failure in this context is When an area ofthe package ruptures (bursts) as the result of pressurization. The rupture (burst) is detected by the sensing ‘mechanism as a rapid decrease in pressure within the body of the package, and the pressure reading device reports the pressure at the point in time just prior 1 the pressure drop. 9.6 Visually examine the tested package and note the position and type of failure, as well asthe pressure at which the failure occurred. Ifthe failure occurred in an arca other than the seal the test may be voided depending on the purpose of the investigation. 10. Report 10.1 The report should include or have traceability to the following:Gp F20sar205am - 13 10.1.1 Test performed (open or closed package), apparatus used, test device machine seitings chosen if operator adjustable (eae of pressurization and sensitivity of pressure drop detec- tion senson, gap distance between resirsining. plates, and blocking agent used (see Appendix X4). 10.1.2 Packaging material types and other characteristics of| package tested, that is, whether with or without package contents inside the package, seal type and configuration, et, package Jot number and source's name. 10.2 Include the date, time, location, and identification of the individual performing the test. The mumber of packages tested, the individual test valucs, andthe units of measure that the sensing device is set to retum as response values, Docu- ‘mentation also may include noxaions of failure mode, area of seal package failure, unusual test conditions and results. 10.3 The conditioning parameters and environmental con- ditions used atthe time of test. if applicable 104 A summary including comments or conclusions, the somple mean and standard deviation, should also be repented ‘where appropriate, 1 Precision and Bias LL A esearch report deseribes a round robin conducted in 1999 in accordance with Practice E4691, involving ten labora: tories testing four package sets for each of two material types. Materials tested are listed in Table |* and statistical results are listed in Table 2 and Table 3. All samples were prepared at one source and then distributed fo each of the laboratories partici pating in the study. Each laboratory performed ten replicate tests for each package set. All testing was conducted using restraining plates set to a gap height of 25.4 mm. Only the open, package tex configuration (see Figs. | and 2) way used for the round robin, precision is assumed to be similar for both open and closed package test configurations *Sapponing ia hve bn dt ASTM interns Hetero ad ay te buted by eguening Rear Repert HRLFOD 10 Tryst reper waar of DP TABLE 1 Descriptions of Package Sets Tested in Reund-Robin Study Teme o Sonpes padage Pathe 1 Diner apt Matar) Tent Naber eet Centguatone™ pert of te A eh Bann sputone Ga PETBE 1010 6 1307 mm x 231m Spuronaea Ge PEVPE 1010 1mm x 2782 Spuroned Oe PETPE 10 154mm 2268 in Spuboued Cle PETPE 10 171.8 mm x 301.8 Per PETE io 143 rx 2223 in Pape PETE o 2360 wm» 360.3 Paper PETE io 4 “Til monion ovens ae remialSrersara 7 wating Pn ‘Messed so tavel verse tassel uel eine pegs ted A Fackagestoindare vesen gue stb cul aches win 1 Saree annoy Ej teal conluraten. Moora eed aro epurconded tn (10798 ease “yet ov maces! grate paper sealed fo PETPE poyesernoleryens) er PETS poyocepeprepyena| Erne ee (Copyih by ASTM at (al igh resend: easier Pactave ‘Be cove ce Sas isos Hae tan toms ° Sas 200 tran 2700 178 e Sos Geer? kos 10158 ‘Sat . Stes Osere Geo tobe Haas o foxes teas Iams tase tao TABLE 3 Summary of intriaboratory Test Resuts, Average COV for al Matera Tonia oan Bae Terape wave Tab merges 38 (Wwe ose, S00 iid Limitations and Considerations The test methods described herein are destructive in nature and do not allow repeat measurements on any given test specimen; therefore, by definition repeatability and reproducibility cannot be assessed as independent of the variability of the materials tested, Any estimate of test method precision in tems of repeatability oF reproducibility will inclide some level of variability atibut- able 10 the materials used. In addition, the selection of test Parameters (flow rate, plate gap height, pressure drop sensor Sensitivity, et.) For any given package configuration (package size, materials used, bonding agents, seal area con! skin area, ete.) will impact test results in terms of observed measurement values. Caution is advised where comparing test results conducted for different materials or test parameters 3 Repeatbility and reproducibility statistics in Table 2 include estimates of variance (standard deviations) and coe't- cients of variation (COV), Table 3 lists summary of resus which are average COVs for all package seis. Measurement Units are in kilopascal (KPa), COVS are included based on the ‘observation thatthe variability generally increases in propor- tion to the mean for any given set of test values. ‘This relationship may of may not apply 10 other materials or materials tested a test parameters other than used for this study. Also included are estimates based on the standard {deviations of the laboratory to laboratory (between laboratory) averages. This is included for the user to consider as an alternative estimate of tet method reproducibility from labo: ratory to laboratory. 4 Bias—There are no recognized standards by which to estimate the bias ofthis test method 12. Keywords 12.1 burst; closed package: exible packuging; inflation; ‘medical packaging: open package: restraining plate method(By F20surrzosam - 13 APPENDIXES (Nonmandatory Information) “XI, RECOMMENDATIONS FOR DETERMINING PLATE GAP DIMENSION X11 Table Xi. Fists recommended maximum plate gap mensions for varying package sizes as based on the rationale ‘deserted in XL3. Other plate gap dimensions may de used ‘depending on the application and suitable rationale for their usage. Experimentation with plate gap sctings shouldbe canducted for any specific aplication o determine suitability for use. Selection of a gap dimension may be dependent on rials tested, of boning mechanism, oe both as well as ‘Beomety ofthe seal. A pilot est of pouches at two oe three gap mensions, which can be correlate to sea strength tests (see “Tet Method F8) o locate the weakest area ofthe pouch seal perimeter can guide user to select that zap, which provides the Tost consistency of indicating the weakest seal area, The rationale ard recommendations described ia the following sections are to be considered a guideline to use as a starting point for plate gap selection X1.2 Asa precautionary warning regarding safety, it should bee noted that reductions in plate gap dimensions will result in higher stresses acting upon the plates for any given package size and design, This should be factored into the structural design of any restraining plates. Reference Appendix X3 for fanther information regarding calculation of stress factors and ssryetural design considerations. X1.3 The rationale for recommended plat a listed in Ta (6 % of the inflated package surface area fully contacts the plate suri, This is intended to ensure that the package is ‘maintained in a state of restraint when fully inflated. Concep- tually avery small gap dimension could be considered ideal for given range of package sizes. Available data indicates that the plate gap should be minimized where possible, Mdeally 90 % oe ‘more of the inflated surface area of the package should be in contact with the plates 10 increase the probability of bursts ‘cocurring at the weakest area ofthe sel; however this mast be braced azuinst the consideration that a very small plate gap may also wholly or partially inhibit the seal area from peeling ina natural manner. Depending on the specifics ofthe package ‘and seal design this could result ia misclasifcation of test results ‘TABLE X1.1 Recommended Plate Gap Dimensions x ° Meeran % ot tated Package Soa Seal Pesbaring Pate Pacha Sutace Direroon Biren oF Mats ‘Maxam Gap Conan wits Resting leat) Brora Paes Copy ty ASTN a al ihe reser: X14 For most applications the recommendations for plate ap dimension listed in Table XI.I are to be considered as a Staring point for determining the maximum plate gap setting. ‘To determine the appropriate maximum plate gap dimension first measure the width (W) and length (L) dimensions of the package to be tested. These measurements shall e taken from the inner seal to seal positions a illustrated in Fig. X11. Using the minimam value of W or L determine to which row of column X the valve corresponds. Then, select the correspond ing gap dimension (D). For example, if W = 63.5 mm and L = 127 mim, X is the lesser of 63.5 and 127, and as such, X = 63.5 vim, [FX = 63.5 mm, then X isin the range forthe row marked 2 $08 mm to < 101.6 mm and the corresponding gap dimension (D) is 12.7 mm. XI.S For reference and as an alternative © the tabled guidelines, the minimum surface area percentage (in contact ‘with restraining plates) may be approximated with the follow ing formu where: w Package width dimensioa (inner di seal), = Package length dimension (inner dimension from seal to seal), D. = Plate gap dimension selected, ‘= The lesser value of W or Ly and 3.141508) yension from seal 10ly F20sar205am — 13 Calculate ¢ asthe percentage of the infsted package surface that isin contact with the restraining plates as follows: Example: Using the dimensions listed in Fig. XU.1 and a plate gap of 12.7 mm. W = 685 mm L = 127mm D = 127mm = = 635mm (Cet) seca xiay X2. FACTORS INFLUENCING TEST RESULTS BETWEEN LABORATORIES X2.1_ Use of this procedure may involve comparing test results ftom various laboratories. The methods outlined herein are applicable to a wide range of products. To obtain results that ure consistent from one laboratory to another users should bbe aware of factors that influence test outcomes. AS a general ‘guideline to assist in understanding variables that influence the ‘outcomes of test results the following should be considered. X2.2 Restraining plate gap dimension should be controlled closely and identical when comparing test results between Inboratories. AS the gap dimension is reduced the volume inside the pouch or bag also is reduced, which will increase the ‘observed pressure at the point in which the pouch or bag ruptures (bursts). Experimentation with varying gap dimen- sions may be used 10 determine a suitable gap for any given pouch type. In gener, the gap dimension should be set so as {to maximize the surface area of the flexible membrane surfaces ‘that contacts the restraining plates and minimize distortions of the membrane during infaion X23 Rate of pressurization flow rate) should be controlled closely and identical when comparing test results between laboratories. This is of particular conoera where various Pressure testing hardware may be used and each hardware ‘manufacture may use a different method of design to control flow rates, that is, one design may be to set flow rate to 4 given ‘constant while another may utilize a design in which the flow rate ramps up. X24 ‘Test rulls for various pouches or bags of varying dimensions or material combinations cannot be compared a identical. Asa bag or pouch surface area increases the pressure load also is distributed over a larger surface area and the resultant pressure a the point in which the structure is observed to rupture (burst) will decrease. Materials used inthe design of the structure or adhesives used to provide a seal bond also may affect the dynamics of how the seal separates and have a resultant effect on the observed pressure at burs X3. CALCULATING STRESSES AND FACTORS OF SAFETY FOR RESTRAINING PLATE FINTURES IN INFLATION SEAL STRENGTH TESTS 3.1 Caleulation of the strestes and factors of safety 10 restraining plates for inflation seal strength tests re- ix basic stops quires X3.L.1 Define the applied load on the plates of the finture, X3.1.2 Calculate the applied loads given the maximam pressure applied to the poueh, X3.1.3 Calculate the stress and deflection on the plates of defined size and materials. 1X3.14 Calculate the applied loads on the fastener X3.1.5 Calculate the fasten size and pre-load fora defined ‘material. X3.1.6 Calvulate the factors of safety for the plates and sasteners. X3.2 This process should be undertaken by a knowledge able engineer or person skilled in the science. An example of this process follows. This example is for demonstration pur- poses only and cannot be wsed for a panicular application Copysa by ASTI Ha al dips serve X31 A pouch of dimensions § in. by 10 in,, made from two poly film materials is heat-sealed on four sides. An ‘experimental test shows that the burst pressure for this pouch {s 10 pst when retrained at / in. The test apparatus can supply up o 50 psig maximum. X3..1.1 The applied load area when the pouch is inflated will be less than the maximum area of the pouch. To be ‘conservative the entire pouch area will be assumed to be inflated. The area is (8 % 10) 80 in, The plates will be larger than the pouch to allow for fasteners. A plate of 10 ia, x 12 in is assumed, X3..1.2 The applied loud on each plate is as follows: Force = Presure x Area; F= 101/280 in? = $00, 3.1) X321.3 The sess and deflection on the plates are derived from empirical formuloe found in engineering text and depend ‘on design and restraining conditions of the plates. We will assume a simple case for plates that are bolted in three places along the long axis ofthe fixture, In this ease, we assure that the plate edges are simply supperied and ate Tree to rotate. In@Qyp F205ar2054m - 13 this ease, the stress and deflection of the phates can be caleulated by the following found in Rourks.° Sree = 8 bee ony and defection Y= Aw BYE? ea where: Aand B= constans, > = plate widits, a the plate length, Hi plate thickness, . applied pressure and F = Young's Meats for the plate materia X3.2.2 The constants A and B ae found from Table X3.1 as provided in Rourke Using these forme and tales we 8 assume that the loa is uniformly distributed over the entice plate. The restraining pates wil be large than the pouch isl to accommodate the bolt fasteners. We will assume that the plate size is 10 in,» 12 in. x78 i. thik. Thon, the af ratio Is 12/10 = 1.2, The calculations follow 5 3762 1Dpi (10) 395) ~ 2678p = 0616 ipa x (10}E(375)* ‘Where for 2024 Aluminum £ = 10.6x 10°, thon ¥ = 11.2 x 10-* (0112) in which is maximum atthe center ofthe piste. X33 Other conditions of pressure should be considered 10 allow for maximum loading Conditions. For example, if the plate gap decreases then the pressures will be higher. The ‘maximum pressure capability of the system is 30 psig. A caleulation at this pressure ll provide information at the ‘maximum condition. 5 = 3002 50 pa (10) 575) = 1578p ¥ = 616% 50 pt (10)1106 10 (375) = OSSinatthe sentir 037) X324 Caleulats the applied loads on the fasteners by first determining the number of bolts (0 he used. We will assume tha ix bolts willbe used atthe edges. For the 800 Ib load on six bolts the load por bolt i 138 I each. In the maximum case 050 ps the Toads 50 psi x 80 = 4000 Ib, 16 = 667 Ib per bolt 3.4) 35) ore) SRowhs Ferma fo Sess and Sin, New Yer, NY, McGraw Ha, TABLE X3.1 Constants A and X32 The bolt Size is determined from ealcubaton of 2 table of allowable loads that can be found in an enginesring text, such 36 SME Tool and Manafaciring Engineers Hand: book (sce Table X32," X5.25.1 The bolt chosen so thatthe minimum terile Joad is greater than the required resistance Io. The maximum load should be considered to prevent bot failure, In this ease the 10-32 bolt could he chosen 10 assure strength at the ‘maximum lod of 667 Ih X3.2.52 To prevent fatigue failure from repeated loads the bolt should be chosen so that when tightened 1 its proper preload the applied load s ess than the preload Value. In this ‘ase the 133 This less than te 655 In a propery preloaded 10-2 bolt. This bolt size wil function propecy even sf the loads re increased substantially. X3.2.6 Once the plate stress and bot load ae calculated, the designer shoul calculate factors of safety. The Fate of safety provides the extra margin of sress or loads for unanticipated Sstuations hat cannot be calculated. A factor of safety of at least 3-5 should be found. Sound engineering judgment must be exercised before the design is complete Facto sty = ont ste reac see (8) Frtipte tngn ne orang oe MSoeecoiadeaee 1 race tc 0p Toe exuossroe 31 fue X3.2.7 While still lower than the target range for factors of| safety, the designer may choose to exereise judgment on whether to continue t0 increase the bolt size or pethaps add more bolts to achieve the desired facior of safety Dail DI (ad, Scie of Manutcting Engi, Ta nd Mani. sarin Engineers Hendiok. ed ,New Yr, RY, McGrew Mal. 1976 Barsae swssaee Sia) int) 60% 1) woe Goer 780 to Copyiht by ASTM al al its resentyy F20sarz05am — 13 Nd, TESTING PACKAGES WITH A LARGE POROUS AREA X4.1 The testing of the seals of packages with porous barrier materials may be limited dae vo the inability o provide sufficict air volume. An example of this inability to provide sufficient aie volume may be encountered when the package is so large that air leaks through the porous harrier faster than it can be appliod. Because of this air Ieakage, inadequate force due to lower pressure will not allow either the bursting of the seals or reaching the desired holding pressure level X4.2 Industry has typically responded 10 this effect by limiting the porous barrier area. There are two major classifi cations of barrier blocking agents, the first being labels or tape, and the second being non-solid agents that are spreid cross the porous bartier material, Caution must be used with any method of blocking to easure that the porous barrier area is ‘consistently and uniformly covered or coated, When using labels or tape as blocking agents, it is important thet the blocking material daes not reinforce the seal stea being tested fom the package. When using. non-solid blocking agents that require spreading over the porous barrier material, eaution "wt be used t0 ensure that the blocking agent does not affect the seal bonding area by penetrating the porous barrier mate- rial. X43 Regardless of the method used, consistency of the area blocked is necessary to provide minimum vanability in the meth. Validation of these techniques is necessary when sed for regulated products. ASTM tnemasora kes pen e829 e Vay ay Bo Hs assed Maren wh Bn meres ‘in sare Users Ps Sana are caves ava at aso fm Way SUS ee Pn finger fc ts. ate ete Bown pcre ‘Th str athe sn atten ye mapa ect armies and rat ero oer fe yao “olrances ea easacvoder mona Yar corms ar ingame ese ota sara = asbesal arase fre shal eased AST rteraseral Meads You commons "oeove cell corodeaion aa mectng oh ‘sponse acres commen, wich you may S50 ou fa at poo ommarts hve et eceNe0 #3 RES as PUG (nate yor vows nun tno AGI Comma on Sana 3 arnt sw Dace