Relevant test methods

ASTM D4169 describes the standard practice for performance testing of shipping containers and systems. It provides a guide for the evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution. The recommended test levels are based on available information on the shipping and handling environment, and current industry / government practice and experience.

The tests should performed sequentially on the same containers in the order given. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequences of tests are completed.

Scope

1.1 This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles. This practice is not intended to supplant material specifications or existing preshipment test procedures.

1.2 Consider the use of Practice D7386 for testing of packages for single parcel shipments.

1.3 The suitability of this practice for use with hazardous materials has not been determined.

1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ASTM D4169-05, DC=13 – testing sequence and types:

Many materials from which containers and packages are made, especially cellulosic materials, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied. Therefore, the package should be placed and kept in a specified atmosphere for a length of time such that subsequent measurements of physical properties will be meaningful and reproducible.

 The conditions described in this practice are either historically accepted standard conditions or special laboratory conditions chosen to represent particular phases of the distribution environment. These special conditions do not necessarily duplicate actual field conditions, but tend to simulate them and have effects on packages and materials which may be related to their field performance.

1. Scope

1.1 This practice provides for standard and special conditioning and testing atmospheres that may be used to simulate particular field conditions that a container, package, or packaging component may encounter during its life or testing cycle.

1.2 This practice describes procedures for conditioning these containers, packages, or packaging components so that they may reach equilibrium with the atmosphere to which they may be exposed.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Shipping containers are exposed to complex dynamic stresses in the distribution environment. Approximating the actual damage, or lack of damage, experienced in real life may require subjecting the container and its contents to random vibration tests. In this way, ASTM-D4728 standard test method for random vibration testing of shipping containers simultaneously excite many product and container resonances.

Resonance buildups during random vibration tests are less intense than during sinusoidal resonance dwell or sweep tests. Therefore, unrealistic fatigue damage due to resonance buildup is minimized. Random vibration tests should be based on representative field data. When possible, confidence levels may be improved by comparing laboratory test results with actual field shipment effects.

Vibration exposure affects the shipping container, its interior packing, means of closure, and contents. This test allows analysis of the interaction between these components. Design modification to one or all of these components may be used to achieve optimum performance in the shipping environment.

Random vibration tests may be simultaneously performed with transient or periodic data to simulate known stresses of this type, that is, rail joints, pot holes, etc. Random vibration may be conducted in any axis (vertical or horizontal) or in any package orientation. However, different test levels may be utilized for each axis depending on the field environment that is to be simulated.

Scope

• 1.1 This test method covers the random vibration testing of filled shipping units. Such tests may be used to assess the performance of a container with its interior packing and means of closure in terms of its ruggedness and the protection that it provides the contents when subjected to random vibration inputs.
• 1.2 This test method provides guidance in the development and use of vibration data in the testing of shipping containers.

Scope

1.1 These test methods cover vibration tests of filled shipping containers. Such tests may be used to assess the performance of a container, with its interior packing and means of closure, both in terms of its strength and of the protection it provides its contents when it is subjected to vibration such as it experiences in transportation. These procedures are suitable for testing containers of any form, material, kind, design of interior packing, means of closure, and any size and weight. They are not intended for determining the response of products to vibration for product design purposes, nor are they intended for tests of products in their operational configuration as other more suitable procedures are available for these purposes.2,3

1.2 The following methods appear:

Method A1—Repetitive Shock Test (Vertical Motion).

Method A2—Repetitive Shock Test (Rotary Motion).

Method B—Single Container Resonance Test.

Method C—Palletized Load, Unitized Load, or Vertical Stack Resonance Test.

1.3 For testing of intermediate bulk containers (IBCs) containing liquid hazardous materials, refer to Test Method D 7387.

1.4 These test methods fulfill the requirements of International Organization for Standardization standards ISO 8318 and ISO 2247. The ISO standards may not meet the requirements for these methods.

1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary  statements are given in Section 6.

The ASTM-D5276 standard test method for drop test of loaded containers evaluates the capability of a container to withstand the sudden shock resulting from a free fall, or the capability of a container and its inner packing to protect its contents during the sudden shock resulting from a free fall. This test method may also be used to compare the performance of different package designs. It may also permit observation of the progressive failure of a container and the damage to its contents.

ASTM-D5276 is particularly suitable for containers that are normally handled manually during some part of their distribution cycle. Containers of such bulk or mass that they cannot be handled manually may be tested more satisfactorily in accordance with Test Method D 880, Test Methods D 6055, Test Methods D 6179, or Test Methods D 4003. See Practice D 4169 for additional guidance.

Scope

• 1.1 This test method covers procedures for the drop testing of loaded boxes, cylindrical containers, and bags and sacks by the free-fall method.
• 1.2 For containers not exceeding 110 lb (50 kg), this test method fulfills the requirements of ISO Standards 2206:1987 and 2248:1985. These ISO standards may describe procedures that do not meet the requirements for this test method.
• 1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

ASTM-D642 is the standard test method for determining compressive resistance of shipping containers, components, and unit loads. Compressive resistance is one of the properties used to evaluate the ability of shipping containers, components, and unit loads to successfully survive the compressive forces they are subjected to during storage and distribution.

Compressive resistance may be determined with either fixed- or swiveled-platen-type testing machines. However, a fixed-head compression machine is required to perform edge-to-edge and corner-to-corner orientations on test specimens. Also, unit loads are generally tested only in the top-to-bottom orientation.

Scope

• 1.1 This test method covers compression tests on shipping containers (for example, boxes and drums) or components, or both. Shipping containers may be tested with or without contents. The procedure may be used for measuring the ability of the container to resist external compressive loads applied to its faces, to diagonally opposite edges, or to corners (Fig. 1 and Fig. 2). This test method covers testing of multiple containers or unit loads, in addition to individual shipping containers, components, materials, or combination thereof.
• 1.2 The test method of applying load may be used to compare the characteristics of a given design of container with a standard, or to compare the characteristics of containers differing in construction.
• 1.3 This test method is related to TAPPI T804, which is similar for fixed platen machines but does not recognize swivel platen machines. This test method fulfills the requirements of International Organization for Standardization (ISO) Test Method 12048. The ISO standards may not meet the requirements for this test method.

 The ASTM D6653 test determines the effects of high altitude / pressure differential when packaged products are transported via certain modes of transport, such as aircrafts or ground over high mountain passes. When exposed to these high altitude conditions, products or packaging systems, or a combination thereof, may be affected negatively by the resultant pressure differential.

These test methods are suitable for package or product, or both, development and engineering. Other test methods, such as Test Methods D3078, D4991 and D5094, test for leakage of packaging systems by vacuum method and are applicable for testing the effects of high altitude.

Scope

• 1.1 Packaged products transported via the feeder aircraft network are liable to experience altitudes as high as 5 791 m [19 000 ft].
• 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

The ASTM-D3078 is the standard test method for determination of gross leaks in flexible packaging containing a headspace gas by bubble emission. The test is conducted by submerging the test specimen in the immersion fluid within the confines of a vacuum chamber. If bubbles or seepage of fluid within specimen attributable to a leak are observed, then the specimen fails the test.

Apparatus & Materials:

Vacuum Chamber: A vacuum chamber shall be any transparent container capable of withstanding approximately one atmosphere pressure differential, fitted with a vacuum-tight cover. A vacuum gage, an inlet tube from a source of vacuum, and an outlet tube to the atmosphere shall be connected to the chamber cover.

Immersion Fluid: Use an immersion fluid which does not degrade the package being tested. The test sample and test fluid shall be at equilibrium with normal room temperature.

Scope

• 1.1 This test method covers the determination of gross leaks in flexible packaging containing a headspace gas. Test sensitivity is limited to 1 × 10−5 atm cm3/s (1 × 10−6 Pa m3/s) or even less sensitive as indicated in a recent interlaboratory test (reported in Section 12).
• 1.2 Small leaks may not be detected by this procedure. Viscoelastic effects on the products, or entrapped air, become significant and prevent passage through small openings. Positive pressure inside the pouch after the vacuum is drawn may force the product to plug small leaks. The size of the leak that can be detected is dependent upon the products contained, the nature of the packaging material, and the test parameters selected.

1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard

ASTM F1140 testing provides a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. It is regularly used to assess packages during the manufacturing process and at various stages of the package life cycle. Pressure differentials may occur during processes such as sterilization and transportation.

If correlations between pieces of test equipment are to be made, it is vital that all parameters of the test method be exactly the same. Typical parameters of ASTM F1140 testing may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article.

ASTM F1140 testing is comprised of the following:

• Burst Test -Determines package strength by pressurizing a package until it bursts.
• Creep Test -Determines package strength by pressurizing a package at a set percentage of the known burst pressure for a fixed amount of time.

Test Methods

In the Burst Test, air is introduced into the package at a predetermined pressure and flow rate. The porosity (or lack thereof) of the package material determines the inflation rate for the burst test. Because air escapes through the walls of a porous package during inflation, the flow rate must be increased to compensate for the lost air through the walls and create the back pressure in the porous package. This pressure creates the force needed to rupture the seal.

In the Creep Test, a whole package is inflated to a constant pressure, which is then held for a specified time, resulting in a pass / fail result. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.

ASTM F1929 testing defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 μm (0.002 in.) wire in package edge seals formed between a transparent film and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.

Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently discovered at seals between package components of the same or dissimilar materials. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.

The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material.

There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. However, since ASTM F1929 testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.

Requirements

• ASTM F1929 testing is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal for a minimum of 20 seconds.
• Prior to ASTM F1929 testing, all test specimens must be conditioned.
• If ASTM F1929 testing is used as the quality control method, the test specimen must consist of a complete packaged device.
• Packaging must be free of condensation or any other source of liquid water. Water already in the seal defects may render them undetectable with a dye penetrant.
• ASTM F1929 procedure requires that the dye penetrant have good contrast to the opaque packaging material.

Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Visual seal defects will often be the initial indication of heat sealing process variation. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.

ASTM F1886 testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package. ASTM F1886 covers the determination of channels in the package seal down to a width of 75 μm (0.003 in.) with a 60 – 100 % probability.

The ability to visually detect channel defects in package seals is highly reliant on:

• Size of channel
• Degree of contrast from sealed and unsealed areas
• Amount and type of adhesive between the two package layers
• Reflecting light angle
• Types of materials used
• Use of magnification

ASTM F1886 procedure is comprised of the following

• ASTM F1886 is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
• Inspection of the seal should be performed at a distance of 30 to 45 cm (12 to 18 in.).
• Completeness and uniformity of the entire seal area of the package must be inspected.
• Any part of the seal where channels appear across entire seal width must be identified and recorded.
• Record the number and location of channels identified on each package.

ASTM F88 is the standard followed when performing Peel tests on Packaging. Peel Tests determine ‘Seal strength’ of the package, which is defined as the measure of the ability of a package seal to resist separation. The test results are not only related to package integrity, but also to measuring the packaging processes’ ability to produce consistent seals. Given that Seal strength is a necessary requirement for packaging, Peel Tests are ubiquitous for all types of packaging.

According to the ASTM F88 standard, a number of fixtures and techniques have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique (Technique A, Technique B, or Technique C) throughout a test series is recommended.

Descriptions and examples of fixtures and techniques from the standard are illustrated in figure below:

• Technique A: Unsupported—Each tail of the specimen is secured in opposing grips and the seal remains unsupported while the test is being conducted.
• Technique B: Supported 90° (By Hand)—Each tail of the specimen is secured in opposing grips and the seal remains hand-supported at a 90° perpendicular angle to the tails while the test is being conducted.
• Technique C: Supported 180°—The least flexible tail is supported flat against a rigid alignment plate held in one grip. The more flexible tail is folded 180° over the seal and is held in the opposing grip while the test is being conducted.

Scope

• 1.1 This test method covers the measurement of the strength of seals in flexible barrier materials.
• 1.2 The test may be conducted on seals between a flexible material and a rigid material.
• 1.3 Seals tested in accordance with this test method may be from any source, laboratory or commercial.
• 1.4 This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure.

The Bubble Leak test, which follows the ASTM F2096 standard, is conducted by visually inspecting for bubble streams caused from a defect in the packaging/sterile barrier system – all while it is submerged under water and gently pressurized. This destructive testing method provides a practical way to examine packages for gross leaks, which may render the product non-sterile. This test method may apply to very large or long packages, which do not fit into any other package integrity test method apparatus.

The intensity of internal pressure for the package is determined by introducing a control defect created in a known location of the package. Pressure is gradually increased until the defect begins to show a constant stream of bubbles indicating a specific area of failure.

Scope

• 1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 μm.
• 1.2 This test method is destructive in that it requires entry into the package to supply an internal air pressure.

The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period (one year, two years, etc.) without any decrease in performance that may affect safety and efficacy when the products are used.

The ASTM F1980 guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006avautuu uuteen ikkunaan, and the physical properties of their component packaging materials.

It is imperative to administer accelerated aging (ASTM F1980) tests to present experimental data in support of performance and shelf-life claims for these products until full-period or “real time” aged samples become available. Extracted information from ASTM F1980 testing may be used to support expiration date claims for medical device sterile barrier systems.

ASTM F1980 procedure for accelerated aging is comprised of the following:

• Select the Q10 value
• Define the desired shelf life of the package (marketing and product needs, etc.).
• Define aging test time intervals (including time zero).
• Define test conditions, room temperature (TRT), and accelerated aging temperature (TAA).
• Use the Q10, TRT, and TAA to calculate the test duration.
• Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
• Age samples at TAA. In parallel, age samples at real-life aging conditions (TRT).
• Evaluate the package performance after accelerated aging relative to the initial package requirements.

Evaluate package, or package performance, or both, after real time agingavautuu uuteen ikkunaan relative to the initial package requirements.

ISTA 1A is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product and package combination to withstand transport hazards. Procedure 1A is useful particularly when used as a consistent benchmark over time.

Many medical device manufacturers use ISTA Procedure 1A. This procedure was developed for a quick and easy way to evaluate a shipping configuration for drop testing and repetitive shock vibration. This procedure does not take into a account random vibration or atmospheric pre-conditioning.

Test Procedure 1A is broken down into two categories: Vibration and Shock:

• Vibration is fixed displacement that complies with ASTM D999avautuu uuteen ikkunaan. Rotary or vertical linear motion of the platform is acceptable.
• Shock testing is broken down into three test types: Drop, Incline-Impact (Conbur), and Horizontal Impact. Drop testing is a free fall test and complies with ASTM D5276avautuu uuteen ikkunaan. Incline-Impact (Conbur) testing complies with ASTM D880, and Horizontal Impact testing is in compliance with ASTM D4003.

When properly applied, ISTA procedure 1A will provide tangible benefits of:

• Shortened packaged development time and confidence in product launch
• Protection of products and profits with reduced damage and product loss
• Economically balanced distribution costs
• Customer satisfaction and continued business

ISTA Procedure 1A – Testing Sequence and Types:

ISTA 1G is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product and package combination to withstand transport hazards.

ISTA procedure 1G is similar to ISTA 1Aavautuu uuteen ikkunaan. The primary difference is that the vibration method used for ISTA 1G is random, whereas 1A vibraton is fixed.

Test Procedure 1G is broken down into two categories: Vibration and Shock:

• Vibration is random displacement that complies with ASTM D4728.avautuu uuteen ikkunaan Rotary or vertical linear motion of the platform is acceptable.
• Shock testing is broken down into three test types: Drop, Incline-Impact (Conbur), and Horizontal Impact. Drop testing is a free fall test and complies with ASTM D5276avautuu uuteen ikkunaan. Incline-Impact (Conbur) testing complies with ASTM D880, and Horizontal Impact testing is in compliance with ASTM D4003.

When properly applied, ISTA procedure 1G will provide tangible benefits of:

• Shortened packaged development time and confidence in product launch
• Protection of products and profits with reduced damage and product loss
• Economically balanced distribution costs
• Customer satisfaction and continued business

ISTA Procedure 1G – Testing Sequence and Types:

ISTA 2A tests are for packaged-products 150 lb. (68 kg) or less, and are a combination of basic test elements from ISTA 1A (Non-Simulation Integrity Performance Testing) and advanced test elements fromISTA 3Aavautuu uuteen ikkunaan (General Simulation Performance Testing). Procedure 2A simulates some actual transport hazards such as temperature and humidity. An example would be to test desert-like conditions (60C and 15% RH), which are dry with low humidity, on a packaged-product.

When properly applied, ISTA Procedure 2A will provide tangible benefits of:

• Shortened package development time and confidence in product launch
• Protection of products and profits with reduced damage and product loss
• Economically balanced distribution costs
• Customer satisfaction and continued business

Test Procedure 2A is broken down in the following sequence:

Test Procedure 3A is for packaged-products weighing 150 lb. (70 kg) or less, and is a general simulation test for individual packaged-products shipped through a parcel delivery system. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Characteristics will include simple shaped random vibration, different drop heights applied to the sample package, and/or atmospheric conditioning (complies with ASTM D4332) such as tropical wet or winter/frozen.

3A tests are appropriate for four different types of packages commonly distributed as individual packages, either by air or ground. The types include standard, small, flat, and elongated packages. Standard packaged-products maybe such as traditional fiberboard cartons, as well as plastic, wooden or cylindrical containers. Small, Flat, and Elongated packaged-products all have to meet a strict set of dimensions and criteria. However, if a packaged-product is both Flat and Elongated, the package should be tested as Elongated.

3A includes an optional test combining Random Vibration Under Low Pressure (simulated high altitude). This tests the container’s (whether primary package or transport package) ability to hold a seal or closure and the retention of contents (liquid, powder or gas) without leaking. This test procedure is used sparingly by Medical Device Manufacturers as it is very severe with the utilization of top load vibration. MDMs may encounter damage that does not happen in the normal distribution environment. This procedure is comparable to ASTM D7386-08. This procedure does not address effects of low pressure High Altitude for non-porous packaging.

When properly executed, ISTA 3A procedures will provide tangible benefits of:

• Product to market time reduction
• Confidence in product launch
• Reduction in damages and product loss
• Balanced distribution costs
• Customer satisfaction contributing to increased market share

For standard packaging the sequence is as follows: