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All three Assurance Levels (AL) of ASTM D4169 are demonstrated with a Compression Test on a corrugated fiberboard container (aka cardboard box).
Assurance levels are based on the probability of events occurring in a typical distribution cycle. Level III (AL III) is a low intensity with a correspondingly high probability of occurrence. Level I (AL I) is a high level of intensity and has a low probability of occurrence. Level II is between these extremes.
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ASTM D4169 Assurance Level Determination
Successful completion of testing at Assurance. Level I proves the most confence in product protection during the normal distribution environment. Assurance …
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Date Published: 12/14/2021
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ASTM D4169 01 Standard Practice for Performance Testing of …
Designation: D 4169 – 01⁹1 … 3.2.2 assurance level-the level of test intensity based on … tion Cycle 18, DC-18 see MIL-STD-2073-1 for definitions of.
Source: www.wewontech.com
Date Published: 2/30/2022
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ASTM D4169 Packaging Testing offered by Micom Laboratories
Typical Experimental Parameters for ASTM D4169 Testing. Distribution Cycle: 1 to 18; Assurance Level: I to III; Number of Samples: 1 (more depending on how …
Source: www.micomlab.com
Date Published: 4/24/2022
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Building Distribution Test Plans In Accordance to ASTM D4169
ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) proves 18 Distribution Cycles (DCs) based on …
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Date Published: 11/8/2021
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ASTM D4169-16: What’s Your Assurance Level?
There are three “Assurance Levels” for ASTM D4169-16. Level III is the lowest intensity, Level II medium intensity and Level 1 the highest intensity. We’ll get …
Source: pkgcompliance.com
Date Published: 4/22/2022
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ASTM D4169 Testing – Tektronix
There are 18 different distribution cycles,10 different test schedules and three assurance levels defined in ASTM D4169. Choosing the right combination of …
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Date Published: 12/14/2022
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ASTM-D4169 – Life Science Outsourcing, Inc.
ASTM-D4169 describes the standard practice for performance testing of shipping containers and systems.
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Date Published: 11/25/2022
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ASTM-D4169-14.pdf
.1 . , .. 3.2.2 assurance level~the level of test intensity based on its … 4.2 For DiStribution Cycle 18, as referred to in hdlL-STD- … D4169 {1:1.
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Date Published: 5/7/2022
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ASTM D4169-16.pdf – PDFCOFFEE.COM
ASTM D4169-16.pdf … 3.2.2 assurance level—the level of test intensity based on its … 4.2 For Distribution Cycle 18, as referred to in MIL-STD2073–1, …
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주제와 관련된 더 많은 사진을 참조하십시오 Westpak Compression Test ASTM D4169 Assurance Levels III II I. 댓글에서 더 많은 관련 이미지를 보거나 필요한 경우 더 많은 관련 기사를 볼 수 있습니다.
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- Date Published: 2020. 7. 28.
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ASTM D4169 Packaging Testing offered by Micom Laboratories
ASTM D4169 is a standard practice for performance testing of shipping containers and systems. It is a practice for packaging distribution that allows us to simulate many distribution environments. Micom Laboratories offers ASTM D4169 testing as part of its Packaging testing solutions.
ASTM D4169 Uses and Factors to Be Considered
For ASTM D4169 testing you will need to know which Distribution Cycle (DC) you want to test for and which Assurance Level you have to meet. Each DC addresses a different shipping environment and different shipping hazards. On the other hand, each Assurance Level provides you with different test intensities. For each DC there are three Assurance levels. Level I is a high level of test intensity and has a low probability of occurrence. Level III is a low level of test intensity but has a correspondingly high probability of occurrence. Level II is between these extremes. Using these testing parameters, we will be able to create a test plan tailored to your package testing requirements. There is a list of 18 DC to choose from in ASTM D4169 such as rail and motor freight, unitized, Assurance Level II, etc. General Motors, for example, since February 2020, in its Specification GM 1738 NA rev.4.0 – GM Packaging and Identification Requirements For Production Parts – requires its suppliers to test their parts pallet loads per ASTM D-4169. They however do not specify the distribution cycle nor the Assurance Level. Since they also specify as an equivalent ISTA 3E, we can infer that what they require is actually ASTM D-4169, DC 6, level II.
ASTM D4169 – Random Vibration Test
Packaging Distribution Testing
Depending on your distribution environment as well as your payload and packaging characteristics, it may be better to conduct some of the tests under special climatic conditions, such as those given in ASTM D4332 or ASTM D951. The ISTA testing methods also offer potential conditioning scenarios based on the most extreme conditions your product could face during transportation. Otherwise, the testing will be done under ambient conditions. Even if most of the time only a pre-conditioning in standard conditions is mandatory, more and more standards and experts strongly recommend to condition samples in real-life conditions prior to testing when it can be detrimental to your packaging performance. For example, a fiberboard box used in a humid environment can see its compression strength dramatically lowered.
Typical Experimental Parameters for ASTM D4169 Testing
Building Distribution Test Plans In Accordance to ASTM D4169
Transportation and Distribution testing is required for all shipping containers used to transport medical devices. This is important as the shipping and distribution environment presents hazards (i.e. shock, vibration, compression, altitude, temperature, and humidity) that can be detrimental to the product and the sterile barrier. This blog post provides guidance on selecting the correct test schedules and methods to ensure the challenges presented are representative of the environment to which the product is subjected.
There are a number of testing options in the standards, and the choices may not always be clear. ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) provides 18 Distribution Cycles (DCs) based on modes of transportation, not on package or product type. The first step in determining the appropriate testing method is to decide how the package will be transported. Will it travel by air, rail, truck, or a combination of these? The most common mode of transport for most medical devices and pharmaceutical products is small parcel through UPS, FedEx, or other carriers. This transport option experiences both air and truck as a routine part of transportation and directly correlates to DC 13 [Air (intercity) and motor freight (local, single package up to 150 lb. (61.8 kg)]. If a package system is over 150 lb., or unitized (i.e. pallet or skid) and shipped via air and truck, then DC 12 would be selected, which subjects the package system to the hazards described above. If the predesigned options don’t fit one’s particular transportation route, there is a user defined cycle (DC 2) that allows for any custom combination of distribution hazards.
After selecting the correct DC, the next step is to select the Assurance Level (AL). The AL is selected based on probability of occurrence pertaining to drop heights, compressive loads, and vibration intensity. Product cost and patient risk (e.g. a permanent implantable device) are considered when selecting the AL. Assurance Level I (AL I) is the most severe and conservative, AL II is the most common and suggested by the standard, and AL III is the least severe/conservative. A more severe AL level may be chosen to challenge the shipping container to determine if the protective packaging is sufficient, over engineered, or under engineered. A risk assessment and justification should be written for all choices made.
If you would like to learn more about building distribution test plans or transportation testing please see our webinar Transportation and Distribution Testing for Medical Devices.
To view our distribution and transportation testing options, please view our Packaging Transportation test page or contact us at [email protected] or +1 (801) 290-7500.
ASTM D4169-16: What’s Your Assurance Level?
Mom’s Birthday Assurance Level
I’ve learned a lot from working in the world of ASTM standards in general and perhaps its most famous, ASTM D4169 transit testing specifically. It’s funny how I now consider ASTM standards as if they apply to my personal life. Recently, I shipped some birthday bath towels to my mom, who lives 1,200 miles away. While boxing them up, I actually found myself pondering ASTM D4169 testing. I instantly decided that Mom’s gift would easily get by on Assurance Level III. How did I know?
One of the most unique features of ASTM D4169-16 is its flexibility in choosing what testing intensity is best for packaging performance. There are three “Assurance Levels” for ASTM D4169-16. Level III is the lowest intensity, Level II medium intensity and Level 1 the highest intensity. We’ll get into that a bit more in a minute. For starters, the Assurance Level you select will be based on some universal questions. We’ll use my mom’s gift as the example. You will ask:
How much damage can be tolerated? In my case, they are towels. Theoretically, a lot could happen and they’d still be OK. As a medical device manufacturer, your stakes are much higher.
What is the product value? Sorry, Mom, I got them on sale, but you’d approve. Answer? Low value. And once again, for medical device clients, the value of each unit can be astronomical—never a time to take a chance.
What is the end use? Repeated post-shower water absorption with an occasional wet dog thrown in. While we all appreciate a fluffy bath towel, life would go on just fine if the towel got ripped in transit. Your medical device doesn’t have that luxury. Instead, your product and its packaging fall on a continuum from topical products or minimally invasive up to internal, invasive human use. Sterility must be maintained!
What’s in a Level?
I mentioned that ASTM D4169-16 sets a range of Assurance Levels I, II and III, with ALI being the most intense testing environment. There are two additional factors besides intensity that define each Assurance Level: likelihood of encountering this condition during transit and duration of this condition when it occurs.
While you, the Medical Device Manufacturer will most often direct the test intensity level, PCL frequently recommends and MDMs overwhelmingly agree that ASTM D4169-16 AL1 testing puts the medical device in the strongest position for success. Not only does AL1 eliminate or mitigate the risk of a packaging breach, it provides a high degree of protection against many potential unsafe end-user conditions. The variables for AL1 ASTM D4169-16 include height of drops in schedule A, target load of compression in schedule C, and duration and intensity of random and fixed vibration in schedules F and E.
Assurance Level II may be considered for certain medical device testing. Lower-risk products, such as minimally invasive or topical categories may qualify. Your testing partner can help you assess ALII product candidates. The variables for ALII ASTM D4169-16 include decreased height of drops in schedule A, a lower target load of compression in schedule C, and shorter duration and decreased intensity of random and fixed vibration in schedules F and E. Once again, the risk level is the responsibility of the MDM to justify in order to conform with ISO 11607:2006, Part 1 and the FDA. Our team is happy to talk you through your thinking. Assurance Level III is not recognized for medical devices.
It would be nice if every shipping plan was as carefree as two sets of Egyptian cotton. But in the exciting and breakthrough world of medical devices, Packaging Compliance Labs is your ASTM D4169-16 testing partner. We’re committed to value, results you can count on and the fastest, most personal service available anywhere.
ASTM D4169 Testing
Overview
ASTM D4169 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. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles. The recommended test levels are based on available information on the shipping and handling environment, and current industry/government practice and experience.
Read more about our full package testing capabilities.
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