Accredited Testing Helps Bring New Medical Device Products to Market
WESTPAK helps medical device companies bring products to market faster and more confidently. As a premier certified third-party testing laboratory, we are dedicated to ensuring the highest safety and performance standards. Our specialized suite of test validation services is designed to aid you in navigating the complexities of regulatory compliance and market requirements.
Our expertise spans a wide range of essential testing services tailored for the medical device industry, including Distribution Testing, Accelerated and Real-Time Aging, Gross Leak Detection / Bubble Testing, Seal Strength / Seal Peel Testing, Dye Penetration / Leak Testing, and advanced Temperature and Humidity Environmental Testing. These services are crucial in verifying medical device products’ durability, reliability, and safety across diverse conditions while conforming to industry standards.
Medical Device Distribution Testing
Distribution Testing is the practice of conducting tests that simulate the distribution environment in a laboratory.
Laboratory testing provides a controlled and repeatable setting whereby the ability of products and shipping units to withstand the distribution environment can be determined. When conducted according to standard industry protocols, the Distribution tests of Impact, Compression, Vibration, Altitude, and Loose-Load simulate the environmental hazards products often encounter during transportation and storage throughout their expiry period.
Impact Testing: evaluates the ability of a package to handle and protect the product against collisions in the distribution environment. The impacts can cause product and package damage if the package is dropped, knocked, or banged around.
The package freefalls onto corners, edges, and flat surfaces during an impact test. Many test procedures conduct all impacts from the same drop height regardless of orientation.
Compression Testing: is critical in determining package design verification. For medical device packaging, it is conducted to determine the maximum safe load the package can withstand.
Vibration Testing: refers to replicating the vehicle or truck excitation to witness the effects and identify weaknesses of the product or package system.
Vibration occurs in all transportation forms and at varying intensity levels. In the real world, vibration is complex and can intensify, given the natural frequencies within a product/package system.
Altitude Testing simulates the reduced air pressure experienced at higher elevations and the impact on the integrity of the sealed package.
An altitude test is either pass or fail. Sealed flexible packages such as pouches, for example, can fail when exposed to altitude if the internal pressure cannot equalize. Note that altitude exposure by truck transport can exceed the levels experienced in commercial air transportation.
Loose-Load, also called “Bounce Testing” and “Fixed Displacement Vibration,” is an attempt to duplicate the adverse effects of vehicle vibration, primarily by truck.
The test apparatus consists of a horizontal platform mounted on an offset cam, resulting in circular synchronous motion for 15 to 60 minutes, causing the packages to bounce back and forth onto each other.
Accelerated Aging per ASTM F1980
Accelerated Aging, also known as Accelerated Shelf-Life or Accelerated Real-Time testing, determines the effects of time relatively quickly.
The Accelerated Aging theory is based on the relationship between temperature and the chemical reaction rate, in which the reaction rate increases as temperature rises. Accelerated Aging uses higher temperatures to represent Real-Time artificially. Manufacturers can utilize Accelerated Aging’s test results as the basis to get a product to market quickly while establishing the safety and efficacy requirements. Real-Time Aging and Accelerated Aging studies must be initiated simultaneously and continued to the product’s claimed shelf life.
WESTPAK conducts Accelerated Aging per ASTM F1980 using 40+ environmental chambers set at commonly requested temperatures of +50oC, +55oC, and +60oC; test samples needing exposure to one of these can usually begin aging within a day of receipt.
Gross Leak Detection / Bubble Testing per ASTM F2096
Gross Leak or Bubble testing is a widely used qualitative method of determining if there is a gross leak in a tray or pouch package system.
Primary barrier packaging is subjected to this test to determine if the ability to maintain a sterile barrier has been compromised by tears, holes, or improper seals. When properly applied as part of a package validation test plan and conducted within the guidelines of ANSI/AAMI/ISO 11607, ASTM F2096 is the most used method to determine the ability of a package to maintain sterility because it quickly tests the entire primary barrier system.
Seal Strength Test / Seal Peel Test per ASTM F88
Seal strength testing is commonly used to evaluate the strengths of seals on pouches and packages. A weak seal can compromise a product’s Sterile Barrier System (SBS), negatively impacting the medical device’s efficacy and patient safety.
A seal strength test aims to evaluate the effectiveness of product packaging objectively and measurably. Product packaging systems must ensure a minimum seal strength to prevent contamination or damage due to environmental factors. If the seal on a sterilized pouch or package fails before the end user opens it, sterility could be lost, rendering the product unsafe.
Manufacturers also use ASTM F88 to create effective package seals.
Dye Penetration Test / Leak Testing per ASTM F1929 and F3039
Dye Penetration testing is used to visually assess potential defects within a sterile barrier system’s seal. This test can provide valuable insights into defects in the material or packaging process by examining the seal integrity of a porous or non-porous medical device package.
In the most used protocol, ASTM F1929, Method A, the test operator injects a package with sufficient dye solution to generate a depth of 5 mm (0.25 in) along the longest edge of the inner seal. The operator quickly locates imperfections and leaks along the seal that may impact the safety and efficacy of the Sterile Barrier System (SBS).
Temperature & Humidity Environmental Testing
Medical device packaging is subjected to exposure to prescribed temperature and humidity levels in preparation for distribution testing (i.e., compression, drop/impact, vibration). This environmental conditioning is necessary because paper-based materials, which are used in most packaging systems, experience changes in physical properties as temperature and humidity change. Also, most plastic components change strength in direct proportion to changes in temperature.
Exposure is conducted using over 65 environmental chambers with tight controls over temperature and humidity and the rates at which these inputs are changed. The test levels chosen and rates of change between these levels are documented in the customer’s test report.
WESTPAK’s accredited lab facilities offer temperature & humidity testing per ASTM D4332, ASTM F2825, ISTA Series (all), and MIL-STD-810.
Press Releases
Meet WESTPAK at MD&M West, Anaheim, February 4-6, 2025
Visit WESTPAK at Booth #2467 at MD&M West expo, February 4-6, North America’s largest and most comprehensive medical design and manufacturing event.New Testing Facility Opens to Improve Product Safety and Deliverability
San Jose, CA – November 14, 2024 – WESTPAK, Inc., a leading 3rd-party laboratory providing trusted testing solutions for the medical device, pharmaceutical, and high-tech industries, officially opens its new state-of-the-art laboratory in Union City, California, on November 13.Ensuring Compliance with WESTPAK’s Seal Strength Testing
Seal strength Testing is commonly utilized in the medical device industry to ensure that the seals on pouches and trays meet their minimum and maximum strength requirements.Watch On Demand: Performance of Thermal Shipping Systems Following Distribution
If you are involved in temperature-controlled parcel shipment supply chains for the pharmaceutical or life science industries, watch and download the slides of our webinar Performance of Thermal Shipping Systems Following Distribution – Part I. Learn about the limitations of ISTA’s 7E “Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment.” ISTA 7E is often used as the protocol to evaluate the ability of thermal shipping systems for parcel shipments to deliver temperature-sensitive healthcare products to awaiting customers.Four New Environmental Chambers Are Ready. Start Testing Now!
WESTPAK’S four new, cutting-edge environmental chambers, Huey, Dewey, Louie, and Rooster, have completed the installation and qualification process, adding to our fleet of over 100 similar capital assets. The added capacity helps us keep lead times short and start test projects quickly.Using Damage Boundary Testing to Improve Products, Lower Costs, and Reach Sustainability Goals
Damage Boundary Testing is helpful for manufacturers who must improve their products, save costs, and achieve sustainability goals. When done correctly, the information obtained from the testing can help one gain an edge over competitors by enhancing product reliability and lifespan, cutting costs, and meeting sustainability targets. After all, a primary goal is to use a minimum amount of packaging to deliver a damage-free, high-quality product at the lowest cost to the customer that works as intended.ASTM D4169-23 Was Released – See What Changed
WESTPAK’s General Manager, Greg Schwinghammer, recently attended the American Society for Testing and Materials (ASTM)’s International Conference in Washington D.C. at the end of October. Greg is an active ASTM committee member and has been part of the working group that developed the latest update to ASTM D4169-23. The conference was hosted by the ASTM International Additive Manufacturing Center of Excellence (AM CoE), supporting over a dozen ASTM technical committees comprising 100 plus scientific committee members.White Papers
What do you need to know about Accelerated Aging for Medical Devices?
The answers are in WESTPAK’s free white paper “Three Critical Items You Must Know to Plan and Start Accelerated Aging for Medical Devices.” Medical device manufacturers must provide adequate documentation that confirms their product and packaging will maintain efficacy and sterility during its shelf-life or expiration period. Manufacturers can utilize accelerated aging to get their products to market in a shorter timeframe. This white paper from Westpak explores three critical elements must be identified before developing an accelerated aging plan.Contact us
- www.westpak.com
- info@westpak.com
- +1 (800) 830-8021
- 83 Great Oaks BlvdSan Jose, CA 95119United States
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