Package and Product Integrity Blog

What was formerly the Medical Device Package Testing Blog, is now the Package and Product Integrity Blog. This will serve as a forum for us share our thoughts and ideas about package and product integrity within the life science, pharmaceutical, cold chain and medical device industries.

With an ever changing, strict regulatory environment, it is important for pharmaceutical and medical device companies to ensure that their products maintain the highest integrity prior to reaching the end user. The blog will regularly discuss regulations, solutions, industry happenings and issues that affect the life science, pharmaceutical, cold chain and medical device industries.

Contributors to the blog will include package testing experts from DDL, Inc., thermal packaging experts from TCP Reliable and Cryopak, as well as leaders in temperature monitoring solutions for the cold chain pharma industry from ATP.

There are a variety of ways to test plastic materials, such as the plastic used in medical device packages.  Puncture testing is a common method where a piercing tool, referred to as a tup, is driven completely through a test specimen.  The energy to puncture is calculated based on how far the tup travels and the force needed to pierce the test specimen.  One variation of puncture testing is high speed puncture testing which requires the tup to move at a rate between 2.5 m/min and 250 m/min (1.64 in/sec and 164 in/sec).

At DDL the high speed puncture test set up consists of a hydraulic actuator, tup, circular clamp, load sensing device, a set of controllers, data acquisition board and a PC.  When the test is run the final test results include the peak load experienced by the test specimen, the distance traveled by the tup and the corresponding energy.  A graph is also created displaying force against travel distance.

This repeatable and reliable test gives customers simple yet important energy values for comparing specimens from different production lots, sterilization methods, aging cycles and other variables of interest.  The analysis of the data can go deeper when the force, displacement, time and various rates of change are further examined.  While the actual puncturing event only lasts 10 to 20 milliseconds, the resultant data provides customers with some very important and easily understood information.

ASTM has two high speed puncture tests, ASTM D 3763 and ASTM D 7192.  D 3763 is for rigid plastics and D 7192 is used for plastic films that are 0.010 inches or thinner.  Both of these tests are part of DDL’s Product & Materials Division’s core test list.

The Package and Product Integrity Blog is the corporate blog for the TCP Family of Companies, including TCP Reliable, Cryopak,  DDL and ATP.  This blog covers topics about package and product integrity. The focus of the information covered in this blog is on the life science, pharmaceutical, cold chain and medical device packaging, as well as product industries.

In continuation of our list from 2 weeks ago, here is the second part of a post highlighting common mistakes made by companies relating to their package validation. Package testing is a crucial component for medical device companies to have done properly to ensure that their packaging is validated for distribution to the market.

6. Having The Wrong Sample Size
The question of the ‘right’ sample size to use for testing is one of the most daunting to answer.  There are many factors that weigh into the determination of sample size.  The factors include; what type of test is it? (e.g. quantitative/variables or qualitative/attributes); what is the sample population? How many samples are available for testing? What are the economics? What are the risk factors?  (e.g. confidence intervals) .  Most often the sample size is too small and renders results that have no statistical significance.

7. Using the Wrong Package Type/Material
Using the wrong package type or material for the product is a package-product compatibility issue, which could have been avoided if pre-qualification of the packaging had occurred at an early stage.  Some of the typical observations that are prevalent include fracturing of thermoform trays as a result of using the wrong plastic material for the intended product (e.g.  Product mass is too great for the impact resistance of plastic).

This can be avoided for large, massive products, by using a high impact resistant plastic such as polycarbonate to reduce the possibility of fracturing during normal distribution and handling. The thermoform design is also critical to ensure that the product is held in place firmly so that a loose product is not jettisoned through the tray lid and fracturing of the plastic doesn’t occur from the inside-out.

8. Squeezing Oversized Pouches Into Cartons
Pinhole defects in pouches can be reduced by inserting the pouch into a carton without folding, wrinkling or creasing the ends.  Pinholes occur at the junctures of the creases and folds when they are vibrated causing the intersection to be ‘worked’ or fatigued at the juncture.   This effect is exacerbated by making complex folds of the pouch causing a very concentrated point of stress at the juncture of the materials.  This can be circumvented by using secondary packages (cartons/shelf boxes) that are large enough to allow for insertion of the pouch without folding.

This can be avoided for large, massive products, by using a high impact resistant plastic such as polycarbonate to reduce the possibility of fracturing during normal distribution and handling. The thermoform design is also critical to ensure that the product is held in place firmly so that a loose product is not jettisoned through the tray lid and fracturing of the plastic doesn’t occur from the inside-out.

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What makes packaging doubly important is that regulatory authorities recognize the critical nature of sterile barrier or primary package by considering them components or accessories to the medical device. This implies that packaging is almost as important as the device itself. And it is. If a package does not keep, for instance, a pacemaker sterile, patients will be put at risk.

The design and development of packaging has rightfully come under closer scrutiny by international and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardizing package development. Some standardization comes in the form of the international standard ISO 11607: Packaging for terminally sterilized medical devices.

As critical as packaging is, some companies occasionally don’t take it seriously. They’ll consider it late in the design cycle, cut corners, or use inappropriate materials.

In part 1 of 2 posts on the ten common mistakes companies make when developing and validating packaging systems for terminally sterilized (inside a closed package) medical devices, here are the first five.

1. Loss of sterile integrity
This is the most common defect in medical packaging and can happen from fractured thermoforms along with pinholes, slits, cuts, and tears in pouch packages. These defects come from handling (or mishandling), vibrations during transportation, storage, and impacts caused by dropping.

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