The Standards Myth: Why Temperature Controlled Packaging Fails And What You Can Do About It

What if I told you that not all standards are created equal. Some are just flat out confusing and some are just unfinished at best. In an ongoing effort to create a global standard, the reality is that those standards have created a baseline, not a target. So how do we get from a baseline to a target? Let’s start with that baseline and work our way through its flaws, how to remediate those flaws, and the steps to take to get past that baseline and closer to a cost effective, protective, and green friendly solution.

Standardization works, in small numbers

Typical standards, like ISTA7E, USP General Chapter , the WHO and others state that their qualification standards, which 99% of the market uses today, are applicable to 90% of the needs of the market. Let’s do some math here:

This is a considerable number. At a cost of just $100 per shipment, that is $1.2 million in hard costs. Now add in the time, energy and money it takes to determine the root cause of the deviation, the retesting of your packaging and refrigerant, and then take corrective and preventative action. You can do your own math, but some recent studies show an average of $3,000 just to manage one deviation. At those numbers, $36 million is not unheard of in the market.

Although you would be hard pressed to find a single standard that would apply to all situations, the growth in global standardization documents make it confusing to navigate. The goal of this article to understand what you can do to go above and beyond the standards maze to set your own standard.

The problem starts with how you are conducting your qualification

What is a packaging qualification study, how is it conducted and what are its benefits?

A qualification study for a payload shipping system is designed to provide documented evidence that the methodology developed to pack a product consistently performs according to design specifications and intended use. It verifies the configuration of the packaging method is established according to the company’s processes , and is set up to eliminate the risk of product excursions from specified temperature limits as required by the product’s manufacturer. It also ensures appropriate operational procedures are in place and that the packaging method can maintain the product within the specified temperature range when the container is exposed to external temperature variations.

Specific tests are then designed to verify the load packaging method in a way that preserves the product against weather season climatic influences. Tests are typically conducted for a specific time period, (let’s say from 24 to 96 hours) under a controlled temperature environment (let’s say 2°c to 8°c) and for a specific season (like winter cold weather seasons).

So what is the problem with today’s qualification standards?

The problem is that one size fits all does not work. You are not trying on a hat or a pair of gloves; you are shipping a sensitive, costly product affected by the type of packaging you use, the amount and type of refrigerant, the transport mode, the length of storage and transit, not to mention the sensitivities of the product itself. Think about it. If you are shipping your product from New York to Texas in the winter, there are very different criteria required than shipping an overnight package from New York to Chicago. So why would use the same criteria for both?

Profiles used by the majority of the market today are used across both small and large companies. And, while larger companies may have the resources to develop and test their own profile, many smaller entities don’t have the experience or personnel to accurately assess whether an industry standard profile or a supplier’s recommended profile is appropriate for their needs. And although they are a good starting point, there is a lack of industry standards that align to the unique requirements of individual transport modes, seasons, shipping lanes, and distribution practices.

Temperature profiles are available from the International Safe Transit Association (ISTA), Parental Drug Administration (PDA), and International Society for Pharmaceutical Engineering (ISPE) work on averages and generalities that are not indicative of the whole picture. The cycle profiles as stated in 7E are averages using

And although e xperimental data was collected as a Thermal Lane Data Package that can be purchased, this data was only collected during summer and winter test campaigns for parcel services. It was not conducted for larger cargo and freight services or for Spring and Fall campaigns.

As an example, standards based data has winter profiles that start at 10 C up to 0 C, but using those numbers to qualify a 2-8 C pack out, would give you the ability to ship and store a product for six months up to a year which is not representative of what’s happening in real life. You can get -20C in winter. The result is specifying a system that is not robust enough, causing multiple failures and using too much or too little refrigerant.

Another reason why standards need to be flexed is that every company has their own processes (transport, storage, packaging preparation, pickup after prep, inspection etc). For example, some companies package their product in the morning and then don’t pick up until the end of the day. There is also a big difference between shipping full truckload vs LTL. Why? Friction causes heat. Door openings cause a loss in internal temperatures. If your product is the last to be delivered, then your products have been exposed to risk.

A risk based approach demands testing in an uncontrolled environment, using real transport equipment, real drivers, in all four seasons and in regions where the product is shipped. Data is then used for constructing data models that prevent deviations altogether.

Why general simulations don’t work when developing temperature profiles

One of the leading companies in the market to look at qualification studies and data analysis versus general simulations and standards is Infitrak, Inc. out of the Toronto area. The following data is based on their analysis of Canadian and US profiles using ISTA standards versus real-time conditions captured using Logtag data loggers over a 48 hour period. All performance Qualifications (PQs) and temperature profile studies were conducted in field tests, not in a chamber. From the graphs you can see that the US and Canada summer profiles align fairly well (the real-time data in the US is only slightly lower than the profile).

Legend: The red line is the ISTA profile. The black lines use Infitrak custom temperature profiles, and all other colors are data captured in real-time conditions.

The real difference is when looking at both the winter profiles (below). This is where the ISTA standard does not align:

Why is real-time data analysis both scary and necessary?

The anxiety for most manufacturers and shippers is that real-time data analysis takes time and can be costly to fully implement.

There’s a saying, "you can make an omelet without cracking a few eggs". The same goes for packaging. You have to expose your products and containers to excursions in an uncontrolled environment in order to reduce the risk of future excursions. Averages (like MKT) and controlled testing environments will not give you what you need.

As you can imagine, the amount of data needed to make a risk adverse assessment can be enormous. You need to know:

External temperature cycles and temperature extremes by region and season The payload size (not the container size, but the amount of payload after PCMs and other packaging material have been added) How many and where to place calibrated data loggers to determine the source and location of excursions Acceptance criteria from the manufacturer Allowable excursions, if any Origins and destinations Mode of transportation and knowledge of loading methodology Length of transport (including dock, customs, and storage) Time and season of transport There are also multiple steps involved, and when real-time testing occurs, you are bound to find issues along the way that require remediation. A typical end-to-end process might look something like this:

These steps take time that can potentially cause delays in product shipping, which naturally affects profitability. Field testing packaging for all four seasons can, well, take four seasons. You also do have some expense in each of these field tests. For example, ISPE qualification standards, state the need to have at least 25 shipments monitored per size, per season to have a representative PQ. The challenge is that if you find an issue, you have to take time to remediate and retest.

Reducing the time needed to design qualified packaging for your product

There are ways of working to shorten this analysis period. One way is by collecting data from every shipment, season, and location to create a statistically accurate transport model. This means using calibrated data loggers on thousands of shipments over a long enough period of time. There are companies, like Infitrak, that that have been collecting temperature data for decades and compiled the data into thermal data models that provide starting points for design and can reduce your analysis time from months to days 2 .

This data can then be used to build performance qualification criteria used for seasonal temperature and lane mapping studies. Data loggers are used on the inside and outside of the pack out to correlate the actual ambient temperature to the profile used to double check if the actual profile of the system matches the data model and standards. Typically data collected from the mapping studies causes a process change that assures the system is working 100%. Process changes may include packaging method, gel conditioning process, performance verification, test methodologies, acceptance criteria or changes to the EPS, PCMs, or product load itself.

With a good benchmark you can then start with a pack out profile that is less likely to fail in the initial testing, and there for get your final pack out and product to market faster.

Observations: Standards and Methodology

While there are many resources out there that present qualification standards and guidance, and this one has presented qualification and testing data, what should you take away from this article? Let’s summarize this into four key points based on the data provided in the Infitrak study:

1. Controls in your distribution environment. Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. This requires a holistic approach whereby you align your shipping conditions and your thermal protection (packages). Parameters to be taken into consideration include: shipping duration, Min/Max/Average profile temperature, and profile area (degrees/hour). This requires data modeling to be conducted.

2. A lack of precise, unified standards. Standardization is not a bad thing. It gives us a benchmark for which we can start testing. The challenge is when multiple organizations use their own data to weigh in on reliable standard temperature profiles for the design of insulated packaging systems and then use that standard or all products. The more "hands in the pot", the more confusion there is on the market. With this in mind, temperature profiles used for the design of packaging should be rationalized based on your own distribution logistics.

3. Temperature profile data can vary greatly based upon seasonal variations in your distribution process: Average Winter conditions versus very cold winters (ie 2014 & 2015). Just remember Pareto's Principle. 20% of the total of the destinations will generate 80% of the extreme profile conditions. Identify that 20% of destinations and focus on those specifically.

4. Temperature alone is not the enemy. The amount of time of exposure is just as important. Determine the amount of time a product will be in transit and storage before you look at the shipping method and route. Use this amount of time to determine the type of packaging and the type of transport needed. This will help you to avoid overestimating the safety factor and thus overspending to rush a product to the client or overdesigning a packaging container. The more precise the thermal performance requirements of your container, the less packaging and conditioning materials are needed (which equals a reduced cost/unit).

The Standards Myth: What to throw away and what to use

Let’s wrap our hands around this now. It comes down to this; If you need the standards as a benchmark, a place to start chamber tests, use them. If you have a sensitive product, where you are concerned about the safety of its environment and the risk, throw away the standards. Invest in analysis. Define your origins and destinations, and your stability data, then reach out to a company to help define the right temperature profile. Conduct a risk assessment and establish GDPs for yourself.

References & Index

2Data source: Infitrak, Inc. data models using multiple transport modes: intermodal, ground, LTL, full truck load, courier services, air freight, and sea freight. Infitrak has studied this data in durations from 24 hours to 14 days and includes mapping data conducted from Canada to Mexico. More information on this process can be found by contacting Infitrak directly. Sources also include but are not limited to content presented by Infitrak CEO Jean Bedard at the 12th annual cold chain global forum hosted by IQPC. General Chapter http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1079.html Working document QAS/04.068 on Good Distribution Practices . PDA Technical Report No. 39 (PCCIGTR 39), Guidance for Temperature Controlled Medicinal Products, Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment . Perishable Cargo Regulations (PCR )manual www.infitrak.com ASTM’s D3103 , standard 20, Standard 7E Have Your Say Rate this feature and give us your feedback in the comments section below