There are only so many ways to package bulky items. But what makes this a more complicated question is that there are many unknown fit-for-use criteria that, as with any package development, must be taken into consideration in order to provide the right packaging for the individual application. Examples of questions that need to be considered include whether visibility of the product through the packaging is required; whether easy opening is necessary; what specifications are required for barrier, slip, and sealant; how the product is being filled, sealed, and sterilized; where and how will it be sold; how the package is opened and used or reused, disposed of, etc.

Aside from the specific fit-for-use needs there are several possibilities. Bags or pouches are always an option. A header is not always necessary; hang holds or a header can be formed into the top of a bag or pouch with a seal, or the pouch can be configured as a stand up with an easy tear-opening feature. Product instructions could either be printed on the bag or on an insert. There are several new square or box-style stand-up pouch formats that could have potential with easy-open features.

Depending on whether this is one rolled tube set or several pieces, another potential solution could be to use a folded paperboard liner that inserts into a bag. The paperboard would form the bottom and sides on the inside of the bag. This could provide a more cost-effective alternative to add rigidity to the bottom and sides. It also provides ease for filling and unpacking as the bag is held open by the paperboard - exhibiting functionality between a rigid tray and a bag. This structure also allows the top to be clear, and the visible side of the paperboard can be used for graphics and copy.

A last option is a vacuum-formed film laminated to a nonformable lidstock. Generally, these are supplied in roll form and run on a machine that heats the web to soften it and then pulls a vacuum to form the web into the right depth and shape for the product being packaged. The product is dropped into the vacuumed or formed portion, and a lidding film is sealed to the top. The lidding, or nonformable web, can be designed to be peeled from the formed web for easy access to the product.

A difficult question, and actually one better suited for chemists involved in testing for FDA compliance than a packaging expert! There are several universities and lab resources that are equipped for these types of inquiries.  As a packaging and film expert, I will give you an “unqualified” answer with help from one of my university resources and to the best of my ability.

I believe the issue you’re raising is that the higher amount, 0.5 ppb, is deemed to be a virtually safe dose (VSD). First, there is no way to define an absolute human exposure level. A VSD is exactly that, a virtual value based on extrapolation from testing. The value is based on the outcome of either safety assessment or quantitative risk assessment (low-dose extrapolation) and is the definition of the daily or weekly exposure that is acceptable, tolerable, or virtually safe. The concentrations of the chemical in different foods are then established for a food additive or contaminant such that the intake by a high consumer would not exceed the safe intake. (Handbook of Food Toxicology, S.S. Deshpande).  So I believe the confusion is that the 0.5 ppb is the former, the VSD, where the 0.05 ppb is the latter - the concentration in a food that wouldn’t exceed the safe intake.

Based on your information, you would not need to ensure that the packaging contains <0.05 ppb. You need to ensure that the packaging is not contributing any more than 10% of that or 0.05 ppb in the food it is coming into contact with in the normal course of package containment.  So, manufacturers should test for extractions showing less than 0.05 ppb in the food, or food simulant, itself.  Again, this answer is my understanding based on available resources. My suggestion is to contact a university or lab that specializes in FDA compliance testing to be sure you get a “qualified” answer and have extraction tests performed on packaged food or food simulants to ensure the package is fit for use and compliant.  It should be tested in the manner it is used. For example, if it is a microwaveable package, it should be tested at the temperatures and times it would see in a microwave.  When it comes to the packaging of foods or healthcare products, extra diligence should be taken.  The cost of outside lab testing is a small price to pay to ensure compliance, safety, and peace of mind.  I hope this was helpful!

Unfortunately, there are a wide range of potential reasons for the failures. Without more specifics on the package type and content, it will be difficult to give you a solution, but I’ll give it a shot and hopefully head you in the right direction. Several factors could weigh in, but there is one piece of information that we can focus on and that is the center seal.

Since the package is only failing at the center seal, this signals that the seal is the weakest part of the current package. You do note that this is a center seal, but it isn’t clear whether this is a fin or lap seal or if the failure is happening along the back of the package or at the apex where the center seal and top or bottom seal meet. This apex is the one of the more difficult areas to seal on a standard pouch. If it is a fin seal, there are four layers to seal through and a difficult apex where the fin meets the end seal. For a lap seal, the apex is not as difficult, but can still cause problems as there are three layers to seal through.

In order to overcome this, good caulkability is required in the seal area. In other words, the sealant must soften, flow, and caulk the apex to ensure it is not a weak point in the package. The issue is how to get heat more efficiently from the jaws on the outside of the package to the sealant on the inside of the package. This can be overcome by longer dwell times during sealing (combine slower speeds with higher temperatures), increasing the seal jaw pressure, utilizing broader seal range resins in the sealant, and using polymers that are more elastic and stretch or elongate during the break.

Testing seals to achieve higher seal strengths over a broader range of sealing temperatures is key to determining the best structure. Once you have the seal profile in the lab, you will have an idea of the temperatures require to get the ultimate seal strength on the packaging machine. If you compare the lab test with seal tests off the packaging machine, you can quickly determine whether you are achieving the maximum seals possible or not. This will tell you whether the changes can be made on the packaging machine or whether the sealant needs to be modified. The sealant material can be modified as described above for a broader range sealant.  Also, a more elastic and tougher polymer can be used, or the thickness can be increased. Since this is a 40-micron sealant, moving toward a thicker sealant, say 60- or 70-micron, could provide more poly to flow and caulk the seal areas.

A secondary factor could be the package headspace.  If this is a dense product or especially a liquid and there is little headspace in the package, the weakest part of the package, in this case the center seal, will fail from the force of the content weight at impact.  This could be part of the problem.  Testing different fill volumes or package sizes to increase the headspace could identify this as a problem.

So, evaluate the seal profile of the laminate compared to the package to ensure maximum seal strength is being achieved. If needed, try adjusting temperature, pressure, and speed to achieve the maximum seal strength. If there are still failures, begin evaluating thicker sealants, broader seal range, and higher seal strength sealants.  Lastly, be sure to optimize the package headspace, keeping in mind that the package must still fit into the same size carton.  Best of luck!