Improving Product Safety with Custom Blister Trays

The Importance of Custom Blister Trays for Product Protection

Increasing Recalls Due to Poor Packaging

Moisture breaches and packaging breaches are the cause of more than 30% of drug recalls. This challenges the integrity of the drug, the sterility of the medication and the safety of the dosing for patients. Custom blister packaging assists with this packaging integrity and safety challenge by better protecting the medication and safety of the packaging. Contamination is eliminated because blister packs seal each individual compartment. Tampering is also easy to identify and, without custom blister packaging, is more likely to occur. Most other packaging systems deteriorate structurally during handling and shipping. The special formed trays discussed here also provide superior protection from handling and shipping stresses. Simply put, the custom formed trays provide a significant improvement over other systems. Most packaging systems simply provide storage. Custom blister packaging focuses on safety and efficacy through the entire storage and transit cycle of the packaging from the manufacturing site to the consumer, especially for the medicines.

The safety barrier provided by unique custom blister trays is further enhanced by tamper-evident sealing.

Blister packaging is made even more secure by using a frangible foil seal and a layer of PETG or similar polymer that is compatible with the sterilization process. When the packaging is tampered with, the frangible foil seal becomes a barrier to opening the packaging. The sealing is also effective at keeping moisture and oxygen out, providing a barrier that protects the packaging's contents. The combination of the seal and the polymer layer also creates a moisture and oxygen barrier, and protects the contents of the packaging. Research into sealing technology in the pharmaceutical industry has shown that a unique custom blister tray seal can reduce counterfeit products by 45%. The unique blister tray design also has a clear window, allowing healthcare workers to easily identify the correct medication, which creates confidence in the healthcare workers and patients.

Design and Material Choices for Custom Blister Trays of Medical Grade

Concerns With Moisture, Contamination, and Mechanical Stress Regarding Diagnostics and Pharmaceuticals

Designing Medical Grade polymer materials incorporates real-world performance and the polymer’s ability to comply with regulations. For example, PETG is a moisture resistant polymer which is particularly useful for both absorbent materials and dried pharmaceuticals. It has moisture vapor transmission rates at approximately 0.5 grams/square meter/day which prevents chemical deterioration and loss of drug efficacy. The ability of a polymer to withstand the various cycles of a sterilization process is also a critical factor in new design selection. Some polymer versions are resistant to gamma radiation and, therefore, are not brittle post irradiation. Others can withstand multiple steam cycles at 121 degrees Celsius in autoclaves and maintain seal integrity on the polymer. These tests and material selections aren't made at random; they are the product of experience in working with controlled and successful outcomes with ISO 11607 compliant packaging.

PETG, thermoformed foil, and sterilization-compatible substrates: performance trade-offs for custom blister trays

PETG is great for visual checks since it offers good optical clarity, and it remains rigid, even when the walls are 0.3 mm. This is great for delicate diagnostic applications. Foil laminates provide better contaminant barrier protection, but at the cost of visibility, and can limit how deep components can be. Materials such as PEEK are good for final sterilization steps, cost can increase by 30% to over 60% when maintaining the strength of the processed material. Getting good seals is critical, for the reason that different materials are best used with specific adhesives. PETG bonds well to specialty lidding films, but foil laminates require specific adhesive matches to avoid delamination in the accelerated aging tests of the ISO 11607 standards.Understanding the Protection Requirements of Products through Precision Engineering and the Custom Design of Blister Tray

Models of retention force specific to the cavity eliminate physical damage and dosing variance

Understanding retention requires knowing how to manage the cavity to create the right retention pressure. If the pressure is too weak retention is compromised, and the dosing accuracy is compromised because the parts can move. However, too much pressure can cause the components to break, or make them too difficult to remove. This is why engineers rely on models, specifically finite element analysis models, to simulate the functionality of these trays in the real world. Engineers are interested in the modifications of the structure during the events of a drop, the transport of the tray, the compression of the trays in a stack during transport, and the tray lids to evaluate the structure's impact absorption, rigidity, and the retention mechanisms of the lids. Research published in the previous volume of the journal Packaging Science, indicated that finishing trays using these methods resulted in a reduction of errors in the dispensing of medications, and breakage of components by almost three-quarters. This means there is simplicity in the handling for both the medical staff and end users, but still controlled and rapid access to the product during the use of the tray from the transport of the trays in the medical supply chain.

The result of adjusting custom blister tray geometry for safety-critical products is from fill volume to shape-driven stability. 

The primary function of a tray geometry is designed to be functionally protective instead of aesthetically pleasing. Performance can be divided into three interdependent parameters.

Fill volume Prevents lateral shifting during acceleration Reduces 89% of particulate generation in injectables 

Cavity draft angles Controls release force during removal Eliminates contamination from excessive extraction force.

Radial wall thickness Distributes impact energy across structure Prevents hairline fractures in glass ampules

The listed parameters help keep oddly shaped things such as tiny medical device sensors and surgical tools stable during transport. The trays are designed with an optimal width to depth ratio so that no item tips during automated handling. The pockets in the trays can hold components of different heights. This design reduces the need for additional protective packaging by approximately 40% (Medical Packaging Standards 2023). The trays are designed to maintain integrity 99% of the time, so they are very ideal for use with high-value humidity sensitive goods. When packaged, the trays are designed to maintain integrity 99% of the time, so they are very ideal for use with high-value humidity sensitive goods. When packaged for transport, and to aid in the prevention of condensation, engineers use computational fluid dynamics to analyze airflow in the packaging to minimize the risk of damage to sensitive components.

This can be sit directly on a factory line or be delivered directly to a hospital bed while managing temp and moisture levels so that everything stays just right.

FAQ

What issues do custom blister trays solve in drug packaging?

Custom blister trays moisture intrusion and failure of container integrity that can affect drug sterility and dosage delivery accuracy.

In what way do custom blister trays improve tamper-evidence?

Frangible foil seals as well as some other simple PETG seals and so on, will show evidence of tampering while also keeping O2 and moisture out.

What are some materials used in custom blister trays?

Custom blister trays are made of types of PETG and foil thermoform as well as other high-performance polymers that provide a variety of moisture barriers, clarity and processability.

What is the role of precision engineering in ensuring the safety of blister trays?

To ensure proper retention with minimal movement or damage, engineers utilize finite element analysis to model the trays' response to various physical stresses.