Thermoforming or Premade Pouches: Which Medical Packaging is Best?

By Mike Terry
Pre-made Pouch vs. Thermoforming

No one can deny the power and performance of premade pouches in medical packaging.

According to industry experts, more than 25% of operators in the sector choose them as their primary format for their versatility, low cost, and sustainable materials. In addition, premade pouches are convenient, can be customized to fit almost any product, and can include modern features – perforations, tear notches, and zippers – for easier access, resealability, and better product preservation.

The Drawbacks of Premade Pouches in Medical Packaging

Pre-made Medical PouchFor all their benefits, premade pouches are far from the perfect packaging system. Opting for premade pouches (vs. thermoformed medical packaging) does come with its own challenges, which require careful considerations before committing to any system investment. If ignored, these factors could even cut into your present efficiency and throughput and limit your ability to scale your operations in the future:

Lower Speeds with Manual Labor

Available skilled and non-skilled human labor is one of the most prominent challenges facing packagers in almost every sector. As the demand and spending for medical device packaging grow by the billions ($12.9 billion with a Compound Annual Growth Rate (CAGR) of 6.13% from 2020-2026), operators will be forced to keep up with demand.

Without system automation, premade pouches must be filled with product manually. This means the addition of calibrated packaging lines with the requisite human labor force to do the work and accurately monitor production.

Even with incentives, hiring bonuses, and increased wages for employees, many workers cannot or will not return to these environments for health and safety reasons. As a result, packagers may have to decrease production or operate at production levels with reduced staff, adding pressure and costs to maintain volume.

Limited Floor Space

Even with digital transformation making profound changes in the medical packaging industry, the physical floor space available for equipment plays an essential role in decision-making. Design, manufacturing, automation, and production all depend on it from the onset. Medical packaging with premade pouches is no different.

Suppose you do not have the operating area to add multiple packaging lines and the accompanying human workforce to fill premade pouches. In that case, you may have to reimagine your operations or turn to complete system automation with a significant monetary investment to compensate.

Material Waste

Premade pouches have a generic shape. While they can accommodate various product sizes, they are not right-sized to fit your specific product dimensions or specific production requirements. This means there will always be material waste when fabricating premade pouches, hindering sustainability efforts overall.

Material Handling and Sanitation

SanitationEmployee and process safety and product sanitation are among the most prominent, hot-button issues in modern manufacturing and packaging.

The Meat and Poultry sector spent over $1.5 billion on prevention, vaccination incentives, and education programs alone in 2020.

The Occupational Health and Safety Administration (OSHA) and the Biden Administration aim to make regular COVID testing and vaccines mandatory for plant workers in facilities with over 100 employees with new emergency temporary standards (ETS).

The US Court of Appeals blocked the measure temporarily in November of 2021. However, if implemented, it would affect more than 2/3 of America’s workforce (84 million employees).

Manual loading and handling of premade pouches facilitate the continued spread of the virus by placing workers, both vaccinated and unvaccinated, in close proximity on the lines. These arrangements create new opportunities for contamination and exacerbate spending on decontamination and sterilization efforts for large and small operations alike.

Enter Thermoforming for Medical Packaging

Thermoformed SyringeAfter examining the challenges of utilizing premade pouches for your medical device packaging, the question then becomes:

“Is there a logical, alternative packaging application that makes sense for my unique production requirements and return on investment (ROI)?”

Many packagers stay with cost-effective premade pouches but completely automate their lines. While automation can alleviate these challenges, it can be cost-prohibitive for certain operations.

Others opt for the advantages of flow wrapping for medical packaging. Doing so keeps TCO down and offers a highly sterile barrier for a full range of medical products.

However, packagers searching for the highest levels of aseptic presentation, protection, system performance, and ease of use opt for thermoformed medical packaging as their chosen method.

Why? Simply stated, choosing a thermoformer as your primary packaging can alleviate many of the major packing concerns – manual labor costs (up to 35% reduction), material waste (up to 20% reduction), floor space – created by premade pouches.

The Thermoforming Process

Thermoforming uses heat and pressure to create rigid, semi-rigid, or flexible film trays. Product is manually or automatically loaded into the tray cavities after being sorted into the desired array. Once filled, the tray is sealed with lidding material made from paper, Tyvek, foil, or film. The trays then enter longitudinal and traverse cutting stations where they are cut into individual packages and travel downstream for secondary packaging and palletizing.

The Many Advantages of Thermoformed Medical Packaging

More than a more precise packaging process, thermoformed medical packaging offers additional benefits and features other applications cannot, improving productivity and efficiency and reducing overall total cost of ownership (TCO):

Right-Sized Thermoformed Medical Packaging 

Premade pouches are designed to fit a variety of medical products. However, they all have a generic shape. Thermoforming, on the other hand, creates a pocket that is custom shaped to your unique medical device, equipment, or product.

This pocket acts as a useful nesting feature to hold your product in place and can be customized with flexible or rigid bottom web with a tailored webbing depth (ranging from 110mm to 210mm), depending on the size of your machine. With right-sized packaging tailor-made by a thermoformer machine, you can reduce waste and increase your material cost savings overall.

Inline Labeling

Traditionally, medical device labeling has been done by hand, reducing throughput speeds and allowing more room for human error and rejection during product inspection. However, with thermoforming, you can fully automate this process or, better still, conduct sophisticated inline printing on the top web of the thermoformed package.

With inline printing, the product is fixtured, the thermoformer controls the web, and specific in-process controls may be added. As a result, product inspections for presence, labeling, printing, and seal integrity improve dramatically. Overall product accuracy also becomes more precise, and product rejection and waste are reduced.

Custom Machine Sizing and Features

A thermoformer machine can be custom designed and manufactured to create a footprint (small to very large depending on plant space) that is perfectly suited to your preferences and production requirements. Thermoforming equipment can also easily integrate full system automation and modern robotics, vision-guided inspection systems, inspection equipment, and advanced controls at every stage of the packaging process. This customization eliminates the need to add more manual labor to your lines.

TFS 300 Thermoformer

Considerations for Thermoformed Medical Packaging

Moving from bar or belt sealers used in premade pouch medical packaging can be a daunting process. You must get the expert guidance necessary to make the most of your system design, fabrication, and overall investment then meticulously weigh all the factors in your transition.

According to industry experts, successfully implementing thermoforming and improving medical packaging operations depends on several key considerations:

Machine Complexity

When opting for a thermoformer, carefully consider the time necessary to navigate system complexity and optimize performance.

For instance, premade pouches can be more flexible than thermoformed packages, offering easier changeovers for the tooling inside the machinery. If you make different pouch sizes, shapes, or styles on the same day, premade pouches may be your least complex option.

However, you can offset the complexity of a thermoforming system with onsite instruction from Harpak-ULMA Packaging’s teams of Product Managers, advanced augmented reality (AR) capabilities for repairs and maintenance, and advanced online learning tools such as the Harpak-ULMA Packaging Academy.

Floor Plan Considerations

As previously mentioned, thermoformed medical packaging systems can vary from small to large, depending on your throughput goals, operation size, and more. Though the machinery is on caster rollers and can be moved with relative ease, you will need to understand all the access points into your cleanroom to move your system in and successfully and integrate them with minimal time, effort, and auxiliary equipment.

Rollstock Inventory Needs

Rolls of FilmA thermoformer machine utilizes rollstock when packaging product. As such, it is crucial to understand your current and future rollstock inventory needs. This includes how you will manage, move, and store your inventory and dispose of any excess materials. These processes may require additional equipment, investment, and personnel.

Additionally, if your current vendor or copacker does not supply rollstock, you may need to find a new one. Finding a new vendor also means you will need to conduct a new approval process before resuming operations.

Utility Needs

Every thermoforming system requires specific utilities to keep it running at peak performance. These utilities include power, air supply, and a centralized exhaust system (ideally). It is essential that you calculate your available power limitations (280v – 480v for most thermoformers), required air consumption amounts, and exhaust capabilities at your facility before designing or implementing your new thermoforming system.

Marketing and Stakeholder Input

When switching from premade pouches to thermoforming, your stakeholders can provide valuable marketing input – customer outlook, usage, etc. – for your products and packaging. It is vital that you thoroughly document this input upfront before system design begins to get a broader perspective on the project’s entirety and understand key production requirements.

You’ve Chosen Thermoformed Medical Packaging. Now what?

Thermoforming is a superior application for medical packaging, especially when combined with system automation. But properly implementing it and seeing positive ROI takes planning.

Talk to our experts here at Harpak-ULMA Packaging about our thermoforming capabilities.

We will help you understand your specific system requirements with detailed performance analyses and cost and efficiency comparisons between systems. With our help, you’ll be on the right path to optimizing your operations with the reduced costs and enhanced throughput insights to justify your investment.

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