Medical Packaging Machines

Solutions for Medical Packaging

Medical industries require reliable, reproducible and traceable packaging solutions now and at all times. Harpak-ULMA offers medical packaging solutions that meet all of the standards required, helping to provide maximum product protection, hermetic sealing, customizable package shapes, hygienic individual or multi-packs, and easy-open options.

This is essential with all medical items, but especially items in critical need today, like surgical gowns, gloves, masks, test kits and respirators. The healthcare industry is tasked with staying equipped to care for a growing number of patients, and we are here to help with that need.

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Flow Wrapping vs. Thermoforming

Flow Wrapping, Explained:

A permeable substrate is wrapped around the device and hermetically sealed. Products travel horizontally in a continuous motion throughout a flow pack machine. The machinery deploys a single layer of wrapping material that surrounds the product, creating a tubular shape, after which the two edges of the packaging material are joined together. Either a longitudinal fin or lap style seal can be applied. In the final station, the cutting head simultaneously seals and cuts the front of one package and the back end of another.

Flow wrapping has the advantage of not requiring sophisticated forming tools and can sometimes provide a lower cost alternative to in-line thermoforming. It is commonly applied to products where the product sterility of the outside of the product is not essential, like nfusion bags or IV sets where the fluid path is sterile, and the sterility of the fluid path will be preserved by the device itself.

Thermoforming, Explained:

Horizontal form, fill and seal (HFFS) technology was originally developed as a high speed alternative to the flow wrapper. HFFS thermoforming combines two materials together – resulting in an effective sterile barrier system combined with a sealed, rigid, semi-rigid or flexible tray – enhancing aseptic presentation by obviating the need to transfer or touch the device prior to use. a variety of formable films (both rigid and flexible) and lidding stocks (including paper, Tyvek, and coextruded or laminated films).

This packaging concept is very application specific and requires specific thermoforming tools, sealing tools and cutting systems. Typical thermoforming applications would be syringes, instruments and procedural trays.

So which option is right for you?

When comparing the two technologies, a number of considerations need to be taken into account: printable area, sealing, material consistency, types of material, sterilization, process validation, products, additional benefits, initial investment, speed/maximum number of packages per minute.

In certain applications flow wrapping can be the preferred, cost-effective solution; particularly in light of recent innovations in applying chevron seals the flow pack. In many typical applications, thermoforming will remain the preferred solution for disposable medical devices.

Medical Packaging Applications

Flow Wrapped Medical Devices

Thermoformed Medical Devices

Options for High-Profile Medical Devices

Featuring our New Chevron Seal Flow Wrapping Solution

Medical device packaging must accommodate the appropriate sterilization process and create an effective microbial barrier that maintains sterility and allows aseptic presentation up to the point of use.

Aseptic presentation is the single most important limitation of employing flow-wrapping for medical devices. Flow wrapping is widely viewed as one of the most cost-effective methods for packaging high-profile products. However, in medical device applications it is more commonly applied to products where the product sterility of the outside of the product is not essential.

Introducing chevron seals with peelable side seals dramatically improves ease of opening, making cost-effective flow wrapping a feasible alternative for dimensional, larger, or bulky disposable products that require a strong, but easy to-open seal. Chevron sealing is ideally suited to such products, as they can challenge seal integrity on all four package sides. This capability is particularly important given recently updated ISO11607 guidelines that emphasize point of use aseptic presentation of terminally sterilized medical devices.

Regulatory Considerations in Medical Packaging

Meeting All of Your Packaging Needs while Fulfilling the Necessary Standards and Requirements

Packaging can impact many facets of product design, including traceability, but in this context it’s the sterile barrier guarantee that makes it subject to rigorous testing and validation.

Several packaging standards are in place today, but the type of regulations that apply will depend on the kind of packaging required, and our solutions meet them all, like ISO 11607, EN 868, ASTM D1585, ASTM F2097 and ASTM F3475-11.

Frequently concentration is put on the device itself in efforts to address regulatory concerns. Is it safe, is it sterile, does it perform its function? However, medical packaging is equally important to the device safety, efficacy and performance.

Packaging solution providers that know how to leverage the latest packaging innovations within the bounds of regulatory requirements, have the in-house capabilities to support such innovation, and can cost-effectively manage the phases of validation process.

Product to Pallet Automation

Automation affords several major benefits for packaging manufacturers. It reduces operational costs by lowering labor costs and minimizing waste from human interaction, increases throughput and productivity, and creates a safer work environment by replacing repetitive and strenuous manual jobs.