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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Medical Flow Wrapping

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.

Key Features of Our Medical Flow Wrapping Equipment

BETTER-SEAL – A system that improves the stability and accuracy of packaging machine sealing element temperatures

Certification – UL-508A certified electrical panel

Printer VideoJet Printhead – Maintains consistent ribbon tension, eliminating ribbon breaks while simultaneously ensuring high-quality print; Printing spot checks conducted in real time, catching commonly occurring print defects

Printer Control – Printer control integrated in UPC screen; Interface integrated into packaging machine display with complete control and diagnostics

Data Integrity – Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records; Each individual accesses the HMI with personal credentials.

Access management per users, groups and roles in Active Directory
User authentication remotely by means of user/password
LDAP client/server communication
User logout following an inactive period
Off-line events registration, in files
System registers machine operation events and parameter changes
Events related to machine operation are managed by UDAQ Generator
Parameters changed by the user are managed by UDAQ Logger

Medical Thermoforming

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).

Key Features of Our Medical Thermoforming Equipment

2-column Servo Drive Lifting System – Interlocking lever mechanism of 2-columns that are supported on the frame of the machine and operated by a servo drive motor; Built with anodized aluminum and stainless steel, and utilizes wear-resistant, lubrication-free IGUS bushings

Pre-heating Station – Both sides of the film heated prior to the forming process

Forming with Plug Assist – For packages requiring high stretch for flexible and rigid films; A mechanical plug or series of plugs of the same shape as the cavity to be formed are incorporated into the top part of the forming system, ensuring a consistent film thickness on the package walls

Longitudinal Cutting System – For longitudinal separation of flexible and rigid film packages; A circular knife presses the film against a rotating flat surface on a disc to cut the film. This generates no film dust, making it ideal for medical applications.

Data Integrity – Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records; Includes a user management system where each individual accesses the HMI with personal credentials

Some other features of our TFS machines include:.

Sealing station pressure sensor
Sealing plate location verification system
Upper/lower film end detectors
Sealing time control
Machine inlet pressure sensor to verify actual air pressure
Forming station pressure sensor to signal for automatic product loading
Package jam detector in longitudinal cutting system
UL-508A certified electrical panel
Heating plate temperature control
Busch Mink vacuum pump
Centralized air exhaust
Additional sealing cylinders for higher sealing pressure
Electrical cabinet ventilator cooling system

Additional Flow and Thermoforming Capabilities

Automation – Product to pallet offering; Automated loading of components; Automated secondary packaging (cartoning, palletizing, etc.)

IOV Document – Verification protocol for ULMA equipment; Design and functionality are checked vs. the built machine according to predefined specifications.

FMEA – Failure mode effects analysis risk assessment

Visual Inspection – Use of cameras to inspect print, product presence, seal criteria

Product Contact Materials – Certificates for product contact materials

Calibration – Certificates for calibrated equipment i.e. Temp Controllers, Pressure Sensors, Timers

Allen-Bradley Controls – Standard on many TFS models; Available on the rest

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

Medical Tray Sealing

The Trave is a groundbreaking innovation in the range of G. Mondini tray sealers. These advanced machines can produce multiple packaging formats on a single tray sealer through a simple tool change. The Trave also features the patented integrated G. Mondini “Platform Technology,” giving producers the flexibility and technology to meet changing consumer demands in a single investment.

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. Our tray sealers are manufactured with the most advanced capabilities for denesting, conveyance, filling, sealing, and secondary case packing, along with full product-to-pallet automation integration. Our brand new Cigno compact tray sealer is ideal for small footprints and medical packaging.

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.