Medical Packaging News

Is this the ultimate clean room pouch sealer? This impulse sealer is stainless steel clad and designed to avoid particulate generation to make it compatible with the strictest of clean room classifications.

The sealing jaws are external to the machine, to avoid the need for cooling fans. Jaw closing is controlled by a double set of electromagnets, ensuring even pressure along the entire length of the seal. The temperature profile is monitored and displayed. Temperature can be varied throughout the cycle. Heating and cooling cycles are accurately timed. Available for a variety pouch widths and with 4 or 8mm weld widths this flexible machine is the ultimate pouch sealer for clean room use!

Medical Pouch Sealer

Read the Full Description (PDF)

Validation of package seal strength and integrity is required for CE marking and FDA submissions for medical devices. Testing is also required following realistic transit simulation and shelf life aging.

MET’s comprehensive service ensures that you document your compliance to parts 1 and 2 of ISO 11607 (Packaging for terminally sterilized medical devices.

Part 1:
Requirements for materials, sterile barrier systems and packaging systems,

Part 2:
Validation requirements for forming, sealing and assembly processes).

Our internal laboratory provides sterile barrier and packaging system testing for your packaging. Our engineers provide on site validation of your packaging equipment. Download our ‘How To Guide’ here.

Medical Device Packaging Test

Does your product require vacuum packing or an inert gas atmosphere? MET’s medical device and pharmaceutical sealers feature options for controlling the gas content of your packages. Whether you are sealing 3 sided pouches or running high speed sachet production this equipment can be fitted and fully validated to your requirements.

Vacuum Pouch Sealer

All MET customers are most welcome to visit the Belco Packaging stands at the following shows.

MDM East http://www.mdmeast.com

June 3 - 5, 2008
Jacob K. Javits Convention Center
New York, NY
Booth 2031

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BIOMed http://www.biomedeviceshow.com

September 10 - 11, 2008
San Jose McEnery Convention Center
San Jose, CA
Booth 1335

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MDM MidWest http://www.mdmmidwest.com

September 23 - 25, 2008
Donald E. Stephens Convention Center
Rosemont (Chicago), IL
Booth 7139

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MDM Minneapolis http://www.mdmminn.com

October 22 - 23, 2008
Minneapolis Convention Center
Minneapolis, MN
Booth 140

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Pack Expo http://my.packexpo.com/SPC-2-10022-75/PACK-EXPO-INTERNATIONAL-2008-FACT-SHEET.aspx

November 9 - 13, 2008
McCormick Place
Chicago, IL
Booth S-2912

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MDM West http://www.mdmwest.com

February 10 - 12, 2009
Anaheim Convention Center
Anaheim, CA
Booth 2155

JR Maruani have developed a new four sided seal pouching machine for alginate dressing manufacture. The packaging system is fed by alginate non woven as a reel stock. The dressing material is first cut into strips and then folded ready for packaging. The folded dressing is delivered into the poucher, in synchronisation with packaging webs from reel-stock and the medical pouch is sealed around the dressing. Packages are then cut into units and collated for boxing.

All operating parameters are fully adjustable and validation services are provided by MET. Also, printing of batch or marketing information onto pouches is available as an option. The system can run at up to 150 cycles per minute. A video showing the equipment in action is available on request.

MET’s medical device packaging ageing service for shelf life validation now offers a variety of ageing chamber temperatures. At 55°C, 6 weeks in the chamber is equivalent to 1 year of real time storage. Some package configurations can withstand ageing at 65°C. At this temperature 3 weeks of accelerated ageing is equivalent to one year of real time.

Following ageing pack seals are subject to strength and integrity testing according to ASTM standards.

MET’s validation and qualification services are fully compliant with the latest version of:

EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices.
Requirements for materials, sterile barrier systems and packaging systems.

A terminally sterilized medical device packaging system should allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation and meet the Essential Requirements of the European Medical Device Directives.

Our laboratory service will test your sterile barrier system for strength and integrity, confirming your expiry date. We will also test the protective packaging in storage and transport to confirm performance of your complete packaging system.

The continuous improvement program at J R Maruani means that the RDM 4SS dressing packaging machine can now run at 150 cycles per minute. This four-sided sealing machine is ideal for production in an ISO 13485:2003 medical production environment.

The new control system and application of the Siemens Simotion PLC makes the system informative, easy to use and very, very fast. Interfacing is via a tactile screen with intuitive programming. Pouch length changes are rapid and efficient, alarms are displayed clearly and printing integration is a doddle.

Machine calibration is handled using ports, which give easy access to temperature, pressure and timing signals. ISO 11607:2006 compliant machine qualification is provided as part of MET’s comprehensive customer support.

Dressings are fed into the machine on a flighted conveyor, allowing manual or automated loading. Automatic systems often include cutting or folding stations to further improve efficiency. Many other products are ideal for packaging by this equipment: catheters, diagnostics, filters and many more. The maximum product height is 15mm.

MET’s packaging machines are complemented by burst and leak testing equipment.

Pouch Machine Cycles at 150 Per Minute

When designing tooling for sealing blister trays we require dimensional and material information on the trays to be sealed. We can apply this produce good tooling design which combined with robust construction ensures perfect seals time after time. This drawing details the required information for tooling manufacture and process development.

Medical Device Blister Drawing (click for full image from our gallery)

Details of MET’s medical device package validation services are now available in ‘printer friendly’ format. Just click the links to find out more about qualifying sterile barrier systems, protective packaging and packaging systems.

Shelf Life Validation Description
Shipping Validation Description

Medical Device Quality Assurance