Wipak Oy of Nastola at COMPAMED 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

Wipak Oy

P.O. Box 45, 15561 Nastola
Wipaktie 2, 15560 Nastola
Finland
Telephone +358 20 510311
Fax +358 20 5103300
info@wipak.com

Hall map

COMPAMED 2018 hall map (Hall 8a): stand S01

Fairground map

COMPAMED 2018 fairground map: Hall 8a

Our products

Product category: Packaging materials

WIPAK® FITFORM – MORE SUSTAINABLE STERILE BARRIER MATERIAL FOR MEDICAL DEVICES

One of Europe’s leading suppliers of premium quality flexible packaging solutions has refined its downgauging technology to further improve its thin and sustainable Fitform coextrusion film.

“With manufacturers increasingly demanding thinner, more sustainable packaging solutions that do not compromise patient safety or packaging performance, Wipak places a great emphasis on making continuous improvements in its operational efficiencies and in the quality of its products to satisfy the customer’s needs,” explained Michel Terwolbeck, Sales & Marketing Director, Health at the Wipak Group.”
 
The new generation of thermoformable, PA/PE based Fitform films were specifically developed as a sterile barrier material for medical devices. A special feature is the film structure which is up to 20% thinner than the market standard yet still provides high mechanical strength. Fitform is also comparable to thicker films in terms of its technical properties. The films are suitable for ethylene oxide and irradiation sterilization, and provide a safe barrier against microbial contamination. This prevents damage to and contamination of medical devices during their transportation and storage.

Using thinner film also has a positive impact on logistics and processing.  It results in more linear meters per roll, optimizes pallet and storage space capacity, and reduces roll changes. These in turn all lead to increased productivity and lower energy consumption at customer site.

To find out more about the Fitform film, and Wipak’s other sterile barrier materials , please contact mdi@wipak.com . Alternatively, please visit www.wipak.com to find your local sales representative.

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Product category: Packaging materials

NEW SERVICE TO ASSIST HEALTHCARE FACILITIES IN THEIR SEALING PROCESS VALIDATION

A documented validation program to demonstrate the efficacy and reproducibility of all sterilization and packaging processes is required in all health care facilities where medical devices are packed and sterilized. To support healthcare facilities in their validation programs Wipak is now offering a new Steriking® service to assist in the validation of the sealing process.

The sterile barrier system (SBS) is a minimum package that prevents ingress of microorganisms and allows aseptic presentation at the point of use. Only intact packaging can serve as a sterile barrier, and the loss of package integrity can compromise patient safety. “ISO 11607-2 standard  for sterilization packaging states that there needs to be a documented validation program in all health care facilities where medical devices are packed and sterilized. The aim of the validation programs is to demonstrate the efficacy and reproducibility of all sterilization and packaging processes.” Explained Mira Santala, product manager, Health Care Facilities, at Wipak Group.

“The validation of sealing process according to ISO 11607-2 includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). In the validation process it is verified that the sealer makes a proper closing and that the final sealed package performs as a safe sterile barrier system. “

Part of new regulation (EU) 2017/745 on medical devices (MDR) requires that devices labelled as sterile shall be processed, manufactured, packaged and sterilized according to appropriate, validated methods, which means that also packaging process has to be validated.

To support healthcare facilities with their validation programs, Wipak is now offering a new service to assist with the validation of the sealing process. The Wipak Sealing Process Validation Service package for one sealing machine comprises of: templates for documenting the Installation, Operational and Performance Qualifications, seal testing of sterilized pouches/packs, pinhole and peel testing, a Multi Seal test kit (MS300) for routine control, validation report with conclusions and recommendations and an access to Steriking® Seal Validation platform.

To find out more about the Seal Validation service, and Wipak’s other sterile barrier systems, please visit https://www.steriking.com/seal-validation-service.

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Product category: Packaging materials

WIPAK® WINDOWBAG – For surgical instrument sets

Wipak® Windowbags are safe and reliable sterile barrier for instrument trays and kits. Window allows breathability and transparent film good visibility.

Technical Details
·         Multilayer PE film or reinforced PE/PA/PE film
·         Printable coated Tyvek® window
Benefits
·         Easy to use with clean peel
·         Reliable barrier during transport, storage and handling
·         Good clarity and transparency
Applications
·         For packaging of custom-assembled sets of instruments
·         Other surgical items such as drapes, individual towels and tubing sets
·         For EO and Irradiation sterilization

Ask more information from Mrs. Jaana Kilpinen, Product Manager MDI (mdi@wipak.com)

Wipak® is registered trademark of Wipak Oy.
Tyvek® is a DuPont™ registered trademark.

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