An Autobag HDE, Automated Packaging Systems' specialist flexible packing system for medical devices, has been installed into PPI Medical's new clean room facility and put to work packing an innovative medical mouth guard into medical paper pouches for terminal sterilisation.
French medical plastics specialist PPI Medical launched its innovative new mouth guard just five years after work on the project began, and manufactures and packs the product at its production facility in north east France, close to the Vosges mountains in an area famous as the birthplace of Joan of Arc.
PPI Medical has adopted a collaborative approach to new product development. Its latest mouth guard is a partnership between renowned Marseille based gastroenterologist Dr Christopher Bastid, investor Patrick Bey, and Vygon, a name synonymous with quality, reliable single-use medical and surgical products.
The injection molded mouth guard is designed with a tongue depressor to reduce incidence of choking. It also offers practitioners a much wider opening in which to work and features a twin-channeled oxygen and CO2 delivery and collection system.
The molded tongue depressor presented engineers at PPI Medical with a challenge, as project manager Christophe Poirot explains: "putting such an innovative product into production can be difficult. In this case the curved channel was the challenge, and we have had to develop a system which liberates this channel from the mold before ejecting the mouth guard itself."
PPI Medical, which sells an average of a million mouth guards each year, initially designed the new mouth guard for gastroenterology but plans to market it for anesthetic applications in the near future.
The mouth guards are packed for terminal sterilisation. Historically PPI Medical outsourced its packing to a contractor but with the new product came the decision to invest in a clean room and pack in-house.
Christophe Poirot and his team turned to specialist bag and pouch systems manufacturer Automated Packaging Systems, a business with a global reputation for reliability and quality. It has recently launched the new Autobag® AB 180 HDE specifically designed for clean room packing of medial devices and goods requiring terminal sterilisation.
The system, which can be configured for manual, semi-automatic, or fully automatic operation, delivers a validatable seal to meet the specific needs of the medical market. Nicolas Kalisz, Automated Packaging Systems head of operations in France and the man responsible for ensuring the Autobag AB 180 HDE works for PPI Medical, explains: "Our medical sector clients make very specific demands on a packing system, so we have developed one capable of producing a validatable seal even on multi layer pouches which combine barrier films with medical papers.
"The pouches come pre-sealed on three sides, and are presented to the operator open and ready for loading, before being welded by the 8mm sealing bar and separated. The temperature, pressure and duration of welding are audited on each cycle, and barriers and guards ensure that operators cannot access the pouch during the welding cycle."
While it's specialist medical bag and pouch system is relatively new, Automated Packaging Systems Autobag AB 180 has been used for years to bag medical devices and products that don't require in-pack sterilisation. With a reputation for quality and reliability, global sales approaching £150 million, a new specialist system for medical applications, and new materials under development, its share of the medical sector packaging spend is set to increase.
Like PPI Medical in France, Automated Packaging Systems invests in a collaborative approach to new product development as well as embracing an NPD culture in house in the US and in its European operations. Its collaboration with materials specialists Westfield Medical is a case in point.
Throughout Europe the Autobag AB 180 HDE system will run medical pouches formed using high quality Westfield Medical materials. System matched medical pouches are created by Westfield Medical, complete with validated side seals, medical grade paper and PET/PE film. They are then finished at the clean manufacturing facility at Automated Packaging Systems in Worcestershire where they are trimmed, perforated and put onto reels.
"By working with Westfield Medical we're able to deliver real efficiencies and improvements in product performance to medical product manufacturers and packers," explains Automated Packaging Systems head of UK sales and marketing Andy Pretious. "Our systems are a logical step-up from hand packing, delivering superb returns on investment that have enabled companies to make genuine bottom line savings just a few months after they've invested in automation. They also represent a real alternative to outsourcing, something which PPI Medical has clearly identified."
Together Westfield Medical and Automated Packaging Systems have selected materials compliant with ISO11607 parts 1&2 and EN868 parts 2-10. These offer superb value and reliability, to deliver a finished pouched product that meets a wide range of needs.
Multilayer heat-sealable PET/PE film is sealed on three sides in a ribbed pattern to 60gsm medical grade paper which can incorporate ETO indicators.
"For many customers this represents a real innovation," explains Ken Robson of Westfield Medical. "Before, our customers' choice was limited; pack by hand to retain flexibility, or invest very substantial sums in significant automation. Now semi-automation with an Autobag HD-E system running Westfield Medical pouches offers increased productivity, output and efficiency without restricting flexibility or demanding substantial capital investment."
Main features of the Autobag AB 180 HDE:
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