Selection Criteria And Critical Factors

One of the most challenging tasks for a Medical Device Manufacturer is selecting the right package for the Medical Device. Device manufacturers need to look for cost-effective packaging solutions which not only make the product presentable but also serve their intended purpose. The right package will have an impact in infection control, patient safety and of course the costs of the Device Manufacturer.

Important points when choosing an appropriate packaging for the Medical Device:

• Permit Sterilization of the Medical Device.

• Maintain Sterility of the Package until the package is opened.

• Permit Aseptic removal of the Device when presenting.

• Protect the Device

• Adequate protection against microorganisms, dust, moisture etc.

• Must be presentable.

• Costs.

Selection Criteria

A variety of choices in the form of Wraps, Pouches and Rigid Containers are available for packaging Medical Devices.

We shall restrict our discussion to Pouches as Wraps and Rigid Containers are more specific to Hospitals than to Device Manufacturers.

Medical Packaging / Sterilization Packaging Products are classified as a Class I, Non-Invasive Non-Sterile Medical Device in the EN Standards but the US FDA classifies the same as a Class II Medical Device which require a 510 (k) approval.

Device Manufacturers need to follow the following steps when choosing a Packaging:

• Nature of Medical Device. (weight, dimension, sharp / protruding edges, criticality of the device).

• Primary, Secondary and Tertiary Packaging (For storage and transportation).

• Method of Sterilization (Steam, EO, Gamma, Gas Plasma).

• Quality Standards maintained by the Packaging Manufacturer.

• In-house ability to pack the medical device (Sealing machines, clean room, qualified staff etc.)

Material Selection

• Disposable Peel-Open Pouches are the most common packaging solution for Device Manufacturers.

• Peel-Open Pouches are generally available in Paper/Poly combination or Tyvek/Poly Combination.

• Paper pouches are sufficient for small and light-weight devices which do not have any sharp edges.

• Paper Pouches for device manufacturers are generally made of a 60 / 70 gsm Medical Grade Paper conforming to EN 868 Part 6 for EO / Gamma Sterilization. The paper is sealed on to a transparent laminate which make the product visible.

• The Films should be laminated to eliminate possibility of pin-holes, should be made from virgin materials, should be sealable and peelable to the paper / Tyvek, should withstand the process of sterilization. The films are preferably transparent and can be tinted blue / green / pink not only to make the package more presentable but also to check the seals along the edges clearly.

• The Pouches are sealed on the 3-sides with a “chevron” seal on top and the bottom side is sealed after insertion of the device in the pouch by the manufacturer by a heat-sealing machine with a minimum seal width of 6mm.

• The recommended Shelf-life post sterilization is 3 to 5 years depending on method of sterilization, storage conditions etc.

• Tyvek is recommended for devices which are heavy and also which have sharp edges or corners.

• Tyvek pouches are generally three times more expensive than paper pouches and need not be used just because the product is being exported!

• Header Bags are recommended for Packing of tubing sets, drape, gowns and dressing kits.

Emerging Global Trends

Medical Packaging is an evolving industry. The past few years have seen a tremendous growth especially in India. Device Manufacturers have moved from transparent /
opaque LDPE bags to Medical Grade Pouches.

The emerging trends point to innovating more cost effective substrates and films.

• All-Over Laminated Papers, Grid Lacquered Papers, Reinforced Coated Papers suitable for Steam, EO & Gamma

• Puncture and abrasion resistant packaging for sharp instruments

• Non-Woven Pouches

• Header Bags with Built-in Pouch for instruction manuals

• Effective Sealing Technologies

• Recyclable Plastics

Requirements For Design Of Material

Medical Grade Peel-Open Pouches should have the following characteristics:

• Should be sealed correctly on all sides

• Peel-Strength and seal-strength should be adequate

• A minimum seal-width of 8mm is recommended

• Minimum or No Fiber Tear when peeling open the pouch

• Must have a “chevron” seal on the topend and preferably a “thumb-cut” for easy gripping and opening of the pouch.

• Should have sufficient barrier properties for protecting the contents

• Should be aesthetic and presentable

Implications Of Material Selection On Design And Packaging Machinery

Device Manufacturers can be classified into two broad categories:

• Device Manufacturers with in-house online packaging facility like Blister Packing Machines and Device Manufactures who manually pack devices.

• In-puts for blister pack machines are recommended by the machine suppliers themselves and generally consist of pouches made of gridlacquered paper and soft-PVC blister films.

• Device Manufacturers who pack devices manually procure the preformed pouches from converters.

• The Converters and device manufactures mutually decide on the best possible options in packaging. The device manufactures need to install only a good and effective sealing machine which needs to be validated at regular intervals.

• Sealing quality should be checked every day with the help sealing check strips.

• The contents of the pouch should occupy not more than 75% of the volume of the pouch. Stuffing the pouch excessively will strain the seals which may lead to the pouch opening at the time of sterilization.

Reducing The Cost Of Packaging Without Compromising The Quality

• Device manufactures should strive to achieve a right balance between costs and quality in packaging.

• A reduction in price need not result in reduction in quality and vice-versa.

• As the market for medical pouches is growing in India, it is natural that there will be newer entrants / converters in the market, who will push down the prices due to competition.

• The prices of sterilization packaging products have reduced by all most 25% in the past 5-6 years.

• Competition, cheaper access to raw materials due to bulk purchases, better machine technology, economies of scale are some of the factors that have led to more competitive pricing from converters.

• Converters are offering more customized solutions to Device Manufacturers which help in reducing costs rather than just offer off-the-shelf products.

• Pre-Printed pouches with built-in sterilization indicators are very common and help reduce overheads of device manufactures.

Services Offered

• We manufacture and supply Sterilization Packaging Products in the Form of Reels and Pouches.

• Generally hospitals purchase reels and device manufactures prefer pre-formed pouches

• Our products are compatible with Steam / EO / Gamma Sterilization / Plasma Sterilization processes.

• Our products are CE Certified and our manufacturing facility is ISO 13485 Compliant.