A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 21st Year of Publication
Page  4 of 5

Cover Story

Key Essentials For The Perfect Medical Device Packaging

Mr. Rahul Prakash Bora
Sales Development Manager
Medical Applications, India and Sub Continent
Sealed Air India Pvt. Ltd.
www.sealedair.com

Selection Criteria And Critical Factors

 

While selecting packaging material for Medical Product; some of the important criterias could be;

  • Product Application - The end application of Product is very important. Some medical devices are used Internally (as Implants like Coronary Stents ) while some products are used externally (as support tool like Surgical Blades ).

  • Type of Packaging - Primary/Secondary - The primary packaging requirements are more stringent than terms of production area used (Cleanroom / Non Clean room), Bioburdens maintained, Polymeric reaction of the products etc.

  • Sterilisation Requirement - Steam/ETO/ Gamma/E-Beam - (Every Polymer reacts differently with different sterilisation methods depending on their thermostability; for ex. some polymers turn soft after steam sterilisation or some polymers change colours after Gamma Sterilisation

  • Sterile Barrier Requirements - Most of the medical products are have Sterile Barrier Requirements- Every packaging is developed to built up the Sterile Barrier system around the package and its requirement may differ product to product. Some medical products have active contents which needs higher Moisture/Oxygen barrier to maintain shelf life and its potency.

  • Regulatory Requirement/Compliances - Based on its application/s, every product has to comply with different regulatory compliances locally and internationally, the primary and secondary packaging also has to comply with these compliances like ISO 11607-2006, ISO-13485, EEC regulation etc.

  • Market Expectations - Most of the medical packaging concepts are designed considering the Aesthetics and Functionality both.

  • Products Shelf Life - Every packaging material has its shelf life depending on the material composition and production or polymerisation process. It also depends on usage. disposable products may need different packaging than regular products.

Emerging Global Trends

 

Most of the new medical devices are expected be packed in Non PVC options. PETG looks to be preferred Polymer for most of Rigid packaging applications, whereas OPA and PP based variants are preferred in Flexible packaging options.

 

 

Requirements For Design Of Material

 

Sealed Air offers a complete packaging system, which differentiates us from other material suppliers. We think Functional and Aesthetic requirements are important in designing a packaging system.

Implications Of Material Selection On Design And Packaging Machinery

 

Most of the medical packaging materials and concepts are designed considering the Aesthetics and Functionality of packaging both. While designing the blisters we must consider, The Polymers Clarity, lay-outs, Finger scoops / Peel Tabs / Finger grips/ Sealing Flanges/ Cavities are designed keeping both functionality and Aesthetics in mind. Some other important factors are Products stacking/Denesting/Possible transportation and its impact.

 

For Packaging Machineries, especially Cleanroom Sealing Machines, we must consider ease of use, ability of give same same results every time even after repeated use, emissions (as these machines are used in Clean rooms they have to be lubrication free), its sustainability, filtration and most importantly their ability to offer Uniform Sealing to create a Uniform sterile barrier around the product.

 

Reducing The Cost Of Packaging Without Compromising The Quality

 

Sealed Air offers efficient and sustainable solutions that create business value for customers, enhance the quality of life for consumers and provide a cleaner and healthier environment for future generations. We combine a unique consultative sales expertise with our global network of science and innovation to demonstrate how better packaging makes the world a better place.

 

Sealed Air always believes in optimising the packaging cost without compromising on Quality with our Innovative products and Solutions. We have most advance resources and technologies to counter the increasing pressure of Cost. If you look at Cost vs Benefits matrix Sealed Air Products has no match globally.

 

Services Offered

 

For Medical Devices and Healthcare sector, Sealed Air is a “Total Solution provider”. Sealed Air Medical is a global specialist in Medical Device and Pharmaceutical packaging.

 

Its Nexcel™ line of products offer superior performance in flexible films used for;

  • Non PVC LVP packaging solutions - Our Pharmasol Films are backed up by extensive regulatory documentation and approvals including a USFDA Drug Master File for the M312 range of pharmaceutical solutions films. Our M312 range of Non-PVC Films recyclable Eco friendly films extruded in Class 100-filtered air. Used for Large Volume Parenteral application as General IV, Special IV, Antibiotics, Nutrition etc.These films complies with USP (Class VI), European, Japanese (XIV) and Korean harmacopoeias.

  • High end Sterilisable Films for soft blistering Medical Devices For Steam/ETO/Gamma Sterilisation. These films comply with most of global standards

  • Sophisticated Ostomy Films. They are used by the major Ostomy care providers for colostomy, urostomy and ileostomy pouches and are in available various thicknesses and in clear or tan versions.

While Nelipak® line of products are leaders in custom thermoformed trays and blisters using the most up to date equipments and softwares, we are able to design, sample and manufacture blisters and trays to the highest standards. We also offer most Sophisticated Sealing Machines for these products and can give validation support for these products. For medical device use.

 

To complete the offering , we also have Tyvek Lids, Tyvek and Aluminum Pouches. All these products are usually made in Class 7 (10,000) cleanrooms and in accordance with ISO 13485, for which Sealed Air Nelipak® sites in Europe are accredited.

 

Page  1  :  2  :  3  :  4  :  5

Back | Back to Top | Previous |Next