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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;
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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 ).
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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.
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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
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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.
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