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Sustainability is a term used across a large number of industries. At the core, one can think of sus

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

tainability as the measurable concept of doing business without depleting resources or harming the co

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

mmunity. Nowhere is sustainability more applicable than in the packaging industry. Containers and pa

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ckaging that are cost effective and environmentally sound are critical to our industry’s business suc

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ess and the impact we have on society. One industry group offers criteria by which the sustainabilit

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

y of packaging can be measured.

Packaging that is beneficial, safe and healthy for people throughout

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

its lifecycle;
Meets market criteria for performance and cost;
Uses renewable energy thr

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

oughout its lifecycle;
Maximizes the use of renewable or recycled source materials;
Is ma

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ufactured using clean production technologies and best practices;
Is made from materials health

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

y in all probable end-of-life scenarios;
Is physically designed to optimize materials and energ

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

y.
A Life Cycle assessment is a key tool in assessing sustainability.

A life cycle assessment (

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

LCA) is the assessment of the environmental impact of a given product or service throughout its lifes

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

an.

The goal of LCA is to compare the environmental performance of products and services, to be able

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

to choose the least burdensome one. The term 'life cycle' refers to the notion that a fair, holistic

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

assessment requires the looking at a product at every step of the way - from raw materials to dispos

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

al, and all the steps in between. In packaging, this means looking at how the materials are produced

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

products manufactured, used/discarded by the consumer, and recycled back into use.

The terms Cradle

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

-to-Grave (complete life cycle), Cradle-to-Cradle (from birth to re-birth), Cradle-to-Gate (Material

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

manufacture to product delivery), and Wheel-to-Well (efficiency of fuels used for transportation) are

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

terms often used to describe the life cycle, or parts of it.

dbanig@prflexbag.com

www.prflexbag.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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