Advice You - Business

With the winter season just a few months away, manufacturers must plan ahead to protect their shipments from the damage that winter

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

weather can inflict. If you use standard paper corrugated products, you’ll run the risk of your package being exposed to elements

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

Examples of combination products may in

like wind, rain, and snow. The result is usually a big soggy mess, when the corrugated paper becomes saturated and begins to break

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

down. And who knows what will happen to the product contained within!

But today’s manufacturers have many more options when it com

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

s to shipping their products. For example, many companies have replaced their cardboard paper products with plastic corrugated – an

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

Combination pro

have done so with many positive results.

Corrugated plastic is a durable material designed to take the place of the conventional

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

paper and cardboard corrugated products which once dominated the packaging and distribution industry. Plastic corrugated is formed

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

hen two plastic liners are fused together on either side of a sheet of wavy plastic known as fluting. Together, these three layers

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

reate a weather and chemical-resistant material whose properties offer a superior alternative to traditional packaging methods.

Un

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

like its cousins, corrugated plastic won’t rust, rot, mildew or corrode like metal or wood, and is completely unaffected by water,

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

umidity, grease, dirt, and most chemicals. In a recent study, both paper corrugated and plastic corrugated were tested for their wa

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

Following aspects would a

er resistance over a period of 24 hours. Upon examination, the plastic corrugated was only .02% saturated, whereas the cardboard pa

dd to the challenges in developing combination products:

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

per corrugated was 75% saturated, meaning the corrugated plastic has a 3,750 fold advantage! And when the temperature drops, there’

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

no need to worry about plastic corrugated returnable packaging cracking or breaking – it can withstand extreme temperatures as low

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

as 17 below zero without risk of damage.

In closing, while companies try to isolate and protect their critical components regardle

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

ss of the season, sometimes Mother Nature can get in the way. Production floors can get wet from shipments delivered from trucks t

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

Professional from academic institutions, pharmaceutical industries, health care indust

at just traveled through a rain or snowstorm, storage areas can be subjected to severe changes in temperature due to open dock and

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

elivery doors, and even employees returning from lunch with wet shoes can leave moisture that could be absorbed by containers made

.

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

from paper corrugated. On the other hand, returnable packaging made from corrugated plastic will withstand these conditions becaus

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

Companies that provide selfless information through particip

they are water resistant and built to last. Armed with this information, there’s no excuse to be left out in the cold this winter

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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