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You may not know it, but almost everything around you was made through plastic injection molding – the

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

mouse you are using to surf, containers you use to store leftover food, etc.

You see, plastic injectio

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

Examples of combination products may in

n molding is the most important process in the manufacturing of plastic parts. It is done by forcing me

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

lted plastic in to a mold cavity until it cools and forms a specific plastic shape. Plastic injection m

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

olding is very useful when the plastic parts that need to be produced are too complex or expensive to d

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

Combination pro

o by machine. With plastic injection molding, many parts can be made simultaneously (using the same mol

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

d).

Plastic molding manufacturers use several distinct molding techniques to produce plastic component

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

s. These techniques include thermoplastic and thermoset injection molding, transferring to resin, blow

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

molding, gyratory molding, compression molding, thermoforming, structural foam molding and many others.

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

Some plastic injection molding companies take your concept from initial prototype through production,

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

delivery and finishing. They have a trained staff of experienced engineers, designers and toolmakers w

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

Following aspects would a

ho work with clients from designing the concept to building the prototype and to the production of the

dd to the challenges in developing combination products:

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

actual custom mold. With the use of sophisticated computer aided design and technology and the latest e

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

quipment, they can provide clients with a technically superior mold and assure every product’s success.

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

It’s a good idea to choose companies that are fast, flexible and customer-driven, especially if you n

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

eed large quantities and fast turnaround or specialized small volume runs. Choose companies that have s

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

Professional from academic institutions, pharmaceutical industries, health care indust

tate-of-the-art plastic injection molding facilities and machines that differ in weight from seventy fi

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

ve to five hundred tons. See if they have full scale thermoplastic and thermoset capabilities with comp

.

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

uter aided manufacturing, skilled machine operators and first class quality assurance team. This guaran

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

Companies that provide selfless information through particip

tees that their output goes through high-quality injection molding, and that it stands the test of time

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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Have you ever thought about how your retail organization handles the distribution and record keeping for its mechanical keys? If you have, what did you conclude? That the current system is a cornerstone of your security program or a liability? If you're like most, you might have reached the decision that it was just too stressful to think about and simply stopped thinking about it.

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