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Water jet machining technology involves the use of high-pressure water jets for cutting parts ou

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

t of different types of material such as soft rubber, foam, extremely thin stuff such as foil, c

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

Examples of combination products may in

rpet, paper, cardboard, soft gasket material, candy bars, diapers, and soft wood. Its use is lim

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

ted, as it cannot cut harder materials such as metals, glass, and hard wood.

The water used in

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

ater jet machining systems is pressurized between twenty and sixty thousand pounds per square in

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

Combination pro

h (PSI) depending on the type of material being cut. The highly pressurized water is released th

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

ough a tiny hole called "jewel" which is typically 0.007" to 0.015" in diameter, creating a very

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

high velocity beam of water capable of cutting soft materials.

Water jet machining process is c

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

ntrolled with the help of computer numeric control (CNC) software that guides the water jet nozz

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

e according to the lines and arcs of a computer aided design (CAD) drawing. The CAD drawing is a

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

three dimensional (3D) graphic representation of parts that are to be fabricated. The technology

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

Following aspects would a

has many advantages such as easy to use components, quick assembly process, reduced turn around

dd to the challenges in developing combination products:

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

ime on the machine, complementariness to other machining techniques, and cutting without heating

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

the material.

One major drawback of water jet machining is that the nozzle often gets blocked d

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

e to dust particles that might be present in the water. The other problem with water jet assembl

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

es is that they are prone to constant wear and tear caused due to high-pressure water flowing ou

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

Professional from academic institutions, pharmaceutical industries, health care indust

of tiny nozzles.

These drawbacks are however ignored, as water jets are the most environment f

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

iendly and safe machining technology used in the present era. It does not produce fine particles

.

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

that might get into the human body and cause fatal diseases such as cancer. Particles if any are

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

Companies that provide selfless information through particip

swept away with the strong force of the water jet and do not pollute the surrounding environment

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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In the past few decades, there has been a great revolution in the way the management deals with and treats its employees and staff. Gone are the days when corporate houses considered it a favor to the employees to have them work with their company. In present times, there has been a paradigm shift in favor of the employees. Every corporate house tries its best to make its working environment rewarding and the job profile lucrative for its staff. Tremendous efforts are made to retain competent staff and increase productivity through a healthy work environment.

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