Digg It - Business

Wire Electrical Discharge Machining, Wire EDM, is a machining process that utilizes a wire filament that carries an electrical char

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

ge through the wire and is used to cut away the hard metal elements.

There are two major components required for the wire EDM mach

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

Examples of combination products may in

ine, not the least of which is the wire used to remove the metal in order to shape the product being manufactured. The degree of pr

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

cision and the amounts of materials that can be removed through successive passes are greatly determined by the composition of the

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

wire, typically copper wire, as well as the type and strength of the electrical current. Certainly, the greater the diameters of th

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

Combination pro

e wire, the more material that can be cut with each pass; however, the trade-off with the larger diameter wire is that the degree o

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

precision is decreased.

Most wire EDM machines today are CNC-controlled tools. The acronym CNC stands for “Computer Numerical Con

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

trol.” Rather than rely on the somewhat inaccurate and imprecise “eyeball” approach, modern wire EDM machines rely solely upon comp

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

uters to guide the wires to cut away only the metal that needs to be removed.

In order to cut designs with greater precision and i

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

order to create 3D objects, wire EDM machines have wires that occupy not only the traditional X and Y axis but also the U and V ax

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

is for a standard 4-axis tooling but can also have a 5th access for even greater precision.

The second component of wire EDM is th

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

Following aspects would a

at the metal being worked is commonly inserted and tooled in a tub of fluid, typically a Deionized water which controls the conduc

dd to the challenges in developing combination products:

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

ivity of the wire for a better cut as well as to help keep the core temperatures down. As is commonly understood, electrical curren

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

ts passing through metals increase internal temperatures and metal tooled in higher heat environments becomes less rigid and have a

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

loss of tensile strength. An additional advantage of tooling in water is to help remove chips and particles from the work area dec

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

easing the amount of accidental scoring of the finished product as well as to decrease the overall “heat affected zone.”

One final

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

Professional from academic institutions, pharmaceutical industries, health care indust

advantage to machining in fluid is that it helps to extend the life of the wire itself. Wire EDM machines are high maintenance. Th

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

e wires must be checked for pitting, scoring, breaks, and other failures on a regular basis. Evidence of any of these if left uncar

.

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

d for, can cause improper tooling of the object, loss of precision or even damage to the machine. By tooling in fluid, the wires ar

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

Companies that provide selfless information through particip

e kept cooler and the electrical charges passed through the wires are maintained at a steady rate, thereby extending the wire lives

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/4589/diggit-Wire-EDM-Machining.html">Wire EDM Machining</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/4589/diggit-Wire-EDM-Machining.html]Wire EDM Machining[/url]

There are two prevalent approaches to the development of Datawarehouse Architectures: A. Data Warehouse (DWH) bus architecture (introduced by Ralph Kimball) B. Corporate Information Factory – CIF (introduced by Bill Inmon) In this article we analyse and compare these two approaches.

IT consultant personality traits are often more important than their technical ones. In this article, learn some key factors that make for a successful IT consultant.

Travel expense reports are the records of the travel and expense (T&E) spending of the employees of business organizations. Indeed, travel and expense spending is the third largest but controllable cost after salaries of employees and data-processing costs of an organization. Every business traveler has to submit expense report to the Accounts Department of his company for claiming reimbursement. Almost all organizations, whether business or service, have their own formats of travel expense reports to be filled out and submitted by the employees at the end of their trips. Along with the submission of the report, an employee has to submit the receipts and vouchers of his expenses.

Tags

Links

Digg It - Wire EDM Machining

Related Articles: