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Other Articles - High Temperature Brazing
Brazing is divided into two types by temperature. High temperature brazing is that done at 1800F or above,
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
in a furnace. Low temperature brazing is done in a furnace from about 1200F up to 1800F Below 1200F is cons
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
idered soldering.
High temperature brazing is ticklish because of four things: the base materials that the
High temperature brazing is ticklish because of four things: the base materials that the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
product is made from, the nearness to the melting point of the base metal during brazing and the probabili
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ty that the base metal may also require a heat treating process different than the brazing cycle to gain ma
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ximum strength, corrosion of the base metal by the brazing alloy during brazing, and a furnace atmosphere t
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
hat will keep the base metal clean and enhance flow of the brazing alloy into the joints for joining.
The
The
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
two best furnace atmospheres are hydrogen gas and a vacuum. Uniform heating of the product is gained with
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hydrogen gas because the gas is flowing over and through the product carrying heat. Depending on the base m
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
etal, hydrogen gas may not keep the base metal as clean as a vacuum furnace will. In a vacuum furnace unifo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rm heating can be a problem depending on the heating element locations as in direct exposure to the product
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
, and because the heat travels in a straight line from the elements going in all directions inside the furn
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ace. Use of a retort helps to provide uniform heating because it becomes a radiator container and distribut
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
or of the heat.
Base metals may contain titanium and aluminum which form oxides on the surface and prevent
Base metals may contain titanium and aluminum which form oxides on the surface and prevent
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
brazing alloy flow in to joints.
Joint design, configuration, can also hinder obtaining solidly brazed jo
Joint design, configuration, can also hinder obtaining solidly brazed jo
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
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
ints.
Integrating all these factors into a successful operation can be tricky, but be better assured by an
Integrating all these factors into a successful operation can be tricky, but be better assured by an
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
experienced person at the outset. You may be doubting my expertise.The following supports that expertise.<
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
br>
http://www.google.com/patents?q=Paul+R.+Mobley&btnG=Search+Patents
Page 1- check items 1 and 6 do
Page 1- check items 1 and 6 do
.
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
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
wn the list;
Page 2- check items 8 & 9;
Page 3 - none;
Page 4-check item 7
High temperature B
Page 2- check items 8 & 9;
Page 3 - none;
Page 4-check item 7
High temperature B
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
razing is useful to obtain higher strength brazed joints, and for processing more than one piece at a 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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