Useful Advices - Business

The Problem

Burn and scald injuries lead the way in workplace injuries that result in lost time from work (average of 5 days per year per burn or scald according the National Institute for Occupational Safety and Health (NI

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

OSH) Publication No. 2004 -146). The economic impact to employers and employees alike as a result of these injuries can be overwhelming. A recent study conducted in Oregon State suggested the average cost in that state for

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

Examples of combination products may in

burn injuries is $5,400 USD per incidence!

The Hazards

A major burn hazard source is found in industrial plants that utilize steam process lines. In many typical applications hot steam lines are initially covered with a

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

permanent fixture of hard lagging and mineral wool insulation. As plant processes evolve or if system problems occur, sections of insulation are often removed for troubleshooting, pipe replacement or line reconfiguration. T

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

e removed sections of insulation are usually irreparably damaged. Replacement costs for these small sections can be cost prohibitive utilizing traditional insulation techniques. The result is that the insulation is often ne

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

Combination pro

ver replaced thereby creating a potential burn hazard.

A second major burn hazard source occurs at high temperature flexible (steam/oil/heat traced) hoses that are connected to moving machinery or equipment. Traditional ha

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

rd lagging insulating technologies are not flexible and therefore are not capable of servicing these hoses. The result is that the hoses are left un-insulated thereby creating a potential burn hazard for personnel who servi

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

ce or operate adjacent equipment.

The scenarios above represent just two of literally thousands of common applications where the potential for a serious workplace burn injury exists.

The Solution

Recent advancements in th

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

rmal protection technologies are utilizing closed cell silicone sponge rubber materials to create a wrap for protecting hot process lines. Unlike traditional mineral wool the sponge wrap system does not required a hard lagg

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

ing to contain the insulation material. It is extremely flexible and may be cut to length with an ordinary pair of scissors to allow for easy installation by in house maintenance staff.

In many cases the insulation wrap is

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

equipped with a hook and loop closure to further simplify the installation on existing lines without line disconnection or interruption. The hook and loop closure also allows for easy access to process lines while performi

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

Following aspects would a

ng maintenance procedures or trouble-shooting system components.

Due to its ease of installation and removable characteristics the sponge wrap provides a good solution for protecting flexible hoses and sections of process l

dd to the challenges in developing combination products:

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

nes that are otherwise left void of insulation.

The Technology

This new technology introduces the use of closed cell silicone sponge rubber as a thermal protection medium. This material has a very low thermal conductivity

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

and a high temperature resistance making it an excellent choice as a burn protection medium.

Unlike traditional insulation technologies (consisting fibrous materials and hard outer cladding) silicone sponge rubber wrap is

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

easy to install and does not require the expertise and skills of a professional contractor. The result is that the cellular silicone sponge wrap is a cost effective technology that is well suited covering a variety of poten

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

tial burn surfaces.

The closed cellular nature of the silicone sponge rubber does not allow for water or other liquids to infiltrate (“wicking”) through the insulation medium. This enables the material to function effectiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly as an insulator in exterior environments when exposed to rain and other elements.

The inherent flexibility of the sponge wrap combined with the aforementioned properties, makes it an excellent technology for providing bu

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

rn protection from high temperature flexible hoses and sections of process lines that are left void of insulation.

The Benefits

With a minimal initial capital investment a typical plant can be equipped with silicone sponge

.

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

burn protection to significantly reduce the risk of workplace injuries resulting in lost time.

In addition to minimizing burn injuries, protecting un-insulated pipes will increase the overall plant efficiency leading to a

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

Companies that provide selfless information through particip

reduction in energy costs.

The Conclusion

Protecting un-insulating hot process lines with cellular silicone rubber sponge technologies will demonstrate unrealized energy savings while creating a safer workplace 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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