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Excavation and trenching are known as the most unsafe construction operations. Excavation is defined as any man-m

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

ade cut, cavity, land clearing or trench in the earth’s surface formed by earth removal. A trench is defined as a

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

Examples of combination products may in

narrow alternative excavation, which is deeper than it is wide, and is not wider than 15 feet (4.5 meters).

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

rong>Dangers involved in Excavation and Trenching

Cave-ins have the maximum risk and are much more prob

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

ble than other types of excavation associated accidents to result in worker fatalities. Other possible dangers in

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

Combination pro

clude falls, falling loads, harmful atmospheres, and other incidents concerning mobile equipment. Trench gives wa

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

y cause dozens of losses and hundreds of harms each year.

Common Excavation and Trenching Rules

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

Heavy equipment tools should be kept away from trench edges.

Surcharge loads needs to be at least 2 feet fr

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

om trench edges.

One should not work under raised loads.

Test for low oxygen, dangerous fumes and othe

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

r toxic gases.

Inspect the trenches that follow a rainstorm.

You should know the location of undergro

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

nd utilities

Self protection

You should not enter an unprotected trench! Trenches 5 feet (1.5

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

Following aspects would a

meters) deep or superior need a protective system unless the excavation is made totally in stable rock. Trenches

dd to the challenges in developing combination products:

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

20 feet deep or better require, which the protective system be designed by an expert engineer or be based on tabu

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

lated data prepared and/ or approved by a registered expert engineer.

Protective Systems

There

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

are various kinds of protective systems available. Sloping comprises cutting back the trench wall at a slant incl

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

ined away from the actual excavation. Shoring needs installing aluminum hydraulic or any other kinds of supports

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

Professional from academic institutions, pharmaceutical industries, health care indust

to stop soil movement and cave-ins. Shielding defends workers by making use of trench boxes and also other types

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

f supports to stop soil cave-ins. Designing a protective system could surely be compound because you have to thin

.

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

k about many factors: soil classification, depth of cut, water soil, changes in the weather or climate condition,

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

Companies that provide selfless information through particip

surcharge loads (e.g., spoil, other tools to be used in the trench) and other operations in the surrounding area

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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