Advice You - Business

When it rains, oil, antifreeze, detergents, pesticides and other pollutants get washed from driveways, backyards, parking lots, and streets into storm drai

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

ns and then directly into waterways. Detergents in particular present a real problem not only for large bodies of water but also for water treatment facil

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

Examples of combination products may in

ities.

Soaps containing phosphates are common contributors to storm water pollution. These phosphates create problems for Publicly Owned Treatment Works

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

POTWs) because these phosphates interfere with the cleaning procedures at the facility. Finding products that can replace harsh alkaline cleaners will hel

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

p reduce pollution.

Even detergents that are marketed as “biodegradable” can still have undesirable effects because they require time to biodegrade. Dete

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

Combination pro

gent products can be quite hazardous until the biodegradation process is complete.

There are currently innovative solutions to the problem of storm water

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

run off. Cleaning solutions should be environmentally safe. Industrial site managers should examine non-toxic cleaners that are also biodegradable. Thes

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

e types of solutions provide an easy and safe alternative to harsher chemicals.

Industrial sites that produce large amounts of hazardous waste are always

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

enerable to EPA fines and sanctions. Providing cleaning techniques and products that are safe is a requirement that is imposed by the EPA.

Other major co

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

ntributors to storm water pollution are the oil and gasoline leaks that are the results of washing vehicles on pavement and close to storm water drains. W

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

shing vehicles or equipment in wash bays hooked up to the sanitary sewer causes the detergents oils and grease to enter the streets or storm drains.

The E

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

Following aspects would a

PA requires that these facilities use products or install complicated drainage system to seal these floor drains. Facilities can use products that provide

dd to the challenges in developing combination products:

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

a tough, durable seal over their drains. This seal will block the pollution from entering the storm drains If the product is lightweight and reusable,

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

it can save the site money and time. Lightweight drain sealers can be retrieved quickly for emergency chemical spills.

Parking lots represent another sour

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

ce of water pollution. Cars and trucks drip oil and grease on to the surface of cement lots. This oil and grease is carried into the catch basins by rain

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

ater. The EPA is very strict on these known pollution sources. Many industrial and sites that produce large amounts of oil and grease use drain inserts to

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

Professional from academic institutions, pharmaceutical industries, health care indust

avoid this problem.

The EPA designates automotive maintenance facilities as stormwater "hot spots." Hotspots are areas that generate significant amounts

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

of hydrocarbons, trace metals, and other pollutants that can affect the quality of stormwater.

Facilities must stay abreast of the state and local regulat

.

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

ons for the specific stormwater pollution requirements in their area. There may be additional requirements for their a particular type of facility.

Pollut

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

Companies that provide selfless information through particip

ion control products are only one piece of the pollution puzzle. Specialized product plus human commitment will help companies comply with EPA regulations

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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