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Sanitizing is the process used to rid or reduce the number of microbes (microorganisms) on the surface. Sanitizing cannot

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

be accomplished until surfaces are clean.

Sanitizers are generally divided into two categories: non food contact sanitize

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

Examples of combination products may in

rs and food contact sanitizers. According to the EPA, non food contact sanitizers include items like air sanitizers, carpe

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

t sanitizers and bathroom sanitizers. Food contact sanitizers remove bacteria from surfaces like eating utensils, dishes

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

and surfaces in food processing and food service situations. Once cleaning professionals understand the differences betwe

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

Combination pro

en sanitizers and disinfectants and the sub categories under each group they can then turn their attention to implementing

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

guidelines.

The following are some basic guidelines for applying sanitizing and disinfecting products:
1) Use prod

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

cts as directed- do not tamper with the product by diluting it ( in order to save money) other then according to the direc

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

tions otherwise causing the product to have partial or no germ killing benefits.

2) Avoid mixing different chemicals. Do

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

not add a disinfectant to a non disinfectant cleaner. Only EPA approved products should be used for disinfecting. Mixing c

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

ould be dangerous and non productive.

3) Look for warning labels. All EPA registered products require a warning statement

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

Following aspects would a

on the label. If there is no warning statement, the product is not EPA registered or approved for use.

4) Disinfectants

dd to the challenges in developing combination products:

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

and antibiotics are different. The efficacy of disinfectants on antibiotic organisms may confuse some users. The truth is

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

disinfecting products kill these organisms in a different way than antibiotics. As long as the EPA approves the testing an

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

you follow label directions for the specific antibiotic resistant organism, disinfectants are effective in killing them.

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

5) Cleaning implements play an important role. The active ingredients in the product kills the germs, but using contamina

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

Professional from academic institutions, pharmaceutical industries, health care indust

ted implements (sponges, cloths, mops, etc) can reapply germs to a clean and disinfected surface. Cleaning professionals s

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

hould replace the implements on a schedule appropriate for the location and situation.

By understanding effective applica

.

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

tion procedures, cleaning professionals can choose products that serve their sanitizing needs as well as tackle their spec

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

Companies that provide selfless information through particip

ific cleaning challenges. Remember a sanitizer may eliminate organisms, but it won't always eliminate dirt and other soils

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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