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There is an article on Mainetoday.com about a chlorine release at a paper mill. The leak was caused when a driver delivering Sodium Hypochlorite to the mill hooked up to a tank cont

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

aining Muriatic Acid. Fortunately, he realized his mistake and quickly shut the valve before too much Hypochlorite was moved into the tank. The resulting chlorine release resulted i

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

Examples of combination products may in

n 60 employees being decontaminated and treated on site and 9 employees being transported to the local hospital for decontamination, treatment and observation.

One of the interesti

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

g things about this accident is that this mill probably used to use Chlorine gas for their bleaching operations and switched to an 'inherently safer chemical', Sodium Hypochlorite.

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

While Sodium Hypochlorite is safer than Chlorine it is not without it's own hazards.

A second interesting thing is that neither Sodium Hypochlorite nor Muriatic Acid (dilute Hydroc

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

Combination pro

hloric Acid) is a 'Chemical of Interest' in the proposed Appendix A to 6 CFR part 27. This means that if there were no other chemicals on the site that were listed in Appendix A (fo

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

tunately this is a paper mill so they have lots of hazardous chemicals), this site would not have to submit to a Top Screen procedure so that DHS could determine if it was a high-ri

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

sk facility. This also means that they would not have to have any security measures in place to protect against terrorist attack.

If this truck driver had been a terrorist instead

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

of some one making an honest mistake, this could have been a deadly attack. The valve would have remained open and most of the contents of the truck would have been added to the tan

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

. This reaction between Sodium Hypochlorite and Muriatic Acid produces heat as well as Chlorine gas. Depending on the concentration of the Sodium Hypochlorite the heat might have be

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

en sufficient to boil the contents of the tank, possibly resulting in a tank rupture as well as the chlorine release. The Chlorine cloud would have been larger, possibly with a leth

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

Following aspects would a

al concentration over some portion of the paper mill property. Due to the very large size of paper mills there probably would not have been much off site effect unless the storage t

dd to the challenges in developing combination products:

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

nks were near the property boundaries.

Security Vulnerability Assessments (SVA) and Site Security Plans (SSP) are going to have to address this type of attack. There are a large nu

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

mber of chemicals that are relatively innocuous by themselves, but become extremely dangerous when mixed with something else. Unfortunately, these situations are not currently regul

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

ated by the US Government, even though the Chemical Safety Board has repeatedly called on both OSHA and the EPA to revise their rules to cover reactive chemistries instead of just h

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

zardous chemicals.

Prevention of this type of attack is relatively easy, once you identify the hazard. First off, no outsider is ever allowed to unload anything. It must be unloade

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

Professional from academic institutions, pharmaceutical industries, health care indust

d by properly trained and cleared site personnel. Secondly, you require the use of a dual key system to unlock the unloading lines (dedicated lines needless to say). The unloader ha

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

s one key and a supervisor can get the second key from the QA lab, after the lab clears the incoming raw material. This is a very low cost, but effective system.

Unfortunately, too

.

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

many facilities never consider this type of problem. If this solution had been in place this accident never would have happened. There would not have been a disruption of the mill o

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

Companies that provide selfless information through particip

perations and no one would have had to go to the hospital or treated for chlorine burns on site. This is another case where a good security procedure is also a good safety procedure

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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