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It looks like someone declared June 8, 2007 to be the day for serious Anhydrous Ammonia spills from refrigeration systems across the country. There were three separate instances of significant spills

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

reported today. Mount Sterling, KY, Wyalusing, PA, and Milwaukie, OR all had releases in the last 24 hours. No one was killed, but a number of people were taken to the hospital, businesses were evac

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

Examples of combination products may in

ated, and residents were told to shelter in place.

There were explosions associated with two of the incidents. There are reports that the ammonia leak at a Nestle Plant in Kentucky caused an explosi

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

n that blew down a wall at that plant; no injuries from the explosion or falling debris have been reported. The American Cold Storage facility in Oregon had an unexplained (as yet) explosion result i

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

the ammonia leak. There were no reports of an explosion associated with the leak at Cargill Taylor Beef Plant in Pennsylvania.

Anhydrous Ammonia is favored in many large cooling systems because it

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

Combination pro

as better heat transfer characteristics and is cheaper than the refrigerant gasses used in home cooling systems and refrigerators. The problem is that this material is very reactive and is classified

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

as a Toxic by Inhalation gas. Fortunately, the gas is extremely irritating at well below the toxic level so that when a minor leak happens, unprotected people evacuate the area quickly with little ur

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

ging. A catastrophic leak, however, can overcome people before they have a chance to get clear. This is partially because many people are temporarily blinded by less than lethal concentrations.

The

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

ood industry has long maintained that they should not have to comply with any handling restrictions on Anhydrous Ammonia required under various Federal laws, since they don?t actually handle Anhydrou

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

Ammonia; it stays in a closed system. During the regulatory comment period they complained about being required to submit information under the new Chemical Facility Anti-terrorism standards based o

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

the 7,500 pound Screening Threshold Quantity (STQ) listed in the proposed Appendix A, Chemicals of Interest, to 6 CFR part 27. Cooling systems having more than 7,500 pounds of Anhydrous Ammonia in t

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

Following aspects would a

e system would make that food processing company a ?Chemical Facility? under the rules of this regulation.

According to the EPA Risk Management Plan (RMP) guidance documents, 7,500 lbs of Anhydrous

dd to the challenges in developing combination products:

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

mmonia released in 10 minutes time from a pressurized system (clearly a catastrophic leak, not a faulty valve) will have a plume with a toxic end point 3.2 miles down wind from the site of the leak (

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

able 9, 1.5 m/s wind speed). That means that anyone between the leak and 3.2 miles downwind could be exposed to dangerous concentrations of Anhydrous Ammonia.

Rather obviously, from the lack of casu

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

alties, none of these three release events came any where near 7,500 lbs in 10 minute release rate required for a 3.2 mile long toxic plume. There is nothing in any of the available article that tell

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

anything about the release rate for these accidents, but from the description they did not seem to be catastrophic release events. But what about the explosion caused by the release in Kentucky?

An

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

Professional from academic institutions, pharmaceutical industries, health care indust

ydrous Ammonia is a very reactive chemical, and even by itself can form an explosive mixture when mixed with air at concentrations of 16 to 25% Ammonia in air, though it would require a strong igniti

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

n source. It reacts to produce explosive by-products when it mixes with Chlorine, Bromine or Iodine. Violent reactions occur with Bleach or Peroxides. It also forms explosive compounds with Gold, Sil

.

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

er and Mercury. So, while explosions are not part of the normal operating conditions of refrigeration systems using Anhydrous Ammonia as a refrigerant, an explosion after a significant leak would not

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

Companies that provide selfless information through particip

be totally unexpected.

Just maybe, DHS was correct in setting the STQ limit for Anhydrous Ammonia at a low enough level so that some refrigeration plant users could be labeled as Chemical Facilities

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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