Advice Pool - Business

It used to be common for workers to scoff at the idea of wearing any sort of personal protection equipment, or PPE. However, the tim

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

es, the technology and the laws have changed. The workplace today is a much safer place as a result.

The Occupational Safety and Hea

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

Examples of combination products may in

lth Act was passed in 1970 to “assure safe and healthy working conditions for working men and women”. OSHA, the governmental agency

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

responsible for the enforcement of the 1970 Act, determines the safety regulations required for all businesses in the US.

Hardhats,

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

safety glasses and goggles, steel-toed boots, protective clothing, harnesses and radioactive dosimeter badges are just a few example

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

Combination pro

s of PPE that may be required on today’s job-sites. The degree and type of PPE use is dependent on the industry.

Mandatory Personal

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

Protective Equipment

OSHA requires that all workers use mandatory PPE in any job that poses a threat to one’s health. It is the emp

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

loyer’s responsibility to assess the workplace for potential health threats and implement the necessary steps to address any hazard.

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

If such a hazard is present, the employer must supply the PPE and educate the employee on both the potential hazards and the prope

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 use of the PPE.

Safety glasses must be worn in any situation where the worker is or might be exposed to flying debris, often in t

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

e form of sparks, dust or splashes. The safety glasses of today have advanced far beyond the thick, black rimmed spectacles or the

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

Following aspects would a

awkward goggles of the 1950s.

Safety glasses can be made to a prescription and safety bifocals, trifocals and progressive focus lens

dd to the challenges in developing combination products:

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

es are standard. The lens material, too, has changed. There now exist several options, from the original plastic to a new substanc

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

e, polycarbonate.

Polycarbonate lenses are lighter and more impact resistant, but sacrifice optical clarity. A third material is Tr

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

ivex, the most impact resistant, while retaining excellent optical clarity, but this lens material is quite expensive and still not

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

as widely available as polycarbonate. All of these materials can be coated a variety of tints, both cosmetic and functional.

Goggles

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

Professional from academic institutions, pharmaceutical industries, health care indust

have become somewhat of a dinosaur, as the tendency to fog, the poor optical clarity and the downright discomfort have made them ob

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

solete, except in specific circumstances.

Z-87 Cerification

Any safety glasses that meet or exceed OSHA standards has “Z-87” stamped

.

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

on the lens or temple piece. Thanks to advances in chemistry and the safety industry, the safety glasses of today, while virtually

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

Companies that provide selfless information through particip

indistinguishable from trendy, brand name sunglasses, protect the user from almost any hazard from a flying chip to a caustic liquid

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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Where do you see yourself and your organization 1,5,10 years from now? What do you want to accomplish? What do you and your organization want to be known for? What do you do for a living? These are all very important questions that need to be answered both on a professional and personal level.

The Fastener Quality Act defines a fastener as a screw, nut, bolt, or stud that has external or internal threads, or a load-indicating washer, with a nominal diameter of five millimeters or bigger, one fourth of an inch or greater that contains any quantity of metal and is held out as meeting a standard or specification which requires through-hardening.

Mining metal detectors are suitable solutions for mining applications. They can prevent damage to crushing machines, conveyor belts and other machinery in advance by detecting iron pieces contaminated in crushed stone and ores.

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