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What are the most frequently cited serious violations of the concrete and masonry standard? The following are OSHA’s top four followed by suggestions and protective measu

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

res you can use to make your jobsites safe.

1) Failure to protect employees from impalement - rebar not capped or covered. Make sure that all rebar is capped/covered wi

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

Examples of combination products may in

th an approved protective device designed for this purpose such as the hard plastic mushroom type caps which are designed to fit various sizes of rebar. Plastic or paper

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

cups, orange traffic cones or tape are not acceptable means of protection. Prevent or limit your employees from working in areas where they could fall into or onto rebar.

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

If this is not possible, limit employee exposure to these areas by use of guardrails or other fall protection measures as outlined in Subpart M. Rebar can be bent as a p

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

Combination pro

rotective measure, however this practice must be approved by an engineer, or the rebar can be covered with lumber (e.g., a 2 x 4 board).

2`) Failure to establish a limite

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

d access zone to limit the number of workers in the danger zone where a masonry wall is under construction. The limited access zone (danger zone) is established to protec

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

employees (in the immediate vicinity of new wall construction) from being struck by flying/falling brick and block in the event of a wall collapse. Only those employees

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

actually engaged in constructing the wall should be within this area. This area must be marked off by means of a chain, rope, tape, or other material that will indicate t

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

o employees that they are not to enter the zone (area). The zone must be equal to the length of the wall to be constructed and extended out (from the wall’s base) a dista

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

ce equal to the height of the wall to be constructed plus 4 feet. Therefore, if the wall to be constructed is 8 feet high and 40 feet long, the zone should be 12 feet x 4

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

Following aspects would a

0 feet.

3) Failure to brace unsupported section of masonry wall over 8 feet in height. A new masonry wall over 8 feet in height should be braced to protect against the h

dd to the challenges in developing combination products:

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

azard of collapse. The project engineer or competent person should determine how best to brace the wall. A typical masonry wall brace will include a vertical member, an

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

inclined strut, stakes, and if necessary a strut brace. 2 x 10 scaffold planks are typically used as the vertical members and the inclined strut and 2 x 4s for stakes and

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

strut braces. 2 x 4s and 2x 6s are inadequate for vertical members or inclined struts. All lumber used must be in serviceable condition. Finally, The American National

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

Standards Institute (ANSI) recommends that the support or bracing be designed and/or performed under the supervision of a “qualified person” to withstand (at a minimum) 15

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

Professional from academic institutions, pharmaceutical industries, health care indust

pounds per square foot and those strong winds need to be considered.

4) Failure to have the drawings or plans at the jobsite that indicate the jack layout and formwork

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

lacement. Make sure that a copy of the formwork drawings and plans are maintained at the jobsite for review by the employer, employees, and OSHA compliance personnel. Yo

.

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

ur formwork must be installed as shown on your drawings and/or plans.

For more information on custom written construction safety programs / manuals, safety training, and

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

Companies that provide selfless information through particip

discrete contractor safety programs / manuals please contact Vic Sunshine at Omni Safety Services (www.omnisafety.com

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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