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Rubber compounding companies have been using batch inclusion plastic bags for years to increase productivity and assure bat

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

ch to batch uniformity. However, these particular packaging bags, also known as low melt bags, can also be counted on to r

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

Examples of combination products may in

duce product loss, decrease solid waste disposal costs and most importantly minimize worker exposure to hazardous materials

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

. As the cost of plastic resin continues to spiral upward here are 7 ways to minimize or even eliminate a price increase.

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

1. Consider using thinner material. Recent advances in film technology can allow you to reduce the thickness of batch incl

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

Combination pro

usion plastic bags while maintaining or even increasing the strength.

2. Know the difference between nominal and full gau

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

e film thicknesses and compare pricing. Nominal gauge means the thickness of your low melt bags will range between +/- 10%

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

. Full gauge means it will range between +/- 3%. Full gauge is always a more expensive plastic bag.

3. Experiment with

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

atch inclusion bags that have different melt temperatures. The lower the melt temperature the higher the cost.

4. Use col

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

ored or tinted film to designate different sizes of low melt bags. The specialized film used for these plastic bags does n

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

t print effectively nor do labels adhere well.

5. Make sure your supplier sends documentation with each shipment verifyin

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

Following aspects would a

that your particular batch inclusion plastic bags melt at the agreed upon level. The melt temperature is critical to your

dd to the challenges in developing combination products:

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

operation. Having these test results, known as a DSC test, is a simple way to assure the quality of these packaging bags.

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

6. Consider a blanket order of low melt bags with extended releases and have your supplier run and hold them. This will

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

minimize your lead time, lock in your pricing (plastic bag pricing is volatile), and reduce your cost. By committing to a

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

arger quantity your per piece price will be lower.

7. Combine orders if possible. Batch inclusion plastic bags are price

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

Professional from academic institutions, pharmaceutical industries, health care indust

d according to the number of pounds of plastic resin it takes to run the entire order. The more pounds you order (even if

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

hey are different sizes) the lower your overall cost.

In closing, using low melt or batch inclusion bags will help assure

.

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

that all your critical ingredients make it into the mixer while compounding, among the other benefits listed above. While

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

Companies that provide selfless information through particip

hey are unique and specialized, their cost is easily justified by increased efficiency and overall better finished products

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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Most successful employers have similar traits when it comes to being driven to succeed. They are perfectionist to the point of almost being obsessive compulsive; happen to be extremely motivated, and stubborn to a fault, and at times extremely difficult to deal with. Nothing gets in their way; they do not dwell on problems, but seek solutions. Their vision is to do whatever it takes to get from point A to Point B while avoiding as many bumps on the road as possible. To accomplish what they have set out to do has been carefully planned, and they try to leave very little to chance.

If you've been following our medical billing series on the GX0 record, the complicated stuff is around the corner. In this installment we cover fields 20 through 23.

Mary Foley explains how you can decide to be part of the elite group of people who enjoy their careers rather than another factor in the statistic of people who hate their work.

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