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Choosing the proper sealer for the job at hand is essential. Choose the wrong one and your packaging operations will grind to a halt.

What you're sealing and how many need to be done per day or per hour will be the determining factors in the seale

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

r you eventually purchase.

The basic types of sealers are single impulse, double impulse and constant heat.

Single impulse units utilize a single piece of Ni-Chrome wire mounted either in the upper or lower jaw of the sealer to produce the desire

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

Examples of combination products may in

d seal. Single impulse units use either a round wire element or a flat wire element of various widths. Round wire elements are typically used for what is called cut and seal operations such as working with shrink film. Flat wire elements are availa

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

le in widths from 1/8" to 3/8" with the 1/8" width being the most popular by far.

Double impulse sealers just what they sound like. These units have an element in both the upper and lower jaws of the machine. Double impulse sealers are normally us

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

ed in the sealing of thick materials, usually up to 20 mil as well as sealing foil bags.

Constant heat sealers, as oppossed to impulse sealers are always on and ready to go. The units use an electrical resistance heater mounted either in or on the

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

Combination pro

sealing bars. The sealing surface of these bars is typically designed to yeild a cross-hatch pattern in the seal but is also available in a horizontal line pattern as well. Temperature on these units is controlled by a thermostat and a thermalcoup

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 is attached to one of the bars to turn power on and off to the heaters as needed to maintain temperature.

Now that you know the types of sealers out there, we can discuss the different designs. These include hand operated, foot operated and auto

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

matic models.

Hand operated units sit on top of a table or bench and are operated by lowering a hinged arm down onto the material being sealed with one hand while holding the material with the other hand.

Foot operated impulse sealers work in the

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

exact same way, but are instead freestanding units that are mounted on a pedestal base and vertical tube. These sealers are activated by depressing a foot pedal mounted on the front of the unit. Being foot operated, this leaves both hands free to

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

ove the product in and out of the machine to increase production.

Automatic impulse sealers, like the hand operated units, are set on top of a table or workbench, but these units once the timers are set properly will operate automatically without

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

any input from the operator. The timers will control when the jaw closes, how long the element wire is energized and then the cooling or congealing time before the jaw opens back up. This makes for the most consistant seals as it eliminates operato

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

Following aspects would a

r error. Most sealers of this type also have a manual override switch to make the unit cycle between timer settings if needed.

Once you have decided on the style of unit you will need - hand, foot or automatic, and then the amount of sealing power

dd to the challenges in developing combination products:

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

you need - single/double impulse or constant heat, you still have a couple of more things to decide on.

Depending on the impulse sealer you're considering and the material you're packaging, you may need to decide on the seal width you need to make

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

. Typical choices are a thin, round wire seal and then the flat wire seals that come in 2mm, 5mm, and 10mm.

Impulse sealers are built around the size of the element wire to be used. This means that the transformer mounted inside the unit is specif

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

ically designed to power a certain element wire. The only interchangability is with the round wire and 2mm flat element wires.

For example, put a 10mm element wire in a unit powered for with a transformer for a 2mm element and virtually nothing wi

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

l happen. Conversely, put a round wire element in a unit designed for a 10mm element and see just how fast that wire melts away!

Match the seal width to the job at hand. Round wire elements are normally used in shrink wrapping work or where a thin

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

Professional from academic institutions, pharmaceutical industries, health care indust

, narrow seal will suffice. 2mm wide seals are considered standard and are used to creat seals on most packaging. A 5mm seal width is used where a stronger seal is required for either package strength or seal integrity such as food product packagin

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

g. The extra wide 10mm seal is most commonly used in medical and dental product packaging where seal integrity is of the utmost importance.

The remaining choice, if you've decided to go with a hand operated impulse sealer is whether or not to opt

.

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

or the unit with the built-in trimmer which will cutt off excess material to within 1/4" of the seal as it is being made. These sealers a sliding handle in the arm with a 2 sided blade attached to remove excess bag material. As the seal is being ma

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

Companies that provide selfless information through particip

de, the operator slides the handle along its track and the cut is made.

Armed with this information you should now be able to make an informed decision and choose the correct machine for your application that will perform well and last a long time

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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Boring - that's the last word we want to hear in our training evaluations! There can be many reasons why our students feel that way. A common reason for boredom and confusion is providing too much information.

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