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Computer-to-plate (CTP) technology is used on a daily basis in offset, flexography, and screen-printing workshops. As for pad printing industry, computer to plate equipment – laser plate-etching systems – have b

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

een introduced only recently. However, with latest developments, laser-based systems have the potential to conquer pad printing market over the next couple of years.

CTP benefits:

• Laser systems enable

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

Examples of combination products may in

the user to convert a digital graphic file to a highest quality etched image in just 1 to 5 minutes.

• Costs of films, chemicals, consumables shipping, exposure units and removal of hazardous materials are elim

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

nated, as are maintenance contracts on processing equipment and costs of outsourcing steel plate making. Double-sided laser-etched plates can accommodate up to four images, which reduces plate usage.

• There ar

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

four steps to make a plate: import the graphic file into the system’s software, apply the halftone pattern to the image, specify the etch-depth parameter in the laser’s operating software, and press start.

• L

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

Combination pro

ser-imaged graphics are first generation so there is no loss of resolution.

• Etch depth and halftone pattern can be accurately fine-tuned to match the type of image you want to print, the viscosity and rheolog

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

of the ink used, the speed of the printing machine, and the durometer of the printing pads used. As specifications can be stored on the computer, resulting image quality is completely repeatable.

• Laser-based

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

CTP systems can accommodate operating settings for fine, combination fine/bold, and bold graphics.

• Laser-engraved plates have a straight-walled etching and more precise inkwell than polymer cliches and thin o

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

thick steel plates.

Choosing a CTP system:

1. Laser type

Today, three types of lasers have been used to make pad-printing plates: diode-pumped Yttrium Aluminum Garnet (YAG), Ytterbium fi

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

er laser (YAG wavelength), and CO2. The primary differences between these units are maintenance, spot size, and ability to etch various materials.

Maintenance – The diode-pumped YAG has a diode bar that

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

eats up and can warp after about 10,000 hours of use, requiring costly replacement. The Ytterbium fiber and CO2 lasers have no diode bar so they have no maintenance requirements for up to 70,000 hours of operati

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

Following aspects would a

n.

Spot size – As the wavelength of a YAG laser (1.064 microns) is ten times smaller than the CO2 wavelength (10.64 microns), the former is able to produce more detailed graphics than CO2.

Materials

dd to the challenges in developing combination products:

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

/i> – YAG lasers are ideally suited for metals. A CO2 laser beam is better absorbed by organic materials – wood, paper, plastics, glass, textiles, and rubber.

2. Software

To ensure seamless integ

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

ation into the workflow of the target company, laser software must be able to import are .ai (Adobe Illustrator), .dxf (CorelDRAW, AutoCad), and .bmp (bitmaps, gradients, process-color images) files.

To achieve

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

halftone or dot pattern, the software must be able to apply different hatches (or separation between the laser lines) to the image. For fine line graphics a small hatch can be applied, for bold graphics a larger

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

hatch will prevent “scooping”.

The power and frequency of the laser must be variable to finely tune the plate depth to provide the best printing plate for the type of ink, production speed and substrate. The ta

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

Professional from academic institutions, pharmaceutical industries, health care indust

get depth of etch in the plate is .001”

3. System features

The CTP systems have several available features to consider:

Size of system footprint – stand alone or benchtop system

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

li>Vector-tracing software
Micro-adjust focal distance

Plate registration systems

Particulate evacuation systems

Pre-etch laser pointer

Availability of auto-loa

.

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

Availability of future expansion

For more information please visit Inkcups Now page on c

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

Companies that provide selfless information through particip

mputer to plate pad printing and computer to plate laser engravers.

Benjamin Adner, president of Inkcups Now Corp

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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Digg It - Computer to Plate: Pad Printing Future

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