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Advice You - Understanding Laser Marking and Laser Etching Systems
Laser marking and laser etching are becoming more and more important in a growing number of industries. The basic reasons to laser marking or laser etch your products include:
• The mark is extremely durable, permanent and in most cases cannot be removed without destroying the product itself, this is t
• The mark is extremely durable, permanent and in most cases cannot be removed without destroying the product itself, this is t
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
rue for laser marking, laser etching, or laser annealing.
• The laser marking process is accurate, 100% repeatable, fast, with very clear sharp results.
• The laser mark or laser etch can quickly and easily be changed without any machine change over, and, without replacing any tools. The changing of a
• The laser marking process is accurate, 100% repeatable, fast, with very clear sharp results.
• The laser mark or laser etch can quickly and easily be changed without any machine change over, and, without replacing any tools. The changing of a
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
laser marking or laser etch is a simple drag and click computer operation.
• The laser requires no consumables and no additional purchases of added materials or supplies. Therefore the operating and maintenance costs of owning and running the laser marking or laser etching system are virtually non exis
• The laser requires no consumables and no additional purchases of added materials or supplies. Therefore the operating and maintenance costs of owning and running the laser marking or laser etching system are virtually non exis
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tent.
Laser Basics
The word laser is an acronym for light amplification by simulated emission of radiation. The laser beam is formed in a sealed tube with an electrode set, laser gas, and electrical discharge. The beam is emitted into a telescope which expands the laser beam from a size of approximat
Laser Basics
The word laser is an acronym for light amplification by simulated emission of radiation. The laser beam is formed in a sealed tube with an electrode set, laser gas, and electrical discharge. The beam is emitted into a telescope which expands the laser beam from a size of approximat
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ly 2mm as the beam exits the laser tube up to 7mm to 14 mm for most laser marking or laser etching operations. The expanded beam is directed into a laser head containing two mirrors located on high speed galvo motors. The laser beam is directed off the mirrors though a single element flat field lens to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the product being laser marked or etched.
Typically the laser marking or laser etching fields created range in size from 65mm x 65mm [2.5” x 2.5”] at the smallest size to 356mm x 356mm [14.0” x14.0”] square at the largest. The next consideration is the laser beam spot size. This is the size of the focu
Typically the laser marking or laser etching fields created range in size from 65mm x 65mm [2.5” x 2.5”] at the smallest size to 356mm x 356mm [14.0” x14.0”] square at the largest. The next consideration is the laser beam spot size. This is the size of the focu
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
sed laser light energy at the laser marking or laser etching point on the product and can vary from approximately 200 micron [micrometers] or .0078” at the smallest to approximately 540 microns or .021” for Co2 lasers. The laser beam spot size ranges from approximately 20 microns or .0007” at the smalle
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
t to approximately 70 microns or .0027” at the largest for Nd:YAG lasers. These small spot sizes and highly focused laser light energy create the detailed, clear, permanent marking that is typical of the laser marking or laser etching process.
Controlling Lasers and Laser Marking Options
Laser markers
Controlling Lasers and Laser Marking Options
Laser markers
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
and laser etchers are controlled via software. Several variables need to be controlled:
1. Laser power as measured in watts
2. Frequency, meaning the pulse frequency of the laser beam
3. Inches per second, meaning the speed that the beam steering mirrors are moving
Determining the correct setting fo
1. Laser power as measured in watts
2. Frequency, meaning the pulse frequency of the laser beam
3. Inches per second, meaning the speed that the beam steering mirrors are moving
Determining the correct setting fo
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 the laser is the single most important and critical element in the success or failure of the laser marking process. Once the proper settings have been determined and demonstrated a 100% repeatable laser mark can be achieved.
Laser controller software is accessed via a PCI interface card. This sends
Laser controller software is accessed via a PCI interface card. This sends
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he digital signals of the computer based marking or etching files to the motors and directs the laser beam to the product being laser marked or laser etched.
There are several different types of laser marking and laser etching and several different considerations in terms of visual results for the laser
There are several different types of laser marking and laser etching and several different considerations in terms of visual results for the laser
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
mark or laser etch.
1. Laser etching produces a visible etching or depression into the material. Laser etching replaces traditional process like mechanical press or pin scribing. Laser etching can be done with either a Co2 or YAG laser on virtually any material surface and to any depth from very light
1. Laser etching produces a visible etching or depression into the material. Laser etching replaces traditional process like mechanical press or pin scribing. Laser etching can be done with either a Co2 or YAG laser on virtually any material surface and to any depth from very light
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
etching to very deep etching. For example, laser etching is used to engrave serial numbers into metal gun frames. Generally speaking with laser etching the material being laser etched is vaporized at the laser etching point due to the typically high power densities of the laser beam at the point of la
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
er etching.
2. Laser marking produces a surface mark with very little engraving and very little disruption of the material surface. This is especially useful in certain industries such as discrete electric components, semi-conductor, electrical fuse, and ceramics where laser etching can actually damage
2. Laser marking produces a surface mark with very little engraving and very little disruption of the material surface. This is especially useful in certain industries such as discrete electric components, semi-conductor, electrical fuse, and ceramics where laser etching can actually damage
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
part or change the conductive qualities of the part. Generally in order to produce the laser mark without deep engraving a high speed per inch setting for the galvo head is used.
3. Laser etching and laser marking generally do not produce any color changes and create a colorless impression. There are
3. Laser etching and laser marking generally do not produce any color changes and create a colorless impression. There are
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 combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
exceptions as certain plastics will sometimes react to and change color under either Co2 or YAG laser light. Also, in some cases, additives can be incorporate into the materials being laser marked or laser etched in order to produce a color change. Another exception occurs when the wavelength of either
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
the Co2 or YAG laser is changed from those typically used in laser etching and laser marking. This can produce a color change after laser etching on some materials.
4. Laser annealing is another popular form of laser marking. This type of laser marking is generally undertaken with a YAG laser on metal
4. Laser annealing is another popular form of laser marking. This type of laser marking is generally undertaken with a YAG laser on metal
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
surfaces using lower power, high frequency and slow writing speeds to produce heat on the surface of the product. Laser annealing can be used to replace electro chemical etching and ink marking as the laser annealing process creates a black mark with no etching. Care must be used, as the heat generated
.
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
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
can cause iron in some metals to be pulled to the surface, and rust can result if the parts are subjected to sterilization after laser annealing. This can be an especially difficult issue for medical devices
5. Laser ablation is also a popular use for laser marking systems. In this case the laser is
5. Laser ablation is also a popular use for laser marking systems. In this case the laser is
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
sed to remove a layer of paint, anodized or some other material covering the surface of the part. For example this process is used to create bear metal contact points on a painted part, to allow battery connection as in cell phones, or to remove paint for identification of parts and manufacturer details
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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