$$ 2D Bar Code / Matrix Code Details $$

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Introduction - Symbology Specification The 2D-Pharmacode symbology offers a supplement to the known Data Matrix Code with specific requirements for packing control purposes. It contains the history of the linear PHARMA-CODE symbology used in pharmaceutical industry since 1968. In this manner of providing the industry with a standard specification, it will meet the rigorous demands that have been made on the previous standard, the PHARMA-CODE Guide, for the last three decades. This document shall be a public available standard specification to which manufacturer of bar code equipment and users can refer when developing equipment and applications. 1. Scope This specification defines the requirements for the symbology 2D-Pharmacode. It specifies the 2D-Pharmacode characteristics, dimensions and code structure. This document is intended to provide a universally agreed standard for the printing of 2D-Pharmacode. Adoption of a standard printing specification has the following advantages. ¾�The quality of the printed code symbol is assured, guaranteeing readability and therefore robustness of reading,

within the scope of multi-national operation. ¾�It guarantees the operation of the reading equipment used conforms to the printed symbols. ¾�By specifying the variability of the positions of the color bars in the 2D-Pharmacode, we ensure that the critical

color information is always present and verified secure. This standard does not specify the information to be encoded. The location of the 2D-Pharmacode on packaging material shall be determined by the company responsible for the design and use. The Pharmaceutical Application Guide’ part of this document is to give all necessary help to the user. This specification does not touch the specifications of the basic Data Matrix code. For specification about the Data Matrix code refer to 1.1.

1.1 Normative References 2D-Pharmacode is based on the specification of the Data Matrix code. Already published Data Matrix code symbology specifications therefore are additionally valid and must be concerned while generating 2D- Pharmacode. This specification incorporates provisions from other publications. The publications are listed below. The latest edition of the publication referred to applies.

AIM International Technical Specification - Data Matrix ANSI X3.182 bar Code Print Quality – Guideline (Same as EN 1635 - Bar Coding: Test Specifications for Bar Code Symbols) EN 796 Bar Coding: Symbology Identifiers EN 1556 Bar Coding: Terminology ISO/IEC 16022 International Symbology Specification - Data Matrix ISO/IEC 15416 Bar Code Print Quality Test Specification - Linear symbols ISO/IEC 15415 Bar Code Print Quality Test Specification - Two-dimensional symbols

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1.2 Definitions and Symbols 1.2.1 Color Field An area printed with a consistent color. Up to eight of those Color Fields can be placed in accordance to the Data Matrix code. 1.2.2 Trigger Mark A bar combination printed on one side or top of the Data Matrix Code. It enables to generate a precise trigger of the reading system which is required for matrix code reading with a matrix camera system especially with high speed movement of the object. 2. Symbol Description 2.1 Basic Characteristic 2D-Pharmacode is intended to be used in pharmaceutical packaging process as a replacement of the traditional PHARMA-CODE. Additional to the main requirement of product or packaging material identification the PHARMA- CODE offered the possibility to check presence of all colors used on the package. With linear PHARMA-CODE this color check was included into the Barcode itself by using colored code bars. The 2D-Pharmacode does not change the basic (Data Matrix) and offer the new features by supplemental elements. For more information about application and advantages of 2D-Pharmacode use please refer to chapter 5. 2.2 Symbol Structure

In particular, these are:

Data Matrix Code (ECC 200):- Can hold considerably more data than a PHARMA-CODE, including alphanumerical characters. Integrated error correction code for Preventing faulty reads.

Supplement A : - Print control of up to eight additional colors.

Supplement B : - Automatic synchronization of barcode Reader for symbols moves very quickly.

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2.2.1 Data Matrix Code 2.2.1.1 Data Matrix Symbol Structure Finder pattern: The finder pattern is a perimeter to the date region and is one module width wide. Two adjacent sides, the left and lower sides, forming the L boundary, are solid dark lines. The two opposite sides are made of alternating dark and light modules.

Quiet zone: The absolute minimum quiet zone is equal to one module width on all four sides. Recommended size is three module widths. Data region: Area inside of the symbol contains data and characters for error correction. Elements, Module: Square dots which represents one bit of binary data and determines the basic size X of the symbol.

= binary "0" = binary "1"

Alignment Pattern: Table 1 shows the absolute minimum and maximum capacity of Data Matrix symbols. For larger data capacities smaller data matrix symbols are combined for a new large symbol separated by alignment patterns as shown in Figure 4. Those symbols are not allowed to be used as for 2D-Pharmacode, see chapter 2.2.1.3 for allowed Data Matrix symbol size.

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2.2.1.2 Data Matrix - Symbol Versions and Characteristics

The Data Matrix Code can be used in several ‘ECC’ versions, which describes the used version of error correction inside the symbol. For 2D-Pharmacode the ECC 200 version is strictly recommended. Beside figure to detect a ECC 200 version, which must have the upper right element to be light on dark symbols or dark on light symbols. ECC 200 symbol have an even number of rows and columns only.

2.2.1.2 Data Matrix - Symbol Sizes and Capacities In principle, the data matrix code can be used in different magnifications. The symbol size is governed by the module size (cell, dot) and number of columns and rows. The 2D-Pharmacode supplements are scaled in accordance with the basic Data Matrix code symbol. The preferred sizes for 2D-Pharmacode are as follows:

Standard 2D-Pharmacode – Module size X=0.5 mm (� 20 mil) Miniature 2D-Pharmacode – Module size X=0.375 mm (� 15 mil) Micro 2D-Pharmacode – Module size X=0.25 mm (� 10 mil)

With preferred symbol sizes above, the data content below can be achieved by using up to 26x26 lines or columns. For larger volumes of data, the data matrix code can be assembled from codes of equal side, although those versions are not allowed for use as 2D-Pharmacode. The code sizes relate to the data matrix code only without quiet zone. For overall dimensions of the 2D-Pharmacode including quiet zone, Trigger Mark see chapter 3.

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2.2.2 Supplement A – Print Color Control Function Up to eight (six) different printed colors can be controlled by Color Fields positioned around the code. Colors must stand out sufficiently against the background. The complete symbol can be rotated in any position on the product desired. If laid out correctly, the code can be read, and colors checked, in any given orientation. The eight color fields can be used in any combination required. For more details about applications see chapter 5. 2.2.2.1 Color Field Alignment To be flexible to adapt the total symbol size to space requirements, the color alignment of the extra colors can be realized in two different variants A and B. In particular, their positioning relative to the finder pattern L boundary is always fixed.

Standard colors: The Color Fields are laid out as shown in Figure 6 (square symbol) or Figure 7 (rectangular symbol).

Square - Color Fields 1…4 can be used. Rectangular - Color Fields 1…4 can be used.

Extra colors (Variant A): The Color Fields are laid out as shown in Figure 6 (square symbol) or Figure 7 (rectangular symbol).

Square - Color Fields 1…8 can be used. Rectangular - Color Fields 1…6 can be used.

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Area three and four must be placed below the finder pattern lower side, area one and two must be printed at the opposite side, area 5 and 6 on the left side beside the finder pattern, area 6 and 8 on the right side of the Data Matrix code. At rectangular symbols area 7 and 8 can not be used with extra colours variant A.

Extra colors (Variant B): The Colour Fields are laid out as shown in Figure 8 (square symbol) or Figure 9 (rectangular symbol).

Square - Colour Fields 1…8 can be used. Rectangular - Colour Fields 1…8 can be used.

Area three and four must be placed below the finder pattern lower side, area one and two must be printed at the opposite side, area 5 and 6 on top of area 1 and 2, area 6 and 8 below area 3 and 4. If less than eight fields are used any of them may be used as you wish. For design purposes multiple fields may be printed with the same colour to create a better look of the symbol. Following figures show the correct alignment with an example using 4 Colour Fields.

Figure 10 Correct alignment of a standard 2D-Pharmacode symbol. Figure 11 Correct alignment of a mirrored 2D-Pharmacode symbol. Figure 12 Correct alignment of 2D-Pharmacode symbol left rotated by 90°. Figure 13 wrong alignments! The Colour Fields 1… 4 are not printed in correct allocation to the finder

pattern. To distinguish from a correct form in Figure 11 the Data Matrix code must be analyzed to see if it is a mirrored version or not

2.2.3 Trigger Mark – Alignment

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Unlike the Colour Fields, the Trigger Mark does not have to be in any fixed relation to the data matrix search pattern (L structure). The code can be used in any position and rotated through 360°. This provides a number of possible design options for the combination of the 2D-Pharmacode, Trigger Mark and Colour Fields. Figure 17 shows some possible alignments, with different directions of movement required.

For correct alignment keep to following notes:

¾�Trigger Mark must not be printed within symbols quiet zone. Concern, there is a quiet zone outside the Colour Fields as well. ¾�Code image captured by reading the Trigger Mark must be completely inside the Code Readers field of view.

2.2.3.1 Trigger Mark – Dimensions For visual adjustment purposes, the Trigger Mark height should always be tailored to suit size ‘A’ of the Data Matrix code, if it is printed directly beside the Data Matrix code. The size of the Trigger Mark modules (bars) as well as the required quiet zone before is fixed to absolute dimensions as specified in Figure 18, and not scaled in relation the Data Matrix module size. The space between Data Matrix symbol and Trigger Mark is determined by the Data Matrix code basic module size X.

2.2.3.2 Trigger Mark - Dimensional Tolerances

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The permitted Trigger Mark tolerances are as follows:

Bars and spaces ± 0.1 mm: Quiet zone behind the Trigger Mark: ��;��$EVROXWH�PLQLPXP�����PP�RU�UHTXLUHG�TXLHW�]RQH�RI�'DWD�0DWUL[

Code The bar height must apply to the application and the reader used to detect the Trigger Mark while reading the 2D- Pharmacode with the Trigger Mark moved in picket fence orientation. 2.2.4 Symbol Quiet Zone

Concern that the total symbol quiet zone must be included all Colour Field locations including dimensional tolerances. Therefore any additional print contrast must not cover the area of used Colour Fields to prevent from misinterpretation. Whereas quiet zone requirements for Trigger Mark and Data Matrix are fixed, the quiet zone outside the Colour Fields must be adapted to the range of Colours used. All dimensions are referenced to the Data Matrix code position and size. Quiet zone requirements: a Before the Trigger Mark: ���PP b Outside Data Matrix: ��; c Colour Field standard tol.: ��; Colour Field expanded tol.: ��; d Extra Colour Field standard tol.: ���; Extra Colour Field expanded tol.: ���; 3. Overall Symbol Size All sizes are calculated with nominal dimensions and standard tolerances, for maximum tolerances allowed the sizes must be corrected. Some typical sizes are presented in Table 3 for the three preferred symbol sizes. Concern following conditions for total size dimensions listed. 3.1 Data Matrix Code including Quiet Zone For Data Matrix the minimum quiet zone is specified to 1X module size on all four sides. For best reading performance of the code reader a quiet zone of minimum 3X on all four sides is recommended, which also is the distance of the Colour Fields.See Table 3 ‘Data Matrix’ dimensions listed with quiet zone increased by 3X at all four sides. 3.2 2D-Pharmacode including Colour Fields:

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The use of Colour Fields will enlarge the required symbol spacing at the side the Colour Fields are placed. The size might differ with use of extra colours and/or expanded tolerances, see chapter 2.2.4 for necessary information’s. The examples within Table 3 ‘Incl, Colour Fields’ are calculated for a 4 colour version with standard tolerances. 2D-Pharmacode - Symbology Specification & 2D-Pharmacode including Trigger Mark The Trigger mark will enlarge the required symbol spacing by additional 7.5 mm at the side a Trigger Mark is placed. 4 Symbol Quality The 2D-Pharmacode symbol shall be assessed for quality using the guidelines presented in the following chapters. These describe the requirements for additional features of 2D-Pharmacode as Trigger Mark and Colour Fields. For original Data Matrix symbol quality requirements, see Data Matrix symbology specification published by AIM and ISO. 4.1 Symbol Contrast and Reflectance Specifications Measurements shall be made on the bar code symbol in its final configuration whenever possible. Reflectivity shall be measured with diffuse light. All measurements shall be made using the wavelength(s) of light specified in the application specification. In absence of such a specification measurements should be made using the wavelength of light that approximates most closely to the wavelength expected to be used in the scanning process. The method described here parallels in many ways the ANSI X3.182-1990 guideline for assessing print quality of linear bar code symbols. Symbol contrast is always the difference between the highest and lowest reflectance value in the scan reflectance profile.

SC = Rmax. - Rmin. A full featured 2D-Pharmacode symbol must be qualified by two different SC values, which are:

SCDM = Symbol Contrast Data Matrix Code including the Trigger Mark SCTM = Symbol Contrast of the Trigger Mark

The measuring aperture for determination of Trigger Mark parameters should match the requirements describes in the ANSI X3.182-1990 guideline. 4.2 Obtaining the Test Image A grey-scale image of the symbol being tested shall be obtained with a precision video camera-based setup. The illumination colour and direction must be equivalent to illumination specified for the application. 4.3 Symbol Quality Parameters 2D-Pharmacode symbol quality is defined by Data Matrix, Trigger Mark and Colour Field overall quality. Data Matrix quality criteria are: Decode, Symbol Contrast, Print Growth, Axial Non Uniformity, Unused Error Correction. For more details see Corresponding, AIM or ISO symbology specifications. 4.4 Overall Symbol Grade The 2D-Pharmacode overall symbol grade is the lowest of the parameter grade achieved including the Data Matrix symbol grade. 4.5 Process Control Measurements Several tools and methods are available which can be performing useful measurements for monitoring and controlling the process of creating a 2D-Pharmacode symbol. These include:

¾�Symbol contrast readings from a linear barcode verifier ¾�Horizontal print growth (Data Matrix) from an ECC 200 reference symbol (see 12.2) ¾�Determination of axial non uniformity by physical measurement

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¾�Test read rate with the symbology printed in a quality as near as possible to its final design (grade level)

¾�Visual inspection Introduction - Pharmaceutical Application Guide This document shall give the required help for best use of the 2D-Pharmacode symbology within pharmaceutical packaging process. It does not specify information to be encoded. The location of the 2D-Pharmacode symbology on objects shall be determined by the company responsible for the design of this object. 5 Summary of 2D-Pharmacode features With use of the 2D-Pharmacode symbology various advantages will be achieved for pharmaceutical applications, following advices for help of best use. Coding on packaging machines can be used to detect the mixing of various packaging materials of the same kind (folding cardboard box, leaflets etc.). Missing or bad print quality can also be detected. Since the 2D- Pharmacode does allow encoding alphanumerical characters and exceeds the PHARMA-CODE capacity limitations it is now possible to encode the internal logistical identifiers directly to the packaging material. It is not necessary to administrate any additional numbers as with PHARMA-CODE. While the basic Data Matrix code is not changed by colours or dimensions, all standard Code Readers are still able to read the Data Matrix code even if the expansion for 2D-Pharmacode functionality is not included. 6 General Design 6.1 General Design Advice The size of the 2D-Pharmacode symbol is determining for the attainable read rate at the final product. It is influenced by a lot of parameters which sometimes can create opposing requirements. Parameter Influenced by Please note Available space Required data contents See Table 3

Code square or rectangular See Table 3 Symbol size incl. quiet zone Select module size

Module (dot) size Code Reader resolution ���SL[HO�SHU�PRGXOH Code Reader field of view See Code Reader manual

Required object speed Available space See Table 3

CS = conveyor speed 6.2 Select Data Capacity Data capacity will be determined by customer request typically. The available space additionally will determine the maximum possible module size. 6.3 Common Use of Pharmacode If packaging material is printed with PHARMA-CODE and Data Matrix for a transitional period, the layout should consider not to influence the PHARMA-CODE reading. Figure 26 shows some possible layouts for use of both symbols on one carton flap. Ideally the Data Matrix code is placed outside the PHARMA-CODE quiet zone.

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6.6 Leaflet Objects Reading on leaflets is the most indicated application for the Trigger Mark. It allows easy gating even with high speed movement and different leaflet sizes. Trigger Mark

1. Applicable, recommended Movement 2. Continuous with Trigger Mark (independent of leaflet size and code position)

3. Continuous without Trigger Mark. Not recommended because of dependent on leaflet size, code position and leaflet extractor function.

4. Standstill without Trigger Mark (dependent on leaflet size and code position). When reading the leaflet during standstill (at table) it is strongly recommended to control the leaflet extractor function and/or leaflet insertion into carton additionally.

General design guidelines:

With leaflets made of thin paper, the reverse side of the code area must be free of print to avoid reading faults.

2. A sufficiently large area H2 must be left free for printing the code. 3. It is not necessary to use different code on the front and back side, because Data Matrix symbols 4. Shining trough from the reverse side are surly distinguished by the Code Reader (mirrored code). But

to avoid reading faults the distance H3 between the front and reverse side code must be considered. 5. Two code printed diagonal on each side of the leaflet will allow to turn the leaflet in all possible

directions and being still readable without any Code Reader adjustment. Trigger mark must be printed in the shown orientation for different reading directions.

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1. Recommended position of the Code Reader at GUK FA21 or SVA 35 folders: - Bottom side, below the leaflet magazine, scanning head position on right side, reading through brass plate. - Upper side, scanning head position on right side 2. On prefolded leaflets, ensure that the code is on the upper side when the leaflet is folded and that the code

quiet zone is visible too. 3. On prefolded leaflets, ensure that the code is on the upper side when the leaflet is folded and that the code

quiet zone is visible too. 6.7 Label Object With small size of the 2D-Pharmacode symbol it is easy to place the code on the label. Typically the Trigger Mark is not required. That means the code can be placed at each location and orientation at the label. For easy product change it is advisable to use same or similar position in relation to the starting edge of the label. 6.8 Cylindrical Objects Marking cylindrical objects with a 2D-Code is the most difficult application due to the strongly reduced evaluation frequency in comparison to 1D-Barcode Readers. On the other side the omni directional reading offers a lot of new applications which are difficult to realize with 1D-Barcode symbologies.

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7. Requirements for Direct Marking At Data Matrix symbology specifications a single module (cell) is specified as square shape. Because direct marked codes mostly will not fulfil this requirement, the use of 2D-Pharmacode symbology is restricted. At direct marking application multiple colours cannot be used. A Trigger Mark created by direct marking will probably create problems while detecting with a contrast sensitive fixed beam sensor. The basic Data Matrix code can be used at those applications, but will require expanded evaluation techniques from the Code Reader side. Following hints are intended to help for best possible use.

7.1 General Advise

Following list to give some basic advices if direct marking technology is used

1. Maximum code size shall be 32x32 rows and columns. 2. The symbol rows and columns shall be in accordance with the ECC 200 specification. The code dot raster (A)

defines the ideal location of the code black and white cells calculated from the synchronization pattern. 3. The matrix may be square or rectangular within ECC 200 requirements. Square is preferred for easier

reading. 4. The dot centre offset (B) must not exceed 25% of the dot raster. 5. Code Reader resolution should be minimum 5 pixels per dot, even at reduced dot sizes (C). If the resolution is

increased by use of multiple dots concern of possible gap in the dot centre, this might be avoided using uneven dots to create one module.

6. Angular distortion (D) of the symbol 90 degree plane between rows and columns shall not exceed more than ± degrees. 7. The quiet zone around the matrix shall be equal or greater than 5 module sizes. 8. If the marking is made on round/curved surface, the symbol coverage shall be less than 16% of the diameter. 9. For more information on symbol position refer to this document or details of marking technology. Symbol

position should allow illumination from all sides. 10. The surface roughness of the object affects the readability of the code. The module size of the Data Matrix

code shall be minimum10 times larger than roughness size.

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8. Pharmaceuticals Packaging Process 8.1 In process control techniques Checking system functionality regularly during packaging process is a typical method in pharmaceutical industries to check the code reader as well as the eject mechanism of faulty products for proper operation. Normally, when using linear barcode readers, the barcode on the product is changed to be not readable, or in case of the PHARMA-CODE to change code contents by manipulation of bar width. The following hints should help to perform this procedure with a 2D-Pharmacode Reader as well. Misread Because of the high effective error correction encoded in the Data Matrix code it is not possible to manipulate a code for a misread. In cases of misread result required you must present a different code (self adhesive label) to the Code Reader instead of the right one. Non read: To force a non read can easily be reached by damage of the code area or remove of the code label. When you try to destroy a Data Matrix code concern also the error correction, it is not sufficient to cover some dots of the code. Take care to use well covering colours to create a sufficient signal contrast.

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Annex (Informative) 9 Additional Support If you encounter problems with products or need more information on PHARMA-CODE assignment, please contact our local representatives of Jekson USA. We would be delighted to assist you in setting up your packaging security systems. 10. Useful Printing control Techniques 10.1 Symbol Contrast To be checked, colours must stand out sufficiently against their background. This depends on both the print and background colours and the characteristics of the code reader itself. Jekson code readers have a diagnostic function that displays the contrast of actual readings. The desired colour combination can be read once the equipment has been calibrated using an appropriate check or test code. Typical linear bar code readers are using a red light LED light source which has a wavelength of typical 660nm. For applications reading a 2D-Pharmacode or even a standard multicolor symbology like linear PHARMA-CODE this kind of illumination is not suitable because the required colour sensitivity over the complete range of visible light. For 2D-Pharmacode readers a white light source is required therefore. The optical characteristics of such light is defined in colour temperature terms rather than in those of peak wavelength, because of the wide bandwidth and relative absence of peaks in power distribution. 10.2 Data matrix ECC 200 - Reference Symbol Data Matrix ECC 200 - Reference Symbol For process control purposes a 16x16 ECC 200 reference symbol can be printed. As shown in Figure 37 the reference symbol has a region of parallel bars and spaces which can be checked for print growth and contrast using linear scanning verifiers. The Reference symbol encodes the data “30Q324343430794<OQQ”.

Further Data Matrix reference symbols are shown in Table 5 to check the correct functionality of Data Matrix Code Reader.

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10.3 2D Pharmacode Reference Symbols To check the correct functionality of 2D-Pharmacode Reader, reference symbols are required as well. Table 6 (square symbols) and Table 7 (rectangular symbols) shows suitable code to test the desired function.

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11 Symbol Printing 11.1 Equipment Selecting the printer is an important step when planning to use a 2D-Pharmacode symbol. The printing must be validated to fulfill requirements at printing accuracy, contrast and code resolution (Code Reader). Under consideration of the intended volume the costs must be analyzed as well before selecting the printing equipment. Following is helpful checklist for assessing the application. Æ Process requirements

When is the label applied? When is the label to be read? Which process will the label be required to go through?

11.2 Printing Techniques Typical used technologies for online and offline printing are: Æ Dot Matrix Low and medium density, medium cost, low quality, low speed, no graphics. Online printing with variable data is possible. Æ Thermal Medium density, low cost, medium quality, medium speed. Labels not UV resist! Online printing with variable data is possible. Æ Thermal Transfer Medium density, low cost, medium quality, medium speed. Online printing with variable data is possible. Æ Flexographic Printing High density, medium cost, high quality, high speed. Æ Offset Printing High density, low cost, high quality, high speed. 11.3 Direct Part Marking Techniques When marking a Data Matrix code to an part or object it is important to ensure that the selected printing technique is compatible to the manufacturing process the object will go through. Typical used technologies for direct marking are Æ Laser Allows online print with variable data. Can create small codes with high accuracy. Marking speed is limited by the surface area and the material. Typical low contrast. Æ Dot Peening Date can not be changed by online setup. Typical low contrast. Æ Ink Jet Allows online print with variable data. The permanence depends on the chemical interaction between ink and object being marked. Contrast depends on colour combination of ink and object. Invisible UV ink may improve difficult contrast conditions. 11.4 Software Symbol Generation Jekson Vision System offers suitable software for a comfortable design of the 2D-Pharmacode symbols in its basic versions. Please contact Jekson Vision System for more information.

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11.5 Cross Reference mil/mm For historical reasons barcode dimensional parameters often are documented in mil (inch) dimensions instead of mm. Following table to shows the most used values.

11.6 Overview of Barcode Destiny Level Barcode module sizes are classified to groups describing the density of the symbol. Following table shows the main steps symbols and code readers are rated to.

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12 ASCII Character Table