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A Robotic-Vision InspectRx® system is installed at Combe Corporation - PR, inspecting and measuring flaws of the entire internal surface of Combe's pharmaceutical, medical and cosmetic tubes 


SpectRx™ NIR - On Line Production System used in Avantis Tablet Production Inspection System to analyze the chemical composition and active ingredients of their production tablets, and capsules.


InspectRx® Vision - General: The invented InspectRx® system developed by American SensoRx, Inc., is used in applications require to identify the exact dimensions, colors, textures, shapes, and configurations of any product that needs highly accurate measurements in microns.

InspectRx® Vision - Speed: The system is capable of inspecting products at a rate of 1960 units per second.

InspectRx® Vision - Current Use- Pharmaceuticals - Inspecting tablets, capsules, gels, and guaranteeing 100% no product mix, ensuring correct products filling bottles or blisters, as well as guaranteeing absolute count accuracy of controlled substances.  Product mix and inaccurate count may lead into loosing the production license causing losses of several billions of invested dollars. Corporate users are Pfizer, Johnson & Johnson, Merck, Avantis, GSC, Baxter, Shearing Plough, and alike
 

InspectRx® Vision - Current Use - Medical – Inspecting and ensuring that vital medical components placed in human body are of the utmost quality, and of the exact configurations, dimensions, and tolerances custom made for each individual.  The system is used in heart valves, heart rhythmic management, Heart, Stents, syringes, catheters, vials, ampoules, blood transfusion tubes, contact lenses, and prostheses.  Also, the system is used in ensuring artificial human tissue for wounds and skin grafting are of accurate dimensions and of superior quality for individual patients.  Corporate users are Johnson & Johnson, Merck, Cordis, St. Jude Medical, Boston Scientific, Ethicon, and alike.

 
InspectRx® Vision - Food & Tobacco – Inspecting and ensuring that meat, pork, and poultry products are of the highest quality for human consumptions.  The system is capable of accurately measuring the amount of lean and fat percentage in beef and pork.  The system evaluates the quality, and determines the price per kilogram of exported or imported beef, pork, and poultry products based on the contents of lean and fat percent, as well as the color grades of the products.  Corporate users are ConAgra, Swift and Company, American Beef, and alike.

Prime Rib Analysis

Prime Rib Lean-Fat Percent

Technology – Products & Services


The reason American SensoRx producing the FilleRx system

Pharmaceutical manufacturers have always wanted to manufacture product and fill their bottles with the correct number of products in each and with all product free of defects and foreign substances.

Until now, that goal has not been successfully met.        

Since the late 1970’s - almost two decades before the establishment of American SensoRx pharmaceutical enterprises had little success in developing efficient product filling and packaging machines.  The problems plaguing the pharmaceutical manufacturers were:

  • Inaccurate counting creating under-filled bottles 2.  Broken or separated product
  • Chipped product
  • Crushed product
  • Dirt presence on product
  • Cracked product
  • Exploded capsules
  • Leaking gel
  • Foreign substance present
  • Intensive labor required
  • No assurance product departed the cavities and entered the designated bottle
  • Product jam in the cavity
  • Full time manual operator standing by the machine watching for empty cavities to manually compensate
  • Long and tedious setup time
  • Significant lead time to change from product to product
  • No Record Keeping, no “Electronic Logbook,” and no Batch History
  • Very Low Speed 
  • Significant product waste
  • Personnel not accountable for running machine efficiently
  • Impossible to “back-track” produced bottle at any instant during a Batch Run
  • No Electronic Record to Cross Reference between the Bottle and its Contents – especially after distribution
  •  No Electronic Daily, Weekly, Monthly, or Periodic History of Maintenance and Operator Interface Difficulty in incorporating retrofitting inspection devices
  • 300 Bottles/minute maximum of 100 Counts/Bottle


Previously, there was a device called “Micro-Scan” filled with Lakso packaging machine, which was placed on top of the entire length of the slat covering all the cavities.  Unfortunately, there was no effective means to remove the jammed product, except by crawling under the machine and physically removing it.  This action of crawling under the machine is both unsafe and time consuming.  In addition, the light beam from the Micro-scan often failed to detect the presence of product especially when the product was very small (which resulted in an insignificant intensity contrast provided by the small tablet), or the photo diode of the Micro-Scan had become contaminated with dust.


Many simple cameras were configured to capture the presence or absence of the products inside cavities, as in the case of the “Cognex” and “DVT” camera systems.  However, these cameras were located at a distance away thus causing a substantial obstacle to the operation and the required tedious set of procedures to program the cameras created a complicated production line.  Still, the cameras in these applications were no more than sensors detecting the presence or absence of product.  There several available sensors that are more economical, and perform a better performance than Cognex or DVT, both are ineffective to tablet inspection as demanded by the pharmaceutical and food applications.


Other efforts attempted to reconcile the counts of the products departing the corresponding cavities and the actual product entering the bottles. This was accomplished by drilling a hole in each cavity.  The hole diameter was made the same as the size of a pin diameter. As the slat turned within the traditional packaging machine, the pins entered the drilled holes of the slat cavities.  This method created as many broken pins as the number of holes in the slat cavities. In addition, holes were enlarged due to some misalignment resulting in some small tablets falling through the holes and not making it into the bottles.  Some pins were also found in bottles distributed to consumers.


One other approach within the traditional packaging systems allowed each slat to pass through a thumper device hoping to loosen the stuck or jammed products. This method caused some fragile tables or capsules to disintegrate or crack, and may leave fragments behind. It was also found that some type of jammed product never departs even with the use of a strong thumper device.  Additionally, the slat had to pass the thumper device at a low speed.


The FilleRx® system is a particular machine developed to automatically handle, arrange, inspect, count, and dispense tablets, capsules, caplets, and gels into two lanes of designated bottles.  The FilleRx® system is the answer to a long awaited system that guarantees 100% product accurate count, ensures and guarantees no product mix up, ensures and guarantees high quality product free from broken, cracked, and discolored tablets, capsules, and gels.  The FilleRx® system measures the dimensions of each product unit in microns before delivering consistent tablets, capsules, and gels to the designated bottles.


The FilleRx® system does not stop or reduce its speed while dispensing the product in the bottle lanes.  It is equipped with sophisticated servomotors that synchronize all motions at any instant of operation.  A group of 20 bottles are carried by the conveyor system at a specific instance delivering them to a precise location under the corresponding tube openings fixed directly above the bottles.  The exact count of product that falls into the bottles is tightly controlled.  The instant all bottles are filled to predetermined levels, the bottle lane is released.  While the bottles are exiting the FilleRx® filling domain, a servomotor precisely directs the other falling tablets to fall into the other lane of 20 bottles that was awaiting until the previous lane is filled.  During the filling operation of the second lane, another set of 20 bottles are directed to take their precise position and await their turn to be filled, as soon as the other lane has completed its accurate filling and counting cycle.           

If a single error is detected during the handling, arranging, inspecting, counting, and dispensing the products the FilleRx® system will remember the precise location of the error and constantly track it until the bottle containing such error is automatically removed or placed in the designated quarantine location.  The system mathematically subtracts the rejected bottle providing highly accurate count of the accumulated product.   


However, if the FilleRx® system detected the presence of any foreign object, or foreign product due to a mix up at any incident, the system automatically shuts down the entire operation.  In addition, the system will freeze the image of the unwanted object or product, and directs the operator to the exact location of the fatal error.  The system cannot advance until a series of passwords are entered and the authorized individual removes the fatal error.  Once the report is completed, and there is assurance that the fatal error was removed and placed in a quarantined location, and the appropriate passwords are entered, the FilleRx® system will resume its normal activities.

The FilleRx® system constantly records and categorizes all the data of every inspected product of every cycle, and then automatically stores it in a special file for evaluation at a later time.  Also, the FilleRx® system stores the images of all the captured errors during the product batch run.

The FilleRx® system solves the problem of products that are jammed inside the cavities in a slat delivery mechanisms.  The FilleRx® system handles any type, shape, color, combination of colors, and configurations of tablet, capsule, and gel products.


The FilleRx® system is an advanced high speed packaging and inspection machine developed to inspect 100% of all products, accurately count, and pack tablets, capsules, caplets, and gels in bottles at a rate of 720 bottles per minute with 100 counts per bottle.  It delivers the product to two highly synchronized parallel lanes of bottles, and ensures that the unwanted bottles are diverted to either a quarantined or a rejected location.  The entire FilleRx® machine is uniquely equipped with highly accurate servo-motors and reliable sensors tracking every move of the machine mechanisms and products.             

The FilleRx® system houses 72 slats.  Each slat may accommodate single or double cavity arrangements and contains 80 cavities, divided into 20 sections.  Each section handles only 4 cavities.  A single bottle is precisely held beneath each section.


         The FelleRx System - Four Cavities Per Section


The FelleRx System - Capsules: Moments prior to Entering Bottle Chute


A decade before the establishment of American SensoRx, Inc., the founder recognized that the packaging and inspection machines in the market place were inefficient and came-short of true “error free” manufacturing systems.  Accordingly, while the two distinct systems, the InspectRx® and the SpectRx™ have taken a prominent position worldwide,  the zeal of American SensoRx, Inc., to create “error free” packaging, and inspection machines had never faded, but rather escalated by the demise of other corporations in the manufacture of packaging and inspection equipments. 


Therefore, American SensoRx, Inc., has created the FilleRx®, system.  The FilleRx® is highly advanced packaging machine that is capable of filling in excess of 720 bottle/minute with 100 counts per bottle, which is 2 to 3 times greater than the current machines in the market today.  At present, American SensoRx, Inc., possesses the InspectRx® vision system, the SpectRx™ NIR system, and the FilleRx® error free packaging and inspection system.  The InspectRx® and the SpectRx™ technologies are embedded in the FilleRx® systems.           

The FilleRx® is placed in protective stick-on plastic sheet to prevent scartching in the stainless steel cover surfaces prior to sales during shipping

A special compartment carrying the proprietary InspectRx® system is fitted above the slat domain,

The InspectRx® Vision System is Located above the Slats
-- The FilleRx® Cameras and lighting cables are placed in protective flexible conduit leading to the base of the FilleRx® system where the entire control cabinet is safely resides.

Also, the InspectRx® compartment is equipped with very high speed multiple color camera systems.  Each InspectRx® camera possesses the ability to obtain product metrological measurements in microns, identify products in every color and configurations.  Each InspectRx® camera is configured so that there is a 100% inspection of all products and each product is accurately counted, and there is assurance that no foreign product or object ever entered the bottle.  Similarly, no bottle will ever contain less than 100% of the predetermined count and is free from debris, broken product, and any unwanted objects.


The cluster of InspectRx® cameras continuously inspects The FilleRx® slats.  Each camera is dedicated to a specific number of cavities.  The proprietary algorithms are highly synchronized to correlate between the inspected products in cavities and their corresponding dedicated bottle receiving the falling products.  All product errors, as detected by each InspectRx® camera within the inspected cavities , are carefully documented, classified, recorded, and then tracked to the bottle, which will receive the product with the unwanted object.  Then each bottle containing an unwanted object is rejected and directed to a quarantined location for further discrimination.  However, if a foreign object is detected at the slat level, the entire machine will shut down instantly.  An intensive auditing will begin, until the foreign object is removed, and the reasons for the mix up will be carefully examined to determine the root cause of the fatal-error.


Each  InspectRx® camera will display its data to the operator on the monitor screen. It will display the exact slat, the exact section of the slat, and the exact cavity within each section of the slat, with the rejected product resting in the cavity.  The images are stored in designated peripheral equipment.


The technologies of the FilleRx® system make it easy to provide a 100% money back guarantee to purchasers. This insures the end users safety, as well as providing complete compliance with federal regulators.  The user interface is based on simple but highly robust touch screen applications that control the entire operation.  Once the appropriate password is entered, the interactive dialogue will lead an unfamiliar operator to select the correct choice from a drop down menu that contains an unlimited number of correlated programs and routines for an unlimited number of products.

The self taught tools of “Neural Network Analysis,” and “Fast Fourier Transformations” along with several other mathematical tools coupled with several servomotors, Figure 3, driving the host of cameras, and their carrying mechanisms will automatically select the optimum positions and angles to view each single product while exiting the corresponding slat cavities. 

This procedure will internally program any new and unfamiliar product that has not been stored earlier during the development.  Therefore, the high cost of programming a new product, and the lead time to debug the routines have shrunk to a mere several seconds.  The programming of a new product is totally unmanned as it employs the InspectRx® proprietary software routines.  The FilleRx® system requests the operator, supervisor, or administrator to enter the appropriate tolerance of various dimensions, colors, type of flaws, the size of flaws, and any other conditions vital to cause the product to be accepted or rejected, as in the case of the Pfizer’s Celebrex™ product. In this instance,  a check is necessary to determine the presence of a single strip or a double strip that is printed on each capsule, as well as the color of the strip signifying the difference between the 100mg from the 200mg capsules. 

Once, the responses are completed the FilleRx® system automatically stores the data, and then incorporates the new routine using the existing drop down menu.


The SpectRx™ System

American SensoRx, Inc. has invented the very high speed spectroscopy vital in production lines -- US patent Number 5900634 and 5369940. The SpectRx™ accurately measures the exact compositions of pharmaceutical products in gas, liquid, powder, semi-solid, and solid forms.  The system instantly measures the amount of active ingredients in the composition of any product.  Also, the SpectRx™ system measures “Hardness and Disintegration” of any tablet dosage as a direct correlation with the energy absorbed or reflected from any solid dosage faster than the speed of production line, “Sabrie Soloman’s law of Solid Dosage Disintegration and Light Absorbed Energy .” 


The Spectroscopy utilized in the SpectRx™ System includes all the analytical processes, which are based on the interaction of electromagnetic waves and matter.  When energy is transmitted, there occurs an interaction between electromagnetic radiation (e.g. photons) and matter. This can be observed, for example, when an atom becomes excited. A photon’s energy is directly proportional to its frequency.

The following equation holds: 

Δ E = h ⋅ ν

In this case, h is “Planck’s Constant,” ν is the wavelength frequency of the photon and Δ E is the energy differential.  This equation is known as the fundamental equation of spectroscopy.  It means that the amount of energy of a photon with a defined wavelength is known.  This amount is known as a discrete energy state.  The electrons in atoms also adopt discrete energy states.  If a photon collides with an electron at rest, it only releases its energy if it pushes the electron into a permitted energy state.  The photon must release all of its energy.  After it releases its energy, it no longer exists.  After absorbing the photon’s energy, the electron jumps to a higher energy level.  The excited electron “seeks” to return to the lowest energy value, that is, to return to its ground state. In order to do this, it must release its energy.  This can happen in various ways.


For example, the electron can transform a part of the energy into kinetic energy, e.g. the vibration of the lattice in a crystal.  The electron then has a lower energy value than it did just after it was excited.  If the electron is then - at an energy level from which the remaining additional energy can be emitted as radiation, the emitted photon has less energy than the absorbed photon.  The wavelength of the emitted particle has been shifted to longer wavelengths energy than the absorbed photon.  If the electron emits the energy as heat, the absorbed energy is transformed into long-wave radiation, which can no longer be detected by a spectrometer.  American SensoRx observed the radiation as having been absorbed.  Electromagnetic waves exist on a frequency spectrum of which we can perceive only a very small part.  Each element or molecule behaves in its own unique way when it interacts with electromagnetic waves.  So every sample has its own specific spectral “fingerprint.”  For most applications it is quite sufficient to observe either a small range of the spectrum or certain discrete wavelengths. 

Method of Spectroscopy
For nearly 200 years, optical spectroscopy has been used in a wide range of disciplines. These include physics, biology, chemistry, medicine, and materials science. Sub-disciplines of these fields that also make use of spectroscopy include: astronomy, organic chemistry, and nanotechnology. Using optical spectroscopy, elements and molecules can be detected in any aggregation state both qualitatively and quantitatively. Information about the change over time of the bonds in a compound can also be obtained. Unlike other analytical procedures the samples do not need time-consuming preparation.

Emission Spectroscopy Fluorescence
Fluorescence is a phenomenon wherein the absorption of a photon triggers the release of another photon at a longer wavelength.  The energy difference ends up as molecular vibration or heat.  With American SensoRx fluorescence measurements it is well established the necessity to distinguish between the excitation spectrum and the emission spectrum.  In measuring the excitation spectrum, American SensoRx is comparing the amount of visible light in relation to the total electromagnetic radiation absorbed by a body for given frequencies of exciting light.  To measure an excitation spectrum, the fluorescent sample is illuminated with different wavelengths one after another.  The intensity of the fluorescent radiation is measured at a fixed wavelength.  The intensity measured at this wavelength is applied at the excitation wavelength.  Reference graphs are then used to determine the wavelength at which the spectrum was taken.  If an emission spectrum is being measured, the fluorescent sample is illuminated with a fixed wavelength.  The sample emits fluorescent radiation over a wide range of wavelengths.  In this event the intensity emitted is applied at the particular emission wavelength.  Reference graphs are then used that show the excitation wavelengths.

In biology, materials, which are said to be fluorescent include: heme, flavin, retinal, and phytochrome as well as the aromatic amino acids phenylalanine, tyrosine, and tryptophan.  Apart from these, metabolites such as porphine, carbohydrates, pigments and coenzymes can also fluoresce.  If the fluorescence is limited, then markers which are suitable for coloring certain cell regions or organelles can sometimes be employed.  Among these markers are: acridine orange derivative, rhodamine 123, doxycycline, and 1-anilinonaphthalene sulfonate. Other fluorescent materials include fluorescein and naphthol. Metals can also be excited to fluorescence using complex agents.

Light Source Measurement
One area where emission spectroscopy is commonly used is light source measurement.  In this kind of measurement, the goal is not to evaluate certain elements.  The measurements are used for the evaluation of light sources with regard to physiological criteria (workplace illumination, solar panels, LED, Computer Monitors).  Emission spectroscopy can also be used for production oversight (e.g. monitoring UV lamps used for hardening). 

Absorbancy
To measure the absorption of a substance, a light source, sample holder and a spectrometer are necessary.  First, the radiation intensity and spectral diffusion of the light source are measured.  This reading is the reference measurement.  The sample is then fixed into the holder.  The spectrometer is set to absorption measurement.  A spectrum is then taken.  The absorption by the wavelength is then displayed. 
For materials in a water solution or as a gas, the Lambert-Beersch Law applies: 

Ι = Ι0 eα(λ)xc 

Where, Ι0 is the reduced intensity of the light without the sample in the optical path.  Ι is the weakened light intensity after the sample has been measured, c stands for material concentration, x for sample thickness and α for the natural molar extinction coefficient.  In decimal form with the decimal molar extinction coefficient 

ε(λ) = α(λ)· 0.4343

log [ Ι / Ι0 ] = ε(λ)xc = A(λ)

 

From this - it follows that the optical density is directly proportional to the concentration of the

material.  In its simple form this law only applies to monochromatic radiation.  When measuring cloudy samples, a sensible choice of reference measurements must be made. 

Both absorption and reflection measurement values change as a result of the dispersion of the radiation. In order to get real spectra, the reference measurements in the observed wavelength range must be transparent but display a comparable dispersion.
    
Reflection
The reflection of light is the most common measurement method in spectroscopy. Applications and measurement equipment vary widely.  Depending on the surface, the reflected light can be diffuse or specular or a mixture of both.  The reflectance (ratio of incident light to reflected light) can be measured, and so can changes in the wavelength. Additionally, the interference of two reflections can also be the object of interest.

The sample reflects the radiation diffusely; the directly reflected radiation is coupled out through the gloss trap.  Only the diffuse reflection is coupled into the optical fiber.  The reference measurement is measured against a comparable strongly diffuse reflecting white reference standard (Spectralon).  The spectrometer is reset to reflection measurement.  The reflectance from the wavelength can be read off on the spectrometer.
The setup for measuring the transmission of a material is identical to the setup for absorption. First the radiation intensity and special diffusion of the light source are measured. This reading is the reference measurement. The sample is then fixed into the holder. The spectrometer is set to transmission measurement. A spectrum is then taken. Depending on the setting, the transmission can be displayed as a percentage or transmittance from the wavelength.

UV spectroscopy comprises a separate field, since it places special demands on the spectrometer.   The cover glass in the sensor must be made of UV permeable quartz glass (Suprasil) and the sensor must be able to detect UV radiation.  UV Spectroscopy is primarily executed as absorption and fluorescence spectroscopy.  Using UV Spectroscopy, nitrite can be detected in drinking water without having to resort to chemical reagents.  Other detectable substances are: nitrate, bisulfite, nitrogen, phosphorus, benzene.

Infrared Spectroscopy
As with UV spectroscopy infrared spectroscopy is also a separate field due to the special demands it places on the spectrometer.  This kind of spectroscopy has become extremely important because the molecular vibrations have an effect on the spectrum in infrared.  Nearly all organic materials exhibit specific absorptions in the near infrared.  NIR can detect differences between polymers in plastic screening, the water content in variance substances, such as fruit or grain.  NIR can detect octane, caffeine, salicylic acid, or nicotine content.  Blood values such as cholesterol, glucose, and oxygen, can also be determined non-invasively.  Additionally, the salt content of sea water can also be determined using NIR spectroscopy.

Laser Spectroscopy
This analytical procedure is similar to atom spectroscopy.  A laser is used as a light source.  The laser is used both as a light source for excitation as well as for illuminating the sample for absorption measurement.  If the sample is excited by the laser, the sample itself begins to emit radiation.  The spectrometer records the radiation at a right angle to the direction of the radiation excitations.  If the sample absorbs the laser beam, the sample is placed between the laser and the spectrometer.

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American SensoRx, Inc., 31 N. Monroe Street, NJ 07450 USA - Phone: 201 447 8999 Fax: 201 447 8998 - info@AmericanSensoRx.com

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