A Revolutionary Pharmaceutical High Speed Packaging Operations Incorporating Combined Advanced Vision Inspection, and On-Line NIR Analysis
American SensoRx, Inc. was established in 1994 based upon its two distinct discoveries in the fields of visible light energy, and near-infrared spectroscopy. As a result of these innovations, two patents were granted. The first was named the “InspectRx® Vision System,” which deals with the inspection of pharmaceutical, medical, cosmetics, and food products. It provides an absolute count and ensures product integrity, thus preventing any mix up. The second is named the “SpectRx™ NIR System,” which analyzes and identifies the composition and active ingredients of pharmaceutical, medical, cosmetics, and food products. American SensoRx, Inc., invented the InspectRx® and the SpectRx™ systems and their corresponding technologies; Patent Numbers 5,679,954, October 21, 1997, and Patent Number 5,900,634, May 4, 2003.
A decade before the establishment of American SensoRx, Inc., the founder, Dr. Sabrie Soloman, recognized that the packaging and inspection machines in the marketplace were inefficient and fell short of the much needed, true “error free” manufacturing systems. While American SensoRx’s two distinct systems, the InspectRx® and the SpectRx™ had taken prominent positions worldwide, its goal continued to be the creation of pharmaceutical “error free” packaging, inspection, and analytical machines. This goal became even more pressing with the demise of other corporations that had manufactured packaging and inspection products.
American SensoRx, Inc. is pleased to provide the FilleRx® system. The FilleRx® is a highly advanced packaging machine that is capable of filling in excess of 720 bottles/minute with 100 counts per bottle. This is 3 to 4 times greater than the current machines in the market today. The FilleRx®is a highly advanced system created to package, count, inspect, and chemically analyze pharmaceutical products.
American SensoRx’s InspectRx® Vision, and the SpectRx™ Near Infrared technologies are embedded in the FilleRx® system (Figures 1, 2, and 7).
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.
Pharmaceutical manufacturers have longed for a 100% accurate machine that would fill bottles to the precise corresponding amount as well as ensure that each product would be free of defects, foreign products, or objects (Figures 5a-5h).
Until now, that goal had not successfully been met. Since the late 1970’s, pharmaceutical enterprises had little success in developing efficient product filling and packaging machines to rid the line from foreign and unwanted products to prevent costly product-recalls.
The problems plaguing the pharmaceutical manufacturers were:
Inaccurate counting resulting in under-filled bottles
Broken or separated product Chipped product
Dirt presence on productCracked product
Exploded capsulesLeaking gel
Foreign substance present
Intensive labor required
No assurance that product departed the cavities and entered the designated bottle
Product jam in the cavity
Fulltime manual operators 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
Product falling into unreachable places with the packaging machine violating the FDA regulations
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 costly device called “Micro-Scan,” which was placed on top of the entire length of the slat, covering all cavities hoping to sense products in the cavities. Unfortunately, there was no efficient means to remove a jammed product. The only method for doing so, would be to crawl underneath the machine and physically remove 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. Pharmaceutical corporations accepted the failure of accurate counting and began dispensing 10-15% more product in a bottle to compensate for the empty cavities and jammed products.
Many simple cameras were configured to capture the presence or absence of the products inside cavities. This proved to be ineffective. The cameras were located at a distance away and they required a tedious set of procedures to be programmed. This obstacle created a very complicated production line. Still, the cameras in these applications were no more than sensors detecting the presence or absence of a product while still providing inaccurate product counts. Jammed products were falsely counted throughout the batch.
Other efforts were attempted to reconcile the counts of products leaving their corresponding cavities and those upon which were 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. Pharmaceutical dust often blocked such holes and rendered the technique useless.
Another approach to fix the situation was to allow each slat to pass through a thumper device in hopes of loosening the stuck or jammed products. This method caused some fragile tablets and capsules to disintegrate or crack, leaving fragments behind. Also, it was found that some types of jammed products would never depart, even with the use of a strong thumper device.
American SensoRx, Inc., devoted thousands of man-hours and made large capital investments with the goal of developing successful products that would eliminate the deficiencies of all products to date. American SensoRx recruited the most prominent mathematicians and computer science, electromechanical, and control engineers from the USA, Japan, Germany, Korea, and Israel. In addition, American SensoRx established an overseas location to host the international work force and achieve economic affordability in creating several working prototypes until the complete FilleRx® system was constructed and mass-produced. The result was the creation of the FilleRx® system, incorporating its highly advanced Patented InspectRx® – SpectRx™ technologies.
The qualitative and quantitative functions of the FilleRx® with its integrated InspectRx® Vision - SpectRx™ Near-Infrared systems are much greater than the current available leading filling machines in the market. The proven technologies manifested in the functions of the FilleRx® - InspectRx® - SpectRx™ systems create the opportunity to capitalize on tremendous cost benefits.
American SensoRx is confident in providing micro and sub-micro inspection levels to several discriminating clients worldwide. This is largely attributed to the robust implementations of the FilleRx® mechanical design and construction, the incorporation of the InspectrRx® - the highly advanced vision technology measuring system, detecting objects in sub-pixel resolution, and the seamless incorporation of the SpectRx™ NIR analytical system.
American SensoRx has developed the SpectRx™ technology so that it may be incorporated with the FilleRx® whereby the chemical composition of tablets, capsules, gels, caplets, and active ingredients are identified, and then calculated by weight through the SpectRx™ NIR. While the current speed of the SpectRx™ is 80 scans per second using a single probe with a limitation of two probes per NIR system, American SensoRx has developed a new type of micro-NIR probe, which will enable 80 micro-probes to be fitted into 80 separate cavities located above the slat. As each product in each cavity slat passes by the NIR probe, it yields 80 independent spectra describing the chemical compositions found in the product (Figure 6).
The FilleRx® system is a particular machine developed to automatically handle, arrange, inspect, count, analyze, and dispense tablets, capsules, caplets, and gels into two lanes of designated bottles (Figure 9).
The FilleRx® system does not stop or reduce its speed while dispensing the product in the bottle lanes. It is equipped with sophisticated servomotors, which 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 counts, the bottle lane is released. While one lane of 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 were awaiting until the previous lane is exited and filled re-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 current manufacturing capacity in the US and overseas is 30 systems a month as long as there is a minimum manufacturing order of 10 units. This capacity can be tripled to almost 100 units a month. There are three main suppliers and sub-contractors already involved in manufacturing the units at the current low volume. These suppliers and subcontractors have passed through the exponential learning experience needed to reach efficient production and are ready to expand their activities.