Case Study 


Electronic inspection of Pharmaceuticals

in-the-Machine-Cycle  

When speaking of guarantees of asepticity, Pharmaceutical Industry is since many decades what really retains the maximum know-how.  It is the Pharma Industry the natural worldwide top excellence-centre for the sensitive products.  We cannot reach ideals solutions but we ask to SCHOTT®, the World Leader of Pharmaceutical containers (125 years of experience): 

“What is the container assuring maximum asepticity to a liquid ?”

They answer is the ampoule in the figure at left side. Ampoules glass-sealed before to leave the Aseptic Filling and Sealing system.


  The ampoules are what is closer to the “ideal container” for sensitive liquids.  Guaranteed by many thousands of Pharma Industries and Biological Scientists (image credit SCHOTT™/2014)









Impossible a posterior contamination of the vial's liquid content, one time it reaches the Market.   Glass-sealed and not capped.   In terms of guarantee of closing, whoever understands that glass-sealing means a guarantee nearly absolute (< 99.999 999 999 ... %) of sealing, much more than a PET Cap’s Tamper Evident Ring.  The ampoules represent what is closer to an “ideal container” for sensitive liquids.  Could we use this kind of packaging for common or sensitive beverages ?   Surely not, because of a long row of excellent reasons.  When Pharma Industry adopts containers different than ampoules, because having a Cap or Closure like the vials, the Electronic Inspection is frequently in-the-Machine.   In-the-Machine at its highest level of safety, with the containers inspected and rejected into the Machine Cycle.   Into the Machine Cycle, and not over a separate Conveyor Cycle following the Machine Cycle, like in the case of the Food and Beverage Aseptic Packaging.  



Pharmaceutical ampoules’ Filling and Sealing Machine.  A container so intrinsically safe, does not need an identification of each one container along its filling, sealing and inspection phases.  It can be safely inspected by a standalone Electronic Inspector, with sensors lying in the same Machine Cycle of the Filling-Sealing Machine.  When Pharma Industry adopts containers different than ampoules, because having a Cap or Closure like the vials, the Electronic Inspection is frequently in-the-Machine.  In-the-Machine at its highest level of safety, with the containers inspected and rejected into the Machine Cycle.  Into the Machine Cycle and not over a separate Conveyor Cycle following the Machine Cycle, like in the today’s common case of the Food and Beverage Aseptic Packaging (image credit SCHOTT™/2014)



Root Cause for Frequent Contaminated Beverages






“When Pharma Industry adopts containers (…) having a Cap (…) the Electronic Inspection is frequently (…) in-the-Machine at its highest level of safety, with the containers inspected and rejected into the Machine Cycle, and not over a separate Conveyor Cycle following the Machine Cycle, like in the case of the Food and Beverage Aseptic Packaging Lines” 





This is one of the main Root Causes for so rare contaminated pharmaceuticals and so frequently contaminated pseudo-aseptic drinks or beverages (dairy, energy, juices, etc.).   Pharmaceuticals bottles, vials or ampoules inspected and rejected into the Aseptic Filler + Closer Machine's Cycle.  Each of them occupying a well-defined cell in the Filler + Closer Machine’s shifting-register: exactly the opposite of the present orientation dominating the Food and Beverage Packaging’s Design.  The strident contradiction between Pharma and Food & Beverage Design philosophies can be synthesized in what is considered the correct answer to a fundamental question:


“What inspection and tracking technology assures rejection of

 the Sensitive Products ?”


Two different answers:

  1. Pharma Industry:  electronic inspection with sensors and rejector in-the-Machine Cycle;


  1. Food & Beverage Industry:  electronic inspection with some sensors in-the-Machine Cycle, other sensors and rejector in a separate Conveyor.

Food and Beverage design philosophy is, in the reality, an example of bad philosophy.  One of those specially exposing the Company packaging sensitive beverages to claims, requests of indemnization and media’s negative advertisement.  


Container Imagined “Glued” to the Conveyor Belt

  All Containers’ tracking Triggers have to be conceived in their true nature: Inspections of the Identity of the Container.  In the figure are visible total 6 Inspections: 3 Tracking Triggers plus 3 Inspections for Closure by mean of Ultrasounds, High Frequency Fill Level and Closure by mean of Visible Light.  Containers are not “glued” nor “weld” on the Conveyor belt, then free-to-slide following the dynamic conditions.  “Free-to-slide” has to be translated in “free-to-loose-their-Identity”

“Pharma Industry studied, practised and rejected yet decades ago the entire Design address today considered “the best” by the Food and Beverage Packaging sector”

The Conveyors outfeeding an Aseptic Bloc are not mechanically joint to the Machine Cycle, nor they can be.   More, containers are not “glued” to the Conveyor (they can slide and they do slide !), nor they could be.  Electronic Inspectors’ container tracking systems can only compensate sliding up to one-half of the container diameter.  One-half of the container diameter means a container sliding ranging until 60 mm, whose median value is 30 mm.   FIFO-based systems, are excellent and we detailed their capability to maintain a correct tracking up to 255 container diameters.  But, we also explained they cannot be used at all as a solution for the tracking of containers sensitive beverages, like juices, energy drinks, dairy, and others filled in aseptic conditions without added preservatives. 

 Containers Sliding in a Shifting-Register.  Blurring the expected future position P  of a container, originated by a precedent observation, to an observed and erroneous position Q 


A Sale-Oriented Sales Manager's Ethic ?







The Vendors of electronic inspectors, know well this limit of their equipments, at least in their Technical Departments.   But, are not openly explaining to the OEMs and Bottling Companies integrating their equipments, how many contaminated persons shall later result.   Why not ?   …try to imagine on your own, and you’ll discover the same old basic Root Cause in the maximum profits orientation of the Industry.  Why to fine-details the negative effects of the use of Our equipments, when we are trying to obtain their maximum sales?  Also, place yourself for a moment in the position of Commercial Manager of a Vendor of electronic inspection equipments.  If he’d be so honest, so open with his prospected Customers, should he have any guarantee that his Competitors shall act the same Ethic way he did ?    Net result is an intentional hole present in the brochures circulating, in the video presentations thinked to promote the sales of the equipments.  A hole which can be felt only by Specialists, other Staff operating in other Companies producing electronic inspectors, allowed to have the widest panorama with the accountancy of the contaminated people.  The hole regards the Layout-sensitivity of the control and rejection of sensitive beverages. Food and Beverage packaging Companies and OEMs, have not the know-how in electronic inspection necessary to evaluate finely these digits.   






Beverages' packaging Companies, as an example, have just estimations based on the comparison of how many containers were produced along a period of time, and how many complaints were received along the same period.  An accountancy known only to their Quality Control Dept. analysts and Directors.  That’s why Pharma Industry studied, practised and rejected yet decades ago the entire Design address today considered the “best” by the Food and Beverage Packaging sector.  Discarded as a bottle contaminated by wrong ideas, because permanently introducing contaminated product in the Market, the best idea to make Your Competitors’ happiness.

sensitive food and beverage


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