Case study 


Electronic inspection of Pharmaceuticals

in-the-Machine-Cycle  


When speaking of guarantees of asepticity, Pharmaceutical Industry is since many decades what really and only 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)


 





“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” 













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

Root Cause for the frequent contaminated 

beverages

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

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. 

sensitive food and beverage



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.



Links to other Case Studies:

In-the Machine inspectors reduced to Standalone. Introduction “Actions to hide the never commissioned synchronisation of Inspector, Labeller and Conveyor, also implying a permanent impossibility for the Bottler to fulfill the triadic quest for: minimum losses, minimum downtimes, maximum rejection of defects and safety” “...service technicians’ skills are part of the final added-value of the Electronic Inspector, because they are those one who shape the future years of the equipment. World’s most expensive and higher Quality Electronic Inspector, left in the hands of some of the worst technicians, always perform much worse than World’s cheaper and lower Quality Electronic Inspector, left in the hands of some of the average-skilled technicians of the World” In the following, we’ll introduce the study of a pattern observed worldwide after 2004 in the operative reality of around one-hundred Electronic Inspectors sold to be operated in-the-Machine (Labeller, Filler, Capper, Closer or Seamer). Follow us in this Root Cause Analysis Case Study and you’ll discover what really is presently hidden under the surface of that beer. The Electronic Inspectors, whatever their Vendor, are built in two configurations: standalone, in-the-Machine. Standalone configuration Standalone configuration is by far the cheapest. 2-5 times cheaper than the in-the Machine. It does not include any connection, sensors, inspections, detectors nor logic relation with a precedent Labeller-, Filler-, Closer- or Seamer-Machine. Its: tasks are limited to handle a single Shifting-Register, rarely a couple of them; hardware is reduced to the minimum, typically one Trigger sensor over which the unique Shifting-Register is logically built, inspections and a rejector. fitting, wiring, starting and commissioning are accomplished in a limited time and, not being particularly complex tasks, they do not require the typically few available top-skilled service technicians. In systhesis: when configured to operate Standalone, all Inspectors imply an installation task that all of the Optoelectronics' service technicians fulfil. In-the-Machine configuration The Electronic Inspectors with locating positions and/or inspections in-the-Machine (Labeller-, Filler, Closer-, Seamer-Machine) are complex and their: tasks extended to handle several Shifting-Registers, typically two minimum; hardware is maximised, several Trigger sensors (inductive and optic) over which the various Shifting-Registers are logically built, many inspections and frequently more than one Rejector. their complexity is reflected in their pricing, always a factor 2-5 more expensive than the corresponding models operating standalone, years of practice, trainings, deep and true comprehension of the Shifting-Register's concept, are pre-requisite to an accomplished Commissioning. Commissioning honouring the Contract between an OEM or Vendor and a Food and Beverage Bottling and Packaging Company, also respectful of a row of legal requirements imposing, as an example, that the Machine Safeties cannot be left systematically disabled to the unaware Customers. Human-factor does matter Commissionings can only be named and underwritten that way in a worksheet whose siognature is asked you when: honouring the Contract between an OEM or Vendor and a Food and Beverage Bottling and Packaging Company, respectful of a row of legal requirements imposing, as an example, that the Machine Safeties cannot be left systematically disabled to the unaware Customers. We are suggesting the Readers that the service technician’s skills are part of the final added-value of the Electronic Inspector, because they are those one who shape the future years of the equipment. World’s most expensive and higher Quality Electronic Inspector, left in the hands of some of the worst technicians, always perform much worse than World’s cheaper and lower Quality Electronic Inspector, left in the hands of some of the average-skilled technicians of the World. Comparing Standalone & in-the-Machine installations’ pricings How to predict what should be the pricing of an Electronic Inspector’s installation, say its fitting, wiring, start-up, Commissioning and Operators’ Training ? Examing a posteriori many hundredths of different installations of Electronic Inspectors in Beverage Bottling Lines: where the above named installation activities had really been made, and made the only way the laws let them be valid in your country, because conformal to Safety rules and other technical good practices it is possible to see that a relation really exist, in different countries, part of Projects of Bottlers in competition (example, Coca-Cola vs. PepsiCo, AB InBev and SABMiller), whose Quality standards are different, configured with all of the existing spectrum of inspections, processing all existing kinds of containers (glass-, PET-, PRB-bottles, metal cans, crates and cases, etc.), from a wide range of productions, from 8 000 til 92 000 containers-per-hour, regression analysis shows an approximate but straightforward relation deriving be the comparison of the prices of the equipments, when the installation activities are not included. The installation pricing factor has empiric origin, nor we’d imagine what another way could be imagined to observe tendential relations which can only be obtained by linear regression studies a posteriori. As an example, if a Full Bottle Inspector costs 8000 € , ~10000 $ (weighs net 18 kg) is mainly but not only because that amount is proportioned to the sum of the values of its mechanical, pneumatical, optoelectronics, automation and documentation components. Another kind of Full Bottle Inspector of that same Vendor, priced ten times more, i.e., 80000 €, ~100000 $ (weighs 138 kg) shall need installation activities extended approximately to a duration 3.5 times longer than 8000 € model, needing just 3 days. Superior model costs ten times more than the basic: it sports many more functions and optionals to install (Rejectors, Triggers, cables, sensors), fit, wire, start, commission and finally train your staff. Five basic questions submitted to you own critical thinking: an Electronic Inspector needing 10 man*day of activities in your site, has been (strangely) delivered you after just 5 man*day ? What let you feel comfortable with the idea that its configuration is what you paid for ? What techniques you used to test it ? Maybe some test bottles had been passed one hundred times before to decide ? If this is the case, you have to know this is the kind of inspection a cheap Standalone Electronic Inspector does. An expensive in-the-Labeller Machine is paid to do many more additional useful things (like, advanced sampling or inspection in-the-Labeller) than just inspection at-the-Conveyor where the test bottles have been introduced. Would you order a new car, without to be informed before about its configuration, motor and performances ? We don’t think so, then it makes sense the following question: Have you received a precise listing of the functions assured you (Electronic Inspector’s Technical Guarantees) by the OEM or Vendor ? If not, why not ? Why Containers' Triggering is vital To let the Reader of these notes fully understand why all of the Triggering subject has so many pages developed to in this web site, there is to remark that: the identity of whatever object is its most fundamental information. It’d make no sense at all to speak of the “defective status of a container” in presence of ambiguity about “what container” is defective. In other words, containers’ Tracking, is much more important than whatever inspection, say whatever measurement of one of the physical properties of an object; when comparing Food and Beverage Packaging Industry with the Pharmaceutical Packaging Industry, we discover that the former with few exceptions discards as dangerous the rejection over an external Conveyor of the containers detected “defective” in-the-Machine. Following Pharma safety standards and customs, detection and rejection have to happen both in-the-Machine. The rejection has not to happen out of its Shifting-Register, one truly satisfying the requisites of rigidity and impossibility of the containers’ sliding out of the cells them attributed. Pharma Industry refrains to operate like Food and Beverage Packaging Industry operates following the OEMs and Vendors’ design choices; Machine-Conveyors-Inspector synchronisation Whatever the case, then also for relatively slow speed Labellers (<1.0 m/s), it is vital to synchronise the ramp-up and ramp-down phases of the Labeller and of the out feeding Conveyor, so that their speed difference results always <0.1 %. 0.1 % is a value knowingly close to the nonlinearity limit of the commercial Frequency Converters. Say the equipments regulating the speed of the motors in the Labeller and in the Conveyance systems. As an example, 0.1 % of divergence between bottle in-the-Labeller and same bottle at-the-Conveyor, at a speed of 1.5 m/s are 1.5 mm. 1.5 mm may appear a small divergence. But it is the maximum which can be allowed to be, keeping apart the today rare cases where containers’ speed is relatively slow (<0.8 m/s). Containers’ speed, being related to the containers’ kinetic energy following a quadratic law, enhances the slidings’ occurrences and then their negative effects. False Triggers and Data Sheets The Trigger controlling the Rejector, say the last one immediately before the Rejector, shall be exposed to count False Triggers, corresponding to bottles whose identity is unknown because lost. False Triggers which, in your own full interest, have to be absolutely be rejected by the Inspector, also if part of them corresponds to correctly labelled bottles. To let the Reader of these notes fully understand why all of the triggering subject has so many pages referred to in this web site, there is to remark that: the identity of whatever is the most fundamental information; it’d make no sense to speak of the defective status of a container in presence of ambiguity about “what container is defective”. the entire Pharmaceutical Industry discards and avoid as excessively dangerous the rejection of containers detected “defective” in-the-Machine, over an external Conveyor; detection and rejection have to happen in-the-Machine and not out of its Shifting-Register truly satisfying the requisites of rigidity and impossibility of movement of the containers out of the cells there attributed. In brief, Pharma Industry refrains to operate like Food and Beverage Packaging Industry is induced to operate by the choices of the OEMs and Vendors; How many of them has to be expected corresponding to correctly labelled bottles, then False Rejects ? A quite precise answer is given by the Inspector Counter menu for False Triggers, visible below as 0.01 %. Exactly that shall be the portion of the total False Rejects due to Falsely Triggered bottles. The mere existence of the Container Presence sensor shall force this rejection. Do not forget what seen above about the Transfer Point of the Labeller Machine's out feed starwheel.

IntroductionIn the following, we’ll introduce the study of a pattern observed worldwide in the period 2005-2014 in the operative reality of around one-hundred Electronic Inspectors sold to be operated in-the-Machine (Labeller, Filler, Capper, Closer or Seamer). …

Jammed Sampling table. Results of this over-sized Sampling Table were poor because of three independent Root Causes (italics) related to: Installation: the black colour side guide indicated by the arrow below, presents a profile inducing fallen cans due to cans’ anomalous fast deceleration. Fallen cans becomes jams in the end of the Table, where it starts the single way belt devoted to accumulate the orderly row of Filler Machine valves and Seamer heads; Design: the belts chosen are models with high friction coefficients, favouring fallen cans and successive jams; Design: no separate lubrification system existing with the effect that front of many more belts than necessary, no lubricant at all is visible, favouring fallen cans and jams. Incoherences like these are frequently encountered and the list above pin-points what to check first, when Sampling operations results in stopped Bottling or Canning Filler Machines. Results of this over-sized Sampling Table were poor because (Root Causes in italics) of: Installation: the black colour side guide indicated by the arrow below, presents a profile inducing fallen cans due to cans’ anomalous fast deceleration. Fallen cans becomes jams in the end of the Table, where it starts the single way belt devoted to accumulate the orderly row of Filler Machine valves and Seamer heads; Design: the belts chosen are models with high friction coefficients, favouring fallen cans and successive jams; Design: no separate lubrification system existing with the effect that front of many more belts than necessary, no lubricant at all is visible, favouring fallen cans and jams. Incoherences like these are frequently encountered and the list above pin-points what to check first, when Sampling operations results in stopped Bottling or Canning Filler Machines. Cans jammed, blocking the entire Table, after attempting a Filler-, Capper-, Closer- or Seamer-Sampling operation. Root Causes are the superimposed issues numbered above 2. and 3. Cans jammed, blocking the entire Table, after attempting a Filler-, Capper-, Closer- or Seamer-Sampling operation. Root Causes are the superimposed issues numbered above 2. and 3.

Case Study Sampling Table always jammedIntroductionTypical problems in a Food and Beverage Bottling Line derive by missing materials like motors, Frequency Converters, detectors, etc. In the following we’ll briefly study a Case where the “material” was much more than necessary. …

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Case study Cap presence control of sensitive beverages in 2001“X” is a great dairy filling and packaging plant. Here were installed, started and commissioned two standalone Full Bottle Inspectors in a new Aseptic Line for PET-bottled dairy products. …

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99.5 % of the non-labelled bottles to the Market

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Canning Line's Layout relevance

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Ampoules Filling and Sealing Machine. 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 always and only 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 (image credit SCHOTT®, 2014)

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