punctured pharmaceutical co med

























Introduction

The Pharmaceutical field is the origin of the technologies adopted today in the Aseptic filling, closing and inspection of beverages without any added preservatives.  Are the Food and Beverage Packaging standards competing with the Pharma standards of, as an example 10 years ago ?    Unfortunately, no.   To feel how delayed is in terms of safety all the Food and Beverage Packaging with respect to Pharma, we’ll quote in the following part of an U.S. Food and Drug Administration Recall Press Release.   Here, Hospice, Inc. the worldwide leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, announced a voluntary nationwide (US) recall of certain lots of several lifecare products due to potential for Leakage.  1000 ml (1 liter) leaking containers recalled because potentially punctured, due to a defect in a Conveyance system:

“The issue, which Hospira notified customers (…), was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. 

The puncture in the primary container may result in leakage that is difficult to detect. 

Leakage may result in an open system, which has the potential for: 

  • contamination, 
  • compromised sterility, 
  • drug waste, 
  • spillage, 
  • inadequate or inconsistent solution/medication dosing, 
  • delay in therapy, 

all of which may require medical intervention and should be reported to Hospira and/or the U.S. Food and Drug Administration (FDA).   Hazardous topical exposure may occur if a hazardous drug is added to the flexible container.   Hospira’s product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless solution is clear and the container is undamaged. 


pharma packaging line med hr

Root Cause Analysis

The root cause is attributed to a defect in a Conveyance system, and corrective actions have since been implemented to prevent a reoccurrence.   To date there have been no reports of adverse events associated with this issue for the impacted lots.  The manufacturing issue that caused this incident has been addressed. Hospira recommends impacted customers check with their local Hospira representative or with Hospira Customer Care regarding replacement product. 

  Pharmaceutical Packaging Lines, however running much slower than the majority of Food and Beverage Lines, are much more critical.  In the Case Study presented here, originating by the U.S. Food and Drug Administration, the liquid into the containers is meant for intravenous injection



















What is affected

The affected lots (see table below) were originally distributed by Hospira to direct accounts from September 2013 through October 2014:

  • Normosol®-R pH 7.4 Multiple Electrolytes Injection Type 1, USP; 1000 mL container
  • Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • 5% Dextrose Injection, USP; 1000 mL container
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container
  • 5% Dextrose and 0.9% Sodium Chloride Injection, USP; 1000 mL container
  • Lactated Ringer's Injection, USP; 1000 mL container
  • Normosol®-R Multiple Electrolytes  Injection Type 1, USP; 1000 mL container
  • 0.9% Sodium Chloride Injection, USP; 1000 mL container
  • 0.45% Sodium Chloride Injection, USP; 1000 mL container
  • Sterile Water for Injection, USP; 1000 mL container


Solution

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately.   This recall is being carried out to the medical facility/retail level (both human and veterinary).   Please notify all users in your facility.   If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level.   In addition, customers should inform potential users of these products in their organizations of this notification.   Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned”

pharma process med



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. …

Case Study The Brewery which considered the TechnicalGuarantees part of a Contract to be honoured  ROC-curve of a Fill Level inspection. Imagine to pass 1000 times a test container through one and the same Electronic Inspector equipped with a dual Fill Level Inspection: X-ray and High Frequency (or, Optic with camera). …

IntroductionPowerade® is a famous energy beverage, the first in a row of energy drinks with great success launched in the World, after 1988. In July 2002, The Coca-Cola Company® updated the bottles of the standard Powerade to a new sport-grip bottle. …

Case study 27% rejects stopping all days a Beverage Bottling Line  The rejects' accumulation table of an Electronic Inspector in a Beverage Bottling Line, as it appeared to the eyes of the Operators and Management along 6 consecutive months after the day of the Line startup. …

reynolds numbers and fillin-2

Case study 1 year of Production lost   In the following a case where the Machine blamed by the Bottler never functioned correctly since the first day. 18 months later, and after two different analysis made by elements acting in conditions of …

Milk and milk-based beverages, filled and capped in an aseptic environment, no preservatives. One more time, the cap is their Achilles’ heel, whatever the technology adopted during their filling. A slightly malpositioned cap is enough to clear all of the cares of the Aseptic Filling + Closing process, creating the optimal conditions for an organic contamination

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. …

milk aseptic filling med hr

Case study Cap Presence control of sensitive beverages in 2010Introduction “Y” is a great dairy filling and packaging plant. Here it has been installed a standalone Full Bottle Inspector in a new Aseptic filling Line for PET-bottled dairy products. …

99.5 % of the non-labelled bottles to the Market

Case study99.5% of the non-labelled bottles sent to the Market Non labelled and flagging-labelled bottles, manually rejected at the outfeed of a Labeller Machine. Manually rather than automatically rejected by the inspection system, because of a design-error in its configuration, amount of tracking Triggers photocells and Encoders. …

Canning Line's Layout relevance

Case StudyCanning Line’s Layout Relevance   IntroductionNo one of us has X-Ray's radiographic eyes. Because of this obvious reason, the cans’ content cannot be visually verified if, due to any reason, the Full Can Inspector is not active. …

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)

Case study Electronic inspection of Pharmaceuticalsin-the-Machine-Cycle When speaking of guarantees of asepticity, Pharmaceutical Industry is since many decades what really and only retains the maximum know-how. …

punctured pharmaceutical co med

IntroductionThe Pharmaceutical field is the origin of the technologies adopted today in the Aseptic filling, closing and inspection of beverages without any added preservatives. Are the Food and Beverage Packaging standards competing with the Pharma standards of, as an example 10 years ago ? …

hardware faults 2800x1582@1x

Case HistoryGold-made electronic cardsImagine two huge cases arrived to your store today, filled with the spare parts you ordered and waited for 4-6 months. Electronic cards and other parts urgently needed to let your Machinery produce in Quality and Safety. …

topology of the saff-sequen 4096x2460@1x

The “Device”Fusing, considered the Root Cause of whatever explosion, is just one superimposed component of an extremely longer sequence of conditions before and after, greater and smaller, than the Fuzing. …

human-factor design and nuc-2 4096x2315@1x

What Root Cause Analysis’ names human-factor plays a decisive role. A role made decisive as root cause of the majority (over 50 %) of all of the incidents registered in the productive processes. …

A seismic Incident

False trail to the Root CauseWe’ll brief in the following the incident happened in 2011 in the nuclear power plant at Fukushima Daiichi, Japan, operated by the Tokyo Electric Power Company (TEPCO). …








                                                                                                            Copyright Graphene Limited 2013-2019