Error-Proofing Pharma

oops Couldn't stay away for the whole week...greetings from The Big Apple and Interphex. Managed to trip while trying to claim a taxi and literally fell on my face on the pavement/now have a most attractive and utterly undisguiseable scrape along the entire length of my nose.  While we're on the subject of "slips," it seems that error proofing may finally be coming of age in drug manufacturing.  Does this mean that the demise of the "GMP bureaucracy" is close at hand? Well, maybe not for a while, but its days appear to be numbered. At Baxter, whose manufacturing teams in Mexico and North Carolina took home the 2007 Shingo Prize for excellence in manufacturing, error proofing and simple visual tools have been the key to improved safety and performance.  Baxter Cuernavaca has assigned process engineers the task of mistake proofing its processes.  The solutions are often very simple, including:
  • Placing a device in a sampling line to prevent the wrong correction.
  • Using different port sizes on a filling line, with a different diameter tubing for each 
  • Putting mailbox flags on containers in which empty bags are moved from one location to another to show whether they're full or empty, or on machines to show the status of production.  
"Poka Yoke is not rocket science," says North Cove's plant manager Tony Johnson. So why don't more facilities have an official error-proofing program in place?  Perhaps it's perceived as too simple-minded or trivial an occupation. Three years ago, at an industry conference, a prominent biotech executive complained about biopharma/pharma's lack of an official mistake proofing strategy, recalling a situation within his own company in which the acid and base used in one reaction were housed in identical containers within the same storage cabinet, resulting in frequent accidents and a few trashed batches. The justification, he said, "We've always done it that way."  (Of course, he'd never let his name be mentioned....but there are likely more situations like this out there). To read more about the Baxter teams and what they did to claim the Shingo Prize, as well as more about that prize, its criteria and namesake, click here. RFID for Safety But vendors appear to be jumping on the "poka yoke" bandwagon, and the error-proofing theme is running through this year's Interphex conference, complete with color-coded and specially designed fittings, and  RFID is also playing a key part.  If the jury's still out on whether the technology will be the answer to pharma security and supply chain management issues, its role in error-proofing may be assured.  Millipore, for instance, has introduced filters with embedded RFID chips, which allow users to record data automatically, and send an alarm message when data for the same filter is recorded twice. The chips are placed outside of the process flow path, eliminating any validation concerns. The company is building an infrastructure that will allow RFID to be used in disposable mixers and other process equipment.   Colder Products has also introduced RFID-enabled "smart coupling" technology which is now being used in chemical applications. AdvantaPure offers a gamma sterilizeable chip, and an array of RFID enabled couplings.  And there were many other examples which we'll discuss in an upcoming article. Could embedded RFID tags eventually be incorporated in all pharma process equipment?  That may take a while, but anything that reduces operator error is welcome. The process of reducing operator error is anything but trivial, and perhaps  a little common sense is in order. Any manager who thinks it's OK to store two potentially reactive ingredients in identical containers in the same cabinet, because it has always been done that way, should be shown other career options.
Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


  • <p>The action agenda is presented in a format that allows community practice sites to document their medication safety activities, which is important for internal quality improvement efforts but also may be important for any external accrediting or regulatory organizations. -<a href="">Guy Riordan</a></p>


  • <p>Hello All,</p> <p>I need your guidance or opinions for a simple yet challenging problem that I am currently facing.</p> <p>I was assigned a project recently. As part of the project, I have a scenario where I need to implement mistake proof solution to a problem.</p> <p>Please refer to the attached file, it contains all the details. </p> <p>I am eagerly looking forward to see your replies.</p> <p>Thank You. <a href="">Frases Romanticas</a></p>


RSS feed for comments on this page | RSS feed for all comments