Instilling Green Values in College Chemistry Courses: How St. Olaf’s is Doing It

College chemistry labs have changed a great deal since the 1980s, with most schools using “micro” quantities of reagents to ensure safety and minimize environmental impact.  It’s about time. There’s no reason to expose kids to unecessarily large amounts of potentially dangerous chemicals.

Analytical chemistry courses involved mostly benign materials.  Not so for organic. Istill recall when a lab partner managed to spill a substantial amount of carbon tet on fellow pre-med team mates during an Organic Chemistry I lab.  Was it accidental? I’ve often wondered.

Some spill or other mishap occurred almost daily in that lab, and there were few precautions taken, beyond the standard-issue safety glasses.

Using smaller quantities of reagents demands more skill on the part of the student, “weeding out” those, like me, who were not meant for lab work, or at least teaching them to be less klutzy.

It also prepares serious students for the ‘reality’ they’ll see if they move on to work in industry.

Recognizing that it’s never too early to think green, many universities have incorporated environmental stewardship into their chemistry courses.  A case in point is St. Olaf’s College in Minnesota, which has evaluated the safety and environmental impact of its advanced undergrad Analytical Chemistry course.  This poster, which was presented by Associate Professor Paul Jackson at February’s Pittcon in Chicago, explains how:  St Olaf’s Green Analytical Chemistry

More Collaboration Needed On Excipient Selection and Development, IPEC Says; Excipient Master Files Would Advance This Cause in Europe

The wrong choice of excipient has led to delays or failures for many new drug candidates. A position brief from IPEC, which recently held a seminar on this subject, notes the need for

• Strong communication channels between suppliers and the pharmaceutical industry are pivotal for the development of innovative excipients that enhance drug efficacy and streamline manufacturing operations
• Close collaboration,  to ensure that regulators take on board the concerns of all those involved in the use of excipients.  

Below, verbatim, is IPEC’s summary of some highlights from its recent seminar.

Carl Mroz, Chair of IPEC’s European Regulatory Affairs Committee advised companies on how to expand their excipient business in markets such as China and Russia. He pointed out that Japan recently amended its 1948 Pharmaceutical Affairs Law to allow for the filing of an Excipient Master File (EMF) and that European stakeholders should focus on doing this in Europe as well.

Mroz said: “We want a mechanism that allows novel excipients to come faster to market in Europe. Without new excipients you are stifling innovation and there are many good ideas which never get off the drawing board because there is no system to introduce new excipients within Europe.”

The EMF model is already in place in Japan and in the USA, and it is imperative that Europe catches up, added Mroz.

“If you are interested in a new drug delivery system that involves a new excipient, there is no impetus to invest in that sort of R&D at the moment because the regulatory hurdles are so high. If a DMF system were in place holding all confidential information safely, eliminating the need to submit sensitive data to every single potential customer to assess multiple times, the boost to the advancement of technology would be enormous.”

Both patient need and process capability must guide excipient selection, seminar delegates said. However, as new legal requirements for Good Manufacturing Practice (GMP) in the production of certain excipients are introduced in Europe, suppliers will be required to offer excipients made to the similar GMP principles as active pharmaceutical ingredients (APIs).
 
To assess the impact of applying GMP regulations on excipients, Dr Rui Santos-Ivo, Enterprise and Industry Directorate-General at the European Commission,  attended the IPEC Seminar and invited all stakeholders to take part in a public consultation and announced the launch of a questionnaire on the directorate’s website.
 
Dr Santos-Ivo said: “We need high safety standards to promote patient safety and that is why we have identified some categories of excipients where legislation is required. Nevertheless, we also believe that adequate regulation is a tool for improving the competitiveness of companies, not only in Europe but worldwide.”
 
“We must also avoid placing unnecessary burdens on those affected by the new directive, without of course compromising patient safety. For me it is very clear that IPEC has ample knowledge in the field so it is very important that those who work directly with excipients offer their expert views in the consultation.”
 
IPEC has already made a significant contribution to the debate by publishing a GMP guide for excipients, a practical authoritative document that not only helps excipient suppliers meet the increasingly stringent demands of the pharmaceutical industry, but also makes it easier for pharmaceutical companies to ensure their suppliers are meeting acceptable quality levels.
 
Impurities
 
Excipient suppliers are also faced with new rules on the acceptable limits for
genotoxic impurities in pharmaceuticals. Although new guidance from the European Medicines Agency (EMEA) that came into force on 1 January 2007 does not refer specifically to excipients, the regulator is expected to take into account the toxicological assessment of genotoxic impurities in excipients before granting marketing approval for new drugs.
 
This poses a great challenge for excipient suppliers because routine synthesis is not possible without the use of reactive materials which are potentially genotoxic, making the presence of genotoxic impurities in excipients inevitable in some cases.
 
Dr Peter Kasper, rapporteur for preparing the EU Guideline on the Limits of Genotoxic Impurities, told the IPEC seminar: “A considerable proportion of all synthesis products in pharmaceuticals potentially contain genotoxic impurities, so this is certainly a major regulatory issue. Whether this poses a health risk is another question, because we are talking about very low levels and it is very difficult to quantify the risk.”
 
“Our guidelines help provide some much needed clarity to the assessment of genotoxic impurities. If companies are aware of this problem from the very start, most have the knowledge and the expertise to deal with it, so I don’t think these new guidelines will have a negative financial impact.”
 
According to the guidelines, published by the EMEA’s Committee For Medicinal Products For Human Use (CHMP), a threshold of toxicological concern (TTC) of 1.5 µg/day intake is considered acceptable for genotoxic impurities without sufficient evidence for a threshold-related mechanism. Higher limits may be justified under certain conditions, such as short-term exposure periods.
 
Variability
 
It is often assumed that such demands for regulatory compliance will inevitably lead to less variability in the excipients used.  But Janeen Skutnik, Director Technical Affairs at Pfizer and Chair-elect of IPEC-Americas, challenged the view that as pharmaceutical manufacturers in Europe concentrate on International Conference on Harmonisation (ICH) concepts, such as Design Space and Quality by Design, they will tighten their excipient specifications.
 
Skutnik said: “A lot of pharmaceutical companies are having discussions with their procurement teams to help them understand the impact of these guidances and urge them to embrace scientific and risk-based discussion with excipient suppliers.”
 
At the moment there is a lot of wastage in pharmaceutical manufacturing as the industry has not been continually improving and understanding process parameters, with the result that waste can be as high as 50% for some products, while factory usage rates can be as low as 15%. In most pharmaceutical companies manufacturing spending constitutes 25% of expenses which is equal to R&D investment.
 
“Pharmaceutical manufacturing produces products of reasonable quality, but at great effort and cost,” according to Skutnik. “Through increased formulation understanding and efficient knowledge transfer, we can implement ICH Q8 Q9 and Q10 while bringing in new excipients that achieve better results for our processes and more effective medicines for our patients.”
 
More extensive knowledge of critical product and process parameters and quality attributes should lead to more innovative use of excipients, yielding financial savings and better medicines, she said.
 

-AMS

Mine Insurer Safety Data, Former FDA Commish McClelland Urges. “Bring That Iceberg Out of the Water”

If industry has difficulty getting to data it needs, so does FDA.  Only the Agency doesn’t have all of that data, as became evident during the Vioxx disaster. Databases run by private insurers provide a wealth of drug safety information, waiting to be tapped, the former FDA Commissioner suggested at an Institute of Medicine meeting yesterday.  Click here for more on that.

New Personalized Medicine Tool: ToxPedia Would Take a Data-Driven Approch to Predict Drug Safety

This computational solution would integrate toxicogenomic data with traditional toxicological end points, and its use could help predict drug safety, the company says. Below, the press release issued today.

Genedata has released Genedata ToxPedia™, a computational solution supporting systems toxicology for drug safety prediction. ToxPedia is an expansion of the Expressionist platform built by Genedata in collaboration with pharmaceutical organizations.
 
       Systems toxicology promises to reduce costly failures in the late stages of drug development and is attracting interest from pharmaceutical companies as well as drug safety regulators.

To gain the greatest benefit from systems toxicology, scientists need to integrate toxicogenomic data with conventional toxicological end points. This integration enables a systematic search for clinically relevant molecular biomarkers that can be used to predict a compound’s toxicity profile, before expensive clinical trials are initiated.

ToxPedia supports a data driven approach to systems toxicology. The system enables biomarker identification based on an integrated analysis of toxicogenomic data, namely of high throughput transcriptomics, proteomics and metabolomics data, with conventional toxicological end points. The ToxPedia system is built on the well established Genedata Expressionist® platform and has been expanded by Genedata’s professional services team in close collaboration with scientists from leading pharmaceutical organizations.

The system is designed to address the specific requirements of systems toxicology. Tight integration with all major high throughput technology platforms, coupled with sophisticated data quality assessment tools, enables ToxPedia to achieve the highest standards in data quality evaluation. Ultimately, the goal is that ToxPedia supports the standardization and automation of the entire systems toxicology workflow from the initial sample gathering stage through to final study reporting phases, and addresses compliancy aims such as 21 CFR Part 11 guidelines.

Genedata also collaborates actively with research consortia focused on biomarker discovery, including the consortia InnoMed, NewGeneris, and INCA. “In collaboration with leading scientists in the pharmaceutical industry as well as in academia, we have developed a state-of-the-art computational system for the emerging field of systems toxicology”, explained Dr. Othmar Pfannes, CEO, Genedata AG. “With ToxPedia, we continue to bring significant value and cost savings to pharmaceutical R&D.”

Purdue Pharma Installs Near-Field Tags in Full-Scale RFID Program

Below, the press release from Impinj, whose RFID technology was selected.  For more details on the project, read our upcoming print and digital issue.

 Purdue Pharma L.P. will integrate Impinj’s Gen 2 RFID products into high-speed pharmaceutical packaging lines for improved pharmaceutical supply chain efficiency and security.
 
Scheduled for production-level deployment in the second quarter of 2007, Purdue Pharma’s Gen 2 RFID-enabled packaging line will utilize the Impinj GrandPrix™ UHF RFID solution, comprising Speedway™ readers, tags powered by Monza™ chips, and application-specific near-field reader antennas.  The packaging line will be certified for production readiness under SYSTECH International’s TIPS® Serialized Product Tracking solution that includes exhaustive tests modeling Purdue Pharma production packaging environments.  During advance testing, the Impinj-powered packaging line surpassed tag read rate requirements with 100% tag read reliability.
 
“We are working to implement innovative solutions that will enhance security within the supply chain,” said Aaron Graham, vice president of Corporate Security and chief security officer at Purdue Pharma. “The Impinj RFID technology has been selected as an integral part of our packaging line improvements to help the company establish an ePedigree process that will significantly improve the delivery of products from the factory to the pharmacy counter.”
 
Successfully deployed in large retail and distribution environments worldwide, the Impinj GrandPrix solution utilizing Monza tag chips and Speedway readers addresses the most important RFID deployment criteria for pharmaceutical supply chain environments — high tag throughput rates, high read and programming reliability and robust, secure track and trace capability.  The Speedway reader achieves superior read reliability with throughput exceeding 1000 tags per second in typical supply chain environments and 200 tags per second in dense reader environments with up to eight interfering readers. The Speedway reader also features a unique mono-static antenna design that delivers the RFID industry’s highest performance while substantially reducing deployment and ownership costs. Monza chips and Speedway readers carry both EPCglobal’s Gen 2 Conformance Certification and Interoperability Certification marks.
 

FDA Deputy Commissioner, Dr. Janet Woodcock on the Critical Path: Focus on Your Customers (from IFPAC `07)

Dr. Janet Woodcock, M.D., Deputy Director and Chief Medical Officer of FDA, gave the keynote address at IFPAC’s plenary session, in which she made clear the connections between PAT, Quality by Design and the Critical Path Initiative.

 

Good morning. Ajaz asked me to talk about FDA’s Critical Path Initiative, and how that fits in with the goals that all of you are here to discuss, which really focus on optimizing pharmaceutical manufacturing, particularly through the application of process analytical technologies (PAT).

I’d like to explain how the Critical Path Initiative and other FDA initiatives such as Pharmaceutical Quality for the 21^st century relate to PAT, and talk about implications that Critical Path and quality initiatives have for PAT.

I’d also like to discuss how we can, in the future, link critical product attributes to clinical outcomes, to gain a better understanding of what we’re trying to control, in other words, to determine the attributes that determine a product’s good clinical performance.  At this point, this is something that we know very little about, except in the very broadest sense.

So the basis thesis behind FDA’s CP initiative, which really resonates across manufacturing, is that investment and progress in basic medical science has far surpassed investment and progress in the medical product development process.

And the analog in the manufacturing world is the fact that R&D investment by companies has far surpassed actual interest and investment in how to make product and actually get it out the door.

The development process is becoming a serious bottleneck.  Our theory at FDA, and we’ve said this publicly, across the board, is that we’re using the evaluation tools and infrastructure of the last century, and, in some cases, tools from very early in the last century to develop this century’s medical advances.

FDA would like to change this.

But all of this must be viewed within the context of this huge R&D investment, which  has driven heightened public expectations that we’re going to have all these novel therapies available based on new science. 

There’s been an explosion in new science.  There are ventures and labs all over the world that have all this great new stuff that’s going to cure more patients and meet medical needs. 

Novel drug submissions, however, have been flat…approvals last year were very low relative to performance in the 80s and 90s, and much less than what came out in the mid 90s.

Although investment in research and discovery has gone up tremendously, we’re not seeing this reflected in output of new products, even though the public is expecting this result. As a result, they’re getting mad at NIH and the pharmaceutical industry.

There’s been a definite plateau in the pharma development pipeline, and a lot of discussion and speculations in the literature as to its causes.  ‘Maybe we invested too much in genomics and it wasn’t ready yet,’ we hear,  and so forth and so on.  You’ve heard all this speculation.

But what we need to do is to work on things we can address and correct.  So the Critical Path focuses more on the development process

At the same time we’re that drug development today has a lower chance of success. That can’t be good news. So despite all the answers you have from science, as you move new products into preclinical and clinical development, their success rate is actually declining. Today,  new compounds going into Phase I have an 8% chance of success reaching the market, compared with 14% a decade and a half ago.

And, more ominously, the Phase III failure rate is now about 50% vs. 20% a decade ago. I say “ominous” because, by the time you get to Phase III you’ve sunk a lot of cost into the compound, and invested a lot of money. It’s very painful.  It also causes your stock value to go down, because you’ve told everyone that you have this great new compound going into clinical trials.

And of course you know, you read about it in the papers all the time, this program had to be abandoned, that program had to be stopped, etc. and all the disappointment that results. So the predictability of the process is not improving right now.

So we looked at all this at FDA a number of years ago.  We knew that these are all big problems, but we saw  that the societal investment on the R&D side has been huge. Investment was now needed in the development process; at FDA, we need to improve our standards and to use a lot of science to help us improve standards for manufacturing.

There’s a huge private and public investment in basic research, and huge investment in the development of specific products, but we don’t see the same kind of investment in “how” to develop an evaluation process. Academia has not been funded, and this is true in clinical trials, believe it or not, as well as manufacturing.

There’s been a little more funding for research in toxicology because of environmental issues.  FDA has done this type of work over the years, but Congress has not funded FDA to do any of this work.

In the private sector where many of you work, these efforts are often viewed as proprietary and confidential, and so knowledge is not generalized.  As a group, we cannot advance our development science as we should, all the way from manufacturing to clinical.

We need to explain this to the public. They’ve never heard about this before.  They think that when one of your scientists has a brilliant idea, in two years they should be able to hand a new drug using that idea over to the patient. There should be no problem, the public reasons, and if there is, then you’ve failed.  And your scientists think that too, by the way.

It’s never been explained that basic research is a long way away from having a product. We’ve adopted the term Clinical Path to explain the fact that this is a long and extremely technically challenging process.

And there’s research that we need to do to make this better.  Some people are talking about translational research and Phase I research along with Critical Path research.

 We tell Congress, the public and medical scientists that the science needed to enable efficient manufacturing is different from basic science, but it’s just as worthwhile, just as necessary to get new products out. There are three types of science:

Safety – to predict whether product will be safe enough

How do you predict how it will look?  Obviously we’re really bad at that. That’s why we have such a high Phase III failure rate.

Industrialization – How to turn an early scientist’s idea into something that can actually be manufactured, consistently, at commercial scale. That’s something that the public can try to understand. If you put it this way, people get it.

We say that each one of these areas faces many challenges.  We’re trying to build a case for everyone here, that we have to do this, we have to invest. And some of the people we’re trying to convert include the CEOs of big companies.

Patient groups are very interested, but just can’t figure out why their diseases, whether MS, ALS or cancer, aren’t getting cured. We’ve invested billions every year in basic research, and people can’t figure out why we don’t have products in hand to help their patients.

We explain how complicated the Critical Path is, how many disciplines are involved, and how all of these need to be improved.  This CP initiative we’re doing has a number of principles.

We’ve had no funding for this at all, specifically from Congress, so we’ve focused on establishing collaboration between government, academia, industry and patient groups, and we focus on developing new infrastructure and tools, not specific products. 

Everyone wants to focus on specific product development, which is viewed as glamorous.  We need, instead,  to focus on the tools that enable product development. We’re trying to build support for an academic science base.

In manufacturing, we talked to NAS and academia.  This is a major industry important to public health and important to biomed science and needs to be supported. 

We need to build opportunities to share knowledge and data instead of keeping it.  If one company implements PAT and nobody hears about it that’s not good

We need to develop enabling standards….standards for clinicals and for genomics. This is a very broad field.

We published an initial report and had open comment period.  We’ve also have multiple partnerships. We’re pleased that industry has stepped up to the plate. 

We’ve published a list of projects that need to be done, including major projects in manufacturing. .

Recently published a list of collaborators and we’re continuing to work…we have a major article that will be published in Clinical Pharacology Pharmacopeia on the Critical Path Initiative, and we continue to crest along

Dust Explosions Remain a Risk for Some Pharma Operations

Several years ago, we scheduled an article on avoiding dust explosions.  The expert contributor assigned to write the article laughed at the premise that such things could even occur, given the rigorous safety and other standards in place. And the idea of such an explosion taking place at a Pfizer or Lilly plant today does seem laughable.

Yet, explosions have occurred at smaller facilities, particularly those that handle compounding,  and they may continue to take place if operators overlook key safety requirements.  This week,  the U.S. Chemical Safety Board released its latest report on avoiding dust explosions, including results of a study of the tragic 2003 West Pharma incident (excerpt below). For more information visit the Board’s web site.

4.2.1 West Pharmaceutical Services, Inc.

On January 29, 2003, a massive dust explosion at the West Pharmaceutical Services facility in Kinston,

North Carolina, killed six workers and destroyed the facility. The explosion involved a part of
the building used to compound rubber.

West produced rubber syringe plungers and other pharmaceutical devices at the facility. In the rubber

compounding process, freshly milled rubber strips were dipped into a slurry of polyethylene, water, and

surfactant to cool the rubber and provide an anti-tack coating. As the rubber dried, fine polyethylene

powder drifted on air currents to the space above a suspended ceiling.

Polyethylene powder accumulated on surfaces above the suspended ceiling, providing fuel for a

devastating secondary explosion. While the visible production areas were kept extremely clean, few

employees were aware of the dust accumulation hidden above the suspended ceiling, and the MSDS for

the polyethylene slurry included no dust explosion warning. Even those employees who were aware of

the dust accumulation had not been trained about the hazards of combustible dust. West did use a safety

review process when the compounding system was designed and modified, but the dust explosion hazard

was not addressed during the reviews.

OSHA, the local fire department, an insurance underwriter, and an industrial hygienist had inspected the

facility, but none had identified the potential for a dust explosion. In addition, the electrical equipment

above the suspended ceiling in the rubber compounding section was not rated for use around combustible

dust, as the National Electric Code (NEC) requires (for areas where combustible dust can accumulate).

The CSB determined that if West had adhered to NFPA standards for combustible dust, the explosion
could have been prevented or minimized.

Novartis Flu Vaccine Snafu Shows Need to Extend “Op Ex” to Contract Drug Manufacturing

If drug manufacturing efficiency varies inversely with the degree of manufacturing complexity, contract drug manufacturing and packaging operations must be the most complex of all.  Can they always be efficient? Contractors, after all, must adapt constantly to shifting products, clients, and key customer markets/regulatory requirements.

Leading contract organiztions do what they do very well, but they may still slip up sometimes.  The latest evidence was reported on yesterday, when The Washington Post disclosed that Novartis had recalled  500,000 doses of flu vaccine after it was found that they had been frozen.  (Click here to read the story). This apparently took place when the vials were in the custody of its contract partner, Cardinal Health.

Cardinal is looking into what might have caused the problem. 

But it made me think that more drug companies should extend their in-house manufacturing excellence programs beyond their company borders—that they should have the same standards in place, and they should track performance regularly, and impose  penalties when standards aren’t met.

Not to suggest that there are structural problems at Cardinal, which has a very good record, or that Novartis isn’t fully committed to op ex.

But formal programs that do this are very difficult to start up and maintain.  It’s hard enough to measure data and keep up with metrics at your own facility, and some contractors may resent too much supervision. 

But it can be done. We reported recently on the work that one group at Wyeth was doing to set standards and ongoing metrics for its partners.  Are more efforts like this going on? Please write in and let us know.

-AMS

Monitoring Workplace Hazards and Operator Performance in Real Time

Pharmaceutical Manufacturing just published an article on Professor Jim McGlothlin’s work at Purdue University’s Exposure Assessment Research Laboratory. 

McGlothlin and graduate students at his PEARL lab have developed an extremely useful tool PEARL VEM and how it works that allows workplace hazards (such as particulates, emissions, noise—and human responses such as heart rate) to be recorded in real time, while videos show how operators are using process equipment.  

VEM may not eliminate the need for air sampling, but would allow such sampling to be used more strategically, says McGlothlin. It also allows top control priorities to be established.

Users access the wireless system (which involves a laptop PC, sensors and video camera) via a specific IP address; sensor and video data are sent simultaneously to the PC…With this equipment, a company could “vet” a contract API manufacturer halfway across the world.  Information can also be stored for future training.

 Could the use of such technology smack of “Big Brother?”  Perhaps, but it could prove to be a powerful tool in preventing operator error and increasing safety.  The story appears below….

.

Monitoring Indoor Air Pollution in Real Time

 

Pharma facilities may not be thought of as environmentally hazardous work environments. After all, GMP and strict safety regulations prevail, and much attention is paid to avoiding cross-contamination.

 

Yet, the batch processing areas of drug development and pilot plants, particularly those that focus on tableting and solid dosage forms, can pose hidden hazards.  And sometimes they’re not that hidden either— for instance, when particulates are made airborne by an operator who doesn’t know how to apply local exhaust ventilation effectively.

 

Hazardous active pharmaceutical ingredients (HAPI) aren’t the problem, either, explainsPurdueUniversity professor John McGlothlin, who has been studying particulate exposure for several years. “Generally, the higher the ingredient’s potency, the more careful operators are about handling it,” he says.  “It’s the less potent materials that can accumulate to have a potentially adverse effect.”

 

Given that a large portion of pharma’s workforce is female and of childbearing age, protection is critical.  But it also makes good economic sense, by preventing the cross-contamination that can destroy batches, as well as the waste that occurs when powders accumulate on the floor and must be vacuumed up.

 

What’s especially interesting about the work that McGlothlin and the 10 graduate students in his
PEARL laboratory are doing, is the fact that they are applying video exposure monitoring, in a system that includes a sensor, wireless air sampling and video to analyze workplace hazards, and pinpoint the most troubling areas, in real time.  Years ago, they’d used radio relay, but now wireless technology and the Internet are expanding the power and potential reach of this technique. 

 

Users access the system via a specific IP address; sensor and video signals are conveyed simultaneously to a wireless laptop computer, where data are collected and analyzed. The cost is minimal, requiring only the computer, sensors, video camera and server, but the Web interface  allows global access to real time data, and video, from anywhere in the world. Users can also archive and recall information and use it in future training materials or control systems.

 

What Purdue provides is proprietary software and a caching system, as well as data encryption. “It’s like a car kit,” says McGlothlin.

 

The online monitoring technology won’t eliminate the need for dedicated sampling, an expensive procedure that costs hundreds of dollars each time.  But it allows one to use such sampling more strategically, and to place additional controls at high-risk process points.

 

Having such a visual tool has surprised even McGlothlin by what it has revealed.  His team has found, for instance, that 90% of the exposure risk typically occurs at only 10% of the points within a given work area and cycle.  In tableting operations, for example, the greatest risk of exposure tends to occur in mixing areas, in areas where ingredients are charged from drums into the mixer. 

 

Typically, McGlothlin explains, a local exhaust system is placed near a mixer, but if the operator doesn’t hold the exhaust hose at just the right position near the funnel, particulate concentration can quickly build up in the room.  “It’s not a matter of being six inches or one foot off.” says McGlothlin. “Sometimes just a few inches make a big difference.”

 

The key is consistency in placement of the hose, so that it’s close to the area where the powders are added, but not too close—it should be at the edge of the scoop so that it doesn’t intrude into the scoop.

 

Video exposure monitoring serves as an excellent training tool, McGlothlin says, but also offers automatic incentives and reinforcement for use of best practices.  For example, if monitoring shows that operators have used best practices to lower exposure risks, they may not have to wear as much protective gear the next shift.  When they don’t use the right techniques, they must wear additional gear.

 

The project has evolved over time, and McGlothlin is working with the National Science Foundation (NSF) and the Center for Pharmaceutical Processing Research (CPPR) to commercialize the technology. 

 

So far, each of the CPPR’s 36 members has access to the video exposure monitoring system, and they are sharing findings every few months. McGlothlin’s lab is also applying the technology in a wide variety of other fields and industries, to monitor other environmental factors and responses, including noise and heart rate.

-AMS 

When Will Pharma Address Operator Error and Alarm Management? Recent Merck Spill Begs the Question

Recently it was reported that Merck operators at a vaccine pilot plant in West Point, Pennsylvania released 25 gallons of untreated potassium thiocyanate directly into the local sewer system in Wissahickon Creek.  The spill killed hundreds of fish, triggered an EPA fine and launched an investigation.

But it also leads to much broader questions:

• When will the pharmaceutical industry, as a whole, analyze operator error and its root causes, in depth?
• When will drug companies implement the Poka Yoke, or error-proofing systems, routinely found in most aerospace and automotive plants? When will they truly embrace the Toyota Production System concept of Jidoka?
•   A recent Pharmaceutical Manufacturing survey showed that very few drug manufacturing plants even have a formal “alarm management” system in place right now. And, given the level of automation in place at some facilities, alarm management is a critical part of eliminating operator error.

 The chemical process industries have already conducted major investigations into operator error and its sources, following major petrochemical plant explosions. Not that this has stopped human error of course ( a recent incident at Nova underscores this point), but other industries at least appear to be giving the issue the attention it deserves.

Is pharma behind in studying operator error because such error manifests itself so quietly at drug plants— in rejected batches of product, recalls, or heavy FDA or EPA fines for noncompliance?

Should it take plant explosions to focus more attention on this subject?

Interestingly enough, within Merck’s MPS team in Arecibo, Puerto Rico, IPT leader Luis Garcia is studying Jidoka closely to determine how it might be applied to operations.  Stay tuned to our magazine and web site for more on his work, and what your peers are doing in this area, in the future.

-AMS