Reporting on the business and technologies
driving today's global industrial gas industry

Compliance Matters
Medical Gas Update
Bob Yeoman
2009.09
For medical gas manufacturers June was a notable month. Effective June 1, 2009, new federal Food and Drug Administration (FDA) requirements for electronic registration of drug manufacturing establishments took effect. A few weeks later the US Pharmacopeia (USP) released a draft of the long awaited medical gas monographs for public comment. In this article we will examine the key elements of these new requirements industry compliance managers will face in the coming months.

FDA STRUCTURED PRODUCT LISTING REQUIREMENTS
For an agency traditionally focused on paper records, the FDA’s new requirements for electronic registration and drug listing, called Structured Product Listing (SPL), are a significant milestone on the road towards transitioning to a total electronic documentation and record keeping system. Although sending the agency an electronic vs. a paper form seems simple enough, experienced compliance managers know that when dealing with FDA requirements, the devil resides in the details. We have been working with the FDA’s new registration process for some time now and find it complex and full of subtle technical details that must be satisfied. Many of these details must be resolved in ways that are not intuitive. Firms without the support of a dedicated IT department, or at least access to someone very knowledgeable about electronic data forms and their transmission, are likely to find this new process daunting at best.

The FDA is moving to SPL for some very basic reasons. First, over the last few decades the management and storage of paper records has morphed into a resource-intensive and cumbersome process. The FDA needs significant resources and time to perform even simple data sorts to get at information they need to effectively manage the safety of the US drug supply. Theoretically, SPL puts this information at their fingertips, making it available almost instantly. The FDA also intends to make this information available to practitioners on their websites. Second, SPL is basically a computer code, not an image file like a PDF document, which makes it an ideal way to store large amounts of information for easy sorting and retrieval. Third, SPL is an open format language, and has been adopted as an ANSI standard as of March 2009. The FDA, as well as drug manufacturers, will therefore not have to pay royalty fees to one specific company to use the basic technology.

The SPL requires that you learn a new language in order to navigate around the process. This includes deciphering technical terms such as Data Universal Numbering System (DUNS) numbers, Global Unique Identifier (GUID) numbers, XHTML forms, SSL Certificates, and Secure Electronic Gateways. If you find sending and receiving emails and surfing the web difficult, these new SPL related issues will require some significant furthering of your computer technology education.

The FDA has adopted the DUNS number as the ID number for a facility. Every business facility in America, as well as throughout most of the world, has a nine digit DUNS number. These nine digits are the equivalent of a social security number for a business location. The DUNS system is administered by Dun & Bradstreet, and if you do not currently have a DUNS number, or do not know what your number is, Dun & Bradstreet will provide that for free. The catch here is that you can only make an application for one site at a time for free, and processing of free applications can take 30–45 business days. This means that if you have 10 branch locations you must file ten applications and wait one to two months. You can shorten this process by subscribing to Dun & Bradstreet’s information database service. Having and submitting a DUNS number is a mandatory requirement for the FDA’s SPL process, so there is no avoiding it.

There are spaces in the different X Forms where you are required to enter a GUID number. Fortunately, the GUID number, which is a randomly generated 128 bit hexadecimal number, is easier and cheaper to find and use. A simple Google^© web search on “GUID Number” will be direct you to various sites that will generate any GUID numbers you need. Downloadable executable file utilities on your computer also will generate GUID numbers, which you can then simply cut and paste into the forms where required. Using GUID numbers is mandatory in the SPL process.

Using the XHTML forms is another mandatory requirement. FDA has contracted with Global Submit (www.global submit.com) as the provider of the XHTML, or X Forms, that will be used in the SPL registration and listing process. These can be downloaded for free. Other companies offer their own X Forms for a fee, and these may be easier to use than the FDA’s versions. Once you have downloaded the SPL X Forms your web browser needs to be configured or modified with an add-on utility in order to read the XHTML format. Each of the three forms has numerous drop-down menus where information must be entered.

Since these forms were designed for all drug manufacturers to use, there are many items for which medical gas manufacturers will be providing information that previously the FDA had not required gas firms to submit. Rather than submitting a label to the FDA, you now have to embed a digital image of each of your labels in the X Form. For bulk product this will include a copy of your Certificate of Analysis. It is also no longer acceptable when entering package (cylinder) sizes to enter “Various sizes as ordered by Customer.” In the new SPL world each cylinder size must be entered separately on the form.

Each form must be run through a software validation process to check for missing or erroneous data. You can do this either before you send the form to the FDA using a downloadable validation package, or the FDA will run it through the validation process once you submit it, and before they publish it. If there are errors, the FDA sends the submission back to you to track down the error and re-submit. The validation software unfortunately doesn’t direct you to where the mistakes may be.

Once you have successfully navigated through the X Form entry and validation process and are ready to send the information to the FDA, you cannot simply attach these files to an email and send them to the agency. To electronically send files to them, you will have to apply for and establish an FDA Electronic Gateway Portal. This involves submitting various documents and certifications to the FDA, setting up the electronic gateway connection along with the requisite SSL certificates, and going through a test and verification process to validate the gateway connection. Also be aware that the gateway will be linked to the one specific computer in your business that was used to establish the link, and there are some specific software configuration requirements for that computer. The smartest approach is probably to use a dedicated computer for the FDA electronic gateway; otherwise you could encounter configuration issues every time you try to connect to the FDA, since most firms will probably only connect to the gateway once or twice a year.

Setting up this process, depending on your level of computer savvy, will involve some significant work and an investment of time and resources. We understand that establishing just the gateway part of the process takes roughly 10–12 work hours spread over three to four weeks. This time commitment assumes you are familiar with the process. Novices should plan on at least double that investment in time.

SPL registration and listing is something that all medical gas manufacturing firms will have to successfully accomplish over the next 6–12 months; the FDA stopped taking paper registration as of June 1, 2009. The good news is that the annual re-registration process is somewhat less painful than the initial registration, provided no changes are needed.

USP PUBLISHES NEW MEDICAL GAS MONOGRAPH DRAFTS
In June, the long anticipated, revised USP monographs were published in the Pharmacopeial Forum as draft notices for public comment. We fully expect that these will be finalized and most likely appear in the USP/NF either early next year, or by midyear 2010. Once the new monographs are published our industry will have roughly six months from that date to be in compliance.

One of the most contentious issues up to this point, the requirement to use USP Reference Standards instead of NIST traceable calibration standards to calibrate medical gas analyzers, appears for now to have been decided in line with input from CGA and other key third parties involved in the discussions, such as B&R Compliance Associates. For the time being the medical gas industry can continue to use NIST certified calibration standards to calibrate medical gas analyzers. However, there are a number of specific changes that will probably require some medical gas firms to purchase new analytical equipment.

For starters, the old burning splint test to identify oxygen and nitrogen is gone. USP saw this test as a holdover from the 1800s and has replaced it with a modern analytical method. For oxygen, the official method to perform ID (as well as assay) testing is now the paramagnetic style analyzer. The old chemical Orsat method is officially retired. The USP/NF method to identify and assay nitrogen is now the gas chromatograph (GC). Firms that fill nitrogen cylinders using a manifold with nitrogen as the only inert gas connected can still continue to use the paramagnetic method to ID and assay, provided they have a validation study for both the analyzer as well as the fill process. This fill process validation is a new twist on what most firms have been doing up to this point, and it is required to test and confirm that nitrogen is the only inert gas available on the manifold. Unfortunately, when filling nitrogen NF on a manifold with other inert gases such as helium or argon connected, you will now have to use either a GC or a set of validated engineering controls in conjunction with a paramagnetic analyzer to perform ID testing. This handful of changes likely affects the majority of medical gas manufacturers. All the other medical gas monographs except carbon dioxide were updated, and there are numerous technical changes in all of them. If you have specific questions on these monograph changes or the process validation/engineering controls issue mentioned above, give us a call and we would be glad to walk you through it.

The USP made significant additions to the medical gas monographs by adding some general chapters covering analytical equipment operation and validation. It is now mandatory to perform an Installation Qualification (IQ), an Operational Qualification (OQ), and a Performance Qualification (PQ) for both GC equipment and paramagnetic analyzers. This IOPQ is otherwise known as a validation of the analytical equipment. The USP lists a number of specific parameters to be considered during the IOQ phase of the validation, such as system suitability, leakage, sampling techniques, sample flow rates, and environmental conditions. The PQ phase involves calibrating and operating the analyzer to verify it operates as intended within the specified range. The old paramagnetic validations that many manufacturers have are no longer useful, as these typically validated that the paramagnetic analyzer was equivalent to the old Orsat method, and did not address any of the issues set out in the new USP requirements. Keep in mind that this USP validation process must now be performed for each analyzer used. You cannot perform one validation for an analyzer model, like the Servomex 570, and use it for all the analyzers at all your branches. While not an especially onerous process, these qualifications are now a requirement, and firms should expect FDA investigators to be looking for them in the future.

The good news is that the medical gas industry was quite effective in getting the USP to incorporate language on sampling processes, analyzer operation, calibration requirements, and system-setting parameters that are consistent with how manufacturers operate and maintain the equipment today. Most of this guidance in previous issues of the USP/NF had been written by scientists, and often did not reflect the reality of how things operate in the field. The USP is currently reviewing the monograph for CO₂ and is apparently seeking to harmonize the Food Codex and the Drug Monograph for this gas. Our industry will be interested in keeping the beverage grade testing requirements from bleeding into the analytical requirements for medical gases, and we will keep you posted on that process.

Based on these two issues, which will begin to have their full impact later this year and on into 2010, we expect compliance managers in the medical gases industry will have their hands full implementing all the new requirements. Over the last year to eighteen months we have seen relatively little activity with regards to new medical gas regulations, but these new requirements clearly signify that government regulators have not forgotten about the medical gas industry. New regulatory issues are beginning to appear on the horizon, and in future articles, we will keep you abreast of those issues as they develop.

Bob Yeoman is President and CEO of B&R Compliance Associates LLC (Lehigh Valley, PA), a consulting firm specializing in medical gases, safety management, and other regulatory compliance management issues relating to the compressed gas industry. He can be reached at (610) 868-7183; Email bob.yeoman@brcompliance.com

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Energy Initiatives
Carbon Recycling: An Alternative to Carbon Capture and Storage
Rowan Oloman
2009.09
Carbon capture and storage (CCS) is being hailed as the answer to the globe’s most pressing question: what to do with the 27 billion metric tons of carbon dioxide emitted yearly from the
burning of fossil fuels? Touted as the most promising interim solution to deal with the greenhouse gas responsible for global warming, CCS still remains unproven, costly, and will not be commercially available for another 10–20 years. Meanwhile scientists are exploring alternatives to CCS by capitalizing on CO₂ as a commodity instead of treating it as a waste. (See “Carbon Sequestration Primer,” CryoGas International, May 2009, pp. 32-36, for a complete discussion of CCS.)

Twenty-seven billion tons of CO₂ is already a hefty number but energy-related carbon dioxide emissions are projected to reach 43 billion metric tons per year by 2030, an increase of 60 percent. A new report by the International Energy Agency (IEA) estimates that growing energy demands from emerging giants like China and India, coupled with a lack of cost-effective alternatives to fossil fuels means that by 2050, 77 percent of the world’s power will still be derived from fossil fuels.

Carbon capture and storage, the process of capturing carbon dioxide and storing it in deep geological formations, in the ocean or as mineral carbonates, is being promoted by the IEA and others as the most promising technology to deal with fossil-fuel derived emissions. Not negating the role of alternative energies, the IEA is merely realistic about the enduring use of fossil fuels and the urgent need to deal with the resulting carbon dioxide.

In May, US Secretary of Energy Steven Chu announced at the National Coal Council that $2.4 billion from the American Recovery and Reinvestment Act will be used to expand and accelerate the commercial deployment of CCS technology, including financing to train a generation of engineers and geologists to work in the field. Chu said, “To prevent the worst effects of climate change, we must accelerate our efforts to capture and store carbon in a safe and cost-effective way.” Governments in Europe, Australia, Canada, and China are also strongly investing in the technology.

UK consulting firm McKinsey figures that adding CCS to the next generation of European power plants could lift their price by up to $1.3 US billion each. Their thorough analysis (www.mckinsey.com) shows that the typical cost of a demonstration project is likely to be in the range of US$80–120 per tonne of CO₂ sequestered. Legally, there are concerns over whether CO₂ transport and long-term storage present human- or ecosystem-related risks and who is ultimately responsible if a leak occurs. While progress is underway in some countries, no country has yet developed the comprehensive, detailed legal and regulatory framework that is necessary to effectively govern the use of CCS.

In fact, no full-scale CCS project that captures and sequesters carbon dioxide from a coal-fired power plant as of yet exists. The IEA is hopeful that 10 full-scale demonstration plants will be up and running globally by 2015 meaning it may be 10 to 20 years before CCS technology is readily available.

So why expensively transport and store the CO₂ underground when it could be profitably recycled post-capture?

Researchers and start-up companies are now investigating a wide range of CO₂ conversion methods. “The market is open for innovation,” states Larry Kristof, CEO of Mantra Energy (www.mantraenergy. com), a company gaining international recognition in the field of carbon recycling. “It is likely that governments will soon legally mandate carbon capture from industrial plants and there needs to be a cost-effective way to implement it,” says Kristof.

Mantra’s technology, named the electro-reduction of carbon dioxide (ERC), aims to take CO₂ directly from industrial waste gases and convert it to formate salts and/or formic acid, both valuable chemicals used in a variety of industrial applications. [According to Wikipedia, a significant amount of formic acid is produced as a byproduct of chemical manufacturing, but this production is insufficient to meet demand so some formic acid must be produced for its own sake. Formic acid is used as a preservative and antibacterial agent in livestock feed, to process sap into raw rubber, as a miticide for beekeepers, for the tanning of leather, in perfumes, in household limescale remover, and in laboratories as a solvent modifier when samples are being prepared for mass spectrometry analysis.]

Formic acid also has the potential to play a leading role in fuel cell development, both as a direct fuel and as a fuel storage material for on-demand release of hydrogen. The ERC technology could provide a net revenue of up to US$700 per tonne of CO₂ recycled, with an ROI previously forecast at 20 percent per year, depending on local costs. Compared with CCS, the ERC provides a positive return on investment, not an unrecoverable cost. Plus a demonstration ERC unit could be installed at a client’s premises within a year and a commercial plant within two years, much faster than for CCS.

In a speech to the US Senate, Margie Tatro, Director of Fuel and Water Systems at Sandia National Laboratories, advocated that carbon recycling is the way of the future. “We must act now to stimulate this area of research and development. Other countries are exploring reuse and recycling of CO₂ and it would be unfortunate if the US became dependent on imported technology in this critical area,” said Tatro.

Carbon recycling options being developed globally vary considerably. The range includes the biochemical conversion of CO₂ into algal biofuel, the thermochemical conversion into methanol, and the biocatalytic or solar photocatalytic conversion of CO₂ to fuels. Each has its own set of advantages and disadvantages and some are more believable than others. At this stage, what sets Mantra and a handful of others apart is that it has a publicly disclosed patent application, backed up by several technical articles in reputable journals, and has already established market interest for its products.

CCS can be an incredibly risky and in many places unworkably expensive solution. More imaginative thinking shows us that the 27 billion metric tons of CO₂ per year may actually represent a business opportunity. A budding industry, carbon recycling for profit offers an exciting and viable alternative to carbon capture and storage programs. Without a doubt, as a portfolio of solutions is developed to address climate change, carbon recycling is destined to be at the forefront.

Rowan Oloman is a freelance writer living in Vancouver, Canada. She holds a Masters degree in Environmental Management from the University of New South Wales and a BA in Environmental Geography from the University of Sydney. Rowan works as the director of several international conservation projects and as a researcher for green tech solutions.

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Saf-T-Corner
A Hard Lesson
Jim Herring
2009.09
I was recently heading out of town with my children and a niece when we stopped in Tunica, MS for gas. While we were parked at the pumps, a hearse pulled in. Seeing this, my niece asked me if there was a body in there. Using this as an opportunity to educate, I asked the driver who responded “not yet,” but that he was headed to pick one up. He said he was the Tunica County Coroner. My niece, who is 14- years old, hates to use a seat belt, so I asked him to tell her how important they are.

The coroner proceeded to tell her horror stories to drive home the point of why and how seat belts save lives. He explained that when a car traveling 60 mph stops suddenly and the occupant is not wearing a seatbelt, the occupant becomes a 60 mph projectile. That seemed to get her attention, at least for the moment.

An hour down the road, I got a call from my wife asking if our daughter had received a text with bad news. After I assured her she had not, my wife revealed one of my daughter’s classmates was killed the previous night in a freak accident. Four boys were in an open jeep driving through the lanes for tractors that surround cotton fields. Well, the boys were joy riding when they hit a rut left by one of the big tractors. The one boy not wearing a seat belt was bounced out of his seat, hit his head on the roll bar, and broke his neck. He died instantly — on the eve of his 17th birthday. The other three boys were unhurt.

I wrote this column just before going to the funeral with my 17-year-old daughter to bury another life cut short because a young man failed to wear his seat belt. I realize there are stories in which someone survived because they weren’t wearing a seatbelt, and if they had they would have surely died. That’s a lot of baloney as far as I’m concerned.

Based on the latest statistics from www.car-accidents.com, if 90 percent of Americans wear seat belts, 5500 lives will be saved, and 132,000 injuries will be prevented annually.

Seat belts keep you in the safety zone of any vehicle, including the cage of a forklift. After writing this article, I noticed several employees not wearing their seat belts as they moved steel around the plant. While you can’t watch every move your employees make, you can put notices throughout your plant or facility reminding employees about the importance of wearing seat belts. Even on the job, seatbelts save lives.

Three things determine how long you live: your genes, whether or not you smoke, and whether or not you wear a seat belt. It’s that simple. Don’t smoke. If you do, quit. Pray the genes your parents blessed you with are good ones. And wear your seat belt, even if going a short distance.

Until next month, be safe, and buckle up.

Jim Herring is Vice President of Marketing and Procurement at Saf-T-Cart in Clarksdale, Miss. He can be reached via email at jim@saftcart.com

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The Art of Selling
Searching for Fractals...
Art Waskey
2009.09
The process of landing the large account had occupied the better part of a year for our organization. It was time to celebrate a job well done!

In his congratulatory message, however, one of the principals in our business had some words of caution. “Let’s not forget the track record of this account. They do not have a history of longevity with vendors. Their pattern is to switch vendors shortly after the initial assets are installed, creating an accounts receivable nightmare. We will have to micro-manage this account, so we don’t lose it through administrative errors.”

The principal’s challenge would be answered by fractalizing the account. Fractals are used in computer modeling in which irregular or fragmented shapes can be repeatedly subdivided into parts, each of which is a smaller copy (version) of the whole.

Simplifying the challenges you face into fractals is a 5-step process:

1st Begin with the end in Mind. (Steve Covey’s Habits)
2nd First things First. (Steve Covey’s Habits)
3rd Plan your Day. “Plan your work. Then, work your plan.”

Schedule 30-minutes alone between close of business Friday and noon on Monday; lay out a plan for your next work week. Each workweek afternoon review the next day’s appointments for possible modifications. My personal checklist is:
✔ things to do
✔ people to see
✔ places to go
✔ things to discuss or delegate

Schedule personal time daily to work on goals, projects, and personal growth activities.

4th Record the Details of your Day.
Schedule 30-minutes a day to debrief your activities, process the day’s paperwork, respond to emails, file, route, or discard information. Recap the activities of the day and review tomorrow’s scheduled activities. Microsoft Outlook is an excellent software package for processing emails, setting appointments, recording contact information, and downloading content to your cell phone.

5th Manage the Details.
My preference is to create some form of manual daily journal to record thoughts and a “things to do” list. This documentation sends a subliminal message of your intent to fulfill your commitment. Review your entries and summarize activities in a “TO DO” list for the next day. Prioritize your entries and include personal requests (emails, voice-mail, or face-to-face), unfinished business, projects, and appointments.

Rather than “micro-managing” a challenging account to death, creating fractals provides a template to develop systems that track and monitor the activities of the account and protect exposed assets. In personal as well as business activities, defining life’s dilemmas in fractals whenever possible and scheduling quality time for the planning and execution of your activities is truly the celebration of success!

Art Waskey is Vice President of Sales and Marketing for General Air Services and Supply Company in Denver, CO. He can be reached at awaskey@generalair.com


 

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