Inside Izotop, The Reactor Accused Of The Europe Iodine Leak

The following is a publicly available document of a corporate tour of the Izotop reactor facility in Budapest Hungary. We have reproduced it here for ease of viewing. It gives a bit of insight into the facility the IAEA says “probably” caused the iodine leak over Europe.

On 10 September 2004, I spent a day-long visit to the Institute of Isotopes (“Izotop”) in Budapest, Hungary.

The Institute was founded in 1959 as an academic branch of the Hungarian Academy of Sciences.  In 1993, after the Soviet occupation of Hungary was no longer a concern, the Institute organized itself as a for-profit venture.  It still, however, maintains close academic ties; the Hungarian Academy of Sciences is a major shareholder of the organization.

I was met at the hotel by Erzsébet Faigl-Birkás, who is in charge of importation and is also the head of the Synthesis Group.  Anna Hever-Szabo, my usual contact, had taken ill and was unable to join us.  It was a little surprising to be taken then by taxi cab to the Institute.  Apparently not many people own personal vehicles; most ride public transit to work.

I inquired about other customers of the Institute, and was told that one of the major companies is Amersham, Inc.  Apparently when they begin a synthesis project, they purchase starting materials and/or intermediates from Izotop.

when we arrived, I asked if it would be permissible to take photographs of specific areas or features.  Permission was granted, which itself was curious because the facility is under extremely close security.  Before entering I was obliged to deliver my passport to a very large and very scary gentleman at the gate house.  It soon became clear why this precaution was warranted:

There is a functional nuclear reactor on the site.

The business offices of the Institute resemble a Russian missile silo (and perhaps was):

I was introduced to Judit Szende, Director of Sales and Purchasing.  We discussed the logistical challenges involved in splitting payment among multiple laboratories and especially among multiple nationalities.  She suggested — and I wish to support her suggestion — that payments be made in their entirety from a single source, and that we ourselves can decide who pays what portion after the fact.

Next I met Mr. András Alexin:

Mr. Alexin is a chemist who specializes in radiochemical organic synthesis.  He is the same chemist who is preparing our current batch of radiolabeled beta-cypermethrin.

It was only natural that my first question to him would be an inquiry as to the status of the current synthesis.  I reminded him that it was crucial that our beta-cypermethrin be delivered into our hands by September 22, and whereas I understand, as a chemist myself, the unpredictable nature of radiosynthesis, it would cause a pronounced hardship to our company should there be any delays.

He said, “Come with me.”

This is our material.  The current step that is being performed in this image is the conversion to cypermethrin.  It needs only to be epimerized to beta-cypermethrin, then purified and analyzed.  Mr. Alexin is confident that it should be ready for shipment by 17 September.  Note the appropriate matting and secondary containment.

I was then given a tour of the laboratory, during which I was permitted to take pictures and to speak with the staff members.  I made the following observations:

 

1)         The laboratory is ISO9001 certified and GMP compliant.

2)         All of their chemists are college graduates, some with advanced degrees, and have extensive experience with radiochemicals.  Mr. Alexin has had 10 years of experience, and another chemist that I met has 30 years of experience.

3)         All of the staff members, to the best of my knowledge, obtained their education in Hungary during the Communist regime.

4)         While care is taken to minimize contamination of work spaces, safety glasses are not routinely worn.  I was also surprised to see a technician loading a scintillation counter with ungloved hands.  I did not feel it appropriate at the time to attempt a random survey of surfaces with a GM counter despite my curiosity.

5)         Radioanalytical instrumentation is limited to HPLC/RAM and radio-TLC.  Other analysis is contracted out as needed.

6)         The reagent cabinets contained large quantities of extremely old chemicals, some of which date to the Soviet era.

 

 

Conclusions:

1)         My assessment of the staff is that they are primarily competent radiochemists with sufficient experience and expertise in radiochemical preparation.  My personal assessment based on candid conversation and observation is that they enjoy their work and are proud of the results they produce.

 

2)         The limited analytical facilities are a minor cause for concern.  Care should be taken in future contracts to specify additional analyses that are warranted so that arrangements may be made for them in advance.

 

3)         Izotop has numerous customers who place repeated orders with them, including some large US companies.  I believe that the service deficiencies that Cerexagri has seen are probably unfortunate anomalies:

 

a)         The erroneous delivery of unlabeled material in December of 2003 is attributed to human error brought about by excessive rushing to produce product by the deadline imposed by Cerexagri..  I was told, and believe it  to be true, that the chemists worked through the night to finish the  preparation and were thus more susceptible to error.

 

b)         There is no explanation at this time for the inability of both Izotop and a local academic laboratory to reproduce Cerexagri’s HPLC results for  DCTO.  The inability of Izotop chemists to detect the desired product  resulted in a long delay in its delivery.

 

4)         The age of both equipment and reagents, while notable, is not likely to produce an  adverse effect on the success of synthetic procedures.

 

5)         The capabilities of Izotop to perform literature searches were not investigated;  however, due to concerns regarding the validity of research conducted under the  Communist regime, Cerexagri should consider providing full synthetic schema to Izotop prior to accepting a quotation.

 

6)         Shipping arrangements are a concern, since there is a very limited number of carriers willing to transport radioactive material from Hungary (FedEx, for  example, will not do so).  I intend to make a specific inquiry to Barthco.

 

My overall conclusion is that Izotop is capable of providing satisfactory radiochemicals for Cerexagri, although caution should be observed when asking them to produce material on an accelerated schedule.  Analytical data required and minimum specifications therefore should be stated in the contract.  I recommend allowing a minimum time frame of twelve weeks from initiation of the request to absolute due date.  I further recommend that a mechanism be established for the immediate payment of the required deposit (usually 40% of the total cost), as well as timely payment of the final sum, from a single payment source, not from multiple sources as in the past.

 

Addenda:

 Much of the expense associated with radiochemical synthesis is the production of labeled precursor molecules.  This image illustrates the complexity of such production.  The apparatus pictured is exclusively for the preparation of 14C-labeled benzene.

The well-manicured flowers and arboreal setting were very different from the stark and Stalinesque concrete desert that I had imagined would greet me.

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