ML20133M681

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Informs of Visit to Mallinckrodt to Evaluate New Research & Development Facility as Described in Dec 1976 Application
ML20133M681
Person / Time
Issue date: 03/25/1977
From: Bell J
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Singer B
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20133G976 List: ... further results
References
FOIA-96-343 NUDOCS 9701230013
Download: ML20133M681 (6)


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MAR 2 51977 MEMORANDUM FOR: Bernard Singer, Chief, Radioisotopes Licensing Branch THRU: N. Bassin, Radioisotopes Licensing Branck M FROM: Jack Bell, Radioisotopes Licensing Branch ,

SUBJECT:

VISIT TO MALLINCKRODT, INC.

As requested, a visit was made to Mallinckrodt, to evaluate their new research and development facility as described in their December 1976 application, their new waste handling and reclamation facility (building 500) and their new production facility (building 600) as described in their March 16, 1976, March 29, 1976, and October 18, 1976 letters and enclosures. I was accompanied by Dr. John Cooper of Region III, I&E.

Dr. Cooper and I met with ' Donald W. Soldan of Mallinckrodt at the Maryland Heights facility on the morning of Thursday, March 24, 1977. ,

The purpose of our visit was discussed with Mr. Soldan and a tentative i schedule established for viewing the various facilities. l A tour was made of Mallinckrodt's present research and development facilities in their building 200. Although the use of radioactive ,

material seemed to be well controlled and the facility, for the most par't, appeared well kept, the facilities were obviously quite cramped and additional space seem to be sorely needed. Many of the staff were i involved in crating material for the move to the new research and l development facility on Brown Road.

A tour was then made of the Brown Road facility with its approximately i 107,000 square feet of buil "ng space for housing approximately 300 l people. The building has three floors and radioactive material will be used at certain locations on all three floors. Less than half the total floor space will be devoted to research and development involving the use of radioactive materials. The greatest amount of this floor space will be utilized for R&D on in vitro medical uses of radioisotopes and will involve relatively small individual quantities of radioisotopes (less than 1 millicurie). First occupancy is planned for April 1,1977.

9701230013 970114 PDR FOIA PDR FLOYD96-343

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l i  : Bernard Singer  !

The Brown Road facility seems to have been very carefull.y planned with respect to the safe use of radioactive materials. All surfaces are made of impervious materials or are covered with impervious materials for ease of decontamination, an adequate supply of standard laborator.y equipment of the most modern design is available and several hoods (some including both charcoal and HEPA) are available. All hoods have the capability of beinq equipped with both charcoal and HEPA filters.

The availability of protective clothing, personnel radiation surve.y

  • equipment, and vaccuum lines for monitoring of airborne concentrations

. of radioactive material seems more than adequate. The combination of l air treatment facilities and the capacity of the heating, ventilating l and air conditioning systems, when considered in association with the l relatively small amounts of volatile radioactive material to be used in the facility, makes it highly unlikely that radioactive effluents from the facility could approach 10 CFR Part 20 concentration limits.

l Two, 4,000 gallon capacity holdup tanks with remote level indicators and alarm devices are available for storage of liquid waste. The vessel vents are filtered and the exteriors of the vessels are easily accessible for detection of leaks. Any material leaking from either of the vessels would be retained in the concrete sump in which they are located.

During the afternoon of Thursday, March 24, we toured Mallinckrodt's new 64,100 square feet production facility, building 600. All proces-sing of radioactive materials (for both in vivo and in vitro products) will be performed in building 600 beginni~ng in June of this year.

Such processing is now performed in building 100. Following the move, the dispensing and packaging of in vitro products'will still be per-formed in building 100. However, the crowding now evident in building 100 will be greatly relieved by the move to building 600.

Building 600 seems to be extremely well planned with respect to the processing of radioactive materials and the production of radioactive products. Facilities involved in the various steps of production of Mallinckrodt's radioactive products seem to be arranged in a sequence and in relation to one another so as to minimize cross flow and redundancy.

A new, modular, hot cell with nine inch thick steel walls and equivalent lead glass viewing windows has been installed for use in subdividing i incoming shipments of large quantities of radioactive materials.

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Although some of the existing equipment in building 100 will be moved to building 600, most of the equipment to be utilized in building 600 will be new and designed to function within the new building.

Effluent air treatment includes activated charcoal absorbers as well l as prefilters and HEPA filters. Mallinckrodt expects that the reduction

factor for the building 600 effluent treatment system will be higher by a factor of 100 to 1,000 than the reduction factor for the present -

facili ty. Each filter combination (roughing, HEPA, charcoal) includes two air sampling lines permitting the measurement of airborne concentra-tions of radioactive materials as the air enters the filter and as the air leaves the filters so as to give a timely indication of filter failure or breakthrough. Filters are also equipped with manometers to

continuously measure filter pressure drop. Building 600 contains one

! central discharge stack for all air systems. This forty-foot high, 42 inch diameter stack has a diffuser cone mounted at its top so as to assure uniform 360' dispersion of effluents. Eight air sampling i stations are arranged at 45* intervals around the stack. Mallinckrodt has studied the relationship between air concentrations and sample i point locations and determined that the location giving maximum air concentration values is on a horizontal plane through the stack discharge point. Consequently, this is where they have located the eight samplers.

a 4 The waste handling and treatment facility, technetium generator recla-mation area and the equipment decontamination and reclamation area in

- building 500 were also toured during the afternoon. This is another fairly new facility being placed in operation approximately nine

months ago. It seems quite well planned for its purposes. Liquid waste from all of the facilities at the Maryland Heights location is I collected in three 5,000 gallon holdup tanks at the lower level of building 500. As in the new R&D facility, the holdup tanks are in a

!. concrete vault giving easy access to the exterior of these tanks and 4

allowing the early detection of any failure of tank integrity. Although not required by Commission or local regulations, Mallinckrodt has chosen to pass their liquid effluent from the holding tanks through '

charcoal filters to reduce the amount of activity in the wastes.

4 The final part of the afternoon of March 24 was spent touring the old production facilities in building 100. It is quite obvious that Mallinckrodt was in need of more floor space for their radioactive products production. Workers in the old production area were literally .

required to work " elbow to elbow." l l

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Bernard Singer i On Friday, March 25, we discussed what we had seen the day before, Mallinckrodt's production license and their procedures, especially those to be in effect at their new R&D facility. Several potential problems were pointed out and it is expected that Mallinckrodt will be revising these procedures in the not too distant future.

The visit to Mallinckrodt was interesting and informative and, I believe, 7 quite helpful to Mallinckrodt. Being accompanied by Dr. Cooper of a Region III, I&E, was a definite advantage. Dr. Cooper was very helpful in pointing out areas of interest during our tours and discussions,

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AP.R1.51977 i

Mallinckrodt, Inc. License No. 24-04206-01 i

- l Mallinckrodt/Nuc1 car

  • ATTN: Mr. John Toomey '

Director of Operations P.O. Box 10122 Lambert Field '

St. Louis, Ho 63145 -

l Gentlemen:

This letter is to solicit your cooperation in a matter that is of concern to me.

In the construction and operation of nuclear facilitics and other activi- i tics licensed by the NRC, a worker occasionally has concerns about the quality of work, radiological safety or safeguards at the facility. I l recognize that in these cases you desire that the individual first ,

approach his supervision and management. However, in our experience some individuals are hesitant or feel frustrated in such contacts.

Because of this frustration or hesitation, I believe that the Office of 1 i

Inspection and Enforcement should make known its direct accessibility to the vorher. I recently have instructed inspectors to wear, as appro- i priate, distinctive "hard hats" and identification badges so that they can be more readily identified during an inspection.

I believe it will be advantageous also to have posted a notice informing your worhers that the Regional Offices of the Office of Inspection and 1:nforec:nent will accept collect telephone calls for discussions of matters which are under Nhc jurisdiction and which are of concern to them. Pending a change in 10 CFR Part 19 (Form NRC - 3), I request your cooperation in posting copics of the enclosed notico in a sufficient munber of places so that individuals may observe a notice on their way to and from their work locations.

I know that vc share mutual interest about quality, safety and safe-guards. I hope you will aCree that these interests can best be served by nssuring that vorhers know of our interest and know of avenues for the '

cxpression of their concerns so that prompt consideration can be given tp their concerns.

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) NOTTCI: TO 1:HPl.0Yl'I:s Any nocicar industry worker who has concerns or questions about the l

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nucicar safety of any facility or activity licensed by the Nuc1 car Regulatory Commission may bring these matters to the attention of an NRC inspector or the nearest NRC Regional Of fice if they cannot bc .

resolved directly with his or her employer. The NRC will treat the .

identity of a worker as a confidential source if the worker requests [

4 that his identity not be disclosed.

In order to improve channels of communication between NRC and Nucicar industry workers, the NRC is making two procedural changes: l

1. NRC inspectors will soon he ucaring identification badnes and t in some caces, safety hats identifyinn them as NRC inspectors.

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2. NRC Renional Offices will accept collect telephone enlis from nucicar industry workers uho wish to speak with an NRC repre-sentative concerning quality of work, radiolonical safety or safenuards prohicms. The telephone number of the appropriat e ,

NRC Renional Office for thin project in 312-858-2660 These changes will be reficered in a revised NRC Form 3 posted to meet requirements of 10 CFR Part 19 and a revisiun of proposed 10 CFR Part 21 (both of'which are in preparation). Until these revisions are published, all workers at NRC-licensed facilitics or activi; tics chuuld be aware of

. thenc improved channelu of communicatlun with incpectorc.

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