Information Notice 1995-07, Radiopharmaceutical Vial Breakage During Preparation

Radiopharmaceutical Vial Breakage During Preparation

ML031060371
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	01/27/1995
From:	Paperiello C NRC/NMSS/IMNS
To:
References
IN-95-007, NUDOCS 9501230260
Download: ML031060371 (9)

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UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.L. 20555 January 27, 1995 NRC INFORMATION NOTICE NO. 95-07: RADIOPHARMACEUTICAL VIAL

BREAKAGE DURING PREPARATION

Addressees

All U.S. Nuclear Regulatory Commission medical licensees authorized to use

byproduct material for diagnostic procedures.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) Is issuing this information

notice to alert addressees to a potential problem that can occur when heating

radiopharmaceuticals.

Although the incidents we describe involve the preparation and subsequent

cracking of CardioliteD (Kit for the Preparation of Technetium-99m (Tc-99m)

Sestamibi) vials, the potential for cracking and significant contamination

exists whenever vials containing radioactive material are heated.

It is expected that recipients will review this information for applicability

to their operation and consider action, as appropriate. However, information

contained in this notice does not constitute new NRC requirements; therefore, no specific action nor written response is required.

Description of Circumstances

NRC was recently notified of 20 separate incidents in which a CardioliteD vial

had cracked during the heating process. The events occurred between

November 3 and January 11, 1995, and included vials from three lots: 3593M,

3594K, and 3595M. Eighteen of the vials that fractured came from lot No.

3594K (Kit lot 3594MK).

Contamination occurred when the contents of the cracked vial either leaked

into the boiling water or came in contact with the hot heating block. In each

case, the Tc-99m labeled Cardiolite* became airborne as steam. The level of

radioactive contamination at each of the facilities varied depending on the

activity in the vial, the preparation site, and emergency procedures employed.

9501230260 4RAQ g 4cF o+,-c, W007 N 17

6Trademark of The DuPont Merck Pharmaceutical Company,

331 Treble Cove Rd., N. Billerica, MA 01862, Telephone: (508) 667-9531 on6

IN 95-07 January 27, 1995 The maximum personnel exposure reported, a total effective dose equivalent

(TEDE) of 80 millirem, occurred at a facility that prepared the Cardiolitee on

an open bench, rather than in a fume hood.

In a letter to Cardioliteb customers dated December 15, 1994, the Dupont Merck

Pharmaceutical Company offered to replace any unused vials of CardioliteO lot

No. 3594N with vials from another lot.

Discussion

Two different methods were used to heat the Cardiolite* vials. The

manufacturer's recommended method involved immersion of the vial in a boiling

water bath for a specified time. The other method involved the use of a

cheating block' (i.e., a block of heated lead containing wells into which the

vial is placed and heated). Although the manufacturer has stated that it

believes that the breakage may be related to the combined effects of low

incidents of vial abrasion and a particularly stressful means of heating, it

has not been unequivocally verified that these are the causes of the vials'

cracking. Additionally, the volume of liquid within the 5 milliliter (ml)

vials varied from less than the 3 ml maximum recommended by the manufacturer

to 4.6 ml. However, it should be noted that each of the affected licensees

had prepared many other Cardiolite* vials in the same way, using the same

heating process and vial volume, with no problems. Therefore, the root cause

for the vial breakage remains unknown. However, the manufacturer plans to

continue its investigation which may lead to further information in the

future.

In the cases described above, the licensees responded promptly, and thereby

avoided overexposing personnel and spreading contamination. Licensees who

prepare radiopharmaceuticals that may volatilize (e.g., such as by heating)

should be aware of the possibility of vials cracking or breaking.

Consequently, licensees are reminded of the importance of having emergency

procedures to respond to unforeseen exposure events, and to ensure that all

supervised individuals are trained in the procedures. Licensees may wish to

review their procedures to ensure that they Include controls and actions to

address unexpected airborne activity when radiopharmaceuticals are heated.

IN 95-07 January 27, 1995 This information notice requires no specific action nor written response. If

you have questions about the Information in this notice, please contact the

technical contact listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Hedical Nuclear Safety

Office of Nuclear Haterial Safety

and Safeguards

Technical contact: Sally L. Merchant, NMSS

(301) 415-7874 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

. . I

K> Attachment 1 IN 95-07 January 27, 1995 Page I of I

LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-01 DOT Safety Advisory: 01/04/95 All U.S. Nuclear Regulatory

High Pressure Aluminum Commission licensees.

Seamless and Aluminum

Composite Hoop-Wrapped

Cylinders

94-89 Equipment Failures at 12/28/94 All U.S. Nuclear Regulatory

Irradiator Facilities Commission irradiator

licensees.

89-25, Unauthorized Transfer of 12/07/94 All fuel cycle and material

Rev. 1 Ownership or Control of licensees.

Licensed Activities

94-81 Accuracy of Bioassay 11/25/94 All U.S. Nuclear Regulatory

and Environmental Commission licensees.

Sampling Results

93-60, Reporting Fuel Cycle 10/20/94 All 10 CFR Part 70

Supp. 1 and Materials Events to fuel cycle licensees.

the NRC Operations Center

94-74 Facility Management 10/13/94 All U.S. Nuclear Regulatory

Responsibilities for Commission Medical

Purchased or Contracted Licensees.

Services for Radiation

Therapy Programs

94-73 Clarification of Critical- 10/12/94 All fuel fabrication

ity Reporting Criteria facilities.

94-70 Issues Associated with Use 09/29/94 All U.S. Nuclear Regulatory

of Strontium-89 and Other Commission Medical

Beta Emitting Radiopharma- Licensees.

ceuticals

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Attachment 2 IN 95-07 January 27, 1995 LIST OF RECEKTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-06 Potential Blockage of 01/25/95 All holders of OLs or CPs

Safety-Related Strainers for nuclear power reactors.

by Material Brought Inside

Containment

95-05 Undervoltage Protection 01/20/95 All holders of Construction

Relay Settings Out of Permits for nuclear power

Tolerance Due to Test reactors.

Equipment Harmonics

95-04 Excessive Cooldown and 01/19/95 All holders of OLs or CPs

Depressurization of the for nuclear power reactors.

Reactor Coolant System

Following a Loss of

Offsite Power

95-03 Loss of Reactor Coolant 01/18/95 All holders of Ols or CPs

Inventory and Potential for nuclear power reactors.

Loss of Emergency Mitiga- tion Functions While in

a Shutdown Condition

95-02 Problems with General 01/17/95 All holders of OLs or CPs

Electric CR2940 Contact for nuclear power reactors.

Blocks in Medium-Voltage

Circuit Breakers

95-01 DOT Safety Advisory: 01/04/95 All U.S. Nuclear Regulatory

High Pressure Aluminum Commission licensees.

Seamless and Aluminum

Composite Hoop-Wrapped

Cylinders

94-90 Transient Resulting in a 12/30/94 All holders of OLs or CPs

Reactor Trip and Multiple for nuclear power reactors.

Safety Injection System

Actuations at Salem

94-89 Equipment Failures at 12/28/94 All U.S. Nuclear Regulatory

Irradiator Facilities Commission irradiator

licensees.

OL - Operating License

CP - Construction Permit

IN 95- K>J January , 1995 This information notice requires no specific action nor written response. If

you have questions about the information in this notice, please contact the

technical contact listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Sally L. Merchant, NMSS

(301) 415-7874 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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1_2 V January , 1995 Contamination occurred when the contents of the cracked vial either leaked

into the boiling water or came in contact with the hot heating'block. In each

case, the Tc-99m labeled Cardiolitec became airborne as steam.. The level of

radioactive contamination, at each of the facilities, varied depending on the

activity in the vial, the preparation site, and emergency'procedures employed.

The maximum personnel exposure reported, a total effec~tive dose equivalent

(TEDE) of 80 millirem, occurred at a facility that prepared the Cardiolites on

an open bench, rather than in a fume hood.

Discussion:

In the cases described above, the licensees fesponded promptly, and thereby

avoided overexposing personnel and spreading contamination. Licensees who

prepare radiopharmaceuticals that may vol'atilize (e.g., such as by heating)

should be aware of the possibility of vials cracking or breaking.

Consequently, licensees are reminded,f the importance of developing an

adequate emergency plan to respond,6o unforeseen exposure events and to ensure

that all supervised individuals have received instruction in the plan.

This information notice requir!es no specific action nor written response. If

you have questions about the'information in this notice, please contact the

technical contact listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

/f Office of Nuclear Material Safety

// and Safeguards

Technical contact: Sally L. Merchant, NMSS

(301) 415-7874 Att4,hments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently IssuedNHRC Information Notices

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IN 95- K> KJ January , 1995 this level of filling of the vials because each of the affected licensees had

prepared many other Cardiolitee vials in the same way and the vials have a

5 ml capacity. Therefore, the root cause for the vial breakage remains

unknown. However, the manufacturer plans to continue their invest+gation

which may lead to further information in the future. I?

Contamination occurred when the contents of the cracked vi 1' either leaked

into the boiling water or came in contact with the hot he ting block. In each

case, the Tc-99m labeled Cardiolites became airborne a ~steam. The level of

radioactive contamination, at each of the facilities varied depending on the

activity in the vial, the preparation site, and emergency procedures employed.

The maximum personnel exposure reported, a totalj,4ffective dose equivalent

(TEDE) of 80 millirem, occurred at a facility Athat prepared the Cardiolites on

an open bench, rather than in a fume hood. /

Discussion:

In the cases described above, the licensees responded promptly, and thereby

avoided overexposing personnel and spreading contamination. Licensees who

prepare radiopharmaceuticals that/iay volatilize (e.g., such as by heating)

should be aware of the possibility of vials cracking or breaking.

Consequently, licensees are reminded of the importance of having emergency

procedures to respond to unfpfeseen exposure events, and to ensure that all

supervised individuals are/trained in the procedures. Licensees may wish to

review their procedures Gd ensure that they include controls and actions to

address unexpected airbdrne activity when radiopharmaceuticals are heated.

This information not ce requires no specific action nor written response. If

you have question;Aabout the information in this notice, please contact the

technical contact listed below or the appropriate regional office.

/ Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Sally L. Merchant, NMSS

(301) 415-7874 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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<January , 1995 this level of filling of the vials because each of the affected license had

prepared many other CardioliteG vials in the same way and the vials We a

5 ml capacity. Therefore, the root cause for the vial breakag e fins

unknown. However, the manufacturer plans to continue their inv igation

which may lead to further information in the future.

Contamination occurred when the contents of the cracked al either leaked

into the boiling water or came in contact with the hot eating block. In each

case, the Tc-99m labeled CardioliteS became airborne s steam. The level of

radioactive contamination, at each of the faciliti , varied depending on the

activity in the vial, the preparation site, and ergency procedures employed.

The maximum personnel exposure reported, a to effective dose equivalent

(TEDE) of 80 millirem, occurred at a facili that prepared the Cardiolite 0 on

an open bench, rather than in a fume hood

Discussion:

In the cases described above, the icensees responded promptly, and thereby

avoided overexposing personnel spreading contamination. Licensees who

prepare radiopharmaceuticals t t may volatilize (e.g., such as by heating)

should be aware of the possi lity of vials cracking or breaking.

Consequently, licensees ar reminded of the importance of developing an

adequate emergency plan respond to unforeseen exposure events and to ensure

that all supervised in viduals have received instruction in the plan.

This information np ice requires no specific action nor written response. If

you have questions about the information in this notice, please contact the

technical contac6t listed below or the appropriate regional office.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Sally L. Merchant, NMSS

(301) 415-7874 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

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