ML20236Q958

QA Program for Siemens Shipping Containers for Therapy Sources

ML20236Q958
Person / Time
Site:	07100551
Issue date:	10/27/1987
From:	SIEMENS MEDICAL SYSTEMS, INC. (SUBS. OF SIEMENS CAPIT
To:
Shared Package
ML20236Q953	List: ML20236Q950 ML20236Q958
References
NUDOCS 8711200383
Download: ML20236Q958 (20)

Text

_ _ _.

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-QUALITY-ASSURANCE PROGRAM FOR SIEMENS SHIPPING. CONTAINERS FOR THERAPY SOURCES.

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SIEMENS AG MEDICAL GROUP 1.

ORGANIZATION 1.1 GENERAL L

SIEMENS AG has closed all activities in design.and.manufac-1 ture of transport containers for' cobalt and caesium sources.

I 1

The activities described here are reduced to maintenance and QA of the existing. containers for transportation' of.new and

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used sources for ' Medical Therapy equipment manufactured by SIEMENS AG.

s SIEMENS-owned containers which are 'licenced according to inter-national rules by the German authority, Physikalisch Technische Bundesanstalt Braunschweig (PTB) (Attachment 1), are Used.by-the manuf acturers.of therapy sources _( Attachment.:2). These manuf ac.

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turers are using the SIEMENS-containers to transport.the sources i

ordered by SIEMENS.They have to follow the rules.given by SIEMENS AG according Attachment 1, 3 and 4.

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Prior to shipping every user has to check the1 containers accor-according to attachment 3. He has to follow all national and in-ternational transportation regulations. The transportation of used sources from customers side back to the manuf acturer is covered by the same procedures.

i This section describes the organizational structure and functio-nel responsibilities for the Quality Assurance Program.' Persons and organizations assigned quality-related ' responsibilities have sufficient authority and organizational freedom to: id ent i f y ',

i evaluate, and recommend solutions of corrective actions; and stop unsatisfactory work and control further processing, delivery, in-sta11ation or utilization of nonconforming items until proper dispositioning has been established.

i B7112003e3 971027 7 PDR ADOCK 071005512 C PDR '

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. The program is implemented by or at the direction of SIEMENS AG. Activities such as QA-testing may be performend by contractors to SIEMENS specifications.

The organizational structure and functional responsibili-ty assignments are such that: (1) attainment of quality objectives is accomplished by individuals responsible for specifying quality or performing work to specifications l

and (2) verification of' quality requirements in Erlangen l

l West-Germany is accomplished through audits performed by i

Radiation Safety Officer of UB Med in Erlangen and the German authority PTB.

An abbreviated organization chart showing those components concerned with implementing this program is presented in attachment 5.

1.2 STAFF ORGANIZATION FUNCTIONS j

The General Manager of CT and Therapy is responsible for i

establishing the QA policies, goals, and objectives. In order to assure compliance with those policies, the Direc-tor of International Sales Therapy has been assigned to set the objectives for the QA-Program.

1.3 LINE ORGANIZATION FUNCTIONS The execution of the QA-program is seperated from the sales-group. Maintenance and revision of the containers are han-died in USA by the QA-department. Check of containers at customers side is done by Therapy Serice/ Technical Support under the supervision of the SIEMENS MEDICAL-SYSTEMS-Radia-tion Safety Officer.

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.l 2.1 ~ QUALITY ASSURANCE PROGRAM An overall:QA-Program is established and implemented which encompasses those activities which are necessary to meet-quality objectives. This program is applicable to PTBElicen-sed containers Typ "B"

used for shipping of Therapy 1 sources.

The program applies to activities affecting the components of the identified packaging to:an extent consistent with-l their importance to safety. Those activities include purcha-l sing, handling, shipping,' storing, cleaning, assembling, in-specting, testing, operating, maintaining and repairing;

_]'lu In the event differences of opinion arises between QA t person-nel and other, personnel involving quality, the issue (s) is brought to the attention of appropriate levels of management H

for solutions.

'l Training and experience qualifications are ' defined for I

each position in SIEMENS AG. In addition, the program provides for indoctrination and training-of personnel performing activities affecting quality in-order to pro -

vide assurance that appropriate' proficiency is achieved i

and maintained. This indoctrination'and training.is l

1 carried out through various documented procedures, per-sonnel contacts and meetings. The purpose of'the trai-1 ning is to assure that personnel responible for quality-related activities are instructed as.to.the purpose,.

scope, and implementation of the quality-related manuals, instructions, and procedures. Personnel performing'quall-ty-related activities are trained'and qualified in'the principles and techniques of'the activity.being performed.

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g 1-2.2 RESPONSIBILITIES OF:

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2.2.1 QA TRANSPORT-CONTAINERS q

i Incomming' Inspection:

. Inspection of returned containers J

and decision'if-repair is necessary.--In:J1. Erlangen.

1 West-Germany, 2. USA.

Maintenance and repair:.Under supervisonlof QA.

l Container Inspection:

a.).

Technical inspection of every : container pr'iorsto' re =

lease to stock and1afixing' test labels to checked!

containers, b.)

5 year's inspection according PTB-licence to' renew

.1 usage-date.

Logging: A11' tests are.to-be logged according;tofthe-Li-cence of PTB.

2.2.2 Store and Shipment: Only: tested and labeled containers 0

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l can be released for shipment to customer 1or so'urce-manu-facturers.

j 2.2.3 Therapy Sales Group:

Relations to departments:of SIEMENS,-

1 to national and international institut' ions and' authorities.

-1 Coordination.and supervision ~ of activities'related to QA-1 Program.

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1 2.2.4 Radiation Safety Officer:

Audit of QA-Program in Erlangen.

2.2.5 Therapy Service:

Inspection at' customer's side according to the check-list, and sending all QA-test reports from I

the field to QA for record keeping.

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2.2.6 Radiation Safety Officer SMS:

Audit QA-Program.in USA.

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ATTACHMENTS 1-

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i Translation from the German' language (certified)

FEDERAL PHYSICAL TECHNICAL INST'ITUTE Licence D/2001/B(U) (Revision 5)

Based on the application of Siemens AG, Erlangen', dated 5 May'1987

- file reference tw-ba - the container with the manufacturer's designation transport container S 1747 is' licensed.as package j

sample of the type B(U) for radioactive substances according to the following regulations:

Regulations for the Safe Transport of Radioactive Materials, 1973 Revised Edition (as amended) of-the International-Atomic -Energy Agency-(IAEA), 5 806.

Code on the national and international transport of' dangerous R

goods by road (Gefahrgutverordnung StraSe - GGVS) dated j

22 July 1985, (BGB1, I, page-1550, with' appendix volume'I to the BGBl.

I, No. 40 dated 30 July 1985). enclosure A, marginal number 3672.

European agreement on the international transport of dangerous goods by road (ADR agreement) of 30 September 1957, in the version.

of 22 July 1985 (BGB1, I. page 1550), enclosure A, marginal number 3672.

Law on the European Agreement dated 30 September 1957, on.

l the international transport of-dangerous goods'by road.

J (ADR), dated 18 August 1969 (BGB1. II, page 1489),

article 4, 51 No.2.

Code on the national and international transport of dangerous goods by rail (Gefahrgutverordnung Eisenbahn.

GGVE) dated l

l 22 July 1985 (BGBl.

I, page 1560, with enclosure volume II.

to the BGBl. I No. 40 dated 30 July 1985), last' changed by the 1st amendment regulation for the railway transport of dangerous j

goods of 21 August 1986 (BGBl. I page 1347), enclosure, i

marginal number 1672.

l Order for international railway transport of dangerous goods I

(RID rules) - enclosure I to appendix B of the agreement-on the international railway traffic.(C0TIF agreement) dated 9 May 1980 (BGBl. 1985 II, page 666), in the version of the.

code dated 22 July 1985 (BGBl. I, page.1560), enclosure, marginal number 1672.

Code on the transport of dangerous goods with. maritime vessels, dated 05.07.1978, enciesure to the 1st maritime dangerous goods modification' code dated 27.07.1982, class 7, section 12.1, subsection 3.

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International Maritime Dangerous Goods Code ( Class 7,12.1.3, page 7033).

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Page 2 of License No. D/2001/B(U) (Revision 5)

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Enclosure A to the code on the transport of dangerous goods on l

.the Rhine (ADNR) dated 23.11.1971 last modified by the 6th j

ADNR modification code dated 24.03.1983, Rn 6461(3).

1 Notification on the permission for conveying dangerous goods in aircraft dated 31.05.1968 L5 - 582 - 38 P/67 (Nachrichten f0r l

Luftfahrer, part 1, dated 13.06.1968, 16th volume No. 84) in connection with the Dangerous Goods Regulations of the Inter-national Air Transport Association (IATA), Section 5.7.44.

In connection with the guidelines of the Federal Minister for Transport dated 18.10.1977 (VkBl. 31. (1977) page 582).

License number of the package sample: 0/2001/B(U)

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Validity of the licence:

up to 31.07.1990 l

Permissible contents:

l 1

l Cobalt-60 and/or caesium-137 in SPECIAL FORM with a total

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activity of maximum 630 TBq (17000 C1), whereby the activity of the radiation source in the upper shaft may not exceed j

260 TBq (7000 C1) and in the lower shaft 400 T8q (110C0Ci).

i Design of the package:

According to certificate of the Federal Institute for Material Testing: 2003 B(U) dated 04.03.1977, in connection with the test certificate dated 08.10.1968 (file reference: 1.2/8879),

expert opinion dated 16.01.87 (No. 1.5/21566) and supplement to opinion of 08.07.87, design S 1747 meets the require-ments placed on type B(U) package (IAEA Regulations,

$5 228 to 241).

Description of the package:

The packing consists of an internal container with the lead shielding and a cylindrical outer container lined with wood.

The internal container has two horizontal " shafts" arranged l

above one another to hold the. heavy-metal drawers which contain the radiation sources. The remaining free space is filled with dummy drawers and suitable lead blocks according to the instructions of the manufacturer.

1 Package S 1747 has the following dimensions:

Length:

approx. 1300 mm Diameter:

approx.

730 mm Total weight: approx. 2000 kg Schematic drawing:

1799188 S 1747 of 13.10.1977

P ge 3 of License No. D/2001/B(U) (Revision 5) 1 i

'I Secondary provisions:

1.

The package must be used and maintained according to the

" Equipment plan for the shafts of the transport container type S 1747" dated 4 May 1984, and the " Check list for checking

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transport containers for radioactive therapy sources", issue

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1986 of the applicant.

2. Every user must register with the Federal Physical Technical Institute before using the package for the first time and he

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must confirm that tua has received the documents stated under 1.

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3. The packages must 'tua tested repeatedly at least at 5-year intervals eccording to the " Test instructions for transport containers type 5 1747 for transporting radioactive therapy sources", issue January 1987 of the applicant with release

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stamp BAM-1.52 dated January 1987; the test certificates must be submitted to PTB/BAM.

Notes:

1. Packages with a total activity of more than 140 TBq (3800 C1)

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may be transported orly as wagon load in rail and road traffic.

Further special measures during transport are not required.

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2. This license does not exempt the consignor from the obligation of complying with any regulations of a country through which or in which the package is transported.

3. This license invalidates license D/2001/B(U) (Revision 4).

Legal information:

An objection can be made to this ruling within one month of notification. Objection must be filed in writing or for the record at the Federal Physical Technical Institute (Physikalisch-Technische Bundesanstalt), Bundesallee 100, 3300 Braunschweig.

Braunschweig, 13 July 1987 I

By order Dr. M. Cosaci Enclosures Appendix to license Schematic drawing:

Transport container 5 1747

Appendix to License No. D/2001/B(U) (Revision 5)

Rev.No. Date of Issue Validity Pe<fod Reason for Revision 0

02.03.1978 02.03.1981 1

07.05.1979 02.03.1981 Extension to maritime traffic 2

09.02.1981 09.02.1984 Extension of validity 3

20.01.1984 20.01.1987 Extension of validity 4

16.01.1987 31.01.1990 Extension of validity and stipulations regarding-quality assurance 5

13.07.1987 31.07.1990 Change of secondary provisions Als vom PrHsidenten des Landgerichts N0rnberg-F0rth 6ffentlich bestellte und allgemein beeldigte Dolmetscherin und Obersetzerin for die englische Sprache versichere ich: vorstehende Obersetzung eines mir als Kopie vorliegenden Zulassungsscheines in deutscher Sprache ist richtig und vollstundig.

Rndh he %k Buckenhof, 5 August 1987 Roswitha Kotzurek l

I, Roswitha Kotzurek, an officially appointed and sworn trans-lator and interpreter for the English language do herewith assure that the foregoing translation of a German License, a copy of l

which was submitted, is true and correct and complete to the best of my knowledge and belief.

/2 p th N k6 Wh Buckenhof. 5 August 1987 Roswitha Kotzurek lh.

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Enclosure'to;the license':T D /2001/ B ( V ) ( Re v. 5 )(.-

Transport container Package complete

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Base Transport container 5 1747/.....

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Manufacturer: Siemens AG, Erlangen Drawing'No. 1799188 5 1747-Older drawing ~No. S.ht.47a License;No. D/2001/B(U)

Packing: type B Contents: radio' active' material in special form Radionuclides:'Co-60 and Cs-137 Maximum permissible total activity:-_17000 Cl Total weiglit: approx. 2000 kp-l z__

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i ATTACHMENT 2 Co-60 SOURCE SUPPLY COMPANIES FOR SIEMENS-0WNED CONTAINERS l

General Electric Company Vallecitos Nuclear Center Vallecitos Road Pleasanton/ Calif.

94566 USA i

Atomic Energy of Canada Ltd.

Commercial Products P.O. Ecx 6200 Postal Staticr 3K2A 3VV3 Ottawa / Canada l

l Kraftwerkunion SeligenstEdter StraGe

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8757 Karlstein West-Germany l

l Amersham International plc Isotope Production Unit Harwell, Didcot, Oxfordshire Encland

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• -d ATTACHMENT 3 CHECK L 1 S T-PAGE for shipping containers 1

for radioactive therapy sources Each shipping container of type 17.99 188 S 1747 is marked-with a Serial Number on labels fitted to the fire-protection hood and to the inner container. This check list should.be used to make sure that the container is shipped in perfect condition. The Item Numbers of the check list refer to the parts illustrated on page 4.

Regular maintenance of each shipping container is mandatory. Shipment of therapy radiation sources is permitted only if the date of the next mandatory maintenance has not been exceeded. For authorized shipping containers, this date is indicated on the Identification Label at the fire-protection hood.

1.

Fire protection hood:

Part No. 17 99 204 5 1747 Keep free of dirt. Check for damage.

2.

Identification Label on fire-protection hood:

1 Identif. Label Part No. 17 99 469 S 1747 Contents: Authorization Number D/2001/B(U),

Serial No. and Date of next mandatory maintenance Identif. Label Part No. 17 81 079 S 1747 Contents: Weight of shipping container These labels should be properly affixed and entirely legible.

3. Inner wooden lining of fire-protection hood:

The wooden parts must be properly fitted and no part should be missing.

4.

Screw connection of fire-protection hood to' bottom:

12 special screws Part No. 17 99 246 S 1747 12 fan washers of Quality A16.5 DIN 6798-St 6980 These screws and washers must be greased and undamaged and none of them should be missing.

5. Bottom:

Part No. 17 99 212 S 1747 Keep free of dirt. Check for damage, especially the wooden lining.

6. Base:

Part No. 20.90 942 S 1747 Check for damage which may affect the stability.

Check attachment of base to bottom.

Bereicn Medizinische Technik Sienmens AG

.The check list' comprises 4 sheets issue 1986

i CHECX L I'S T PAGE for shipping containers f.or radioactive therapy sources 2

I Part No. 17 99 378 5'1747

7. Sealing ring:

The sealing ring should be. undamaged and properly situated in the groove so that it still protrudes over the flange surface.

8. Insulating boards:

Part No. 17 91 056 5 1747

'The height of the board package should be 120 mm,-

but not less than 110 mm.

9. Screw connection between base and bottom:

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4 screws of quality M16 x 120 DIN 931-8.8 6603 l

4 fan washers of. quality A 16.5 DIN 6798-St 6980 1

These screws must be greased, undamaged and none of

.i them should be missing.

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10. Inner container.:

Part No. 17 99.196 5 1747' i

Keep free of dirt. Check for damage.

11. ' Identification Label on inner container:

Identif. Label Part No. 1019 SRN 825 Contents: Serial No.

1 The Serial No. of the inner container must coincide with the Serial No. of the fire-protection hood. The label.

l should be safely affixed and properly legible.

12. Cover for source-drawer channels:

2 covers Part No. 17 99 634 5 1747 l

Keep free of dirt. Check for damage.

13. Cover sealing:

2 Klingerit gaskets Part No. 17 99 683 5 1747 The Klingerit gaskets should be affixed to the covers with adhesive. Check for damage.

14. Cover screws:

24 screws Part No. 35 39 129 5 1747 I

of quality M 20 x 40 OIN 6912.8.8 None of these screws must be missing.

They should be undamaged and greased.

1

15. The channel symbols I and.II and the two red marking lines on the wooden lining of the bottom and on the inner container should be legible.

16. Condition of source-drawer channels:

The channels I and 11 must not be deformed. When in-serting the source drawers, care is required, especially when using remote-control instruments, inLorder.to avoid damage of.the channels. The channels should be kept.

free of ridges, dust and grease.

Bereich Medizinische Technik ShuseAG The check list comprises 4 sheets issue 1986

s CHECK LIST PAGE for shipping containers for radioactive therapy sources 3

17. Condition of centering flanges:

The surface of the centering flanges should be smooth because the Gammatron head has to be fastened here in an exactly defined geometric position for reloading.

The' recesses on the centering flanges should be free of ridges and undamaged.

18. Seal to prevent unauthorized opening of the. shipping container:

Prior to shipping a therapy radiation source, a seal or a padlock should be attached to this eyebolt.

The shipping container with Serial No. S 1747 /

has been checked in accordance with this list and is reac, for shipment. Any objections have to be reported prior to shipment to Siemens AG, HenkestraBe 127 in D.8520 Erlangen, FRG, Dept. TDV 1.

The two channels were loaded according to shipment mode No.

of the equipment plan for the shipping container of type S1747, version of 4 May 1984 The non-adhesive outer contamination amounts to less than 3.7 Bq per square centimetre.

Place, date and signature and stamp or name of sender Bereich Medizinische Technik Siemens AG The check list comprises 4 sheets issue 1986

1 CHECK LI5T.

PAGE for' shipping containers for radioactive therapy sources 4

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. ATTACHMENT'4

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EQ-UIPMENT PLAN SHEET-for the channels of transport container Type S 1747 1

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For the forwarding of therapy radiation sources in transport

-i container type S 1747, the two channels must be. filled up completely with shielding material to prevent any unpermis'-'

sibly high local dose values at the surface of the transport container.

1 Forwarding of radioactive therapy radiation sources is only' permitted if both channels 'have been equipped according:to l

one of the following modes of dispatch' 2 to 16., Mode of dis-patch 1 is envisaged for the dispatch of empty transport

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containers.

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Radiation direction of the sources Y

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sereicn uomsniseno Tec.nnik L

Siemens' AG The equipment ~ plan comprisesI4 sheets 4 May 1984 i

EQU IPMENT PL AN

$HEET' for the channels of transport container i

Type S 1747 2

Radiation direction of the sources V

Channel Loading a

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42 81 119 51601 17 99 253 5 1747 Bereich Med!!!nische Tecnnik Siemens AG The equipment plan comprises: 4 sheets 4 May 1984

m EQUIPMENT PL AN SHEET for the channels of transport container l

Type S 1747 3

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-17 99 261 51747 Befeich Medl2inlSche Technik Siemens AG The eauicment plan comprises 4 sheets 4 May 1984

1 EQUIPMENT PLAN SHEET for the channels of transport container Type S 1747 4

l Radiation direction of the sources V

Mode of dispatch Channel Loading 1799 261 S T147 1799279 5 1747 o

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