radiopharmaceutical transport packaging · radiopharmaceutical transport packaging . description...

Type A for Solids & Liquids

External Dimensions 320 mm x 220 mm x 180 mm

Gross Weight (without contents) 2.2 kg

Maximum Weight of contents 10.7 kg

Qualified for a wide range of product vials (see certificate)

Design No: GP 3708B

www.onet-technologies-uk.com

Radiopharmaceutical Transport Packaging

Description

Packaging design no. GP 3708B is a small hand portable aluminium con-tainer with a dense foam insert, designed to hold up to 8 CDCs or W4 lead pots* allowing transportation of patient doses of radiopharmaceuticals. * Lead pots and CDCs not included

The 3708B is lightweight, easy to store, load and transport.

Manufactured and sold under licence from AEA Technology Plc


ONET Technologies UK Ltd William Kelvin Building Claylands Road Bishops Waltham Southampton Hampshire SO32 1BH Tel: +44 (0) 1489 896010/897300 Fax: +44 (0) 1489 894382 email: [email protected]

For further information contact:

IW7018/GP3708B/CoA001 Page 1 of 11 Issue: 10 Amendment 0

VALID UNTIL 01/07/2013

THIS DOCUMENT SUPERSEDES ALL PREVIOUS ISSUES

CERTIFICATE OF APPROVAL OF

PACKAGE DESIGN NUMBER GP3708B

FOR THE CARRIAGE OF

RADIOACTIVE MATERIAL



Amendment Record

Page Numbers Amendment No 1 2 3 4 5 6 7 8 9 10 11

Authorised Date

0 X X X X X X X X X X X

On subsequent updating of the procedure, the amended page will be identified by an X on the above amendment record.

Issue Record

Document Issue Notes Authorised Date

Issue 1 Issued G. Holden 29/06/00

Issue 2 Re issued to embody wider range of vials/pots G. Holden 27/3/02

Issue 3 Re-issued to incorporate Statutory Instrument 2002 No 1093

G. Holden 23/07/02

Issue 4 Re-issued to incorporate smaller pot diameters & update Codes of Practice

G. Holden 23/03/04

Issue 5 Re-issued to update Quality Assurance G. Holden 17/03/05

Issue 6 Re-issued to update References. G. Holden 28/11/05

Issue 7 Incorporation of TS-R-1 2005 Edition D Windley 17/10/07

Issue 8 Addition of Sealed sources (See C3137) G Holden 21/01/08

Issue 9 Updated to clarify expiry date, include latest regulations and re-issue of Operating and Maintenance Instructions

D Windley 31/01/10

Issue 10 Incorporation of TS-R-1 2009 Edition D Windley 03/06/11



CONTENTS SECTION DESCRIPTION PAGE AMENDMENT RECORD.....................................................................................2 ISSUE RECORD .................................................................................................2 CONTENTS.........................................................................................................3 REFERENCES ....................................................................................................4 1. CERTIFICATE .....................................................................................................5 2. REGULATIONS AND CODES OF PRACTICE ...................................................6 3. SPECIFICATION OF PACKAGING.....................................................................7 4. DESIGN SAFETY REPORT................................................................................7 5. PERMITTED CONTENTS ...................................................................................7 6. RESTRICTIONS ON CONTENTS.......................................................................8 7. RADIATION LIMITS.............................................................................................8 8. QUALITY ASSURANCE......................................................................................8 9. OPERATIONAL CONTROLS..............................................................................9 10. PRE-SHIPMENT REQUIREMENTS....................................................................9 11. MAINTENANCE...................................................................................................9 12. CONTAMINATION...............................................................................................9 13. EMERGENCY RESPONSE.................................................................................9 14. PACKAGE ILLUSTRATION...............................................................................10 APPENDIX 1 LIST OF VIALS..................................................................................................11



REFERENCES 1. IAEA Safety Standards, Safety Requirements No. TS-R-1, Regulations for the Safe Transport of

Radioactive Material, 2009 Edition. 2. Design Safety Report for Package Design No. GP3708B. Onet Technologies UK Ltd. Reference: IW7018/GP3708B/DSR001 Issue 4. 3. Operating and Maintenance Instructions for Package Design No. GP3708B Onet Technologies UK Ltd. Reference: IW7018/GP3708B/OPINS Issue 7. 4 BS 5288:1976 Specification Sealed Radioactive Sources



Certificate of Approval of Package Design for the Carriage of Radioactive Material

Package Design No. GP3708B

1. This is to certify that the Approval Authority has assessed the packaging and contents, as

described under Sections 3 and 5 of this document, as complying with the relevant requirements of the International Atomic Energy Agency Regulations for the Safe Transport of Radioactive Material, TS-R-1 (reference 1). By virtue of compliance with the IAEA Regulations, this package also meets the requirements of the National and International Regulations stated in Section 2 of this document.

Approved Type: Type A (solids and liquids) Approved Modes of Transport: All Road Only when carrying Options 2 and 7. This Certificate is valid until: 1st July 2013 It is the responsibility of the consignor to ensure that packaging conforms fully to the

requirements of the design specification detailed in Section 3, that the contents are as specified in Section 5, and that the operational, pre-shipment and maintenance requirements specified under Sections 9, 10 and 11 are met.

In the event of any variation in the composition of the package, the packaging design or in any

of the facts stated in the Design Safety Report for the package, this certificate will cease to be valid, unless the Approval Authority is notified and confirms the validity of the certificate, having taken account of any such variations.

This certificate does not relieve the consignor from compliance with any requirement of the

government of any country through or into which the package will be transported. Signed..................................................................................... Date: 3rd June 2011

D Windley Signed..................................................................................... Date: 3rd June 2011

G V Holden On behalf of the Approval Authority:

Onet Technologies UK Ltd (Gravatom) William Kelvin Building Claylands Road Bishops Waltham Hampshire England SO32 1BH Telephone: 01489 897300

Fax: 01489 894382 Any questions relating to this Certificate should be addressed to the Approval Authority.



2. REGULATIONS AND CODES OF PRACTICE GOVERNING THE TRANSPORT OF RADIOACTIVE MATERIALS INTERNATIONAL International Atomic Energy Agency (IAEA) TS-R-1, Regulations for the Safe Transport of Radioactive Material 2009 Edition International Maritime Organisation (IMO) International Maritime Dangerous Goods (IMDG) Code, 2010 Edition (Amdt. 35) International Civil Aviation Organisation (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air. 2011 Edition International Air Transport Association (IATA) IATA Dangerous Goods Regulations 2011 52nd Edition United Nations Economic Commission for Europe (UNECE) European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR). 2011 Edition Intergovernmental Organisation for International Carriage by Rail (OTIF) Convention concerning International Carriage by Rail (COTIF) Appendix B: Uniform Rules Concerning the Contract of International Carriage of Goods by Rail (CIM) Annex 1 Appendix C: Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID). 2011 Edition. UNITED KINGDOM ROAD AND RAIL GREAT BRITAIN The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009, Statutory Instrument 2009 No. 1348. SEA British registered ships. All other ships whilst in United Kingdom Territorial waters. The Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations 1997, SI 1997 No. 2367 Merchant Shipping Notice No. MSN 1820(M), "The Carriage of Dangerous Goods and Marine Pollutants in Packaged Form – Amendment 34-08 to the International Maritime Dangerous Goods (IMDG) Code". AIR The Air Navigation Order 2005, SI 2005 No. 1970 The Air Navigation (Dangerous Goods) Regulations 2002, SI 2002 No. 2786. The Air Navigation (Dangerous Goods) (Amendment) Regulations 2008 SI 2008 No 1943 The United Kingdom regulations do not in all cases extend to Northern Ireland.



3. SPECIFICATION OF PACKAGING Specification: The packaging is specified by Drawing No 1 IW7018/01, Issues B, C, D, E or F General

Arrangement, Reusable Transport Case, Design No. GP3708B. The inner shielding and containment is one of the following options:

(1) W1, W2 or W3 lead pot or CDC container with a P6 or Schott 10R glass vial or those listed in Appendix 1.

(2) GW3 Lead pot with a solid resin type dose calibration source comprising a 25ml

polyethylene vial. *See note below. (3) Stainless Steel holder and Am-241 Special Form Sealed Source (additional 1mm

thick lead shielding may be used). (4) Elution Vial Lead Pot containing Amersham 29mm diameter × 86mm × 1mm wall

Elution Vial. (5) IBS600P containers, 38mm and 50mm diameter. (6) 30mm or 35mm Lead Pots may be used with appropriately sized additional Plastazote

packaging, and assuming that the maximum gross weight is not exceeded. (7) Sealed source classification C64444 in W1, W2 or W3 lead pot or CDC container. #

See note below

* The 25ml polyethylene vial provides the containment, however the 25ml polyethylene vial is not capable of withstanding the pressure differential applicable to air transport without leakage and is therefore limited to carriage by road. The Special form sealed source may be considered to be a component of the containment system.

# The C64444 designation (reference 4) demonstrates that the source will withstand a drop in ambient pressure to 25kPa and is therefore limited to carriage by road

Description: See Section 14 for package illustration. Package Design No. GP3708B comprises an aluminium case fitted with a hinged lid secured using two toggle latches. The two halves of the case are lined with closed cell expanded polyethylene (CCEP) foam and absorbent material is incorporated.

4. DESIGN SAFETY REPORT The evidence against which the package design has been assessed as complying with the

requirements of the IAEA Regulations (reference 1) is contained in the Design Safety Report for Package Design No. GP3708B (reference 2). The packaging has been justified in accordance with the requirements of the IAEA Regulations (reference 1) for a Type A package.

5. PERMITTED CONTENTS

Various radionuclides as solid or liquids as given in the IAEA Regulations (reference 1), Table 2, subject to the restrictions in Section 6.



6. RESTRICTIONS ON CONTENTS The quantity and activity of radioactive material may be up to the Type A limits as specified in

paragraph 428 of the IAEA Regulations (reference 1). Mixtures of radionuclides shall be limited to the equivalent A2 value determined in accordance with paragraph 429 of the IAEA Regulations (reference 1).

Gaseous contents are not permitted to be transported in the package.

Fissile material is limited to the fissile excepted package quantities as defined in paragraph 417 of the IAEA Regulations (reference 1).

The materials mixed together as payload must be chemically compatible with each other and no

payload may be chemically aggressive to the materials of construction of the package. Materials having other hazardous characteristics such as flammability, pyrophoricity, chemical

toxicity and corrosiveness, must not be carried. The user must ensure that daughter products do not create any additional hazards. When carrying liquids, the total contents of the receptacle must not exceed 80% of the

maximum capacity of the receptacle leaving ullage space to accommodate variations in temperature, dynamic effects and filling dynamics.

Lead pots and CDCs used for shielding vials must have their joint circumference taped with 1¼

turns of radioactive warning tape. 7. RADIATION LIMITS The contents must be limited such that the following radiation limits are not exceeded during

transport:- Non-exclusive Use

(i) 2 mSv/h at any point on the external surface of the package. (ii) 0.1 mSv/h at any point 1 metre from the external surface of the package. (iii) 0.1 mSv/h at 2 metre from the external surface of the conveyance. Exclusive Use Limit (i) 10 mSv/h at any point on the external surface of the package. (ii) 2 mSv/h at any point on the external surfaces of the vehicle. (iii) 0.1 mSv/h at 2 metre from the external surface of the conveyance.

8. QUALITY ASSURANCE The package design has been tested and safety documentation prepared by Gravatom

Engineering Systems Ltd, within a Quality Assurance System in accordance with BS EN ISO 9001:1994 Quality Systems: Model for Quality Assurance in Design, Development, Production, Installation and Servicing or BS EN ISO 9001:2000 or 2008 Quality Management Systems - Requirements.

The manufacture or refurbishment, loading, handling, inspection, transport and in-transit storage

must be carried out under a Quality Assurance programme to ensure compliance with the requirements of this Certificate of Approval, and the National and International Regulations.



9. OPERATIONAL CONTROLS Operation of the package shall be in accordance with the Operating and Maintenance

Instructions for Package Design No. GP3708B (reference 3). The package must be restrained during transport in an effective manner with due regard to the

transport employed. Consignors are required to complete and include with the transport documents, for each

consignment, a consignor’s (Shipper’s) Certificate (or equivalent). 10. PRE-SHIPMENT REQUIREMENTS The pre-shipment requirements are specified in the Operating and Maintenance Instructions for

Package Design No. GP3708B (reference 3). The consignor shall ensure that the person responsible for packing/unpacking of this package

has copies of the Operating and Maintenance Instructions. 11. MAINTENANCE The turn-round inspection procedure and periodic maintenance requirements are specified in the

Operating and Maintenance Instructions for Package Design No. GP3708B (reference 3). 12. CONTAMINATION Non-fixed contamination on the external surfaces of the package; and on the internal and

external surfaces of freight containers, overpacks or vehicles used for transporting packages shall be kept as low as practicable and shall not exceed the limits specified below:

a) Beta emitters, gamma emitters and low toxicity alpha emitters: 4 Bq/cm² b) Alpha emitters other than those of low toxicity: 0.4 Bq/cm²

13. EMERGENCY RESPONSE The consignor must ensure that the carrier is provided with emergency instructions appropriate

to the package. The consignor must ensure that appropriate documented emergency arrangements are in place

in the event of a radiological emergency.



14. PACKAGE ILLUSTRATION

Overall Dimensions: 308mm x 206mm x 166mm deep Mass of packaging (empty): 2.4 kg (nominal) Maximum gross mass of package: 11.4 kg

Typical Pots

Typical Vial

Foam Packing

Aluminium Case



APPENDIX 1 LIST OF VIALS Vial Size mm Dia x Height

Wall Thickness

mm

Compound Manufacturer Manufacturer Ref

25.5 x 57 1.2 Nanocis B CIS DS/01 1051.A

Nanocis A CIS DS/01 1051.A

Cholecis CIS DS/01-1054.A

Pulmosis CIS DS/01-1046.A

22 x 57 1 Amerscan (Hepatate) Nycomed Amersham V/418 002

Ceretec Nycomed Amersham V/4037/96/2

Myoview Nycomed Amersham V/4183/01

Amerscan (Medronate II)

Nycomed Amersham V/4008/98/03

Amerscan (Pentetate II)

Nycomed Amersham V/4009/01

Stannous Medronate - -

22 x 55 1 Nanacoll Nycomed Amersham M0350555 120A

22 x 56 1 Technescan (HDP) Mallinckrodt N4-10360D

Technescan (DTPA) Mallinckrodt N4-10374D

Technescan MAG3 Mallinckrodt N4-10574D

24 x 52 1 Amerscan (DMSA) Nycomed Amersham V/4174 01/03

Amerscan (DMSA) Nycomed Amersham V/4174 01/03

24 x 38 1 Cardiolite Du Pont HA2/5 310-4

29 x 86 1 Elution Vial Amertec II Amersham -

GP3708B/OPINS Sheet 1 of 11

Issue 7 Amendment 0

THIS DOCUMENT SUPERSEDES ALL PREVIOUS ISSUES

OPERATING AND MAINTENANCE INSTRUCTIONS

FOR PACKAGE DESIGN GP3708B

Prepared By: Date: 3rd June 2011 D WINDLEY CEng MNucI Onet Technologies UK Ltd. Approved By: Date: 3rd June 2011 G HOLDEN CEng MNucI Onet Technologies UK Ltd.

© Copyright The information contained herein is the property of Onet Technologies UK Ltd. and may not be copied used or divulged in whole or in part except with prior written permission of the company, or if it has been furnished under a contract with another party as expressly authorised under that contract.


Issue 7 Amendment 0

AMENDMENT NUMBER Sheet Number

0 1 2 3 4 5 6 7 8 9

1 2 3 4 5 6 7 8 9 10 11

X X X X X X X X X X X

On subsequent updating of the procedure, the amended page will be identified by an X on the above amendment record. The amended text will be identified by a | in the margin.

ISSUE RECORD

Document Issue

Notes

Issue 1 February 2000

Issue 2 April 2002

Issue 3 March 2004

Issue 4 Reviewed and updated. August 2007

Issue 5 Option 7 payload added January 2008

Issue 6 Paragraph 2.2.1 amended to allow extended life Padlock requirement clarified

Issue 7 Re-issued in Onet Technologies format. June 2011


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CONTENTS

SECTION DESCRIPTION PAGE

FRONT SHEET ....................................................................................... 1

AMENDMENT RECORD ......................................................................... 2

ISSUE RECORD ..................................................................................... 2

CONTENTS............................................................................................. 3

1 GENERAL DESCRIPTION ...................................................................... 4

2 MAINTENANCE....................................................................................... 4

2.1 Maintenance Frequency ............................................................... 4

2.2 Maintenance Instructions.............................................................. 5

2.3 Completing Action ........................................................................ 5

3 OPERATING INSTRUCTIONS................................................................ 5

3.1 Turn Round Inspection Procedure................................................ 5

3.2 Packing Instructions ..................................................................... 6

3.3 Unpacking Instructions ................................................................. 7

3.4 Handling and Tie-down................................................................. 8

APPENDIX 1 SAMPLE VIALS....................................................................................... 9

APPENDIX 2 OPENING AND CLOSING TOGGLE LATCHES ....................................10

FIGURE 1 ILLUSTRATION OF PACKAGE DESIGN NO. GP3708B .........................11


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1. GENERAL DESCRIPTION 1.1 Package Design No. GP3708B is used for the road, rail, sea and air transport of solid and

liquid material up to Type A limits as specified in IAEA Safety Requirements No. TS-R-1.

The package comprises an aluminium alloy deep drawn case with a hinged lid. The two halves of the case are lined with closed cell expanded polyethylene (CCEP) foam and absorbent material is incorporated. The payload can be held in one of the following options:

Option (1) W1, W2 or W3 lead pot or CDC container with a P6 or Schott

10R glass vial or one of those listed in Appendix I.

Option (2) GW3 Lead pot with a solid resin type dose calibration source comprising a 25ml polyethylene vial. *See note below.

Option (3) Stainless Steel holder and Am-241 Special Form Sealed Source (additional

1mm thick lead shielding may be used). Option (4) Elution Vial Lead Pot containing Amersham 29mm diameter × 86mm × 1mm

wall Elution Vial. Option (5) IBS600P containers, 38mm and 50mm diameter, containing a capsule. Option (6) 30mm or 35mm Lead Pots may be used with appropriately sized additional

Plastazote packaging, provided that the maximum gross weight is not exceeded.

Option (7) Sealed source classification C64444 in W1, W2 or W3 lead pot or CDC

container. # See note below.

* The 25ml polyethylene vial provides the containment, however the 25ml polyethylene vial

is not capable of withstanding the pressure differential applicable to air transport without leakage and is therefore limited to carriage by road. The Special form sealed source may be considered to be a component of the containment system.

# The C64444 designation (reference 29) demonstrates that the source will withstand a drop in ambient pressure to 25kPa and is therefore limited to carriage by road.

Closure of the case is effected by two toggle latches. One shall be fitted with a padlock and

the other secured with a wire seal or pin. The overall dimensions of the packaging are 308mm x 206mm x 166mm high. The maximum permissible gross weight is 11.4kg. Refer to Gravatom Drawing No. IW7018/01, General Arrangement, Reusable Transport Case,

Design No. GP3708B for details of the package. THIS IS A REUSABLE PACKAGE. 2. MAINTENANCE 2.1 Maintenance Frequency The maintenance frequency for this package is 12 CALENDAR MONTHS or at any time within

this period should the package be found to be damaged.


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2.2 Maintenance Instructions Ensure that the Packaging has Health Physics clearance prior to starting any work. If in doubt,

do not proceed. When opening lids and removing embedded seals, etc. radioactive material may be released. Call for Health Physics advice BEFORE the removal of such items.

2.2.1 Check the date of manufacture of the outer case. If the case is found to be over 10 years old it

should normally be discarded. If it is considered suitable for further use the complete package should be returned to Onet Technologies UK Ltd. for inspection. The package will then be subject to further inspection by Onet Technologies UK Ltd. at 30 month intervals.

2.2.2 Release the toggle latches on the case in accordance with the instructions in Appendix 2.

Open the lid, lift out the foam packing block if present, then lift out the payload container(s). 2.2.3 Remove the lids of each container and retain for refitting. 2.2.4 Clean all items if necessary. 2.2.5 Examine all items (including those retained for refitting) of the assembly for damage which is

likely to impair the safety or effectiveness of the package, i.e. dents, distortion of the lid flanges or slackness/wear in catches or hinges. Minor dents and scratches on the case are acceptable but there must be no penetration of the case.

2.2.6 Ensure that there is no excessive crushing to any of the CCEP packing used in the assembly. 2.2.7 Check the integral rubber seal around the top of the case body for signs of wear or damage. 2.2.8 Check that all required labels and markings are present, secure and legible. 2.2.9 After inspection and any resultant renovations or replacements have been carried out, re-

assemble the packaging in accordance with the drawing. During this operation, Inspection and Health Physics staff should be available to provide certification of the completed assembly.

2.2.10 Record the date of when the next maintenance is due. 2.3. Completing Action 2.3.1 Details of maintenance work carried out including tests, defects and repairs are to be logged

by the maintenance department and retained. 3. OPERATING INSTRUCTIONS 3.1 Turn Round Inspection Procedure 3.1.1 This procedure must be followed in all cases for discharged packaging before it is re-packed

for another journey. 3.1.2 If the proposed journey can be completed before the next maintenance inspection is due, then

proceed to follow the Turn Round Procedure as from section 3.1.4 If the proposed journey cannot be completed before the next maintenance inspection is due or

if the maintenance inspection is already due, then the journey cannot take place. 3.1.3 Inspection and Maintenance will be carried out by arrangement with the appropriate

maintenance department who will arrange for inspection certification and where appropriate Health Physics certification of the case and its associated items.

3.1.4 The packaging must not be accepted unless it has a valid Health Physics certificate.


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3.1.5 Examine all parts for visible signs of wear and/or damage, security of fixing, ease of working

and cleanliness. All protective finishes shall be full and complete. All sealing devices shall be in sound condition. All markings and labels shall be fully legible and securely attached.

3.1.6 If the condition of any item or its marking is in doubt it should be inspected and repaired or

replaced if necessary. 3.1.7 Packages with unsound packaging must not be offered for transport. 3.2 Packing Instructions NOTE: Proceed in accordance with Local Standing Instructions. 3.2.1 Ensure that the payload complies with Type A Package activity limits in accordance with IAEA

Safety Requirements No. TS-R-1 paragraph 428. 3.2.2 When carrying liquids, the total contents of the receptacle must not exceed 80% of the

maximum capacity of the receptacle leaving ullage space to accommodate variations in temperature, dynamic effects and filling dynamics.

3.2.3 Refer to section 6 of the Certificate of Approval for details of Restrictions on Contents. 3.2.4 Unfasten the two toggle latches on the case in accordance with the instructions in Appendix 2

and open the lid. 3.2.5 Lift out the foam packing block if present, then lift out the relevant payload containers and

remove any residual radioactive warning tape and their lids; retain lids for refitting. 3.2.6 For Option (1): Position a loaded P6 or Schott 10R glass vial, or one of those listed in

Appendix 1, into the cavity in the W1,W2, W3 lead pot or CDC container.

For Option (2): Position a solid resin dose calibration source in the GW3 lead pot. For Option (3): Position a Sealed Special form Am-241 source in the stainless steel source

holder. For Option (4): Position an Amersham Elution Vial (29mm dia x 86mm x 1mm wall) in the

Elution Vial Lead Pot. For Option (5): Position the loaded capsule into the IBS600P container (38mm or 50mm). For Option (6): Use additional appropriately sized Plastazote packaging around each pot,

including below the base should the pocket be too deep for the pot being used, prior to assembly of the loaded pots.

For Option (7): Position the source into the cavity in the W1,W2, W3 lead pot or CDC. Use

additional appropriately sized Plastazote packaging around each pot, including below the base should the pocket be too deep for the pot being used, prior to assembly of the loaded pots.

Replace the lids onto the payload containers.

For the W1,W2, W3 lead pot, small diameter pot, CDC container, Elution Vial Lead Pot and GW3 lead pots apply 1 1/4 turns of radioactive warning tape around the circumference of the lid to body joint to ensure the lid is held in position.


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3.2.7 Place the loaded payload containers into the aluminium case. Place the foam packing block in

position if required. Close the lid and carefully fasten the two toggle latches in accordance with the instructions in Appendix 2.

3.2.8 Fit a padlock to the appropriate toggle latch. Apply a suitable wire security seal or pin through

the other latch. 3.2.9 Transportation may not normally take place if the dose rates exceed 2 mSv/hr at any point on

or 0.1 mSv/hr at 1m from the external surface of Package Design No. GP3708B. Should these radiation levels be exceeded then consideration may be given to transporting the

package under ‘Exclusive Use’ conditions, with the exclusive use package and conveyance radiation level limits applying. Seek advice from the DGSA (Dangerous Goods Safety Adviser) or equivalent responsible person.

3.2.10 Transportation may not take place if contamination levels on the external surface of the

package exceed 4 Bq/cm2 for beta and gamma emitters and low toxicity alpha emitters or 0.4 Bq/cm2 for all other alpha emitters. These limits are applicable when averaged over any area of 300 cm2 of any part of the surface.

3.2.11 Affix a “UN2915 Radioactive Material, Type A Package” label, to the outer case. 3.2.12 Each package must be legibly and durably marked on the outside of the packaging with an

identification of either the consignor or consignee, or both. 3.2.13 Affix two labels conforming with the appropriate model (Category I-WHITE, Category II-

YELLOW or Category III-YELLOW), to opposite sides of the package ensuring that the labels do not cover any other markings on the package. Each label shall be completed with details of the contents, activity and transport index (no transport index entry is required for Category I-WHITE labels).

3.2.14 Notify the consignee and gain agreement for shipment. 3.2.15 Despatch to consignee complete with appropriate transport documentation. 3.3. Unpacking Instructions Warning When opening lids and removing embedded seals, take care that any trapped activity is not

released. Call for Health Physics advice BEFORE the removal of such items. NOTE: Proceed in accordance with Local Standing Instructions. The package should not be accepted

without the appropriate certification. 3.3.1 Ensure the security seal or pin is intact and the padlock secure. 3.3.2 If the seal/pin and padlock are intact and secure proceed as from 3.3.3. Should the seal/pin or

padlock be broken or show signs of having been tampered with, quarantine the package, inform the consignor and await instructions before proceeding further.

3.3.3 Remove the security seal or pin from the toggle latch. Remove the padlock from the other

toggle latch and retain for re-fitting. 3.3.4 Release the toggle latches in accordance with the instructions in Appendix 2 and open the

case lid. Lift out the foam packing block if present, then lift out the lead pots, CDC pots, source holders or IBS600P containers.

3.3.5 Remove the radioactive warning tape where applied and the lids of the containers.


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3.3.6 Lift out the inner vial, or capsule in the case of the IBS600P, or sources. 3.3.7 Transfer the payload and any internal packing into their appropriate receptacles. 3.3.8 Check internal and external surfaces of the lead pot or container and case for contamination

which may indicate leakage from the receptacle. Contamination level should not exceed 4.0 Bq/cm2 for Beta/Gamma emitters or 0.4 Bq/cm2 for Alpha emitters. If levels are exceeded further tests and decontamination may be necessary. Seek Health Physics advice before proceeding.

3.3.9 Re-assemble the packaging, remove or cover any labels relating to the radioactive contents

and remove the complete packaging assembly to a controlled storage area (or return to user) together with the relevant Health Physics and Inspection certificates, as appropriate.

3.4 Handling and Tie-down 3.4.1 A handle is fitted to the aluminium case to enable lifting. The maximum weight of the package

is 11.4kg. 3.4.2 No dedicated tie-down system is provided for locating the package during transport and no tie

down attachment points are fitted to the package. The package must be restrained during transport. Table IV.1, in Appendix IV of the Advisory Material for the IAEA Regulations, suggests recommended values of acceleration to be applied to the package for the various modes of transport. The restraint method will vary with the type of conveyance used for transporting the package but the use of cargo netting, webbing straps or ropes and sheeting would be appropriate.


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APPENDIX 1 SAMPLE VIALS Vial Size mm Dia x Height

Wall Thickness

mm

Compound Manufacturer Manufacturer Ref

25.5 x 57 1.2 Nanocis B CIS DS/01 1051.A

Nanocis A CIS DS/01 1051.A

Cholecis CIS DS/01-1054.A

Pulmosis CIS DS/01-1046.A

22 x 57 1 Amerscan (Hepatate) Nycomed Amersham V/418 002

Ceretec Nycomed Amersham V/4037/96/2

Myoview Nycomed Amersham V/4183/01

Amerscan (Medronate II)

Nycomed Amersham V/4008/98/03

Amerscan (Pentetate II)

Nycomed Amersham V/4009/01

Stannous Medronate - -

22 x 55 1 Nanacoll Nycomed Amersham M0350555 120A

22 x 56 1 Technescan (HDP) Mallinckrodt N4-10360D

Technescan (DTPA) Mallinckrodt N4-10374D

Technescan MAG3 Mallinckrodt N4-10574D

24 x 52 1 Amerscan (DMSA) Nycomed Amersham V/4174 01/03

Amerscan (DMSA) Nycomed Amersham V/4174 01/03

24 x 38 1 Cardiolite Du Pont HA2/5 310-4

29 x 86 1 Elution Vial Amertec II Amersham -


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APPENDIX 2 OPENING AND CLOSING TOGGLE LATCHES 1. Releasing the Toggle Latches Place the thumb onto the face of the latch with the index finger under the latch tail. Carefully

ease the latch tail forward and use the thumb to regulate the release. Continue until the latch is completely released. If it is preferred to allow the latch to spring open ensure that the thumb and fingers are well clear of the opening latch. This latter method is not recommended.

Once released the latch can be unhooked from the lid. See Figures 1, 2 and 3.

Figure 1 Figure 2 Figure 3 2. Closing the Toggle Latches It is recommended that the latches are closed using the thumb, keeping fingers clear of the

latch. Ideally, the closing action should be one continuous motion, the force being applied from the front in a downward and rearward action until completely closed. See Figures 4 and 5.

Figure 4 Figure 5


Issue 7 Amendment 0

Figure 1: Illustration of Package Design No. GP3708B

Typical Pots

Typical Vial

Foam Packing

Aluminium Case

GP

37

08

B

Type A for Solids & Liquids

External Dimensions 320 mm x 220 mm x 180 mm

Gross Weight (without contents) 2.2 kg

Maximum Weight of contents 10.7 kg

Qualified for a wide range of product vials (see certificate)

Design No: GP 3708B


Radiopharmaceutical Transport Packaging

Description

Packaging design no. GP 3708B is a small hand portable aluminium contain-

er with a dense foam insert, designed to hold up to 8 CDCs or W4 lead pots*

allowing transportation of patient doses of radiopharmaceuticals.

* Lead pots and CDCs not included

The 3708B is lightweight, easy to store, load and transport.

Manufactured and sold under licence from AEA Technology Plc

GP

37

08

B


ONET Technologies UK Ltd William Kelvin Building Claylands Road Bishops Waltham Southampton Hampshire SO32 1BH Tel: +44 (0) 1489 896010/897300 Fax: +44 (0) 1489 894382 email: [email protected]

For further information contact:

radiopharmaceutical transport packaging · radiopharmaceutical transport packaging . description...

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