Design No: GP 3400C · The Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations...

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Design No: GP 3400C ONET TECHNOLOGIES UK William Kelvin Building, Claylands Road, Bishops Waltham, Hampshire, England, SO32 1BH Phone: +44 (0)1489 897300 Email: [email protected] www.onet-technologies-uk.com PROJECT N° PS GP34ooC Packaging Design No. GP 3400C is a hand held portable aluminium container with a dense foam insert, designed to hold an aluminium containment system with integral lead shield (if required), allowing transportation of patient doses of radiopharmaceuticals in syringes or vials. The GP 3400C is lightweight, easy to store, load and transport. Type A for Solids & Liquids External Dimensions 461 mm x 347 mm x 206 mm Gross Weight (without contents) 6.8 kg Maximum Weight of contents & shielding 4.2 kg

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Transcript of Design No: GP 3400C · The Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations...

  • Design No: GP 3400C

    ONET TECHNOLOGIES UKWilliam Kelvin Building, Claylands Road, Bishops Waltham, Hampshire, England, SO32 1BHPhone: +44 (0)1489 897300Email: [email protected] www.onet-technologies-uk.com

    PRO

    JEC

    T N°

    PS G

    P34o

    oC

    Packaging Design No. GP 3400C is a hand held portablealuminium container with a dense foam insert, designed to holdan aluminium containment system with integral lead shield (ifrequired), allowing transportation of patient doses ofradiopharmaceuticals in syringes or vials.

    The GP 3400C is lightweight, easy to store, load and transport.

    Type A for Solids & Liquids External Dimensions 461 mm x 347 mm x 206 mmGross Weight (without contents) 6.8 kgMaximum Weight of contents & shielding 4.2 kg

    mailto:[email protected]�http://www.gravatom.com/�

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    THIS DOCUMENT SUPERSEDES ALL PREVIOUS ISSUES

    CERTIFICATE OF APPROVAL OF

    PACKAGE DESIGN NUMBER GP3400C

    FOR THE CARRIAGE OF

    RADIOACTIVE MATERIAL

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    Amendment Record

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

    Authorised Date

    0 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 incorporate Statutory Instrument 2002 No 1093

    G. Holden 23/07/02

    Issue 3 5mm shielding option added Label plate option added

    G Holden 27/03/03

    Issue 3 Amndt 1

    Xe133 added in excepted quantities G Holden 09/06/03

    Issue 4 Gaseous contents added G Holden 19/3/04

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

    Issue 6 Incorporation of TS-R-1 2003 Edition G. Holden 17/01/06

    Issue 7 Incorporation of TS-R-1 2005 Edition D Windley 31/10/07

    Issue 8 Updated to clarify expiry date, include latest regulations and re-issue of Operating and Maintenance Instructions

    D Windley 31/01/10

    Issue 9 Incorporation of TS-R-1 2009 Edition UN No. 3373 BIOLOGICAL SUBSTANCE added Limits on gases introduced

    D Windley 03/06/11

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    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

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    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. GP3400C. Onet Technologies UK Ltd. Reference: IW7019/GP3400C/DSR001 Issue 3. 3. Operating and Maintenance Instructions for Package Design No. GP3400C Onet Technologies UK Ltd. Reference: IW7019, GP3400C/OPINS Issue 8. 4. Design Safety Report for Package Design Nos. GP3400C and GP3500 for the Transport of

    UN No. 3373 BIOLOGICAL SUBSTANCE. Onet Technologies UK Ltd. Reference: C3507_GP3500_DSR002 Issue 1.

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

    Package Design Number GP3400C

    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, liquids and gases) Approved Modes of Transport: Solid/liquid: Road, rail, sea, air and inland waterway Gas: Road, rail, sea and inland waterway

    This Certificate is valid until: 1st July 2013 Package Design Number GP3400C may be used as an Excepted Package if appropriately labelled in accordance with the Operating Instructions (reference 3)

    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.

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    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.

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    3. SPECIFICATION OF PACKAGING Specification: The packaging is specified by Drawing No 1 IW7019/01, Issues B, C, D or E, General

    Arrangement for Type A Package Design No. GP3400C. Identification:

    COMPONENT TITLE DRAWING No.

    Packaging Assembly Packaging Design No. GP3400C IW7019/01

    Outer Case Transport Case IW7019/01/1

    Containment Canister Assembly C2285/01

    Shielding (optional) Lead Liner C2285/01/003 or C2285/01/005 and C2285/01/004

    Description:

    See Section 14 for package illustration. Package Design No. GP3400C utilises an aluminium case fitted with two toggle latches and a foam lining. The foam lining is shaped to fit an aluminium containment system. The aluminium containment system has provision for a 3.6mm or 5mm thick lead liner which itself may be fitted with foam furniture, to support syringes or vials.

    The outer aluminium case may be fitted with two optional Zintec Label Plates for the attachment of magnetic labels.

    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. GP3400C (reference 2). The packaging has been justified in accordance with the requirements of the IAEA Regulations (reference 1) for a Type A package.

    Package Design No. GP3400C has also been justified for the transport of UN No. 3373

    BIOLOGICAL SUBSTANCE (liquid). The assessment is contained in Onet Technologies UK Design Safety Report for Package Design Nos. GP3400C and GP3500 for the Transport of UN No. 3373 BIOLOGICAL SUBSTANCE (reference 4).

    5. PERMITTED CONTENTS

    Various radionuclides as solid, liquids or gases as given in the IAEA Regulations (reference 1), Table 2, subject to the restrictions in Section 6. UN No. 3373 BIOLOGICAL SUBSTANCE (liquid).

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    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).

    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 (syringe, vial, etc.) must not exceed

    80% of the maximum capacity of the receptacle leaving ullage space to accommodate variations in temperature, dynamic effects and filling dynamics.

    Gases shall only be carried in sealed receptacles. The quantity shall be limited such that if all

    the gas should escape from the receptacle into the containment, the pressure within the containment would not exceed 0.5 bar g.

    The package may be used to transport Xe133 in quantities up to Excepted limits in gas tight

    syringes. 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.

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

    Instructions for Package Design No. GP3400C (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). When liquids are carried sufficient absorbent material to absorb twice the liquid contents must be

    placed within the containment. UN No. 3373 BIOLOGICAL SUBSTANCE (liquid) must be carried in syringes packed in

    accordance with the Operating and Maintenance Instructions (reference 3). 10. PRE-SHIPMENT REQUIREMENTS The pre-shipment requirements are specified in the Operating and Maintenance Instructions for

    Package Design No. GP3400C (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. GP3400C (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.

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    14. PACKAGE ILLUSTRATION

    Overall Dimensions: 461mm x 347 mm x 206mm deep Mass of packaging (empty): 11.4 kg (nominal) (with 5mm lead shielding) Maximum gross mass of package: 12.4 kg

    Aluminium Case

    Foam Packing

    Aluminium Container

    Typical Receptacles

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    THIS DOCUMENT SUPERSEDES ALL PREVIOUS ISSUES

    OPERATING AND MAINTENANCE INSTRUCTIONS FOR

    PACKAGE DESIGN NUMBER GP3400C

    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.

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    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 March 2003 – Use as Excepted Package

    Issue 3 Latch details added, note added about Xe133 syringe security

    Issue 4 Gaseous contents added

    Issue 5 Reviewed and updated. July 2007

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

    Issue 7 Re-issued in Onet Technologies format. Revised to include the transport of UN No. 3373 BIOLOGICAL SUBSTANCE. New section 3.5 added. Previous section 3.5 re-numbered. March 2011.

    Issue 8 Minor administrative updates. June 2011.

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    CONTENTS

    SECTION DESCRIPTION PAGE

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

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

    REVISIONS RECORD............................................................................. 2

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

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

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

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

    2.2 Maintenance Instructions................................................................ 4

    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 Packing Instructions – Use as an Excepted Package ..................... 8

    3.5 Packing Instructions – UN No. 3373 BIOLOGICAL SUBSTANCE.. 9

    3.6 Handling and Tie-down................................................................... 9

    APPENDIX 1 OPENING AND CLOSING TOGGLE LATCHES ....................................10

    FIGURE 1 ILLUSTRATION OF PACKAGE DESIGN NO. GP3400C .........................11

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    1. GENERAL DESCRIPTION 1.1 Package Design No. GP3400C is used for the road, rail, sea and air transport of solid, liquid

    and gaseous material up to Type A limits as specified in IAEA Safety Requirements No. TS-R-1. Package Design No. GP3400C may be used as an Excepted Package when appropriately labelled. Refer to section 3.4.

    The package comprises an aluminium alloy deep drawn case with a hinged lid that can be

    fitted with two optional label plates. The two halves of the case are lined with closed cell expanded polyethylene (CCEP) foam that supports an aluminium containment. The aluminium containment may be fitted with an optional 3.6mm or 5mm thick lead liner. The payload may comprise various receptacles, surrounded by a liquid absorber (when liquids are carried), capable of absorbing twice the volume of the contents.

    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 461mm x 347mm x 206mm high. The maximum permissible gross weight is 12.4kg. Refer to Gravatom Drawing No. IW7019/01, General Arrangement, Reusable Transport Case,

    Design No. GP3400C 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. 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 1.

    Open the lid, then lift out the aluminium containment. 2.2.3 Unscrew the four swing bolts and remove the lid of the containment. Retain for refitting. 2.2.4 Clean all items if necessary. Do not use abrasive materials when cleaning sealing faces or ‘O’

    ring seating surfaces. 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 latches or hinges. Minor dents and scratches on the case are acceptable but there must be no penetration of the case.

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    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 Carefully remove the ‘O’ ring from the lid and wipe clean to remove traces of grease. If the ‘O’

    ring has not been replaced within the last five years then it should be disposed of and a new ‘O’ ring fitted. If the ‘O’ ring is less than five years old it can be re-used if in satisfactory condition.

    Visually inspect the ‘O’ ring for any of the following defects:-

    i) Permanent distortion, mechanical damage (e.g. cuts, tearing or pinch marks), flats or

    other similar defects. ii) Tackiness or noticeable surface softening or hardening. iii) Cracks appearing when the surface is flexed. If any defects are found, replace the ‘O’ ring.

    Prior to re-assembly apply Dow Corning or equivalent high vacuum grease sparingly to the ‘O’ ring and wipe with a lint free cloth to remove surplus.

    2.2.9 Carefully examine the ‘O’ ring seating and the body sealing face. There should be no damage to these surfaces as even minor scratches can result in leakage from the container. If in any doubt the container should be leak tested or the item replaced.

    2.2.10 Check that all required labels and markings are present, secure and legible. 2.2.11 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.

    2.2.12 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.

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    3.1.4 The packaging must not be accepted unless it has a valid Health Physics certificate. 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 (syringe, vial, etc.) 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 1

    and open the lid. 3.2.5 Lift out the aluminium containment, unscrew the four swing bolts and remove its lid. Retain for

    refitting. 3.2.6 Position the payload into the cavity of the aluminium containment with sufficient absorber to

    absorb twice the liquid contents (if liquids are being carried). For sources in steel or lead receptacles cushion the receptacles by filling the gap between the receptacle and the containment with 45kg/m3 density Closed Cell Expanded Polyethylene (CCEP) foam (trade name Plastazote®). The radial and axial gap after cushioning should be minimised as far as possible. Replace the lid of the aluminium containment, and tightly secure with the four swing bolts. The bolts should be manually tightened – tools such as a mole wrench should not be used.

    3.2.7 Place the loaded aluminium containment into its recess in the aluminium case foam. Close the

    lid and fasten the two toggle latches in accordance with the instructions in Appendix 1. 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. GP3400C. 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.

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    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, trapped activity may be released. Call for

    Health Physics advice BEFORE the removal of such items. Take particular care when the package is carrying gaseous contents which may have escaped into the containment.

    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 1 and open the

    case lid, then lift out the aluminium containment. 3.3.5 Unscrew the four swing bolts, remove the lid of the containment and check that the payload is

    intact. 3.3.6 Lift out the payload and any CCEP foam or absorber. 3.3.7 Transfer the payload and any internal packing into their appropriate receptacles. 3.3.8 Check internal and external surfaces of the containment system 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.

    3.3.10 When carrying UN No. 3373 BIOLOGICAL SUBSTANCE, If any substance has leaked and

    has been spilled in a vehicle or container, it may not be reused until after it has been thoroughly cleaned and, if necessary, disinfected or decontaminated. Any other goods and articles carried in the same vehicle or container shall be examined for possible contamination.

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    3.4. Packing Instructions – Use as an Excepted Package NOTE: Proceed in accordance with Local Standing Instructions, pay particular attention when

    transporting Xe133 that the syringe hubs are properly sealed and are secure. 3.4.1 Ensure that the payload complies with Excepted Package activity limits in accordance with

    IAEA Safety Series No. TS-R-1 paragraph 422. 3.4.2 Unfasten the two toggle latches on the case in accordance with the instructions in Appendix 1

    and lift open the lid. 3.4.3 Lift out the aluminium containment, unscrew the four swing bolts and remove its lid. Retain for

    refitting. 3.4.4 Position the payload into the cavity of the aluminium containment with sufficient absorber to

    absorb twice the liquid contents (if liquids are being carried). For sources in steel or lead receptacles cushion the receptacles by filling the gap between the receptacle and the containment with 45kg/m3 density Closed Cell Expanded Polyethylene (CCEP) foam (trade name Plastazote). The radial and axial gap after cushioning should be minimised as far as possible. Replace the lid of the aluminium containment, and tightly secure with the four swing bolts. The bolts should be manually tightened – tools such as a mole wrench should not be used.

    3.4.5 Place the loaded aluminium containment into its recess in the aluminium case foam. 3.4.6 Fix a label marked “RADIOACTIVE” on the containment system so that it is visible when the

    package is opened. 3.4.7 Close the lid and fasten the two toggle latches in accordance with the instructions in

    Appendix 1. 3.4.8 Fit a padlock to the appropriate toggle latch. Apply a suitable wire security seal or pin through

    the other latch. 3.4.9 Transportation may not take place if the dose rates exceed 5 microSv/hr at any point on the

    external surface of Package Design No. GP3400C when used as an Excepted Package. 3.4.10 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.

    3.4.11 Use PVC adhesive tape to completely cover the part of the outer case label that references

    “Type A”. 3.4.12 Affix a “UN2910” label to the outer case indicating Radioactive Material, Excepted Package –

    Limited Quantity of Material. 3.4.13 Ensure previous shipment labels are removed or are no longer visible. (No shipment labels

    are required for Excepted Packages.) 3.4.14 Ensure the package is marked with an identification of either the consignor or consignee (or

    both). 3.4.15 Notify the consignee and gain agreement for shipment. 3.4.16 Despatch to consignee complete with appropriate transport documentation.

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    Issue 8 Amendment 0

    3.5 Packing Instructions – UN No. 3373 BIOLOGICAL SUBST ANCE 3.5.1 The package may also be used to transport UN No. 3373 BIOLOGICAL SUBSTANCE in liquid

    form in syringes. 3.5.2 Proceed in accordance with section 3.2 or section 3.4 as appropriate depending on the

    radioactive nature of the payload. The following addition requirements are applicable when carrying UN No. 3373.

    3.5.3 The syringes shall be fitted with tapered caps. 3.5.4 The syringes shall be wrapped in polythene bags and packed in the aluminium containment

    with sufficient absorbent material to absorb the entire contents of the syringes. The syringes may be wrapped individually in polythene bags or together in a single polythene bag. The absorbent material may be inside or outside the polythene bag(s). If multiple fragile syringes are placed in a single polythene bag they shall be individually wrapped in absorbent material (this requirement does not apply to more robust plastic syringes).

    3.5.5 Affix the mark illustrated below to the outer surface of the package. The mark shall be

    displayed on a background of a contrasting colour and shall be clearly visible and legible. The mark shall be in the form of a square set at 45o (diamond-shaped) with minimum dimensions of 50 mm by 50 mm; the width of the line shall be at least 2 mm and the letters and numbers shall be at least 6 mm high.

    If the package is being transported as an Excepted Package, the UN2910 label specified in

    paragraph 3.4.12 is not required. 3.5.6 The proper shipping name “BIOLOGICAL SUBSTANCE, CATEGORY B” in letters at least 6

    mm high shall be marked on the outer packaging adjacent to the diamond-shaped mark. 3.5.7 For transport by air, an itemised list of contents must be enclosed between the secondary

    packaging and the outer packaging and the additional requirements of packing Instruction 650 must be met (this is not required for other modes of transport).

    3.6 Handling and Tie-down 3.6.1 A handle is fitted to the aluminium case to enable lifting. The maximum weight of the package

    is 12.4kg. 3.6.2 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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    Issue 8 Amendment 0

    APPENDIX 1 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

  • GP3400C/OPINS Page 11 of 11

    Issue 8 Amendment 0

    Figure 1: Illustration of Package Design No. GP3400C

    Aluminium Case

    Foam Packing

    Aluminium Container

    Typical Receptacles

  • Design No: GP 3400C

    ONET TECHNOLOGIES UK

    William Kelvin Building, Claylands Road, Bishops Waltham, Hampshire, England, SO32 1BH

    Phone: +44 (0)1489 897300

    Email: [email protected] www.onet-technologies-uk.com

    PR

    OJEC

    T N

    °

    PS G

    P3

    4o

    oC

    Packaging Design No. GP 3400C is a hand held portable aluminium container with a dense foam insert, designed to hold an aluminium containment system with integral lead shield (if required), allowing transportation of patient doses of radiopharmaceuticals in syringes or vials.

    The GP 3400C is lightweight, easy to store, load and transport.

    Type A for Solids & Liquids

    External Dimensions 461 mm x 347 mm x 206 mm

    Gross Weight (without contents) 6.8 kg

    Maximum Weight of contents & shielding 4.2 kg

    mailto:[email protected]://www.gravatom.com/http://www.gravatom.com/http://www.gravatom.com/http://www.gravatom.com/http://www.gravatom.com/

    PS GP3400C.pdfSlide Number 1