GED3(Gaseous Effluent Discharge reporting system v3)

Bernhard WarrRadiation Protection SpecialistDEAL, GE Healthcare

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• Business started in the 1940s by Dr William Grove.

• Primarily making luminous dials.

• 50s & 60s, primarily involved in Ra-226 business, waste products Ra-226 & Rn-222.

• 70s & early 80s, primarily involved in QSA source business, calibration & test sources, life sciences work involving H-3, C-14, significant quantities of Am-241 from AmBe neutron sources, also of Cs-137.

• Late 80s & 90s, increasing quantities but reducing variety of life sciences & medical isotope manufacture, primarily S-35, I-125, I-131, Sr-90, Mo-99/Tc-99m, Se-75, Tl-201, Ga-67.

• 2000s, introduction of F-18 manufacturing.

A bit about The Grove Centre(Amersham plc, Amersham Intl, Nycomed Amersham, The Radiochemical centre)

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• Based at the Grove Centre in Amersham.

• Provide Dosimetry to GEHC sites at Amersham, Harwell, Cardiff, Slough & Hammersmith.

• Run Gaseous Effluent Discharge programs required by EA Authorisation under RSA93 at The Grove Centre and Harwell.

• Run Environmental Monitoring program at The Grove Centre.

• Run Workplace Air Sampling (WAS) and Personal Air Sampling (PAS)programs at The Grove Centre.

• Provide public dose assessment services to all GEHC facilities in the UK.

A bit about DEAL (Dosimetry & Environmental Assessments Laboratory)

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RW/RW/18

Rn-222

I-125

I-131

Se-75

H-3

All other Alpha

All other Beta > 0.4MeV

All other radionuclides

Old Authorisation (RW/RW/18)

(April 1992-April 2004)

BE9241

Rn-222

I-125

I-131

Se-75

H-3

All other Alpha

All other Beta > 0.4MeV

All other radionuclides

Other noble gases (Xe & Kr)

S-35

New Authorisation

(April 2004-)

Amersham plc

ALL DISCHARGES

The Grove Centre

DECOM & POCO OPERATIONS

Plus

Indicate on monthly report

when greater than 50% of the discharge value

is made up of measurements

below the MDL

Include fraction of D&P limits, fraction of operations limits & fraction of total limits. (D&P + operations ≠ total)

Why develop a new system?

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March 2008 discharge return

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GED3 - Benefits

GED 2.5 (Old System):

• Approximately 7000 pieces of data checking per month

• No sample managementfunctionality

• Single user MS Excel spreadsheet

• Separate systems for GC & Harwell

• Validated to GxP standard after production

GED3:

• Approximately 150 pieces of data checking per month

• Sample tracking from deployment to reporting stage

• Web based multi-user system with varying permissions and in-built reporting tools

• One single system with site level access

• Designed, validated and tested to GxP standard

• As future-proof as we can be

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The development process

• Choice of offshore or in-house development models.

• Offshore development chosen for business reasons.

• Developed with GxP validation in mind, ie robust change control, division of administrative/technical duties.

• Produced URS (User requirement Specification)

– FRS (Functional Requirement Specification)– Prototype

– UAT (User Acceptance Testing)– Iterative testing

– PQ (Performance Qualification) prior to the move to validated TGC data-centre– Parallel Run (3 months)

– Acceptance into service

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Automatic sample counters

(Tennelec)

TGC Particulate measurements

Work Area Samples (WAS)

Personal Air Samples (PAS)

DRKS2

PAS Report

WAS Report

GED Report (TGC)

Harwell Particulate Measurements

GED Report (HIBC)

SpreadsheetF-18

Manual entry

Y-spec, Radon, H-3, S-35

Harwell C-14, H-3 & Radon measurements

How does it work?

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1000 cts

Data can be:

- Rejected (deleted)

- Referred (by email)

- Edited

- Advanced

100 cts

1000 cts

Trust Level 2 – Reportable DataTrust Level Null

Trust Level 1 Validation

User 1

User 2

�

�

1200 Bq

850cts

� 9500 Bq

Trust Level 1

Trust Level 2 Validation

Admin

Only an Administrator can change data in

Trust Level 2

The ‘Trust-Level’ process

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To the system itself

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Lessons learnt & questions raised?

• In-house development may be more expensive, but is definitely easier!

• What is the right validation standard to apply? GxP? S-OX?

• Build in as much future-proofing as you can.

• Never assume that your requirements have been interpreted correctly.

• A system is as only as good as it’s testers (test, test and test again).

• Can any system ever be 100% perfect?

• Should regulators assume that this is possible?

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Thanks for listening…

…any questions?