bernhard warr radiation protection specialist deal, … · 2009-11-26 · bernhard warr radiation...
TRANSCRIPT
GED3(Gaseous Effluent Discharge reporting system v3)
Bernhard WarrRadiation Protection SpecialistDEAL, GE Healthcare
2 /GE Title or job number /
26/11/2009
• 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)
4 /GE Title or job number /
26/11/2009
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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26/11/2009
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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26/11/2009
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
8 /GE /
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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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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?