Download
1 / 13
130 likes | 153 Vues
ESH & Q. DOE-NP Annual S&T Review of Radionuclide Research & Production (RR&P) J. Bullis November 19-20, 2009. Summary of RR&P Facility Characteristics. 2 Buildings 1 Accelerator Facility (BLIP) Not normally occupied An accelerator facility covered by SAD/ASE ( November 2009)
E N D
ESH & Q DOE-NP Annual S&T Review of Radionuclide Research & Production (RR&P) J. Bullis November 19-20, 2009
Summary of RR&P Facility Characteristics • 2 Buildings • 1 Accelerator Facility (BLIP) • Not normally occupied • An accelerator facility covered by SAD/ASE ( November 2009) • 1 Radiological Facility (per BNL Facility Hazard Categorization SBMS subject area), the Radionuclide Research & Production laboratory (Bldg 801) - • Target Processing Laboratory (1 hot cell, 8 hot boxes) • 7 additional Labs (R&D and production support) • Machine shop • Offices
Summary of Environmental AspectsNote: The BLIP was among the first facilities at BNL to receive ISO 14001 certification – August 2000 • Industrial Waste • Hazardous Waste • Mixed Waste • Regulated Medical Waste • Radioactive Waste/R-RMW • Atmospheric discharges • Liquid discharges • Storage/use of chemicals/radioactive material (D-Waste tanks/BLIP tanks) • Soil activation • Nanomaterials
Summary of Radiological Hazards • Low- and High-level Contamination • Radioactive Waste • Radioactive Atmospheric Discharges • Radioactive Liquid Effluents • Storage / Use Of Radioactive Material • Soil Activation • Residual-radiation From Activated Materials
Summary of OSH Hazards • Radiation (ionizing) • Chemicals • Compressed Gases • Cryogenic Liquids • Electrical • Noise • Oxygen Deficiency • Power Tools • Material Handling (cranes/forklifts) • Machine Shops • Nanomaterials • Animals (Bite/Scratch/Allergies) • Falls • Confined Spaces
Applicable Requirements • DOE Orders and Federal Regulations • DOE Order 420.2B, Accelerator Safety • DOE Order 420.1A, Facility Safety, §§ 4.2 and 4.4 • DOE Order 414.1C, Quality Assurance • 10CFR835, Radiation Worker Protection • 10CFR851, Occupational Worker Protection • BNL SBMS Subject Areas • Scores of Subject Areas Contain ESH Requirements That Apply • Accelerator Safety • Work Planning And Control • Voluntary Management Systems • OSH Management System, OHSAS 18001 • Environmental Management System, ISO 14001 • Human Performance Initiative, INPO • Good Manufacturing Practice Regulations • International Conference on Harmonization (ICH), Q7
ESH Systems • As part of the Life Sciences Directorate, Medical Department, the following are managed at the Directorate or Department levels; • Integrated Safety Management • Work Planning & Control • Experiment Safety Reviews • Work Permits/Work Control Coordinators • ALARA Committee • Environmental Management System • Training • Self Assessment Program • Routine Safety Inspections (“Tier 1”) • The RR&P Group ESH Coordinator participates in all of these functions or serves as the point-of-contact for each
Safety Performance • Injury Cases – none in the last 10 years • Lost work days – none in nearly 12 years • Occurrences (see table) • Radiological Awareness Reports (RAR) • Occurrence Reporting and Processing System (ORPS) • Collective Annual Average Equivalent-Dose, 1995-present – 0.74 person-rem
Quality Assurance • Some radioisotope products are used in manufacture of radiopharmaceuticals, therefore subject to Good Manufacturing Practice (GMP) requirements. • Formerly the driver requirements were in 21 CFR 211, now International Conference On Harmonization Of Technical Requirement For Registration Of Pharmaceuticals For Human Use - ICH Harmonized Tripartite Guideline - Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 (“ICH Q7”) • These requirements are numerous and time-consuming. Compliance is difficult, given the small size of the RR&P group. • Production program is audited by customers, now international customers. The number of non-US customers and the number of products coming under these requirements is expected to increase. • A recent audit by a new customer resulted in 4 major and 4 minor observations.
Draximage Audit Findings10/20/09 Visit • Observation 1 (Minor) – Modifications to the Master Production Record (TPL 604) are required regarding reagent preparation. • Observation 2 (Major) – Routine QC on balances is required. IQ/OQ on balances required. • Observation 3 (Minor) – Certificates of calibration from provided by contractors must be signed by QAU. • Observation 4 (Major) – Modifications to the Master Production Record (TPL 604) are required regarding critical process parameters and in-process controls. • Observation 5 (Minor) – Batch Certificates of Analysis must be signed by QAU. • Observation 6 (Minor) – Training procedure BLIP-TPL 801 must be modified to exempt procedure authors and reviewers from briefings/training on those documents. • Observation 7 (Major) – A Master Validation Plan and appropriate Validation documentation packages must be prepared. • Observation 8 (Major) – Self-inspection and Product Quality review are required. IN DISPUTE – both of these requirements are currently met but were not discussed during the audit. • Observation 9 (Major) – A product recall program must be established.
Quality Assurance – cont. Additional anticipated QA effort: • Sr-82 process requires retrospective validation investigation and documentation and preparation of revised Drug Master File (DMF) • Ge-68 production must be made GMP-compliant to support a clinical Ge-68/Ga-68 generator. This will require; • Process development/modification • Preparation, implementation, and documentation of Prospective Process Validation • Preparation of a Drug Master File for new process and submission to FDA
Summary • The safety program is satisfactory regarding compliance. • Safety oriented events (injuries, lost work days, RAR & ORPS) are not a significant issue. • GMP compliance will require a significantly increased effort.
