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Detection and Monitoring of Hazardous Materials in Aseptic Preparation

Detection and Monitoring of Hazardous Materials in Aseptic Preparation. Mark Oldcorne Wrexham Maelor Hospital North Wales NHS Trust. COSHH Regulations 1. Hierarchy of control. COSHH Regulations 2. Control can be demonstrated by. Monitoring of Equipment. Good supervision

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Detection and Monitoring of Hazardous Materials in Aseptic Preparation

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  1. Detection and Monitoring of Hazardous Materials in Aseptic Preparation Mark Oldcorne Wrexham Maelor Hospital North Wales NHS Trust

  2. COSHH Regulations 1 Hierarchy of control

  3. COSHH Regulations 2 Control can be demonstrated by

  4. Monitoring of Equipment • Good supervision • Demonstration that equipment is performing correctly • Isolators • Leak testing • Pressure regimes – proving negative pressure • HSE\MHRA viewpoints • Class II Microbiological Safety Cabinets • Airflow patterns • KI disc test – prove air curtains • PPE • Gloves • Provide effective seal • Penetration rates - material\ double gloving

  5. Monitoring of Workspace Environment 1 • Contamination • Airborne • Surfaces • Sources • Poor technique • Aerosol generation • Surface contamination of purchased medicines • Spillage • Poor cleaning techniques – spreading of agents

  6. Monitoring of Workspace Environment 2 General methods • fluorescence • bioluminescent estimation of residual mutagenic activity • HPLC • HPLC - mass spectrometry • GC - mass spectrometry • Adsorptive voltammetry • Ion mobility spectrometry • Requirements of methods • Qualitative – identification of cytotoxic agents • Quantitative – at what level?

  7. Monitoring of Workspace Environment 3 • HPLC-MS • sensitive and reproducible • long sample preparation and run time • waste disposal • GC-MS/FID • sensitive and reproducible • little waste produced • long sample preparation and run time • Ion Mobility Spectrometry (IMS) • sensitive and reproducible • little waste produced • very fast • little sample preparation

  8. Monitoring Services 1 QC North West • Method • HPLC – mass spectrophotometer • Sampling System • Swab

  9. Monitoring Services – QC north west Range of Monitoring

  10. Monitoring Services 2 QCWest Midlands • Method • Ion-Mobility Spectrometry • Sampling System • Swab • 100% hydroentangled polyester nonwoven fabric • Validation • LOD, LOQ • Linearity • Repeatability %RSD • Recovery from Swab • Stability on swab

  11. Monitoring Services – QC north west • Strategy • Monitor on annual basis • Use appropriate mix of kits • Samples ideally returned within 24 hours of sampling • Cost • £390 per kit • Including dispatch etc.

  12. Monitoring Services– QC West Midlands Range of Products

  13. Ion Mobility Spectrometry equipment

  14. Plasmagram detecting 5-FU & cyclophosphamidea chromatogram in real-time on the machine

  15. Monitoring of personnelHealth Surveillance - General • Medical History • Initial on employment • Physical Examinations • regular • Laboratory Tests • blood counts • LFTs • renal function

  16. Monitoring of personnelMonitoring of cytotoxic drugs levels • measuring concentrations of cytotoxic drugs or their metabolites in body fluids, usually urine, blood and plasma • a number of compounds can be evaluated in this way • e.g. Cyclophosphamide, Platinum • Advantage - measure total uptake by all routes of exposure. • Problems - lack of sensitivity, poor validation, can they identify real risk

  17. Monitoring of personnelMonitoring of Biological Indicators 1 • Mutagenicity • Urine • Ames test • Simple and cheap • Problems • Lacks sensitivity • Lacks specificity • DNA damage • Measure DNA strand breaks (alkaline elution or comet assay) • Problems • Costly • Complex • Interpretation of data

  18. Monitoring of personnelMonitoring of Biological Indicators 2 • HPRT assay – gene mutation • Altered DNA bases • Alkylating anticancer drugs – formation of DNA adducts • detected by • physicochemical methods – depends on structure knowledge • immunochemical techniques – non-specific 32P-postlabelling • Predictive of cancer risk - highly sensitive methods • Problems • Specific to alkylating agents • Intra laboratory variation • Not validated

  19. Monitoring of personnelMonitoring of Biological Indicators 3 • Chromosomal Aberrations • Direct estimate of heritable changes – measures long lasting lesions • Cumulative damage • Problems • Insensitive • Laborious • Lack of data • Micronulceus Assays • Sister chromatid exchange (SCE)

  20. Monitoring of personnelMonitoring of Biological Indicators 4 • How much health surveillance should I subject my staff to?? • Should we monitor the urine and blood of staff?? Aware of limitations Interpretation of data Interference from other factors

  21. Monitoring Strategies for Hazardous Materials in Aseptic Suites Hierarchy of monitoring

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