Aseptic Processing Practices and Process Validation of Aseptic ...
Isolators versus laminar flow for aseptic radiopharmacy work
Transcript of Isolators versus laminar flow for aseptic radiopharmacy work
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Isolators versus laminar flow for aseptic
radiopharmacy work Paul Maltby
Royal Liverpool & Broadgreen University Hospitals NHS Trust
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Barrier Technology • Vertical Laminar Flow Cabinets (class II safety
cabinets) • Isolators
– Laminar flow – Turbulent flow
• Hot cell – Laminar flow – Turbulent flow
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Barrier Technology • Both VLFC and isolators can be negative pressure
or ambient pressure (effectively re-circulating). Isolators could be positive pressure (cf. CIVAS)
• Hot cells are by definition negative pressure although a few ambient pressure models are available
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Factors affecting choice of technology
1. Health and Safety – Radiological – Biological – Ergonomic
2. Economics
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2 –glove Techne-um isolator Transfer hatches – Can they be VHP?
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Touch screen for SOPs
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Automated Tc99m radiopharmacy in a double hot cell
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Transfer hatch for consumables and kits
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Factors affecting choice of technology
1. Health and Safety – Radiological – Biological – Ergonomic
2. Economics
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Radiological • Therapy/diagnostic/PET • Level of (radio)activity • Half life • chemistry
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Radiological • Diagnostic radionuclides for dispensing only
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Diagnostic Radionuclides • Acceptable to use LFC or isolator and can be re-
circulating or extracting to the external environment.
• Local shielding eg lead perspex/glass and L barrier
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Laminar Flow isolator – neutral
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Lead glass “L” screen
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Radiological • Generators
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VLFC grade A zone to elute 99mTc Generators
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Single chamber transfer fromTc generator
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Dual chamber transfer from Tc generator
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Environment for Generator – is it grade A?
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Therapeutic and Positronic Radionuclides • Recommend heavily shielded isolator or hot cell
and can be extracting to the external environment
(or re-circulating depending on radionuclide - half life or volatility)
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Heavily Shielded Isolator 50mm Pb
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ExtracBng heavily shielded isolator
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Automa-c loading and remote handling
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Ga68 non‐extrac-ng hot cell
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Ga68 Isolator with door open
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Factors affecting choice of technology
1. Health and Safety – Radiological – Biological – Ergonomic
2. Economics
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Biological • Blood labelling • Gene therapy monitoring • Antibody
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Biologicals • Use negative pressure isolator preferably in a
dedicated (separate) suite • Gene therapy labelling suite may need separate
AHU at negative pressure with respect to the radiopharmacy suite (at moment we are only labelling markers of gene expression)
• Antibody labelling goes from facile (eg Leukoscan) to therapeutic iodination
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Built in centrifuge and dose calibrator
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Factors affecting choice of technology
1. Health and Safety – Radiological – Biological – Ergonomic
2. Economics
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Ergonomic • Outputs (numbers and speed)
– Operator comfort –(Throughput in commercial setting may lead to Upper Limb Disorders)
• Degree of complexity • Length of procedure
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Access if something goes wrong?
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Si-ng of power sockets
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Poten-al air leak due to unsealed socket
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Don’t lose them!
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Factors affecting choice of technology
1. Health and Safety – Radiological – Biological – Ergonomic
2. Economics
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Economics 1. Initial cost of workstation 2. Ease of installation 3. Commissioning costs 4. Power consumption 5. Annual maintenance costs and spares 6. Background environment costs - AHU/grade of room/
clothing 7. Estimated (working) lifespan 8. Replacement - decommissioning and removal costs
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Conclusion • The choice of barrier technology is entirely dependent
on the circumstances for which it is being used • No single type of workstation is suitable for a range of
functions • All have both advantages and disadvantages • For a larger radiopharmacy it would be pragmatic to
purchase a range of products thus increasing multi-tasking ability and future proofing
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Acknowledgements • Amercare Ltd • Envair Ltd • Cirrus Containments • Walker Safety Cabinets Ltd • Manchester Royal Infirmary Radiopharmacy Dept • Preston Pharmaceuticals • Royal Liverpool Radiopharmacy