From The FRAVALET™ Company Limited

1. From The FRAVALET™ Company Limited Innovation in Health Care Delivery The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

2. KI-DISCUS • A summary of the basic steps to be taken in performing a KI-DISCUS containment test Presented by Professor Raymond Clark OBE CEng FSEE and Professor M. Leonardo de Calcina-Goff FSEE FBPA The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

3. KI-DISCUS Containment Testing System KI-DISCUS is manufactured by: Containment Technology Limited 9 Telford Road Ferndown Industrial Estate Wimborne Dorset BH21 7QW United Kingdom Managing Director David Pollington Telephone: + 44 (0) 1202 870189 Fax: + 44 (0) 1202 870212 The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

4. BIOLOGICAL SAFETY - relies very much on good safety cabinets and other LEV systems To provide worker and environmental protection the air flows at the front apertures of open fronted containment facilities must adequately contain potentially pathogenic aerosols that may be generated in the working area. This is a requirement of Standards and Regulatory Authorities Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

5. Flow visualisation and air velocity measurements complement safety cabinet performance assessment but cannot take the place of containment tests The sequence of performance tests for the front aperture is: 1. Flow visualisation 2. Air velocity measurement 3. Containment to measure OPERATOR PROTECTION FACTOR 1 3 2 The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

6. Schlieren flow visualisation puts containment on the map In the 1970’s Schlieren cine-photography dramatically identified poor performing cabinets where potentially contaminated air would spill out of the cabinet and surround the worker These studies highlighted the need for tests to measure containment or “OPERATOR PROTECTION” The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

7. Development of containment tests Originally a microbiological test was used with spores or bacteria sprayed towards the front aperture However, this produced contamination and could be dangerous Another easy and safe test was needed and KI-DISCUS was developed The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

8. How to carry out KI-DISCUS containment tests The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

9. The directions given here apply equally to Class I and II safety cabinets as well as fumecupboards, open fronted cabinets for radiopharmaceutical and cytotoxic work etc. The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

10. First make sure that the cabinet or cupboard to be tested has been properly decontaminated according to regulatory authority requirements (COSHH in the UK) The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

11. Wheel the KI-DISCUS equipment to the front of the cabinet to be tested and disassemble the various parts of the trolley The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

12. It is important to find a clean, dry bench top away from the cabinet for the filter development equipment Lay out the two small glass dishes, one filled with palladium chloride and the other with distilled water, together with the filter papers (to dry the membranes from the samplers), the magnifier and 3 pairs of tweezers The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

13. Return to the cabinet and begin to assemble the components at the front aperture The trolley is placed at the centre line of the aperture. The artificial arm is assembled and placed in the circular support in the air suction tube mounted in the base of the KI-DISCUS trolley Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

14. The suction tube is next adjusted in height so that the artificial arm is level The spirit level built into the end section of the arm indicates when it is level The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

15. The air samplers are next positioned at the aperture Two air samplers are placed on the spigots on either side of the arm. The support for holding the upper two samplers is assembled and the samplers placed in the prescribed positions. The air hoses are connected to the suction take off points in the lower part of the trolley. The air samplers are placed between 150-160mm from the plane of the aperture. The openings of the upper 2 are placed level with the top of the aperture The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

16. Professor R. P. Clark & M. L. de Calcina-Goff Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

17. Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

18. The spinning disc generator is next positioned according to the type of cabinet being tested For a Class I cabinet or fume cupboard the generator disc is placed centrally under the arm with the disc edge 100mm inside the cabinet as measured from the plane of the aperture For a Class II safety cabinet the spinning disc is placed level with the top of the aperture and again 100mm inside the cabinet The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

19. The air samplers are next loaded with the filter membranes The filter loading may be done either with the samplers in position in front of the aperture or with them taken to a bench away from the cabinet To avoid contamination it is most important that one pair of tweezers is dedicated to loading the membranes into the air samplers. Care must be taken to ensure that the blue “separator” discs between the white membranes are removed before the membranes are placed in the samplers The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

20. The air flow through the samplers is next adjusted Once the samplers are loaded and placed on their suction tubes, the air flow through them is adjusted using the barrel valve on each sampler. The suction pump is switched on and the pressure gauge is attached to the measuring point on each sampler in turn The barrel valve is adjusted to give a reading of 8 ins wg (200mm wg) which ensures the correct air flow rate through the sampler orifice of 100 litres/minute The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

21. Setting up the spinning disc generator The time for the peristaltic pump to deliver 20ml will previously have been measured and the run time set on the digital timer.This ensures that when the start button is pressed exactly 20 ml of KI will be dispensed on to the spinning disc for aerosolization To prime the tubing to the spinning disc, on MANUAL CYCLE, switch on the pump until KI has completely filled the supply line to the spinning disc. Once everything is set up, the test begins by pressing the automatic start button Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

22. Developing the filter membranes after the test At the end of a test the spinning disc and air samplers will automatically stop in the correct sequence. Without wetting the tweezers place the filter into the palladium iodide solution with the surface on which any KI landed, upwards Remove the filter membranes from the samplers using the sharp pointed tweezers (designated solely for this purpose) The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

23. After some 20 seconds the development process will be complete Use a third pair of tweezers (again designated solely for this purpose) to remove the filter membrane from the palladium chloride . Rinse the filter membrane in water in the second glass dish and lay it to dry on the filter paper When the filter membrane is fully impregnated with palladium chloride the chemical reaction turning KI into palladium iodide will be complete Professor R. P. Clark & M. L. de Calcina-Goff The FRAVALET Company Limited

24. The magnifier is used to identify and count the number (n) of grey/brown dots on each filter membrane The protection factor (PF) is evaluated from the formula: PF = (62 x 105) ÷ n If there are more than 62 spots on ANY ONE filter membrane then the test has failed and the protection factor is less than 105 The convention is that membranes from all sampling heads must EACH have fewer than 62 dots for the cabinet to pass the test The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

25. At the end of a series of tests the spinning disc and artificial arm must be carefully cleaned and dried using soft tissues and water Careful cleaning will solve most contamination problems It is also important to wipe the cabinet to avoid possible staining of painted surfaces The FRAVALET Company Limited Professor R. P. Clark & M. L. de Calcina-Goff

26. KI-DISCUS The End Presented by: Professor Raymond P. Clark OBE CEng FSEE HonFRPS & Professor M. Leonardo de Calcina-Goff ASIS FRPS FSEE FBPA The FRAVALET Company Limited INNOVATION IN HEALTH CARE DELIVERY 5 B High Street, Newport Pagnell, Buckinghamshire, MK16 8AR Telephone: 01908 211790 Email: fravalet@medi.demon.co.uk Professor R. P. Clark & M. L. de Calcina-Goff