Case Study: Controlling exposure to isoflurane used in animal surgical procedures in Research & Development

Michel Vangeel, Janssen Campus Belgium

IOHA London 2015, 25-30 April 2015 Hilton London Metropole

Introduction

• Janssen Research & Development• All stages of Discovery • 1800 employees• Beerse, Belgium• Johnson & Johnson

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

Anticipation

• Reports acute adverse health effects• During animal surgical procedures • Headaches, dizziness, loss of concentration,

numbness fingers;• 3 Janssen R&D sites J&J• Isoflurane exposures 10-23 ppm range• Internal J&J OEL: 20 ppm

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

IdentificationBasic characterization: isoflurane

• Boiling point: 48.5 °C (1013 mbar) - Vapor pressure: 440 hPa (25°C) - Relative Density: 1.45 g/cm3

• Routes of entry: Inhalation - may provoke:Headache, dizziness, loss of concentration, unconsciousness

• In case of contact with eyes: irritation, redness

• Occupational Exposure Limits (IFA - GESTIS databank)

- Canada: 2 ppm- Sweden, Finland, Austria: 10 ppm – 20 ppm (STEL)- J&J: 20 2 ppm

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

IdentificationBasic characterization: work stations & activities

Isoflurane evaporator Surgical interventions (Masks)

Induction Box

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

Filled with mixture of air and 2-5 volume % isoflurane minimum 30% O2 (till 100%), flow rate 1l/min

EvaluationExposure monitoring

• Identification work stations & sampling plan

• Personal & area monitoring:- SKC Anasorb 747 (100/50 mg)- flow rate: 200 cc/min.

• Continuous monitoring:- Thermo SaphIRe MIRAN- detection limit 0.04 ppm

• Statistical Analysis results- IDHA – Bayesian stats UCL95,75

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

ControlInduction box

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

= creates under pressure

• Controlled supply• Adjusted diameters &

position supply & exhaust• Glide lid in 2 steps• Adjusted sizes/animal• Speed removing• Additional exhaust

ControlAnesthetic masks

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

• Supply isoflurane inside• Exhaust outside• Avoid to cover whole table• Controlled supply isolfurane

with indication on screen

ControlWorkstations: correct use LEV

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

• Correct use of supply & exhaust- No disturbances flow pattern = recipients & equipment / covers (sheets)- Close valve supply on time- Proper connections tubing

• Isoflurane filters- Saturated filters = source of exposure- Good maintenance & follow up- Evaluate removal & connection with LEV

• Expansion LEV- No improvisation/bad connections

ControlWork practices & training

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

• Wipe of fur- Wipe off fur animal in front of extraction unit- Reduction of 10 times the concentration- Without wiping: 60- 88 ppm- With (5 times) : 1.7 – 6.8 ppm

• Manipulations- Opening lid induction box: 2 steps- Speed removal animals

Conclusion

• Connection & teamwork OH, IH, toxicology, EHS colleagues, business

• Respect pillars of Industrial Hygiene• Control: combination of engineering controls,

good work practices and training & awareness

• Reduce exposure < 2 ppm (new J&J OEL)

IOHA London 2015, 27-30 April 2015, Hilton London Metropole

IOHA London 2015, 27-30 April 2015, Hilton London Metropole