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Exposure Risk Assessment
of
Methylene Chloride
Both Alone and in Combination
with Methanol in a
Pharmaceutical Plant
Presented by:
Bernard L. Fontaine, Jr., CIH, CSP
The Windsor Consulting Group, Inc.
Copyright© 2000 The Windsor Consulting Group, Inc.
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Initial Investigation to Evaluate:– Weight and Mix Solvents in Solution Prep
Room – Purge Spray Nozzles - Coating Room– Spray Pills in Ventilated Chamber
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Sampling Methods
• MSA Escort sampling pumps calibrated at 100 cc/minute using silica gel tubes for methanol vapors
• MSA Escort sampling pumps calibrated with two charcoal tubes at 100 cc/minute for methylene chloride vapors
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Analytical Methods
• Methanol - NIOSH Method 2000 - Desorb in water - GC/FID - LOD is 0.01 mg.
• Methylene Chloride - NIOSH Method 1005 - Desorb in carbon disulfide (CS2) - GC/FID - LOD is 0.01 mg.
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Exposures (Initial)
• Weigh and transfer coating solution to mixing kettle - 140 ppm (86 minutes)
• Divide coating - 27 ppm (81 minutes)
• Purge spray nozzles - 62 ppm (87 mins.)
• Spray pills - 22 ppm (149 minutes)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Exposures (Initial)
• 8-Hour TWA - 47.7 ppm
• OSHA SAE - 0.12
• 95% CI - (42.0 - 53.4 ppm)
• 8-Hour ACGIH TLV-TWA - 50 ppm
• 8-Hour OSHA PEL-TWA - 500 ppm
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methanol Exposures (Initial)
• Blend and mix solvent - 71 ppm (87 minutes)
• Divide coating into two batches - 3.7 ppm (82 minutes)
• Purge spray nozzles - 13 ppm (85 mins.)
• Spray pills - 8.1 ppm (149 minutes)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methanol Exposures
• 8-Hour TWA - 18.3 ppm
• OSHA SAE - 0.22
• 95% CI - (16.1 - 22.3 ppm)
• 8-Hour ACGIH TLV-TWA - 200 ppm
• 8-Hour OSHA PEL-TWA - 200 ppm
Methylene Chloride and Methanol in a Pharmaceutical Plant
• ACGIH TLVs for Chemical Mixtures with Additive Effects
∀Σ = 47.4 ppm + 18.3 ppm = 1.05
50 ppm 200 ppm
• Methylene Chloride and Methanol
•
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride 1st Follow-Up Survey
• Transfer solvent to mixing kettle - 16 - 30 ppm (38 - 41 minutes)
• Divide solvent coating into two batches 24 - 38 ppm (72 - 87 minutes)
• Spray pills - 16 - 29 ppm (81 - 83 mins.)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Follow-Up Survey
• 8-Hour TWA - 8.4 ppm - 13.1 ppm
• OSHA SAE - 0.12
• 8-Hour ACGIH TLV-TWA - 50 ppm
• 8-Hour OSHA PEL-TWA - 500 ppm
Methylene Chloride and Methanol in a Pharmaceutical Plant
• OSHA Methylene Chloride Standard (29 CFR 1910.1052)
• New OSHA PEL-TWA - 25 ppm
• New OSHA STEL-TWA - 125 ppm
• ACGIH TLV-TWA - 50 ppm
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride 2nd Follow-Up Survey
• Transfer solvent to mixing kettle - 83 ppm (23 minutes)
• Purge and calibrate spray nozzles - 140 ppm (37 minutes)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Follow-Up Survey
• Assist calibration of nozzles - 190 ppm (13 minutes)
• Area sample above sprayer - 54 ppm (15 minutes)
• Loading tablets into sprayer - 17 ppm (42 minutes)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride 2nd Follow-Up Survey
• Spray dye coating on tablets - 2.8 ppm (20 minutes) - 2.9 (49 minutes)
• Loading tablets while spraying - 44 ppm (124 minutes)
• 8-Hour TWA - 16.7 ppm
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Sample Results
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Methylene Chloride and Methanol in a Pharmaceutical Plant
• Methylene Chloride Sample Results
• Work task exposure - 46.8 ppm (171 minutes)
• Work task exposure - 32.6 ppm (139 minutes)
• Work task exposure - 56.8 ppm (403 minutes)
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Recommendations
• Engineer or administratively control 15-minute STEL exposure
• Use appropriate respiratory protection and PPE while implementing controls
• Inform workers of the test results and location of exposure data
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Recommendations
• Inform workers about health effects of methylene chloride alone and combined with methanol, isopropanol or n-butanol
• Monitor for methylene chloride along with other volatile organic compounds
• Upgrade levels of respiratory protection, surveillance, and written program
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Recommendations
• Upgrade electrical equipment and wiring to conform to NEC Class I, Division II
• Install area monitors to warn employees in the Solvent Prep room of elevated level
• Post warnings to regulate work area and prevent unauthorized entry
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Recommendations
• Re-monitor worker exposures to methylene chloride and methanol
• Implement medical surveillance program for affected workers
Methylene Chloride and Methanol in a Pharmaceutical Plant
• Conclusions
• Consider chemical substitution for methylene chloride
• Improve ventilation in Solvent Prep room
• Supplement with air supplied respirators
• Improve employee work practices and procedures