EtO monitoring requirements EtO monitoring equipment

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EtO MONITORING REQUIREMENTS EtO MONITORING
EQUIPMENT
Presented By
Michael D. Shaw
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ETHYLENE OXIDE
Anprolene Dihydrooxirene Dimethylene
Oxide 1,2-Epoxyethane Oxacyclopropane Oxane
Oxidoethane a,b-Oxidoethane Oxiran Oxirane
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EtO HEALTH EFFECTS
Although there are limited studies in humans to
directly link EtO to human cancers, there is
sufficient evidence in experimental animals to
conclude that ethylene oxide is carcinogenic to
humans
Inhalation causes nausea, vomiting, neurological
disorders and in some cases death
Traces of gas in gloves or clothing may cause
burns
Residues in vascular catheters can cause
thrombophlebitis whereas in endotracheal tubes,
tracheitis
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Mortality of workers exposed to ethylene oxide
extended follow up of a British cohort.Coggon
D, Harris EC, Poole J, Palmer KT.MRC
Environmental Epidemiology Unit, University of
Southampton, UK. Occup Environ Med. 2004
Apr61(4)358-62
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AIMS To obtain further information about the
risks of cancer associated with occupational
exposure to ethylene oxide
METHODS Follow up was extended by 13 years for a
cohort of 2876 men and women with definite or
potential exposure to ethylene oxide in the
chemical industry or in hospital sterilizing units
RESULTS Analysis was based on 565 deaths, of
which 339 had occurred during the additional
period of follow up. Mortality was close to or
below expectation for all causes
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Occupational Exposure Standards
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OSHA Standards
The TWA (8-hour time-weighted average) is 1 ppm
The Excursion Limit is 5 ppm, as averaged over a
sampling period of 15 minutes
The Action Level is 0.5 ppm, calculated as an
8-hour time-weighted average
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OSHA Regulations per 29 CFR 1910.1047
1910.1047(d)(1)(i) Determinations of employee
exposure shall be made from breathing zone air
samples that are representative of the 8-hour TWA
and 15-minute short-term exposures of each
employee
1910.1047(d)(3)(i) If employee exposure action
level but the 8-hour TWA, repeat monitoring for
each such employee at least every 6 months
1910.1047(d)(3)(ii) If employee exposure gt 8-hour
TWA, repeat monitoring for each such employee at
least every 3 months
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1910.1047(d)(6)(i) Monitoring shall be accurate,
to a confidence level of 95, to within 25 for
airborne concentrations of EtO at the 1 ppm TWA
and to within 35 for airborne concentrations
of EtO at the action level of 0.5 ppm
1910.1047(d)(6)(ii) Monitoring shall be accurate,
to a confidence level of 95, to within plus or
minus 35 airborne concentrations of EtO at the 5
ppm excursion limit
1910.1047(d)(7)(i) After 15 days, must notify
affected employee of these results in writing
1910.1047(e)(1) Regulated area required wherever
EtO may exceed the TWA
1910.1047(e)(2) Access to regulated areas shall
be limited to authorized persons
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1910.1047(i)(1)(i)(A) Medical surveillance
program required for all employees who are or may
be exposed to EtO at or above the action level,
without regard to the use of respirators, for at
least 30 days a year
1910.1047(j)(1)(i) Signage required (regulated
areas)
DANGERETHYLENE OXIDECANCER HAZARD AND
REPRODUCTIVE HAZARDAUTHORIZED PERSONNEL
ONLYRESPIRATORS AND PROTECTIVE CLOTHING MAY BE
REQUIREDTO BE WORN IN THIS AREA
1910.1047(j)(1)(ii)(A) And on containers
DANGERCONTAINS ETHYLENE OXIDECANCER HAZARD AND
REPRODUCTIVE HAZARD
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1910.1047(k)(2)(iii) The employer shall keep an
accurate record for 30 years IAW 29 CFR
1910.1020 of all measurements taken to monitor
employee exposure to EtO
This includes
The date of measurement The operation involving
exposure to EtO which is being monitored Sampling
and analytical methods used and evidence of
their accuracy Number, duration, and results of
samples taken Type of protective devices worn, if
any Name, social security number and exposure of
the employees whose exposures are represented
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ACGIH (American Conference of Governmental
Industrial Hygienists) Threshold Limit Values
8 hr Time Weighted Average (TWA) 1 ppm A2
Suspected human carcinogen
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ACGIH EQUIVOCATION
Threshold Limit Values (TLVs) and Biological
Exposure Indices (BEIs) are determinations made
by a voluntary body of independent knowledgeable
individuals
TLVs and BEIs are not standards. They are
guidelines designed for use by industrial
hygienists in making decisions regarding safe
levels of exposure to various chemical
substances and physical agents found in the
workplace
Since TLVs and BEIs are based solely on health
factors
There is no consideration given to economic or
technical feasibility
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NIOSH Recommendations
RELs (Recommended Exposure Limit)
10 Hr Time-Weighted Average lt0.1 ppm
10 min/day ceiling value 5 ppm
NIOSH considers ethylene oxide to be a potential
occupational carcinogen
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MONITORING FOR ETHYLENE OXIDE
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TOXIC GAS MONITORING PRECEPTS AS APPLIED TO
ETHYLENE OXIDE
The most important precept in ANY toxic gas
monitoring application is protecting the
employees
First priorityyou must monitor where people are
working
Additional considerations
The sterilizers and aerators
Drain areas
Gas cylinder storage area
Ventilation characteristics
Any other leakage or exposure possibilities
Note that these precepts relate to CONTINUOUS
monitoring Portable, survey monitoring has
little applicability here, other than for
initial testing or backup purposes
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MONITORING METHODOLOGIES
Semiconductor Sensor (Solid State)
Inadequate sensitivity and no specificity
Completely outmoded and outdated
Possible application for catastrophic leak
detection
What about occupational health?
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Photoionization Detector (PID)
Responds to all organics so a chromatographic
column must be used to remove interferences
More commonly known as GC or gas chromatography
method
AdvantageConventionally deployed
stream-switching many points even if this
precludes meaningful data collection
DisadvantageNot true continuous monitoring
AdvantageExcellent interference rejection, but
if used in the presence of isopropyl alcohol,
will consume columns at an alarming rate
DisadvantageExpensive
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Electrochemical Voltammetric Sensor
AdvantageExcellent sensitivity, and good
interference rejection to all but isopropyl
alcohol (IPA)
Solution to this is replacement of IPA with
phenol-based germicide or temporary analyzer
pump shut-off while area is being wiped down with
IPA
AdvantageTrue continuous monitoring at all
points, facilitating meaningful data acquisition

AdvantageNot expensive for majority of
applications
DisadvantageCan become costly in those few
industrial sterilization applications that
really need to monitor scores of points
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IMPORTANCE OF DATA ACQUISITION
ARCHIVING/REPORTING
Even if you've been a good corporate citizen, and
have installed sensors for toxic compounds all
around your facility, to protect your employees
Can you document long-term employee exposure?
Do you have any idea how close their exposure is
to the allowable levels?
High concentration alarms are fine, but they're
not enough!!
You cant disregard long-term low level exposure
the kind of exposure that lawsuits are based on
Unless you have a documented record of exposure,
if you're sued, you'll be scrambling for data,
desperately trying to re-create the past
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WHAT ABOUT BADGES?
Badges only offer an appreciation of employee
exposure retrospectively
Shortcomings include but are not limited to
Inability to alarm at an instantaneous
concentration value
An absence of time-history
A rounded "single number" value often
insufficient to generate a realistic assessment
of exposure levels
Whats the solution?
To know what's happening in real time!
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SOME ETHYLENE OXIDE MONITORING PRODUCTS OFFERED
BY
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PORTABLE ANALYZER
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CONTINUOUS MONITORING SYSTEM SINGLE POINT
APPLICATION
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CONTINUOUS MONITORING SYSTEM TWO POINT
APPLICATION
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CONTINUOUS MONITORING SYSTEM MULTI-POINT (THREE
OR MORE) APPLICATION
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ARC-MAX DATA ACQUISITION, ARCHIVING, AND
REPORTING
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ARC-MAX MAIN SCREEN
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ARC-MAX SHIFT REPORT
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ARC-MAX TRENDING
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ARC-MAX ALARM LOG
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CONCLUDING REMARKS
REGULATIONS / RECOMMENDATIONS VARY BETWEEN OSHA,
NIOSH, AND ACGIH
IT WOULD APPEAR THAT ETHYLENE OXIDE
CARCINOGENCITY HAS BEEN OVER-TOUTED
MAINTAINING A GOOD RECORD OF EMPLOYEE EXPOSURE IS
CRUCIAL FOR DEFENSE PURPOSES
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SPECIAL THANKS TO JOE HADLEY AND THE MEMBERSHIP
OF EOSA