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San-I-Pak's
method (steam sterilization) is accepted by medical waste regulatory
agencies and state health departments in all 50 states as defined
in Medical Waste Handbook, Federal and State Regulation written
by David S. Freeman and Gregory H. Siskind. San-I-Pak
equipment meets and/or exceeds all existing State and Federal
regulations for the treatment and disposal of infectious wastes
and has in fact been the standard for developing these regulations
for years. Steam autoclaving, which is the basis of the San-I-Pak
treatment process, is the most accepted alternative method of
medical waste treatment in the world.
San-I-Pak
systems have been developed to insure the proper efficacy of every
load infectious waste processed. The chambers are designed to
insure proper load density and waste penetration for "Total
Sterilization".
Upon initiation
of the sterilization cycle, San-I-Pak
systems first pulls a vacuum (pre-vacuum) within the sterilization
chamber in order to remove the air. The pre-vacuum is an important
element of the sterilization process because it eliminates the
excellent insulating qualities of air. The air and any airborne
microorganisms, which are extracted during pre-vacuum, are mixed
with 307º F. steam and piped into a sanitary sewer line.
After pre-vacuum, steam is pumped into the sterilization chamber,
because of the vacuum conditions, steam makes contact throughout
the contents of the chamber instantly. Steam enters the sterilization
chamber until the vessel reaches a minimum of 38 lbs. of pressure.
Pre-vacuum then steam injection ensures total penetration of the
steam into the waste. After a temperature of 270º F is achieved
within the chamber, a 30 minute timer is automatically activated.
Within minutes, the chamber will reach its ultimate temperature
of 281º F - 284º F. Tests run by various certification
and regulatory agencies have proven that temperatures in excess
of 270 degrees F., combined with a pre-vacuum cycle, will kill
Bacillus Stearothermophilus.
Processing
safeguards incorporated into San-I-Pak's
design are to ensure complete treatment of the waste. San-I-Pak
units are programmed to only discharge the waste after operational
parameters have been successfully achieved. Parameters for sterilization
include the pre-vacuum cycle, chamber pressure, time duration
and temperature. The sterilization parameters are programmed into
the unit's Programmable Logic Controller (PLC) and cannot be changed
by the operator, unless San-I-Pak
is directed to provide optional programs for the PLC. The analog
capabilities of the PLC are extremely reliable and allow simple
and accurate monitoring of the San-I-Pak
sterilization process.
Each San-I-Pak
unit is equipped with a digital display which clearly shows each
machines function as it takes place. The display will also alert
the operator if there is a system interruption or problem, i.e.,
power has been shut off to the unit, the sterilizer won't initiate
a cycle because the key switch hasn't been depressed, etc. When
an 'alarm' occurs, the digital display will explain what actions
need to take place in order to resume operations. The alarms are
stored in the units computer for future reference. In addition
to the digital display each San-I-Pak
unit is equipped with a strip printer which records time, temperature,
pressure and vacuum for each sterilization cycle. Any alarms that
may occur will be printed out with the date and time listed.
To further
insure operational quality San-I-Pak
offers the 'In House Monitoring System' which enables the remote
monitoring of the San-I-Pak
equipment by either Environ-mental Services or Engineering management.
The software allows the manager to monitor current, real-time
functioning of the equipment and provides complete machine diagnostic
capability. Additionally, the manager can down load all historic
cycle information directly into the software's data base. The
information provides the manager with total machine performance
levels. From collected data, main-tenance requirements can be
scheduled prior to experiencing any un-scheduled down time. The
software enables the facility to have on file, a synopsis of every
cycle the machine runs during its lifetime.
Strict
programming of the control electronics of all San-I-Pak
units prevents the discharge of un-sterilized waste. San-I-Pak
employs parametric motoring, which is superior to Biological Test.
The computer has a built-in steam table that enables constant
comparison of vessel temperature with vessel pressure. Other fail
safes such as time to vacuum, vacuum level, time to temperature,
droop control and vent time exceed conventional testing. In the
unusual occurrence of any discrepancy in the programmed parameters,
the process will be halted and then after correction cycle must
be restarted.
Select
to View Info on Efficacy Testing of San-I-Pak Equipment
Testing
Performed on San-I-Pak Equipment:
A
study composed by the Advisory Committee on Dangerous Pathogens
(U.K.) entitled Categorisation of Biological Agents According
to Hazard and Categories of Containment recommends that contaminated
CJD materials be treated in a high vacuum sterilizer at temperatures
no less than 134°C (273°F) for 18 minutes. The parameters
of the San-I-Pak
system are 285°F for 30 minutes.
Due to San-I-Pak's
treatment parameters and unique design, San-I-Pak
was the only technology tested by the United States Environmental
Protection Agency, USEPA, to achieve total kill with each and
every test that was performed on the San-I-Pak
system. Because of San-I-Pak's
proven reliability, several institutions across the country that
have admitted CJD patients have processed this waste material
through a San-I-Pak
system. In cases where the hospital did not have a San-I-Pak
system, the waste was transported to a San-I-Pak
location for treatment because the hospital was not confident
their current disposal method would properly treat the waste.
J.
L. ANALYTICAL SERVICES:
In 1982 J. L. Analytical Services was contracted, by San-I-Pak
, to run efficacy tests utilizing the San-I-Pak
located at Sonoma Hospital (Attachment 1).
Six pathogenic microorganisms were used:
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