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Sterile Technology Industries, Inc. In-service Training Session. BIOMEDICAL WASTE MANAGEMENT BY STEAM STERILIZATION . Sterile Technology Industries, Inc. . Total Treatment without Incineration. Biosafe Engineering, LLC., 485 Southpoint Circle, Bldg. 200 Brownsburg, IN 46112
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In-service Training Session
Total Treatment without Incineration
Biosafe Engineering, LLC., 485 Southpoint Circle, Bldg. 200
Brownsburg, IN 46112
Phone: 317-858-8099 Fax: 317-858-8202
Toll Free: 888-858-8099 Email: firstname.lastname@example.org
for on-site treatment of RMW at your facility
If your state issues approval letters, STI will provide a copy to you for your files.
A. YES. Normally, the user must make application for on-site use by permit, or permit by rule.
A. YES. The STI Series 2000 is commonly used to shred confidential records instead of hiring a mobile service for this purpose.
A. YES. You will have a need to haul away Chemotherapeutic waste. You may also want to haul away pathological waste for perception purposes. Normally, both of these types of waste combined amount to 0.5% of the total Regulated Medical Waste stream.
A. Yes, no air, water, or soil pollution is associated with the
STI Series 2000.
A. No, the unit is entirely automatic, dumping an entire cart and its contents without the need for an operator. Typically, environmental service employees that pick up the waste roll the cart into the machine and push one button. That’s it!
A. NO, because the equipment is going to shred both the waste and the waste containers. Use the least expensive, compliant bags you can purchase to meet your needs!
A. Each time the unit raises and dumps a cart load of waste, a small pump turns on and dispenses a tiny (ml) amount of Bleach and water solution for only about 10 seconds through spray nozzles (like on the top of a Windex bottle). A gallon of bleach will last several days in the typical hospital. The use of bleach in the system is approved by the USEPA, FIFRA branch for compliance with USEPA standards and does not have a negative impact on the environment. If you begin to notice an unpleasant odor, merely increase the amount of chemical delivered (not the concentration).
A. Yes. The STI system can be installed indoors or outdoors as the user likes. In areas where freeze is a concern, STI heat-traces and insulates plumbing interconnections that may come in contact with cold temperatures.
A. STI estimates the cutters to last between 2-3 million pounds of throughput prior to replacement. This is unheard of in our industry.
A. Life expectancy of the STI system is thought of in terms of pounds of throughput, not years. This is because the system is maintainable. To date, the oldest single system (installed in 1995) has processed approximately 250 million pounds of waste.
Q. How much waste will your facility generate this year?
A. STI hires, directs, and pays the professional heavy rigging crew, plumbers, and electricians licensed in your state to assist with the installation. Following installation, STI will train your staff to both operate and maintain the system, and will initially test the system for efficacy verifying conformance with State performance standards. STI is also available by phone to troubleshoot over modem if required.
for the STI Series 2000™
* Introduction to RMW and OSHA basics for personal awareness
* Discuss suggested handling techniques of RMW Blood Borne Pathogens
* RMW spill concerns
* Safe handling of the treatment chemical
* Recommended Protective apparel
* Why and how sodium Hypochlorite (chemical) is used to
decontaminate the system in automated fashion.
* Chemical use and MSDS sheet
* Why shredding is employed
* Discuss use of steam and explain safety protocols for operation and maintenance
Discuss the use of electrical power and related safety issues
Emergency stop functions, interlock switching for personnel protection
Show actual system controls and explain their use as it pertains to the unit
Pre-start check list
Automatic system start up and shut down
On-Going Quality Assurance Program (Periodic Spore Testing)
Basics behind the design of the STI Series 2000™ system
(press spacebar for exploded view)
* Approved RMW waste stream for treatment
( No Pathological or Chemo. Wastes)
* Safety in Use & Maintenance = Lock-out/Tag-out procedures and
common sense. No “Horse Play”
* Operator & Maintenance Certification Requirements
* Recommended Maintenance schedule
* Trouble shooting techniques
* Recommended spare parts & lead times on parts/parts stocking
Efficacy Testing / Quality Assurance / Technical Data
The STI system is regularly tested by challenging the system with known quantities of Bacterial Spores like B. subtilis (now known as B. atrophaeus.) The system is capable of achieving a Level III inactivation of these organisms or a 106 reduction of colony forming units.
Most states require Level III inactivation of Bacterial Spores, otherwise known as 10 Log 4 reduction of these organisms. The following presentation provides a brief visual description of how the Quality Assurance Program is carried out with the STI system. This QA program is tried, proven, and reliable.
PVC “testing eggs” are used to hold the bacterial challenge. They are perforated to allow steam to enter the inside of the carrier. The “eggs” are identifiable unlike the shredded waste, and are are introduced below the shredder. The Bacterial spores inside of the carrier see the exact same level of treatment as the balance of the waste being processed.
In testing done for California, sealed test tubes with 1 X 108 M. terrea were prepared for the efficacy runs. The vials completely isolated the organisms from the cleansing sanitizer used during the process, thus making this test a confirmation of the steam treatment process of the STI system
3-M ATTEST brand Bacterial spores are typically used to challenge the STI Chem-Clav process. The use of the 3-M ATTEST eliminates the need for elaborate laboratory testing, making the QA process easy for users.
The tubes were placed within PVC “testing eggs”, wrapped in sterilization paper to prevent breaking of the tubes during the process.
Bacterial spore tubes are placed inside of the “eggs” shown here!
The “egg” is capped, then placed into the spore test port just below the shredder. It typically takes in excess of 1 hour for the egg to travel through the system prior to discharge.
The waste temperature is measured directly through two type “J” thermocouples mounted on the bottom of the auger section, the lower one in the steam injection portion, and the upper one in the dehydration section. The thermocouples receive the actual waste temperature and transmit the signal to the digital readouts and chart recorder shown at the right
Hard copy strip chart recorder
Lower Clav Waste Temperature
The processed egg and its contents are recovered at the end of the process on a catch grate just above the waste receiving compactor
The eggs are opened and the tubes removed. The autoclave tape on the tubes indicate that high temperature was achieved
The 3-M ATTEST tubes are incubated for the prescribed period of time and read. The reading is a simple color test. An untreated control is also incubated for comparison. Results are logged in a book for the state regulatory personnel.
Most states require that the QA testing procedure take place a minimum of once every 40 hours of machine operation. STI recommends that this QA testing be performed on the waste entering each compactor bound for the landfill prior to departure to the landfill. Testing frequency should not be less than the prescribed frequency by law. By testing the waste in each compactor, the landfill authority will appreciate the diligence on the part of the waste generator.
Volume of Test Suspension (ml)
1.0 X 108
1.0 X 109
1.2 X 108
1.2 X 109
2.2 X 108
2.2 X 109
Test Suspension Processed
Volume of Test Suspension Filtered*
No. of M. terrae Survivors Recovered
Log Reduction (Log Kill)
Under the conditions presented in this report, the STI Series 2000 Medical Waste Treatment System demonstrated complete kill of M. terrae. The population challenge loads yielded a total log10 reduction of greater than or equal to 8.30.
Day 1 Day 2 Day 3
Test Date: 4-5-02
Machine: STI Series 2000
Compactor: # 1
Time in: 11:40AM
Time out: 12:45PM
Lot #: 123456
Technicians Name: R. McKee
Visual Temp Readout: 226
Hour Meter Reading: 1480
Treated sample PASS: Yes Yes Yes
Treated sample FAIL: No No No
Control Growth: Yes Yes Yes
1.Where can you find a copy of the Operation & Maintenance Manual to review?
2.What is the name of the chemical used to clean the hopper and
shredder for the system and where can you find the MSDS sheets?
3.What is the main treatment process of the RMW in the STI Chem-Clav® unit?
4.What is the MAX. operating pressure of the pressure vessel?
5.What does the touch-screen do for you?
6.What conditions must have occurred to allow the processed waste to be transported to the landfill?)
7.How often does the unit require the on-going Q.A. testing in number of hours.of machine operation.
8.What are MSDS sheets? (What does this stand for?)
9.What signifies that you are authorized to operate or maintain the equipment?
10.What specific section of the Federal Register were you supplied by STI which applies to Bloodborne Pathogens?
11.What is the name of the indicator organism used for on-going testing?
12.What does LOCK-OUT/TAG-OUT refer to?
13.What potential dangers exist in and around the machinery? List 4
14.What does spill containment refer to?
15.What section of the manual discusses procedures and instructions for testing the unit?
16.Once the waste is dumped into the machine there is no need to test the unit for proper operation. ______True ______False
17.Since the machine uses a chemical to clean the waste, there is no need to put on personal protective apparel prior to entering the unit to remove an obstruction in the shredder or hopper. ______True ______False
19.The operating temperature of the system is between 205 - 245 degrees F. _______True ______False
20.The machinery is a perfect device that will never leave an intact needle from a syringe. ______True ______False.
21.What must the operator do if the SHREDDER/RESET LIGHT is on?
22.What indicates that the unit is ready for the next load of waste?
23.What happens if the compactor becomes full?
NOTE: End of Operator Testing Section (maintenance continue)
25.Where does a person find the recommended frequency
for service on the machinery?
26.What is the maximum operating temperatures of the system in degrees F.?
27.Where do you find the service frequency for changing oil in
the main gear case of the shredder?
28.How often should you “Rod-out” steam injection lines?
29.What detects the actual temperatures in the Auger?
30.If large pieces of waste are seen frequently coming from the
unit, what may be the culprit?
ORDINARY red bags work fine in the STI system.
NO EXPENSIVE AUTOCLAVE BAGS to buy
Nothing compares!TYPICAL CUTTER ARRANGEMENT
When new, tolerances are about .005”
Maximum odor control; STISeries 2000 steam treats and dries the waste making it light & inexpensive to landfill.
31.What happens to cutters as they wear? (how is it normally noted)?
32.How large should the gap be between cutters before they usually
33.How often should you lubricate the bearings on the shredder?
Name of Trainer giving test: __________________________STI
STI Series 2000™