Sterile Technology Industries, Inc. In-service Training Session

1. Sterile Technology Industries, Inc. In-service Training Session

2. 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 Phone: 317-858-8099 Fax: 317-858-8202 Toll Free: 888-858-8099 Email: info@biosafeengineering.com

3. State-of -the-Art Stainless Steel STI Series 2000™ for on-site treatment of RMW at your facility

4. Frequently asked Questions & Answersregarding the implementation of the STI Series 2000Medical Waste treatment system

5. Q. Does the STI Series 2000 comply with state Regulations pertaining to RMW? A. YES If your state issues approval letters, STI will provide a copy to you for your files.

6. Q. Do you need to apply for a permit to use the system on-site at one or more of our facilities? A. YES. Normally, the user must make application for on-site use by permit, or permit by rule.

7. Q. Can you use the STI Series 2000 system to destroy confidential HIPPA documents? A. YES. The STI Series 2000 is commonly used to shred confidential records instead of hiring a mobile service for this purpose.

8. Q. Will you have any off-site hauling needs with the use of the STI system? 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.

9. Q. Is the system environmentally friendly? A. Yes, no air, water, or soil pollution is associated with the STI Series 2000.

10. Q. Do you have to manually load the system requiring an operator? 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!

11. Q. Does the STI Series 2000 require expensive autoclave bags? 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!

12. Q. How much chemical (sodium Hypochlorite)(Bleach) is used in the system and does it have a negative environmental impact? 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).

13. Q. What is the source that treats the waste in the STI Series 2000? A. Steam

14. Q. Can the unit be installed outdoors without worry of freeze or extreme heat? 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.

15. Q. How long do the cutters last in the shredding chamber? A. STI estimates the cutters to last between 2-3 million pounds of throughput prior to replacement. This is unheard of in our industry.

16. Q. What is the useful life of the STI Series 2000 system? 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?

17. Q. What occurs during and after the installation of the STI system? 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.

18. STI In-Service Training Outline 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

19. STI will train users in safety, recommend the use of PPE and promote safe handling.

20. STI In-Service Training Outline 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)

21. Exploded View of the STI Series 2000 System

22. STI In-Service Training Outline * 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

23. STISeries 2000™ Efficacy Testing / Quality Assurance / Technical Data

24. 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.

25. 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.

26. 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.

27. 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.

28. 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!

29. 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.

30. Upper Clav Waste Temperature 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

31. 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.

32. 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.

33. Cycle No. Challenge Load (cfu/ml)* Volume of Test Suspension (ml) Challenge Load (cfu) 1 1.0 X 108 10 1.0 X 109 2 1.2 X 108 10 1.2 X 109 3 2.2 X 108 10 2.2 X 109 Cycle No. Volume of Test Suspension Processed Volume of Test Suspension Filtered* No. of M. terrae Survivors Recovered Percent Reduction Log Reduction (Log Kill) 1 10 ml 2 ml 0 100% >8.30 2 10 ml 2 ml 0 100% >8.38 3 10 ml 2 ml 0 100% >8.64 IV.Conclusion 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.

34. SPORE TESTING LOG (SAMPLE) INSPECTION DAY 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

35. 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: info@biosafeengineering.com • TRAINING COURSE / IN-SERVICE • TEST • For the: • STI Series 2000™ • TRAINEE’S NAME: _________________________ • (PLEASE PRINT CLEARLY) • Date____/____/____

36. TESTING FOR OPERATION OF THE STI CHEM-CLAV® • (Please complete this section by writing in the correct answer) 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?)

37. TESTING FOR OPERATION OF THE STI CHEM-CLAV® • (Please complete this section by writing in the correct answer) 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?

38. TESTING FOR OPERATION OF THE STI CHEM-CLAV® • (Please complete this section by writing in the correct answer) 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

39. TESTING IN OPERATION OF THE STI CHEM-CLAV® • (Please complete this section by writing in the correct answer) • 18.Always disconnect all electrical power prior to service or welding • on the machinery. _______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)

40. TESTING IN MAINTENENCE FOR THE STI Series 2000 • (Please complete this section by writing in the correct answer) • 24.What is the main voltage of the STI ® unit?_____VAC. 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?

41. Route HIPPA documents and RMW to the STI Series 2000™ 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”

42. Landfill with Confidence! Maximum odor control; STISeries 2000 steam treats and dries the waste making it light & inexpensive to landfill.

43. TESTING IN MAINTENENCE FOR THE STI Series 2000 • (Please complete this section by writing in the correct answer) 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 require replacement? 33.How often should you lubricate the bearings on the shredder? Name of Trainer giving test: __________________________STI Date Graded_____/_____/_____

44. One stop for the tools you need to eliminate your Regulated Medical Wastes Sterile Technology Industries, Inc. www.biosafeengineering.com • Regulated Medical Waste treatment without incineration STI Series 2000™