STERIPLUS INFECTIOUS MEDICAL WASTE GRINDING AND DECONTAMINATING UNIT

Transcription

1 STERIPLUS INFECTIOUS MEDICAL WASTE GRINDING AND DECONTAMINATING UNIT Page 1 of 9

2 What is steriplus INTRODUCTION The SteriPlus machine converts clinical waste to inert waste which is approved for disposal direct to landfill as general waste without any additional treatment in many countries. BEFORE AFTER Dangerous Medical Wastes Non-infectious & Unrecognizable Treated Wastes The SteriPlus unit is designed for use by individual generators of clinical/medical waste which can be treated by Steam Sterilization / Autoclaving. The only exclusions are human body parts, cytotoxics, radio-active materials, prescribed pharmaceuticals and chemicals. These items generally make up approximately 5% of a hospital waste stream. The units have been built to international standards and are accredited with a CE (European Community) Certification. Additionally, the units have been inspected and acknowledged as conforming to a range of French Standards, as required by industry in general, and medical facilities in particular by a Registered Professional Engineer. To avoid the costs and risks associated with biohazardous waste storage and transport, particularly for health care providers that generate small volumes, Tesalys STERIPLUS Systems range have been developed with the following objectives: Ease of use for waste generators Can be installed wherever required, as close as possible to the waste generation site Respects time limits for biohazardous waste generation and disposal Uses advanced, easy-to-validate technology Adapts its capacity to the quantity of waste to dispose of Can manage small on-the-spot flow of waste Requires moderate investment/budget Particular thought was given to green design concepts: apart from treating the air and effluents produced by the equipment, the system consumes very little electricity and water, thanks to heat-recovery mechanisms. Page 2 of 9

3 OPERATION Tesalys STERIPLUS System is a disinfection pre-treatment solution for biohazardous waste, according to the French standard NF X It is a sterilizer (autoclave) with an integrated shredder, which first shreds the waste before performing an autoclave cycle with steam at 135 C/275 F. Once treated with STERIPLUS, biohazardous waste is transformed into waste similar to municipal solid waste that can be destroyed like any other inert industrial waste or household waste. I. SHREDDING The TESASHRED shredder was specially designed by Tesalys for processing biomedical waste. Robust and efficient, it transforms waste into unrecognizable 8-10 mm pieces. The shredder s cutting blades perform low-speed movements back and forth. If the shredder becomes blocked, it automatically continues in the opposite direction. The waste is pushed towards the shredder by a plate that drops automatically. The system is capable of detecting the level of waste in the shredding chamber to ensure that all waste is correctly shredded. The shredded waste drops by gravity into the decontamination chamber. Liquids flow by gravity into a specific cavity at the bottom of the decontamination chamber, where they will be processed before being discharged. Page 3 of 9

4 After shredding, the volume of solid waste is reduced by 80%, according to the type of waste. Shredding with the TESASHRED system transforms waste to render it unrecognizable and eliminate any mechanical risks. Materials that can be shredded with STERIPLUS : All types of flexible or rigid plastic, rubber, textile, non-textile, paper and cardboard, metal (small sized such as needles, scalpels, small surgical instruments, etc.), glass, human or animal tissue (such as placentas, biopsies) or bone tissue (bone fragments or small-sized bones), liquids. II. AUTOCLAVE STERILIZATION autoclave/ steam sterelizes the material to ensure the waste is classed as non-infectious to International requirements Autoclaving/sterilization at 135 C/275 F reduces the starting microbial load to 8 log10. FEATURES: STERIPLUS was specially designed to be installed as closed to the biohazardous waste generation site as possible, thus reducing the risk associated with storage, transport and disposal. The main features of STERIPLUS include: 1. Reduces contamination by 6 log10 with an autoclaving cycle of steam at 135 C/275 F (reduces bacterial spores by 8 log10) 2. Waste loading chamber: Automatic steam decontamination between cycles 3. Shredder feed system: Fully sealed and automatic, with waste level detection 4. TESASHRED shredder: Unique shredding system. Transforms waste into unrecognizable 8-10 mm pieces 5. Reduces solid waste by up to 80% in volume, up to 50% in weight 6. Liquid waste and effluents decontaminated before disposed of down the drain 7. Air released filtered by a 0.2 µm filter 8. Water softener, water booster pump and air compressor incorporated 9. Inlet water pre-filtering system 10. Ventilation of the electrical cabinet 11. Full traceability of the treatment cycle via built-in printer Page 4 of 9

5 PERFORMANCE The SteriPlus machine performs the following steps: renders the waste non-infectious to internationally recognized standards, renders the waste unrecognizable, significantly reduce the volume and mass of the waste, avoids production of unacceptable levels of hazardous or toxic by-products, is environmentally acceptable, is verifiable for treating wastes, has automatic controls and failsafe mechanisms and waste cannot bypass the treatment process. Each SteriPlus machine operated over an 8 hour shift will process the equivalent of approximately 7 x 240 liter wheelie bins of waste. One SteriPlus machine, working daily throughout the year, has the capacity to treat 43,800 kilograms or 2,576 x 240 liter wheelie bins of clinical waste. (This estimation is based on bin weights provided from 3 separate sources; national waste transporter, large public hospital and clinical waste treatment company). Waste is generated 365 days per year in a hospital and the SteriPlus machine allows you to treat your waste every day. This can reduce the required storage space within the facility. Due to the small size of the machines (footprint 1.0m x 0.7m = 0.7m2) and the ease of installation, it is very simple to place a unit close to where the waste is being generated. As an example, a machine could be placed on the same floor as the operating theatres. This way the waste can be treated virtually as it is generated. The sound from an operating machine is no more than that of a modern washing machine. The result is a reduction of staff time involved in moving waste from theatre or generation point to storage area on the ward and from ward storage to facility storage. With a SteriPlus unit, waste can be moved direct from generation point to treatment or a bank of machines can be established so that the waste can be processed rather than stored in the usual waste areas. The SteriPlus machine reduces the volume of your waste by up to 80%. As an example 5 x 240 liter bins would be reduced to approximately 1 x 240 liter bin of treated material. The treated solid waste from the SteriPlus machine has received international approvals for disposal with general waste. BENEFITS The benefits of having an on-site treatment option are significant. Self-management will always be less expensive than having a contractor involved in the process. As an example, the process associated with a contractor includes many more steps to the treatment and disposal process including: 1. Waste Created - Waste is generated from the normal activities within the hospital. 2. Waste Packaged - The waste is moved from small bins into larger containers. 3. Ward Storage - The larger containers are stored in the ward. Page 5 of 9

6 4. Relocation - Empty bins replace full bins and moved from ward area. 5. Storage - The full bins are moved into the facility storage area. 6. Collection - The contractor vehicles come on site and collect full containers. 7. Transport - The contractor transport the bins to a selected facility. 8. Unloading - The bins are stored until a sufficient quantity is held for disposal. 9. Treatment - The treatment process is carried out at the facility. 10. Collection - Treated material is collected and stored till sufficient quantity on hand. 11. Disposal - Treated material is transported for disposal or further treatment. By eliminating the cost of storage, double handling by staff and contractor, transport to and from disposal facility, destruction costs, associated maintenance by the contractor on equipment as well as their overheads and profits, you will be greatly reducing the costs to your facility. You will no longer be relying totally on a third party. This eliminates potential problems that could arise due to industrial action, road accidents, road closure (floods), inclement weather, and incinerator break down or maintenance shut-down. Additionally, under legislation in many countries, the generator of the waste owns the waste until it is sign for at an approved treatment facility. If an accident occurs the waste generator is partially liable for any possible litigation. STANDARDS AND QUALIFICATIONS Tesalys STERIPLUS systems are entirely designed and manufactured in France under ISO 9001 quality assurance and in accordance with the strictest regulations, such as the French standard NF X They have been tested by independent laboratories and are approved in France by the Ministry of Health and the Ministry of Ecology and Sustainable Development. The sterilization cycle has been qualified in accordance with international standards EN 554 and EN ISO Tesalys STERIPLUS systems have standard IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) protocols that are specifically adapted to verifying the correct operation of bio contaminated waste treatment systems. Qualification focuses on shredder performance, microbiological efficacy and environmental performance. The efficacy of the STERIPLUS System has been tested under various aspects: Microbiological efficacy of the decontamination cycle: reduced to 8 log10 Revival of processed waste: analysis of non-recontamination after 28 days incubation Physical transformation of the waste (shredder efficacy): cut into pieces between 8-15 mm. Environmental efficacy: treatment of the air released by the system through a microbiological filter; treatment of liquid effluents released from the system at 135 C/275 F EPA REQUIREMENTS Environmental departments from various international governments have provided written support for the STERIPLUS machine to operate at 135 C for 20 minutes. The laboratory tests, clinical trials and independent analysis prove the STERIPLUS machines achieve International requirements for non-infectious status in accordance with the Log10 kill rate of 4 for bacteria spores and Log10 kill rate of 6 for vegetative spores. A quality assurance program can be instigated, whereby samples of treated material from operating machines will be collected by SteriPlus every three months and sent for laboratory analyses. The results will be provided Page 6 of 9

7 to the Facility and relevant government authorities to qualify the ongoing commitment of SteriPlus to meet regulatory standards. The co-mingling of treated material from SteriPlus machines with general waste has been endorsed by a number of government through-out the world. DISPOSAL TO SEWER OF LIQUID RESIDUE In accordance with requests from local authorities, SteriPlus conducted tests on the liquid residues evacuated from the SteriPlus machine under supervision and control of a Registered Professional Engineer. The purpose of the tests was to determine the effect the process had on plastics and metals. The purpose was not to test the operational performance of the SteriPlus machine in relation to contaminated wastes as these tests have already been performed by the Faculté des Sciences Pharmaceutiques as part of the clinical trials conducted by the French government. The materials treated were individually counted and weighed under supervision before being processed through the machine. The liquid residues were collected by the Engineers in sterile containers provided by the NATA Certified testing laboratories. The Engineers then delivered the samples direct to the testing laboratories who were asked to conduct particular tests. The analyses performed were: Total Organic Carbon (TOC) Suspended Solids (SS) Heavy Metals - Cd, Cr, Cu, Hg, Pb, Ni, Zn Semi-volatile Organic Compounds (SVOC) Volatile Organic Compounds (VOC) There were no recorded concentrations of compounds found in the water samples that were above the acceptance guideline values published. Page 7 of 9

8 INSATLATION AND TRAINING The machines are installed within 12 weeks of the order. Every machine is individually manufactured and the process includes a minimum of 2 weeks testing for each unit. This is one of the quality assurance requirements self-imposed by the manufacturer that has assisted in being granted the important CE Approval (European Community). We require our customers to confirm certain requirements for the machine, including single or 3 phase power, external panel requirements, colour etc. Assistance is provided for suitable location selection on the customers premises. Once the machines have been connected to power, water supply and sewer for waste water disposal, STERIPLUS conducts Acceptance Testing as part of the commissioning process. At the completion of this testing, STERIPLUS will commence the Training Program. The Training Program is conducted in conjunction with the Operators Manual. It is held over a period of one week to ensure all relevant staff are included as well as Supervisors and in-house Trainers. While the actual hands-on training will require only two days, our staff member will remain on site for the full week to observe operators and pass on suggestions or advice to achieve maximum results. It is in the interest of STERIPLUS that our customers achieve the best possible results from our machines to encourage positive feed-back within the marketplace. SAFTY The STERIPLUS machine has been designed and constructed to meet the stringent safety standards required throughout Europe as signified by the CE Approval. The CE Approval immediately confirms the equipment is accepted by all countries of the European Economic Community. This approval not only relates to quality of construction but also has a heavy focus on the safety features of the equipment manufactured. The STERIPLUS machine has been inspected by a Registered Professional Engineer. This company is a Registered Research Agency and a Registered Product Development Consultant. As a result of the inspection, the Engineer has noted the STERIPLUS machine also conforms to Australian Standard AS Safeguarding of Machinery - General Principles. The equipment design features a comprehensive list of automatic controls and fail-safe mechanisms including: Digital display featuring operating procedure and operating parameters (pressure, temperature, time), Printout of every cycle for easy recording, Restriction of two shredding loads per cycle in conjunction with limits of hopper eliminates the possibility of overloading the machine, Processor controls to only allow operation of the shredder after hopper lid has been locked to provide maximum operator protection, Combination of automatic bactericide spray and vacuum system maximises operator protection during loading of hopper, "Guillotine" valve isolates the treatment chamber from the external environment, protects the operator, insulates the treatment chamber and allows sanitation of the shredder during every cycle, Automated autoclave procedure ensures every load is treated to the required time pressure and temperature for every cycle, Page 8 of 9

9 Locking mechanism prevents accidental or deliberate opening of the hopper, Trip device on hopper lid monitors hopper and shuts down the unit if the hopper is forced open or tampered with during treatment process, Automatic "cleaning cycle" every time machine is turned on to ensure machine is clean and empty before use to eliminate operator exposure, Sensor warning when bactericide level is low, Two levels of pressure relief (one mechanical and one processor controlled) for steam generator and treatment chamber to ensure machine will not be over pressured The following mechanisms ensure waste cannot bypass the treatment process: If a power surge or power failure disrupts the cycle, the machine will automatically restart from the "cleaning" cycle to ensure no waste can bypass the treatment cycle, The waste outlet will only open when the autoclave process is complete and the chamber pressure has reached ambient pressure. The "guillotine" valve prevents access to the waste after shredding and while autoclave process is in operation, There is no available mechanism to access waste once it has been loaded into the hopper and hopper lid is closed. During the first loading cycle, the operator has the option to add more waste after the bactericide cycle and before shredding. At no other time can the waste be seen or accessed until the completion of the full treatment cycle. The operating parameters of each cycle (time, temperature, pressure) are measured and acknowledged by: Real time display on screen, Paper printout at the completion of the cycle which provides minute by minute recordings, Communication by the on-board modem connection. Page 9 of 9