STERILE PROCESSING PACKAGES

Our Sterile Processing Packages are engineered to meet the evolving requirements of AAMI TIR34, soon to be replaced by the more stringent ANSI/AAMI ST108:2023 standard for water used in reprocessing medical devices. These packages offer a comprehensive approach to ensure that every drop of water used for cleaning, rinsing, disinfection, and sterilization meets the highest quality standards, enhancing sterility assurance and patient safety.

Key Features and Benefits

Comprehensive Water Quality Management:

Advanced Filtration Systems: Incorporates multi-stage filtration, including reverse osmosis, ultrafiltration, and deionization, to produce high-purity water that meets critical water standards.
Endotoxin Control: Equipped with high-efficiency filters designed to remove endotoxins, bacteria, and other contaminants, supporting sterility assurance and enhancing medical device processing.
Water Purity Analysis: Real-time monitoring of total dissolved solids (TDS), total organic carbon (TOC), and heterotrophic plate count (HPC) ensures consistent water quality across all processing steps.

Automated Testing and Compliance:

Microbiological and Endotoxin Testing: Integrated systems perform automated microbiological testing and endotoxin detection, providing immediate feedback on water quality and compliance with ISO 11139:2018 and ST108 standards.
Performance Qualification (PQ) and Validation: Built-in validation and verification processes support ongoing compliance testing and performance qualification, ensuring reliable operation and adherence to new standards.
Data Logging and Risk Analysis: Advanced data logging capabilities facilitate continuous quality improvement, allowing for comprehensive risk analysis and proactive management of water quality issues.

Compact and Easy Integration:

Space-Efficient Design: Designed to fit seamlessly into sterile processing environments, these packages require minimal space while delivering maximum performance.
Pre-Piped and Pre-Wired: Fully assembled and tested before delivery, our packages offer a plug-and-play solution that integrates effortlessly with existing water treatment systems.

Continuous Quality Improvement and Compliance:

Real-Time Monitoring: Automated systems continuously track key water quality parameters, with alerts for any deviations, ensuring that your processes remain compliant and efficient.
Sterility Assurance and Validation: Meets and exceeds requirements for sterility assurance, with features designed to support robust validation and verification processes, enhancing the overall safety and effectiveness of medical device processing.

Designed for Future Standards Compliance

As the guidance of AAMI TIR34 evolves into the ANSI/AAMI ST108:2023 standard, our Sterile Processing Packages are designed to stay ahead of regulatory changes, providing a future-proof solution that keeps your facility compliant. With features like comprehensive water monitoring, advanced filtration, and automated testing, our packages support every aspect of water quality management, ensuring that your sterile processing meets the highest standards of safety and efficacy.

Upgrade to the Ultimate Sterile Processing Solution

Ensure your sterile processing operations are equipped to handle the latest standards with our all-in-one Sterile Processing Packages. From performance qualification to continuous quality improvement, our packages provide everything you need to achieve and maintain compliance, optimize water quality, and enhance sterility assurance in your facility.

SPECIFICATIONS

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	SP 45 Package	SP 90 Package	SP 135 Package	SP 190 Package	SP 260 Package	SP 390 Package	SP 525 Package
Reverse Osmosis - Gallons per day - Gallons per hour	CGD14 1,080 GPD 45 GPH	CGD24 2,160 GPD 90 GPD	CGD34 3,240 GPD 135 GPH	PG34 4,560 GPD 190 GPH	PG44 6,240 GPD 260 GPH	PG64 9,360 GPD 390 GPD	PG84 12,600 GPD 525 GPH
Pretreatment System	821013 Dual 35 Gallon Tanks w/Pumps for SP45, 90 & 135	821013 Dual 35 Gallon Tanks w/Pumps for SP45, 90 & 135	821013 Dual 35 Gallon Tanks w/Pumps for SP45, 90 & 135	821011 Dual 35 Gallon Tanks w/pumps for SP190 & 260	821011 Dual 35 Gallon Tanks w/pumps for SP190 & 260	821021 Dual 35 Gallon Tanks w/pumps for SP390 & 525	821021 Dual 35 Gallon Tanks w/pumps for SP390 & 525
Remote Alarm	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase	823100 Alarm assy w/100 ft 2 strand wire, 115v, single phase
Storage Tank Size	870110 100 gal / 30” x 94”	870110 100 gal / 30” x 94”	870110 100 gal / 30” x 94”	870215 250 gal / 44” x 93”	870215 250 gal / 44” x 93”	870215 250 gal / 44” x 93”	870315 350 gal/44” x 110”
Distribution Pump	850202 18 GPM @ 52 PSI, 1 phase	850202 18 GPM @ 52 PSI, 1 phase	850202 18 GPM @ 52 PSI, 1 phase	850300 50 GPM @ 50 PSI, 3 Phase	850300 50 GPM @ 50 PSI, 3 Phase	850300 50 GPM @ 50 PSI, 3 Phase	850300 50 GPM @ 50 PSI, 3 Phase
Multi Cartridge Vessel for Bacteria / Endotoxin	880100 Stainless Steel with (5) absolute rated cartridges (2.5” x 20”). 50 GPM	880100 Stainless Steel with (5) absolute rated cartridges (2.5” x 20”). 50 GPM	880100 Stainless Steel with (5) absolute rated cartridges (2.5” x 20”). 50 GPM	880101 Stainless Steel with (5) absolute rated cartridges (2.5” x 30”). 75 GPM	880101 Stainless Steel with (5) absolute rated cartridges (2.5” x 30”). 75 GPM	880101 Stainless Steel with (5) absolute rated cartridges (2.5” x 30”). 75 GPM	880101 Stainless Steel with (5) absolute rated cartridges (2.5” x 30”). 75 GPM
Clean in Place for RO Disinfection/Cleaning	821900 35 Gallon Tank w/inlet & outlet for SP45, 90 & 135	821900 35 Gallon Tank w/inlet & outlet for SP45, 90 & 135	821900 35 Gallon Tank w/inlet & outlet for SP45, 90 & 135	821901 35 Gallon Tank w/inlet & outlet for SP190 & 260	821901 35 Gallon Tank w/inlet & outlet for SP190 & 260	821902 35 Gallon Tank w/inlet & outlet for SP390 & 525	821902 35 Gallon Tank w/inlet & outlet for SP390 & 525