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1. Our entire machine base structure is fabricated from stainless steel with a solid top base plate of 28mm thick with a ground finish. |
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2. Our machine control electronics are based on the proven Siemens S-7 PLC platform with Profibus/Profinet and Simatic totally integrated automation. This is an internationally recognized standard that has world-wide local support. |
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3. Our machines utilize HEPA air absolute filtration to maintain the environment of the Class 100 filling zone. This is very economical compared to the use of expensive cartridge filters and it also decreases production time by eliminating the need to conduct integrity filter testing. |
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4. There is no need for the use of pure steam during normal production (economic advantage). Steam is used only during SIP, and we confirm the sterility of the process/product path through the fully automated sterilization cycle. |
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5. We offer the Kleen Kut® knife technology option (patented) for Low Density Polyethylene resin applications on all machine models, which eliminates over 99% of the particle counts created by using a hot knife! |
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6. We provide an integrated, 21CFR Part 11 compliant, temperature/process data logger to document all temperatures during SIP. Multiple (20-30) Pt-100 sensors or thermocouples are strategically placed throughout the product path to ensure sterility. The sensors can be calibrated in place, using the data logger’s built-in capability. |
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7. We offer a dedicated airborne particle counter for continuous on-line monitoring of particulate counts in the critical zone, ensuring compliance with FDA and other regulatory authorities who require close monitoring of particle count in the nozzle shroud area (conforming to class 100 standards in dynamic conditions). Output from the particle counter can be sent directly to the data logger for secure data collection. |
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8. Our machines do not use steam traps to capture the temperature during SIP. We achieve excellent temperature distribution throughout the process piping by placing fixed orifices in strategic locations. |
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9. Our patented, modular electronic time/pressure fill system is operated by direct acting individual DC solenoid valves at the point of fill. The entire fill system is manifold mounted and designed for rapid changeover and easy maintenance. |
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10. A complete Preliminary Validation Documentation Package is provided to enable easy on-site customer commissioning and qualification. |
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11. Extensive research has been conducted on Weiler machines utilizing live micro-organisms for challenge tests. Peer reviewed published articles supporting the technology are available which illustrate the robust nature of the Weiler designs. |
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12. On-screen diagnostics are provided on both the machine mounted and remote mounted (standard) operator panels to provide quick setup, reference and trouble-shooting information. |
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13. The machines are manufactured to the highest standards and are fully compliant with all GAMP, CE and international regulatory standards. |
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14. Our machines are designed for maximum OEE and several hundred machines are currently operating in registered pharmaceutical facilities, producing sterile product in every major market in the world. |
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15. Flexible product filtration configurations are available. Our standard filtration package is a dual stack housing arrangement designed to accommodate 0.22 or 0.1 micron filters. Options include bypass lines, auxiliary buffer tank with recirculation systems for suspension products and large filter housings with multiple filters for high throughput applications (large volume containers). |
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16. An integral mold cooling integrity test circuit is included as a standard feature on all Weiler machines. The circuit is designed to minimize the amount of liquid retained in the mold when executing a tooling changeover to help facilitate clean and rapid tooling changeover. |
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17. All of our machines are compatible with multiple resins with a simple tooling change. The use of a 24:1 extruder with three zone control of heating and cooling ensures tighter control of extrusion parameters; a critical element for processing of both polypropylene and high density polyethylene resins. |
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18. Modular mold components facilitate the design of “families” of products to minimize tooling requirements and simplify product changeovers. The modular format also permits easy repair/replacement which results in lower maintenance cost. |
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19. The use of a proprietary aluminum/bronze base mold material permits easy machining, excellent heat transfer and long life. Many of our molds have a demonstrated service life of more than 15 years. |
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20. Weiler Engineering, Inc. utilizes standard components wherever possible in the manufacturing process, using components that are readily available in local markets to help assure maximum uptime from the machines. |
