Aseptic Custom Packaging for the Pharmaceutical and Healthcare Industries
About Us
Weiler Engineering, Inc. is America`s leading provider of aseptic custom packaging for pharmaceutical and healthcare applications. Continuous innovation and incorporation of the latest technological advances in equipment design and systems assure our customers of the highest level of quality in the production of sterile liquid products. Since 1959, Weiler has brought innovation in design, development, technology, validation and regulatory science to each project. We are committed to the highest standards of excellence and to further expanding our products and systems to enhance patient care. Blow/Fill/Seal Systems for Sterile Process Development Weiler Engineering, Inc.`s proprietary Blow/Fill/Seal System is the culmination of more than 40 years of innovation in machine design and sterile process development, producing the most advanced aseptic liquid packaging system available today. ASEP-TECH® Blow/Fill/Seal technology integrates blow molding, sterile filling and hermetic sealing in one continuous operation to produce aseptically manufactured products that are distinctive, more cost effective, and more reliable than any other method. We are committed to the development, enhancement, and scientific understanding of this advanced aseptic manufacturing technology. This level of commitment extends into the custom design of each Blow/Fill/Seal machine. Comprehensive Product Development We offer comprehensive product development, from container/closure concept to complete production tooling ready for your in-house manufacturing on ASEP-TECH Blow/Fill/Seal machinery. Our skilled craftsmen and designers can develop virtually any container mold through the use of sophisticated CAD/CAM technology and 3-D modeling. These design systems, when interfaced with the latest in CNC and EDM machinery, ensure fabrication of key components to precise tolerances. Focus on Blow/Fill/Seal Technology We continue to place a strong emphasis on the science of Blow/Fill/Seal technology as it relates to the optimization of machine design to enhance process capabilities relating to sterility assurance. These efforts are recognized by the worldwide regulatory community and will change the future of aseptic manufacturing. Weiler`s pro-active stance has positioned it prominently at the forefront of these developments. We are continually applying the results of our scientific research to the design of our next generation Blow/Fill/Seal machines, firmly setting the standards to the highest level of sterility assurance for aseptic technology. The Asep-Tech® Model 628 Blow/Fill/Seal machine from Weiler Engineering, Inc. features a two-piece stepped base design for easy maintenance and convenient product discharge. All existing Model 624 tooling (molds, fill systems, parison heads) can be used on the Model 628 machine, making it an attractive upgrade for current users. The versatile Model 628 has the flexibility to produce sterile, liquid filled, tamper-evident containers ranging in size from 0.5mL up to 250mL, in full-scale production quantities. Several other machine models are offered to fulfill higher output and/or larger container size requirements. During the Achema exhibition in Frankfort, Germany from May 15 to 19, 2006, Weiler Engineering will be demonstrating the Model 628 machine tooled to produce 10mL ampoules at a rate of 4,500 units per hour. Additional tooling to produce a “family” of container sizes will be delivered to the customer with this machine. The Model 628 comes complete with an integral product buffer tank designed to meet tight fill tolerances and all digital controls interfaced to a Data Acquisition System that features Wonderware® software. Worldwide Sales, Support and Service Every machine sale is supported worldwide. Dependable service, on-site training and complete recommended spare parts are included for you as part of the ASEP-TECH System package. Continuous, reliable, after-sale service support is an important part of our company`s profile. When you purchase an ASEP-TECH System, you invest in a partnership that includes product development, design engineering, validation, regulatory experience, and long-term support.
Weiler Engineering, Inc. is America`s leading provider of aseptic custom packaging for pharmaceutical and healthcare applications. Continuous innovation and incorporation of the latest technological advances in equipment design and systems assure our customers of the highest level of quality in the production of sterile liquid products. Since 1959, Weiler has brought innovation in design, development, technology, validation and regulatory science to each project. We are committed to the highest standards of excellence and to further expanding our products and systems to enhance patient care.
Weiler Engineering, Inc.`s proprietary Blow/Fill/Seal System is the culmination of more than 40 years of innovation in machine design and sterile process development, producing the most advanced aseptic liquid packaging system available today. ASEP-TECH® Blow/Fill/Seal technology integrates blow molding, sterile filling and hermetic sealing in one continuous operation to produce aseptically manufactured products that are distinctive, more cost effective, and more reliable than any other method. We are committed to the development, enhancement, and scientific understanding of this advanced aseptic manufacturing technology. This level of commitment extends into the custom design of each Blow/Fill/Seal machine.
Comprehensive Product Development
We offer comprehensive product development, from container/closure concept to complete production tooling ready for your in-house manufacturing on ASEP-TECH Blow/Fill/Seal machinery. Our skilled craftsmen and designers can develop virtually any container mold through the use of sophisticated CAD/CAM technology and 3-D modeling. These design systems, when interfaced with the latest in CNC and EDM machinery, ensure fabrication of key components to precise tolerances.
We continue to place a strong emphasis on the science of Blow/Fill/Seal technology as it relates to the optimization of machine design to enhance process capabilities relating to sterility assurance. These efforts are recognized by the worldwide regulatory community and will change the future of aseptic manufacturing. Weiler`s pro-active stance has positioned it prominently at the forefront of these developments. We are continually applying the results of our scientific research to the design of our next generation Blow/Fill/Seal machines, firmly setting the standards to the highest level of sterility assurance for aseptic technology.
The Asep-Tech® Model 628 Blow/Fill/Seal machine from Weiler Engineering, Inc. features a two-piece stepped base design for easy maintenance and convenient product discharge. All existing Model 624 tooling (molds, fill systems, parison heads) can be used on the Model 628 machine, making it an attractive upgrade for current users.
The versatile Model 628 has the flexibility to produce sterile, liquid filled, tamper-evident containers ranging in size from 0.5mL up to 250mL, in full-scale production quantities. Several other machine models are offered to fulfill higher output and/or larger container size requirements.
During the Achema exhibition in Frankfort, Germany from May 15 to 19, 2006, Weiler Engineering will be demonstrating the Model 628 machine tooled to produce 10mL ampoules at a rate of 4,500 units per hour. Additional tooling to produce a “family” of container sizes will be delivered to the customer with this machine.
The Model 628 comes complete with an integral product buffer tank designed to meet tight fill tolerances and all digital controls interfaced to a Data Acquisition System that features Wonderware® software.
Every machine sale is supported worldwide. Dependable service, on-site training and complete recommended spare parts are included for you as part of the ASEP-TECH System package. Continuous, reliable, after-sale service support is an important part of our company`s profile. When you purchase an ASEP-TECH System, you invest in a partnership that includes product development, design engineering, validation, regulatory experience, and long-term support.
Blow/ Fill/ Seal Process
The ASEP-TECH® System automatically delivers a finished package in five steps: Thermoplastic resin is extruded into a tubular shape called a parison. When the parison reaches the proper length, the mold is closed and the parison is cut. The bottom of the parison is pinched closed and the top is held in place. The mold is then conveyed to a position under the blowing and filling nozzle. The blow-fill nozzle is lowered into the parison until it forms a seal with the neck of the mold. The container is formed by blowing sterile filtered compressed air into the parison and expanding it against the walls of the integrally cooled mold cavity. Next, the sterile air is vented from the container and the sterile product is metered into the container through the fill nozzle, which then retracts. Separate sealing molds close to form the top and hermetically seal the container. The mold opens, and the formed, filled and sealed container is conveyed out of the machine.We are exhibiting at Achema in Frankfort, Germany - May 15-19, 2006. We will have the Model 628 machine operating with demonstrations scheduled throughout the week at Hall 3.0, Stand B22-C24.
The ASEP-TECH® System automatically delivers a finished package in five steps:
Design and Prototyping
We offer comprehensive product development, from container/closure concept to complete production tooling ready for your in-house manufacturing on ASEP-TECH® Blow/Fill/Seal machinery. Our skilled craftsmen and designers can develop virtually any container mold through the use of sophisticated CAD/CAM technology and 3-D modeling. These design systems, when interfaced with the latest in CNC and EDM machinery, ensure fabrication of key components to precise tolerances.
Packaging Systems
ASEP-TECH Blow/Fill/Seal machines are designed and manufactured by Weiler Engineering, Inc. in Elgin, Illinois. Our team is dedicated to the highest performance standards in the design and development of blow/fill/seal packaging systems. This unique combination of world-class engineering, leading-edge automation and process design, assures years of reliable, high quality production. The fabrication techniques and manufacturing methods employed in every custom-built machine reflect the finest state-of-the-art practices available in today`s machine building environment. Our factory acceptance testing (FAT) procedure incorporates a pre-validation documentation package (PIQ, POQ) that is provided with each machine to assist you with your own on-site validation program. Introductory training is provided at our facility during your machine factory acceptance trials. During commissioning at your plant, hands-on instruction in all aspects of machine operation and maintenance is provided to your operating personnel. This in-house training is integral to the long-term success of your manufacturing operation. Complete System Capabilities Our mold designs have evolved from years of experience that incorporate features to enhance flexibility and ease of use. These modular designs can create a family of container sizes simply by changing mold inserts. Custom engraving and coding can be included to provide specific product information, such as lot number and expiration date. Each ASEP-TECH Blow/Fill/Seal machine accepts a variety of molds for different product applications. Our machine design capabilities also extend to product finishing lines to meet your final inspection and packaging needs. We have designed and installed systems that incorporate deflashing, labeling, electronic leak detection, printing and final packing. In addition, we can provide automated machine vision systems to support enhanced quality control and electronic documentation. We can meet all of your data acquisition requirements and provide links to your computer aided manufacturing network. Our integrated internal data acquisition and machine control package can be provided with man/machine interface compatibility with Wonderware®, WINCC or other software packages. Design and Development for the Future: A patented electronically-controlled fill system, an automatic sterilization system (SIP) with integral data acquisition, and a filter integrity test system are provided as standard equipment for each machine configuration. Each machine is also equipped with a HEPA air shower to assure a Class 100 environment under dynamic conditions in the nozzle shroud area. Accessories are available for the ASEP-TECH Blow/Fill/Seal System, including a transport cart to assist with tooling conversion, a stainless steel buffer tank to help assure accurate control of stringent fill requirements, and custom barrier isolation systems for container designs requiring inclusion of injection molded components as part of the aseptic package. Optional parison shrouding is available to assure a Class 10,000 environment under dynamic conditions in the extrusion zone and the critical transport area between the extrusion and fill nozzle shroud. The new KleenKut parison cutoff option affords dramatic reduction of non-viable particulates in the extrusion zone. KleenKut is a revolutionary approach to parison cutting and effectively reduces particle generation by over 99% when compared to a traditional ``hot knife``.
ASEP-TECH Blow/Fill/Seal machines are designed and manufactured by Weiler Engineering, Inc. in Elgin, Illinois. Our team is dedicated to the highest performance standards in the design and development of blow/fill/seal packaging systems. This unique combination of world-class engineering, leading-edge automation and process design, assures years of reliable, high quality production.
The fabrication techniques and manufacturing methods employed in every custom-built machine reflect the finest state-of-the-art practices available in today`s machine building environment. Our factory acceptance testing (FAT) procedure incorporates a pre-validation documentation package (PIQ, POQ) that is provided with each machine to assist you with your own on-site validation program. Introductory training is provided at our facility during your machine factory acceptance trials. During commissioning at your plant, hands-on instruction in all aspects of machine operation and maintenance is provided to your operating personnel. This in-house training is integral to the long-term success of your manufacturing operation.
Complete System Capabilities
Our mold designs have evolved from years of experience that incorporate features to enhance flexibility and ease of use. These modular designs can create a family of container sizes simply by changing mold inserts. Custom engraving and coding can be included to provide specific product information, such as lot number and expiration date. Each ASEP-TECH Blow/Fill/Seal machine accepts a variety of molds for different product applications.
Our machine design capabilities also extend to product finishing lines to meet your final inspection and packaging needs. We have designed and installed systems that incorporate deflashing, labeling, electronic leak detection, printing and final packing. In addition, we can provide automated machine vision systems to support enhanced quality control and electronic documentation. We can meet all of your data acquisition requirements and provide links to your computer aided manufacturing network. Our integrated internal data acquisition and machine control package can be provided with man/machine interface compatibility with Wonderware®, WINCC or other software packages.
Design and Development for the Future:
A patented electronically-controlled fill system, an automatic sterilization system (SIP) with integral data acquisition, and a filter integrity test system are provided as standard equipment for each machine configuration. Each machine is also equipped with a HEPA air shower to assure a Class 100 environment under dynamic conditions in the nozzle shroud area. Accessories are available for the ASEP-TECH Blow/Fill/Seal System, including a transport cart to assist with tooling conversion, a stainless steel buffer tank to help assure accurate control of stringent fill requirements, and custom barrier isolation systems for container designs requiring inclusion of injection molded components as part of the aseptic package. Optional parison shrouding is available to assure a Class 10,000 environment under dynamic conditions in the extrusion zone and the critical transport area between the extrusion and fill nozzle shroud. The new KleenKut parison cutoff option affords dramatic reduction of non-viable particulates in the extrusion zone. KleenKut is a revolutionary approach to parison cutting and effectively reduces particle generation by over 99% when compared to a traditional ``hot knife``.
Applications
The ability to provide sterile liquid products that meet corporate, scientific, regulatory and end-user requirements can be a demanding task in today`s environment. Through your implementation of ASEP-TECH® Blow/Fill/Seal technology, these application challenges can be met by the creative container and closure designs available with each system. Several machine models are available to choose from, designed to manufacture containers ranging in size from 0.2mL to 1000mL at production rates of up to 15,000 units per hour, depending on container configuration. Small Volume Parenterals (SVP`s) Large Volume Parenterals (LVP`s) Ophthalmic`s Respiratory therapy Other applications New concepts
The ability to provide sterile liquid products that meet corporate, scientific, regulatory and end-user requirements can be a demanding task in today`s environment. Through your implementation of ASEP-TECH® Blow/Fill/Seal technology, these application challenges can be met by the creative container and closure designs available with each system. Several machine models are available to choose from, designed to manufacture containers ranging in size from 0.2mL to 1000mL at production rates of up to 15,000 units per hour, depending on container configuration.
Customer Support
Every machine sale is supported worldwide. Dependable service, on-site training and complete recommended spare parts are included for you as part of the ASEP-TECH® System package. Continuous, reliable, after-sale service support is an important part of our company`s profile. When you purchase an ASEP-TECH® System, you invest in a partnership that includes product development, design engineering, validation, regulatory experience, and long-term support. Introductory training is provided at our facility during your machine factory acceptance trials. During commissioning at your plant, hands-on instruction in all aspects of machine operation and maintenance is provided to your operating personnel. This in-house training is integral to the long-term success of your manufacturing operation.
Every machine sale is supported worldwide. Dependable service, on-site training and complete recommended spare parts are included for you as part of the ASEP-TECH® System package. Continuous, reliable, after-sale service support is an important part of our company`s profile. When you purchase an ASEP-TECH® System, you invest in a partnership that includes product development, design engineering, validation, regulatory experience, and long-term support.
Introductory training is provided at our facility during your machine factory acceptance trials. During commissioning at your plant, hands-on instruction in all aspects of machine operation and maintenance is provided to your operating personnel. This in-house training is integral to the long-term success of your manufacturing operation.
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