シンテゴンテクノロジー List of Products and Services

The SVE ZAP is equipped with the ZAP system, an applicator that applies sealant to the sealing area of the SVE series vertical packaging machine, allowing for the application of sealant only to the sealing part of unprocessed pure paper packaging materials. This enables the production of high-seal-strength paper packaging. 【How to balance cost and environment?】 By manufacturing and filling bags in-house instead of purchasing pre-made bags and filling them, significant cost savings can be achieved. Additionally, using 100% paper raw materials eliminates the need for pre-sealant processing, further reducing packaging processing costs. Environmentally, by applying sealant only to the adhesive area of 100% paper raw materials, it results in a recyclable packaging package with over 95% paper weight ratio. Moreover, the SVE vertical pillow machine alone can accommodate a variety of bag shapes while also being compatible with packaging materials such as paper, mono-plastic, and composite plastic.

• Food Packaging Machinery

In traditional gummy manufacturing using starch, large drying rooms and expertise in starch handling are required. However, the starch-free gummy manufacturing system "NutraFlash" eliminates the need for starch handling, making the system more compact and facilitating easier entry into gummy production for newcomers. Additionally, while conventional starch production requires a drying process that takes from one day to several days, NutraFlash employs cooling for solidification within the system, reducing the time from liquid filling to product completion to just a few hours, significantly improving productivity and reducing energy consumption. Furthermore, in the production of supplement gummies (functional gummies), which are gaining interest as a new dosage form, the use of polycarbonate molds allows for the exchange or cleaning of molds for each product, effectively preventing contamination. NutraFlash is offered as an all-in-one system that seamlessly connects the functions of gummy dough production, molding, and drying.

• Food Processing Equipment

The revised version of EU GMP Annex 1, which came into effect on August 25, 2023, has significantly expanded the documentation, particularly strengthening the sections related to barrier technology. The prevention of product contamination in aseptic manufacturing processes has become increasingly emphasized, and the introduction of isolators and RABS is recommended to minimize contamination risks from operators. This revision impacts pharmaceutical companies worldwide, making the formulation of contamination control strategies (CCS) essential for maintaining sterility. One of our solutions that meets these stringent aseptic requirements is the glove-less isolator integrated aseptic filling system "Versynta microBatch." It is a small-batch production unit designed for highly active formulations, utilizing robotic technology to eliminate manual intervention by operators. At the symposium in October, we will provide detailed explanations of the new standards for aseptic manufacturing following the Annex 1 revision and key points for pharmaceutical companies to consider, as well as introduce our latest solutions. [Overview] - October 7, 2024 (Monday): Tokyo - October 10, 2024 (Thursday): Osaka If you wish to participate, please refer to the related links below.

• Filling and bottling machines

Pharmaceuticals such as injectables are typically manufactured on a much smaller scale during clinical trial phases than in commercial production, with batch sizes often reduced to several thousand units. Particularly in advanced personalized medicine, such as autologous cell therapy, where treatments are customized based on the patient's cells, batch sizes become even smaller, with an average of about 5 to 10 injection vials needed per patient. With the growing demand for personalized medicine, the need for small-scale production of pharmaceuticals is increasing, and our company has released the "Versynta Series," a multi-product filling system that accommodates small batch and micro-batch manufacturing. This system provides solutions for low-volume, high-variety products, enabling efficient and flexible production. The attached materials and product catalog provide a detailed overview of the "Versynta Series" and its features. We invite you to read about the functions and benefits of this series that meets advanced manufacturing needs. 【Overview】 ■ A new trend in small-scale production ■ Modular small batch production equipment ■ Gloveless micro-batch production ■ Expanding RTU container market ■ Reduction of total costs

• Filling and bottling machines

As a manufacturer of pharmaceutical production equipment, we provide sterile filling lines for injectable products such as syringes, vials, ampoules, and cartridges. Our isolators are designed and developed as an integrated system with filling machines, supporting everything from installation to validation. 【Features of Syntegon Isolators】 ■ Complete Offering: We integrate isolators, filling machines, decontamination equipment, and HVAC technology to ensure a highly efficient and safe process necessary for sterile processing. ■ Smooth Project Management: Since the isolator and filling line are integrated, a dedicated project manager will oversee the progress from kickoff to the completion of qualification on-site. ■ Accelerated Production Start: By delivering the isolator and filling machine as an integrated system, we conduct comprehensive testing at our facility before installation on-site, avoiding unexpected issues in advance. ■ Reduced decontamination time (non-production time) to secure more production time: In commercial production, we achieve a decontamination cycle time of less than 60 minutes to reach 1 ppm. * For more details, please refer to the downloadable materials below.

• isolator

We would like to introduce a case study of the "vial filling line" implemented at IDT Biologika. The company planned a large-scale investment to expand its production capacity. In searching for a state-of-the-art line for aseptic filling, they required the ability to handle speed and large volumes, as well as flexibility with various filling systems. After implementation, the line has the capacity to fill 80 million to 100 million 2R vials annually, supports a maximum batch size of 500,000, and is equipped with two supply magazines that allow for accurate counting of individual units. This has enabled them to process a wide variety of products. [Case Overview (Partial)] ■Challenges - Speed - Ability to handle large volumes - Flexibility with various filling systems *For more details, please refer to the PDF document or feel free to contact us.

• Filling and bottling machines

The "GKF Capsylon 6005" is a capsule filling machine specialized for nutritional and health foods. It can fill up to 360,000 capsules per hour. Two parallel dosing stations continuously fill a large number of capsule holes with the product, achieving productivity that significantly surpasses our conventional machines. Additionally, by using a slide gate, the same dosing station can handle both pellets and granules, enhancing the flexibility of the equipment. 【Features】 ■ 48 segment holes and 2 dosing stations ■ Capable of filling 360,000 capsules per hour ■ Slide gate technology improves product yield and minimizes dust impact ■ Intuitive click system that requires no tools ■ Significantly reduces changeover time for format parts *For more details, please refer to the PDF document or feel free to contact us.

• Filling and bottling machines

Biotechnology has begun to be adopted for the treatment of diseases, and personalized medicine using advanced therapy medicinal products (ATMPs) such as cell and gene therapies is becoming more widespread. As a result, many pharmaceutical companies have started to invest in the development and commercialization of small-volume pharmaceuticals, which differ significantly from traditional production and filling requirements. Pharmaceuticals used in personalized treatments are generally extremely expensive and require substantial resources for research and development. During the manufacturing phase, flexible processing known as small batch or micro batch production is necessary to respond to changing demands, and there is a need for highly specialized manufacturing equipment concepts. *For more details, please refer to the PDF document or feel free to contact us.*

• others

We are pleased to announce the "Shintegon In-House Show 2023." We will provide explanations and demonstrations of the fluidized bed technology manufactured by the German company Hüttlin. The demonstration equipment, the fluidized bed granulator "Solidlab 2 Plus" for clinical trial drugs and research and development, contributes to the creation of homogeneous and high-quality products through its unique bottom spray technology. With its highly scalable design and supporting software, scaling up from development machines to production machines is achieved simply and reliably. We sincerely look forward to your visit. 【Overview】 ■ Date: November 24, 2023 (Friday) 10:00 AM - 3:30 PM ■ Venue: Shintegon Technology Co., Ltd. Musashi Factory ■ Address: 1464-4 Tsukinowa, Namegawa-machi, Hiki-gun, Saitama Prefecture, 355-0813 ■ Nearest Station: Tobu Tojo Line "Tsukinowa Station," 10 minutes on foot ■ Capacity: First 10 participants (up to 2 participants per company) *For more details, please refer to the PDF document or feel free to contact us.

• Other physicochemical equipment

This product is a nest syringe filling line designed for ultra-high-speed production. We offer a line that integrates a back opener, tab opener, and filling machine. It features a sophisticated and precise design, equipped with a barrier system (RABS). Additionally, various filling systems and sealing methods can be selected according to the product characteristics. 【Line Configuration and Features】 < Fully Automatic Bag Opener (ABO 5000) > ■ Automatically opens and removes the inner bag of the tab for nest syringes ■ Minimizes the risk of contamination by utilizing the protective characteristics of the bag ■ Ensures reliable handling of bags with excellent reproducibility ■ Ensures high safety through integration into the line ■ Clearly separates the cleanroom area *For more details, please feel free to contact us.

• Filling and bottling machines

We would like to introduce the "Prefilled Syringe Equipment" that we handle. Our lineup includes the fully automatic inner bag opening and removal device for nest syringes, vials, and cartridges, the "ABO 5000," as well as the "FXS 3100," which is equipped with Syntegon's renowned automation technology, and the filling and capping machine "FXS 5100," which is specialized for high-speed and ultra-high-speed production. All necessary filling and stopper systems, including vacuum filling, vacuum capping, and gas replacement, are available. 【Partial Lineup】 ■ Fully automatic outer bag opening and removal device "ABO 5000 DB" ■ Fully automatic inner bag opening and removal device "ABO 5000" ■ Peristaltic pump ■ Mass flow filling system ■ Time pressure filling system *For more details, please refer to the PDF materials or feel free to contact us.

• Filling and bottling machines

The "FXS 2052" is a fully automatic filling and capping machine suitable for low to medium-speed production of nested syringes. It features a compact design that allows for easy equipment layout and is ideal for safe and high-precision pharmaceutical processes. By enabling speedy movement of nests and simultaneous loading and unloading processes in the filling and capping area, it reduces downtime and improves equipment efficiency. 【Features】 - Slim design with high hygiene and aesthetic appeal - Ensures high cleanability and accessibility - Proven track record with rubber stopper supply, adopting a clean feed method - Gasket capping allows for the selection of sleeve capping method or vacuum capping method (optional) *For more details, please feel free to contact us.

• Filling and bottling machines

We would like to introduce the "Vial Liquid Equipment" that we handle. With a space-saving and flexible layout, we can accommodate special requests, featuring a range of products including the pharmaceutical general-purpose washer "RRU/RRN," mid- to high-capacity vial filling and capping machines "FLC 3000," and freeze dryers. We can provide everything from standalone machines to total production lines that include water supply equipment, preparation equipment, freeze drying, and secondary packaging machines. 【Partial Lineup】 ■ Pharmaceutical general-purpose washer "RRU/RRN" ■ Modular injection liquid process system "SVP/LVP" ■ WFI production equipment "MWFI" ■ Peristaltic pump ■ Mass flow filling system *For more details, please refer to the PDF document or feel free to contact us.

• Other cleaning machines
• Filling and bottling machines
• Drying Equipment

We would like to introduce the research and development equipment we handle. The tabletop stirring, mixing, and granulating machine "Mycromix" for small-scale production can accommodate containers ranging from 0.5 to 10 liters. The drive unit is stored at the bottom, making operation easy. In addition, we offer "Solidlab1," which allows for easy switching from a fluidized bed module to a drum coating module, and "Solidlab2," which facilitates easy scale-up. 【Features】 <Mycromix> ■ The drive unit is stored at the bottom, making operation easy ■ Containers can be exchanged according to capacity ■ Container with inspection window ■ Gentle wing with torque measurement ■ Equipped with a chopper *For more details, please feel free to contact us.

• Mixer/agitator
• Granulating Equipment
• Other physicochemical equipment

- Image processing applications using deep learning methods - Equipped with AI vision, capable of high-precision inspection of items that are difficult with conventional methods through simple operations. - Compact design featuring the latest mechanics, control, and machine vision. - By adopting a sophisticated oscillate drive system, the relative position of the inspection system and lighting to the product is consistently maintained. Achieves micron-level precision inspection that remains unchanged during transport. - Compliant with IP54, CE/UL standards. - For foreign object inspection, select the most suitable solution based on product characteristics, from SD sensors/image difference methods.

• Visual Inspection Equipment

- Transporting products consistently in a non-contact manner from supply to recovery. - Incorporating AI technology for external foreign matter inspection of syringes to further improve inspection accuracy. - Achieving space-saving and high operability through integrated design. 【Configuration of Syringe Inspection Line】 ■ De-nester ■ AI-equipped inspection machine for syringes AIM 52S ■ Re-nester ■ Empty container transport (optional) *For more details, please refer to the PDF document or feel free to contact us.

• Other inspection equipment and devices

The "GKF60" is the latest capsule filling machine designed for research and development. 【Features】 ■ Selectable from a total of 9 filling methods, including a newly developed filling method that accommodates a filling amount of 0.1mg. ■ Flexibly supports highly pharmacologically active formulations at OEB3 to OEB5 levels. ■ Space-saving body design allows for the installation of up to 3 filling stations. ■ Automatically calculates suitable filling parameters based on product characteristics. ■ 100% weight measurement system (optional). *For more details, please refer to the PDF document or feel free to contact us.

• Filling and bottling machines

The "AIM 5022S AI+" is a compact and easy-to-work-with automatic inspection machine for external foreign substances in syringes, designed with consideration for cleanliness and maintenance. Foreign substances in the liquid are double-checked using a unique SD (Static Division) system, ensuring more reliable detection of contaminants. For inspecting the top surface of rubber stoppers, which often leads to false detections due to air bubbles, AI deep learning methods are employed to simultaneously improve the detection accuracy of defective products and reduce false detections of good products. 【Features】 ■ Foreign substances in the liquid are double-checked with a unique SD system for more reliable detection. ■ AI deep learning methods are used for inspecting the top surface of rubber stoppers, which often results in false detections due to air bubbles. ■ Compact and easy-to-work-with size design. ■ Consideration for cleanliness and maintenance. ■ Format changes are simple and require no tools. *For more details, please refer to the PDF document or feel free to contact us.

• Other inspection equipment and devices

The "AIM5023V" is an automatic inspection machine for external foreign matter that combines a high-resolution camera and lighting to accurately capture external defects and stationary foreign objects. With its unique SD (Static Division) system, it double-checks for foreign matter in liquids, ensuring more reliable detection. It is also suitable as a multi-purpose machine for inspecting formulations with different properties. 【Features】 ■ Fewer false detections of good products, improving productivity ■ Short delivery times ■ Compact and easy-to-work size ■ Design considered for cleanliness and maintenance ■ Format changes are simple and require no tools *For more details, please refer to the PDF materials or feel free to contact us.

• Visual Inspection Equipment

The 'AIM5023V' can be used for both appearance foreign matter inspection of freeze-dried preparations and solutions. We deliver in a short time. By optimally combining a high-resolution camera and lighting, it accurately captures appearance defects and stationary foreign matter. It has a compact and easy-to-work size, designed with consideration for cleanliness and maintenance. 【Features】 ■ Unique SD system for double-checking foreign matter in liquids ■ Accurately captures appearance defects and stationary foreign matter ■ Reduces false positives for good products, improving productivity ■ Compact and easy-to-work size ■ Designed with consideration for cleanliness and maintenance *For more details, please refer to the PDF document or feel free to contact us.

• Visual Inspection Equipment

The "AIM3000 Series" is an automatic inspection machine for vials and ampoules that conducts high-precision inspections based on the inspection requirements for each product, checking for the presence of foreign particles and various other aspects. Two inspection stations are equipped with an LED lighting system that utilizes both transmitted and reflected light, ensuring more reliable detection of foreign objects. The press pin function allows for the product to be rotated 360° and inspected accurately from below using four high-voltage channels. 【Features】 ■ Modular design body ■ Equipped with a multi-inspection compatible camera station ■ Checks multiple inspection items with a single inspection station ■ 100% double-check to prevent missing foreign objects ■ High-voltage leak inspection module (optional) *For more details, please refer to the PDF document or feel free to contact us.

• Other inspection equipment and devices