J.J.CORP Solution

The production of liquid pharmaceuticals requires purified media as a basic requirement. At JJ Corp, we offer a wide range of solutions for this, including distillation and cold membrane processes for WFI, as well as thermal generation solutions for WFI and pure steam. Additionally, we provide well-designed system concepts for the storage and distribution of PW and WFI.

For the production of the actual solutions, our formulation systems are designed to assist you. We provide solutions for preparation, filtration, centrifugation, and chromatography, which are customized to meet the specific requirements of your product. Our team of experts is always available to assist you in selecting the right solution for your products.

• Production of purified media for liquid pharmaceuticals including distillation, cold membrane processes for WFI, and thermal generation solutions for WFI and pure steam.
• Introduction of a new cold membrane process (MWFI) for generating high-quality water for injection.
• Well-designed system concept for the storage and distribution of purified water (PW) and water for injection (WFI).
• Formulation systems available for various process steps including preparation, filtration, centrifugation, and chromatography to support the production of actual solutions.

The entire aseptic process, including before, during, and after sterile filling, requires strict sterility measures. At JJ Corp, we provide both internal and external cleaning machines for vials and other containers. Our cleaning process begins with pre-cleaning the vials with Water for Injection (WFI), followed by sterilization and depyrogenation using dry heat in our HQL tunnel. Once filled and capped, the vials are then transferred to our RAN external cleaning machine, which ensures that no particles stick to the outer sides of the vials. This step is crucial in ensuring the safety of operators and healthcare workers.

• Cleaning machines are designed for a flexible and space-saving layout.
• Ultrasonic bath is used for cleaning.
• Tunnel design of HQL ensures dry-heat sterilization with proven efficacy.

Our vial filling systems provide precise and flexible solutions to meet your specific needs. We offer a wide range of technologies, including valve piston, peristaltic pump, mass-flow, rolling diaphragm pump, and time-pressure filling – or a combination of these technologies within our combi filling station. Tool-less format changes and a variable number of filling heads provide increased flexibility. Our subsequent sealing methods offer a variety of options, such as pick and place or continuous stoppering – without vacuum. High-speed continuous capping completes the reliable closing process. We ensure quality with 100% check weighing (IPC) and inline inspection systems such as empty vial inspection, stopper position, crimp quality, and print check control.

• Our filling systems are modular and come with barrier systems that are integrated and harmonized from a single source.
• We offer various inline inspection systems that are integrated into the filling systems.
• Our filling systems can handle small batches to high speeds of up to 600 vials per minute while ensuring 100% in-process control (IPC).

Product safety is paramount in aseptic filling, and a key aspect of this is the separation of operators and pharmaceutical ingredients. To achieve this, isolator technology can be utilized as a crucial barrier. JJ Corp offers a comprehensive portfolio of isolator solutions, including open RABS, closed RABS, containment, and isolator systems. Our solutions are customized to meet specific customer requirements, from machine design and development to on-site installation and validation.

• Emphasis on integration instead of interfaces
• Capabilities for aseptic and high-potency applications
• Utilization of rapid bio-decontamination cycles

The freeze dryer manufactured by SBM, a subsidiary of JJ Corp, is a versatile machine with a modular and flexible design that makes the best use of the available space. The freeze dryer adheres to GMP standards, can process various container sizes and formats, and is suitable for both small and large batches. The machine is also energy efficient, with light product shelves that minimize the amount of material requiring cooling and heating. This not only reduces the time taken for secondary processes but also increases the freeze dryer’s energy-saving potential.

• Harmonized interfaces, components, and documentation for seamless integration with JJ Corp’s upstream and downstream equipment
• Uniform temperature distribution across the product shelves for better performance
• Slot door opening with continuous height adjustment for flexible processing of a wide range of container sizes

Quality inspection is crucial in ensuring patient safety and enhancing the entire pharmaceutical production process. Our comprehensive range of manual, semi-automated, and fully automated inspection machines are designed to detect container defects and particles in liquid and lyophilized pharmaceuticals. We utilize cutting-edge technologies for visual inspection and container closure integrity testing (CCIT), such as high voltage leak detection (HVLD), static division (SD), and headspace analysis (HSA), thanks to our extensive inspection expertise. During the filling process, we also provide inline inspection systems that improve product quality through the detection of empty vials, stopper position, and crimp quality.

• Inspection is crucial to ensure quality and safety in pharmaceuticals.
• We offer a range of inspection machines, including manual, semi and fully automated options.
• Our inspection machines can detect particles and container defects in liquid and lyophilized pharmaceuticals.
• We use advanced technologies such as high voltage leak detection, static division, and headspace analysis for container closure integrity testing (CCIT).

The efficient production of pharmaceuticals requires flexible equipment with robotic applications and comprehensive services, as well as the ability to manage and utilize large amounts of process data. Our data acquisition solutions allow you to reliably monitor and record crucial process data on both line and container level. Our system provides real-time machine and process data in one dashboard, allowing for transparent line and batch control. We manage data for single containers, ensuring supply chain security and preventing costly incidents such as complaints.

• Complete insight into all production operations and processes
• Recording and analysis of errors for continuous improvement
• Centralized access to individual machines and entire production lines
• Mitigation of production risks
• Traceability of products at the container level

The JJ Corp has an extensive range of sterilization solutions that can effectively sterilize porous loads and liquids in open, semi-sealed, or closed containers. These solutions include vacuum-steam, steam/air mixture, and hot water shower processes that enable you to achieve consistent equipment and terminal sterilization while reducing energy consumption.

• Broad range of processes
• Design for hygienic applications
• Recipe editor for customized processes
• Automatic in-line filter sterilization.