マツボー List of Products and Services

Incorporating Bioquell's hydrogen peroxide vapor decontamination technology, which has a long-standing reputation and track record in Japan, this isolator can improve workflows and enhance productivity. With customizable configurations of 2, 4, or 6 gloves, you can implement an aseptic workspace at a reasonable cost and with a short lead time. It offers excellent advantages in terms of materials and structure, as well as ease of installation and operation, as follows:

Both routine and emergency decontamination can be automated using Bioquell ProteQ as part of contamination management, allowing for the decontamination of rooms and areas. The latest 35% hydrogen peroxide vapor decontamination system can decontaminate everything from small laboratories to large bioprocessing areas. Powerful dispersion reduces cycle times, and new wireless features enable networking of multiple units, making it ideal for areas of any size. For GMP and non-GMP applications, you can choose from pre-registered time cycle or parametric cycle control. Bioquell ProteQ has a built-in aeration function, but you can further optimize the cycle with an optional wireless aeration unit that can be stored directly in the main unit. Validated high-level decontamination allows for easy coverage of all exposed surfaces with vapor in a single cycle.

The L-4 can be used for the multipurpose elimination of biological contamination in machines or small enclosure systems, open spaces, and rooms. It allows for quick connections and easy room setups, achieving validated 6-Log kill decontamination. Bioquell's hydrogen peroxide vapor technology effectively decontaminates contaminants such as isolators, BSCs, freeze dryers, pass-throughs, and rack washers connected to the Bioquell L-4. The room decontamination option further enhances the system's versatility. The Bioquell L-4 can be used by installing an indoor distribution head or by connecting from outside the zone to meet specific needs. When using Bioquell products, there is no need to wait for limited temperature or humidity ranges. From the start, the dual-loop technology of the Bioquell L-4 releases steam first and then rapidly converts hydrogen peroxide vapor into water vapor and oxygen, demonstrating its effectiveness. Details of all cycles are printed, and real-time cycle data can be recorded via Ethernet for LIMS, BMS, SCADA, or other data collection systems.

The Sepha Multi-Q is a multifunctional leak tester that can perform multiple types of leak tests with a single device. By changing attachments, it can accommodate leak testing for all types of packaging, including vials, syringes, ampoules, pillow packs, pouches, four-way/three-way seal packages, and MAP (modified atmosphere packaging). It complies with data integrity standards, 21 CFR Part 11, and CCIT. It can detect pinholes as small as 1µm, and testing methods include vacuum differential pressure (ASTM F2338-09(2013)), pressurized differential pressure, and pressure decay methods.

High-Speed Inline Total Leak Testing Device for Vials, Syringes, BFS, and IV Bags This device is designed to enable non-invasive, non-destructive testing of various types of pharmaceutical containers and their contents at high production speeds in a 100% inline state. The tests are fast, highly reliable, reproducible, and provide consistent results, allowing for complete batch control without compromising the functionality of the containers or contents. The empty leak or pressure leak methods fully comply with current GMP international regulations. The container integrity test (CCIT) is based on ASTM F2338-09 (Standard Test Method for Non-Destructive Leak Detection of Packages) using vacuum and pressure decay methods. High-class machine design and automation solutions facilitate operations and support the reduction of downtime. The device is equipped with electronic batch record management or manufacturing execution systems and can be integrated into an Industry 4.0 environment.

1. A special film with extremely high resistance and stability against a wide variety of solvents is adopted. 2. The film is FDA, USP, and EP approved. It has antistatic properties and does not generate dioxins during incineration. 3. Compared to hard wall isolators, the initial investment is about one-tenth and the delivery time is shorter. Design changes after delivery are also easy. 4. Customizable design allows for adaptation to various concepts and can be flexibly applied to existing equipment. 5. Due to the disposable concept, cleaning validation is unnecessary, and complicated verification processes are not required. 6. A unique dedicated crimping tool allows for easy separation of sleeves and bags without exposing them. 7. Containment level achieves OEL < 1μg/m³. 8. It also supports negative pressure management.