バイオメディカ・ソリューション List of Products and Services

The "BM wiper-s" is a product that has been commercialized as a sterilized wiper for clean rooms. It is made from low-dust materials suitable for use in clean rooms, with low static electricity generation that does not attract dust. It is triple-packaged, minimizing the introduction of bacteria and dust into sterile areas. The minimum packaging unit is 20 pieces, and it can maintain a sterilized state until just before use. Additionally, even when disposed of after each work shift, it is economical with minimal waste. It excels in water absorption, chemical resistance, and heat resistance, making it comfortable to use for various tasks. 【Features】 ■ Sterilized with 25KGy gamma rays, with an irradiation certificate included ■ Low static electricity generation that does not attract dust ■ Economical with minimal waste even when disposed of after each work shift ■ Excellent water absorption, chemical resistance, and heat resistance ■ Usable for various tasks *For more details, please refer to the PDF materials or feel free to contact us.

• Wipers

The "BM Humitainer" is a pouch with a spout designed to prevent the growth of bacteria and mold in the humidification bath inside an incubator. It is individually packaged and sterilized with 20KGy gamma rays, maintaining a sterile condition until just before use. Even if disposed of after each work shift, it is economical with minimal waste. The pouch combines a transparent film and a moisture-permeable film, allowing for easy transport without leakage once the cap is secured after filling with water. 【Features】 ■ Pouch with spout that prevents the growth of bacteria and mold in the humidification bath of the incubator ■ Individually packaged and sterilized with 20KGy gamma rays ■ Maintains a sterile condition until just before use ■ Can be transported without leakage once the cap is secured after filling with water ■ Allows for easy water replacement even in places like clean rooms where handling water is difficult *For more details, please refer to the PDF document or feel free to contact us.

• Packaging Bags

We would like to introduce a case where our "iPS cell-derived organ manufacturing system" has been implemented at the Graduate School of Medicine, Yokohama City University, Public University Corporation, in the field of Organ Regenerative Medicine and Advanced Medical Science Research Center. The system connects isolators with an interchange unit, allowing for the simultaneous large-scale culture of multiple different cells. The materials used can also be decontaminated and stocked within the system, and automatically transported to designated isolators as needed. This system is composed of an existing closed system (isolator technology) and includes an aseptic operation unit, supply stock unit, interchange unit, pass box unit, hydrogen peroxide vapor generation unit, and automated cell culture transport unit. [Overview] - Automation based on a closed system (isolator technology) - Connection of isolators via an interchange unit - Capability for simultaneous large-scale culture of multiple different cells - Ability to decontaminate and stock materials within the system - Automatic transport to designated isolators as needed *For more details, please refer to the PDF document or feel free to contact us.

• others

We would like to introduce the case of CPC implementation at Kanazawa Medical University Hospital's Regenerative Medicine Center, which we have worked on. By introducing cleanliness management, room pressure management, and isolators, we adopted a facility design that minimizes the risk of contamination. The use of large windows between the management room and the cell preparation room creates a sense of openness and reduces stress for the operators. Additionally, the culture scenes can be viewed from outside the controlled area, allowing for active acceptance of visitors as an educational facility. The cell preparation room and supply room are equipped with airtight automatic doors, enabling smooth material handling. [Overview] - Introduction of cleanliness management, room pressure management, and isolators - Facility design that minimizes the risk of contamination - Large windows between the management room and the cell preparation room - Creates a sense of openness and reduces operator stress - Airtight automatic doors in the supply room for smooth material handling *For more details, please refer to the related links or feel free to contact us.

• Clean Booth

We have introduced the automated controlled robotic hand-equipped large-scale CO2 incubator 'AC800' at the Keio University School of Medicine's Center for Cardiac Regenerative Medicine. The robotic hand automatically transports cell culture containers from the sterile operation unit to the culture stage. Used items such as cell culture containers are expelled from a dedicated waste disposal box, enabling all necessary tasks to be performed within the incubator. Optional features include a waste disposal box, dedicated CO2 chamber, microscope unit, and forced CO2 ventilation system. [Overview] - Introduced a large-scale CO2 incubator equipped with an automated controlled robotic hand - Automatically transports cell culture containers from the sterile operation unit to the culture stage - Enables all necessary tasks within the incubator - The main unit has corrosion resistance due to hydrogen peroxide vapor decontamination *For more details, please refer to the PDF document or feel free to contact us.

• incubator

Our company has had the opportunity to provide various services such as the construction of cell culture processing facilities, cell culture support, facility operation management support, document preparation support, and quality testing outsourcing, accumulating experience and know-how. In order to utilize this experience for the early realization of regenerative medicine and cell therapy, we are expanding our contract services for cell culture processing. We comprehensively undertake cell culture processing, including the preparation of necessary documents such as procedures, instructions, and records, the construction of facilities suitable for our clients' cells, preliminary tests and culture by experienced staff, and the establishment and implementation of various performance and quality tests. 【Service Contents】 ■ Document preparation ■ Optimization of culture facilities ■ Cell culture ■ Establishment of various performance and quality tests *For more details, please refer to the related links or feel free to contact us.

• Processing Contract
• Other contract services

We would like to introduce the "Other Quality Tests" that we offer. To realize regenerative medicine and cell therapy as soon as possible, we flexibly respond to our customers' needs. We have a track record of contract testing such as DC surface antigen measurement tests (FACS) and WT1-CTL measurement tests (FACS). In addition to tests using our analytical equipment, such as cell surface marker measurement with the 2-laser 4-color FACS system CytoFLEX and gene expression analysis using real-time PCR (7500 Fast Real-Time PCR System), please feel free to consult us about other tests as well. 【Examples of Contract Testing】 ■ Cell surface marker measurement with the 2-laser 4-color FACS system CytoFLEX ■ Gene expression analysis using real-time PCR (7500 Fast Real-Time PCR System) *For more details, please refer to the related links or feel free to contact us.

• Contract measurement

Our company offers "Mycoplasma Detection Testing." Due to its size, mycoplasma can pass through sterilizing filters, and many antibiotics are ineffective against it, making it easy to contaminate cell culture media. Additionally, even when it contaminates and proliferates in cell culture media, it is difficult to detect visually, necessitating special management. We conduct mycoplasma detection testing using a real-time PCR method designed to detect over 90 types of mycoplasma. We also offer testing to confirm the suitability of measurements by adding a known quantity of mycoplasma DNA to the sample. [Features] - Mycoplasma can pass through sterilizing filters due to its size. - It is easy to contaminate cell culture media because it is resistant to antibiotics. - Special management is required because it is difficult to visually detect even when it contaminates and proliferates in cell culture media. - Real-time PCR method designed to detect over 90 types of mycoplasma. - We also conduct tests to confirm measurement suitability by adding a known quantity of mycoplasma DNA to the sample. *For more details, please refer to the related links or feel free to contact us.*

• Contract measurement

We offer contract services for the "Endotoxin Test" (gelation method, turbidity method, colorimetric method) in accordance with the Japanese Pharmacopoeia. Endotoxins, which are components of the cell walls of Gram-negative bacteria, are pyrogenic substances that are universally present in the environment. The contamination of endotoxins in the bloodstream can cause fever and shock. Due to the difficulty in inactivating or removing endotoxins, strict management is required for cells used in regenerative medicine that are directly administered into the body. 【Features】 ■ In accordance with the Japanese Pharmacopoeia ■ Gelation method, turbidity method, colorimetric method ■ Strict management is required for cells used in regenerative medicine that are directly administered into the body ■ We also offer reliability confirmation tests for calibration curves and tests for reaction interference factors *For more details, please refer to the related links or feel free to contact us.

• Contract Inspection
• Contract measurement

We offer a test called "Sterility Test," which examines the presence of bacteria and fungi using culture methods. To detect a wide range of microorganisms, we use two types of media (Soybean Casein Digest Medium and Liquid Thioglycolate Medium). We conduct sterility tests (direct method and membrane filter method) in accordance with the Japanese Pharmacopoeia. We also accommodate media performance tests and method suitability tests as per the Japanese Pharmacopoeia. 【Features】 ■ Two types of media are used to detect a wide range of microorganisms ■ Sterility tests in accordance with the Japanese Pharmacopoeia ■ Support for media performance tests and method suitability tests as per the Japanese Pharmacopoeia ■ Sample inoculation is performed within an isolator *For more details, please refer to the related links or feel free to contact us.

• Contract Inspection
• Contract measurement

Our company provides facility operation services called "Maintenance Services." We conduct essential inspections for the maintenance and operation of cell culture processing facilities, such as checking whether air conditioning equipment, culture-related equipment, and storage devices are functioning properly, along with validations to prevent troubles. We perform air conditioning maintenance, equipment maintenance, and various system HD backups. Additionally, we identify issues and contribute to skill enhancement through proposals for operational improvements and hosting study sessions. 【Main Maintenance Categories (Partial)】 ■ Clean Rooms ■ Air Conditioning Systems ■ Biohazard Countermeasure Cabinets ■ Particle Counters ■ Particle Pumps *For more details, please refer to the related links or feel free to contact us.

• Other contract services

We provide sanitation services for cell culture processing facilities. Contaminants such as dust, dirt, and bacteria are not visible to the naked eye and may be lurking within clean rooms. To disinfect, remove dust, and sterilize these contaminants to a safe level, we use hydrogen peroxide-based and peracetic acid-based agents according to the grade management of the facilities and equipment, performing cleaning, dust removal, and application of agents. As a finishing touch, we remove residues with ethanol wiping and conduct microbial evaluation tests. 【Overview】 ■ Targets - Cell culture processing facilities/CPC - Equipment such as isolators, biosafety cabinets, clean benches, incubators, pharmaceutical refrigerators, and freezers ■ Control - Microbial evaluation tests - Measurement of particle count/purity using a particle counter *For more details, please refer to the related links or feel free to contact us.

• Contract Inspection
• Other contract services

"Validation" refers to the process of verifying and documenting that the equipment, system, or device in question provides the expected results. Before conducting process validation, it is necessary to complete four steps of qualification assessment. For equipment with sterilization functions, sterilization validation is performed to confirm sterilization performance using indicators. In large-scale projects where the scope of validation is broad and there are multiple individual plans, a validation master plan that encompasses all of them will be created. 【Steps of Qualification Assessment】 ■ Design Qualification ■ Installation Qualification ■ Operational Qualification ■ Performance Qualification *For more details, please refer to the related links or feel free to contact us.

• Other contract services

The "BMF-U390VH" is a product capable of providing a stable low-temperature storage environment by enabling fast pull-down through an HC refrigerant and inverter compressor cooling system, along with VIP insulation material. Equipped with a drying filter and expansion tank, it allows for normal operation of the cooling system even in abnormally high-temperature environments. The integrity of long-term sample storage has been improved. With a controller featuring a delayed start function, it allows for off-peak settings of 0 to 30 minutes, reducing circuit load due to simultaneous starts. The excellent U-Vacua vacuum insulation material combined with rigid polyurethane foam has enhanced thermal insulation and heat retention. 【Features】 ■ Achieves -90℃ ■ Equipped with a drying filter and expansion tank ■ Improved integrity of long-term sample storage ■ Off-peak settings of 0 to 30 minutes possible with a delayed start function controller ■ Enhanced heat retention and insulation effect *For more details, please refer to the PDF document or feel free to contact us.

• Refrigerators and freezers

We would like to introduce the biomedical freezer "VH Series" handled by Biomediqa Solutions Co., Ltd. It achieves a minimum temperature of -40°C. The exterior, interior, and door are made of painted steel plates, and the shelves are coated with polyethylene on hard steel wire. With excellent U-Vacua vacuum insulation material and rigid polyurethane foam due to VIP vacuum insulation technology, the thermal insulation and heat retention have been improved. 【Features】 ■ Low-temperature storage container ■ Minimum temperature of -40°C ■ Excellent U-Vacua vacuum insulation material ■ Rigid polyurethane foam used as insulation material ■ Improved heat retention and insulation effect *For more details, please refer to the PDF document or feel free to contact us.

• Refrigerators and freezers

The "BMR-310 and BMR-410 series" are pharmaceutical refrigerators that provide suitable storage environments for reagents, samples, media, and more. The large glass doors make it easy to check the contents, and the heat-reflective film effectively prevents condensation. To prevent gaps that can cause temperature increases when the door is closed and to avoid forgetting to close it, hinges are used. To maintain a uniform temperature inside the unit, twin fan motors are employed. This allows for more efficient forced circulation of cold air and rapid temperature recovery. 【Features】 - Effectively prevents condensation with heat-reflective film - Equipped with twin fan motors - More efficient forced circulation of cold air for rapid temperature recovery - LED lighting achieves highlights and energy savings - Coated steel plates designed for durability, rust resistance, and corrosion resistance *For more details, please refer to the PDF document or feel free to contact us.

• Refrigerators and freezers

The "Closed Safety Cabinet - CSC Series" achieves a high-level sterile environment for cell preparation with space-saving design and low running costs, and it can handle cells and tissues from multiple donors by adopting a detachable cell culture CO2 incubator. Equipped with a hydrogen peroxide vapor generator, it allows for validated high-level decontamination during changeover. The cell culture CO2 incubator is detachable, enabling support for cells and tissues from multiple donors by adding more units. The cell culture CO2 incubator and centrifuge unit dock together, allowing the main processes of cell preparation to be carried out in a sterile environment. This eliminates the need for a large cleanroom, significantly reducing both initial and running costs. 【Features】 ■ Eliminates the need for expensive sterile clothing, greatly reducing the burden on operators along with running costs. ■ Equipped with a window for an LCD monitor, allowing projection of observation images from commercially available microscopes. ■ Equipped with a decontamination pass box, allowing the exterior of reagents and instruments brought into the work area to be decontaminated with hydrogen peroxide vapor. ■ Ensures reliable decontamination through CT control. *For more details, please download the PDF or contact us.

• Glove box

Introducing the 'AC408xy' equipped with an automatic transport function that can be connected to an isolator. Traditionally, cell culture for multiple donors required a small incubator for each donor, which posed significant challenges in terms of space and cost when expanding facilities. This product aims to reduce space by automatically transporting and storing multiple independent chambers connected to the isolator, thereby preventing cross-contamination within the chamber and avoiding cell mix-ups. 【Features】 - Automatic transport between the incubator and the isolator - Capable of storing multiple independent chambers - Solves various issues such as cross-contamination and cell mix-ups *For more details, please refer to the PDF document or feel free to contact us.

• incubator