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  3. 日本ベクトン・ディッキンソン 品質管理・研究開発・注射剤の製剤研究・CMO
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日本ベクトン・ディッキンソン 品質管理・研究開発・注射剤の製剤研究・CMO

Establishment1971 year
capital68750Ten thousand
number of employees600
addressTokyo/Minato-ku/Akasaka 4-15-1, Akasaka Garden City
phone0120-8555-90
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last updated:Nov 12, 2024
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日本ベクトン・ディッキンソン List of Products and Services

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Quality Control – Rapid Inspection Equipment Quality Control – Rapid Inspection Equipment
Quality Control – Pharmaceutical Inspection Quality Control – Pharmaceutical Inspection
Quality Control - Food Inspection Quality Control - Food Inspection
Research culture media products Research culture media products
Research and Development - Drug Discovery and Regenerative Medicine Research and Development - Drug Discovery and Regenerative Medicine
Research and Development - Clinical Trials Research and Development - Clinical Trials
Formulation research and CMO of injectable preparations Formulation research and CMO of injectable preparations
Quality

Quality Control – Pharmaceutical Inspection

BD offers a range of products, including gamma-irradiated triple-packaged stamp media, suitable for various applications in surface microbial count measurement for environmental monitoring in sterile pharmaceutical manufacturing areas according to the Japanese Pharmacopoeia.

Environmental Microorganism <Surface-Attached Bacteria> Testing BD Rodac™ Plate

We use secure lid petri dishes with protrusions that fix the lid and base together, providing ease of handling and reducing contamination risk.

By using BD RODAC™ plates, microbial contamination of the working environment, such as the surfaces of instruments and equipment, can be easily monitored. The RODAC method is the most widely adopted method internationally. Furthermore, the various media used in BD BBL BD RODAC™ plates comply with the composition standards of the American Public Health Association (APHA) and are strictly quality controlled. By using this highly reliable BD RODAC™ plate agar for environmental and food hygiene assessments, high testing accuracy can be expected.

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Gamma-irradiated culture medium for manufacturing environment monitoring

Gamma-irradiated culture medium for environmental monitoring, composed and tested for quality and performance in accordance with the three major pharmacopoeias: Japanese Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia.

The "BD BBL (TM) γ-ray irradiated culture medium series" is quickly transported under refrigeration to a γ-ray irradiation facility after the medium is manufactured, and irradiation is performed within a specified time frame from the start of medium dispensing. We issue a certificate of analysis for each lot, clearly stating the recovery rates for all microbial strains used in the performance testing of the medium, as per the microbial limit test of the 18th revision of the Japanese Pharmacopoeia, the microbial evaluation test method for sterile pharmaceutical manufacturing areas, and the preservation efficacy test method, so you can use it with confidence. 【Features】 ■ Manufactured at the Fukushima plant, ensuring stable supply ■ Can be stored at 4°C to 25°C It can be stored in a refrigerator or in a sterile manufacturing area at room temperature. ■ Easy locking of petri dishes The locking petri dish prevents the lid from falling off even if dropped, preventing contamination after sample collection. ■ Side printing Information such as lot numbers that may hinder the observation and measurement of colonies is printed on the side of the petri dish. ■ Wide neutralization capability, SCDLP Plus To reduce the risk of false negatives caused by residual disinfectants and sterilants on surfaces of equipment and instruments, as well as within pharmaceutical manufacturing areas, it contains four neutralizers. *For more details, please feel free to contact us.

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BD(TM) gamma ray sterilization wipe environmental inspection swab double packaging

This is a gamma-sterilized, double-packaged swab with rinse solution, suitable for wipe environment testing in clean rooms and pharmaceutical/medical device manufacturing sites.

1. Gamma-ray sterilization (SAL10-6) double packaging Suitable for wipe sampling environmental testing in clean rooms and pharmaceutical/medical device manufacturing sites. 2. Compact design The shaft is 8.5mm / swab 5mm, making it convenient for wiping details and recesses. The swab does not contain ATP. 3. Buffer solution 10mL Facilitates the collection of dry samples. Eases the retention of microorganisms (samples) and also has neutralizing ability for disinfectants.

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Triptych case soy broth γ-ray irradiated (Japanese Pharmacopoeia medium filling test)

This is a medium for the "Medium Filling Test (Process Simulation)" of the 16th edition of the Japanese Pharmacopoeia, and it can be used simply by dissolving it in sterilized water.

BD BBL Trypticase Soy Broth γ-ray irradiated is a medium for the "Medium Filling Test (Process Simulation)" listed in the 16th edition of the Japanese Pharmacopoeia, and it can be used simply by dissolving it in sterilized water. It is a γ-ray irradiated Trypticase Soy Broth formulated in accordance with the tripartite pharmacopoeia, designed for use in pharmaceutical manufacturing area environmental monitoring with minimal risk of microbiological contamination to the environment. Quality and performance tests compliant with the pharmacopoeia are conducted, and a Certificate of Analysis is issued for each lot in accordance with these tests.

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Non-animal derived culture medium for filling test medium 'Trypticase Soy Broth γ-ray'

We deliver non-animal-derived culture media for filling tests from a factory dedicated to animal-free products! Used to ensure sterility in the manufacturing lines of sterile pharmaceuticals and beverages.

The "BD BBL Select APS Triptych Case Soybroth" series is a soybean-casein-digest medium that complies with the three-pronged pharmacopoeia for medium filling tests. To provide safer products, it is manufactured in a dedicated animal-free facility that does not use animal-derived materials or antibiotics. Additionally, it incorporates an even stricter quality system than conventional factories to minimize the possibility of cross-contamination. 【Features】 ■ Soybean-casein-digest medium that has been γ-irradiated for medium filling tests and complies with the three-pronged pharmacopoeia ■ Animal-free, reducing BSE/TSE risks ■ Manufactured in a dedicated animal-free facility ■ Mycoplasma/endotoxin testing conducted

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Japanese Pharmacopoeia-compliant room temperature storage medium series

Delivering fresh culture media from our domestic factory! A series of media that can be stored at room temperature.

The "Japanese Pharmacopoeia Compliant Room Temperature Storage Medium Series" is a highly convenient medium that can be stored at room temperature between 2 and 25°C. Included in the lineup are the Soybean Casein Digest Agar "BD BBL SCD Agar RT," as described in the Japanese Pharmacopoeia for viable count testing, and the "BD BBL R2A Agar RT," which is mentioned in the quality control of purified water in the Japanese Pharmacopoeia. The "BD BBL R2A Agar RT" is also recommended as a medium for measuring the viable count of auxotrophic bacteria according to the dialysis fluid purification guidelines and the water quality testing methods. 【Features】 ■ Compliant with the Japanese Pharmacopoeia ■ Can be stored at room temperature (2-25°C), enhancing convenience ■ Shelf life of 6 months ■ Manufactured domestically in-house *For more details, please refer to the catalog or feel free to contact us.

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Time-lapse image analysis method that enables the rapidization of agar cultivation methods.

Limited to the first 20 people! Technical paper and novelty gift related to "Microbiome μ3D" will be presented!

This document is a technical paper on Microbio μ3D by Hiroyuki Ogawa (Microbio Co., Ltd.), published in the magazine "PHARM TECH JAPAN December 2016 issue special edition." The "time-lapse image analysis method" is an analytical method that fully automates the agar medium culture method, speeding up detection and counting. By transitioning from manual visual inspection to a fully automated rapid microbial detection device, we can expect a reduction in quality inspection time and labor. Currently, we are offering the original paper and a novelty item to the first 20 respondents! *Please note that what you can download is only a part of the paper. For more details, feel free to contact us.

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Rapid and labor-saving solution for microbial testing using time-lapse imaging technology.

Limited to the first 20 people! A technical paper introducing the application fields of Microbiome μ3D and a novelty gift will be presented!

This document is a paper published in the magazine "PHARM TECH JAPAN," titled "Fully Automated Rapid and Labor-Saving Solutions for Microbial Testing Using Time-Lapse Imaging Technology." It introduces the rapidity, labor-saving features, and performance of the fully automated rapid microbial testing device "MicroBioμ3D," which is commercialized based on "time-lapse image analysis" categorized under the microcolony method, as well as its application fields. Currently, we are offering the original paper and a novelty item to the first 20 people who respond! *Please note that only a portion of the paper is available for download. For more details, please feel free to contact us.

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Biological culture medium (adjusted medium)

Series of media for food hygiene management

BD established a domestic factory in Fukushima Prefecture in 1987, and by integrating Japan's excellent production technology and quality control, it has developed into a production base that boasts world-class quality. By having factories in the three regions of the United States, the EU, and the Far East, including Japan, we have established a system that can respond to diverse needs. Our company offers a variety of 'live media' products, including the room-temperature storage medium series (compliant with the Japanese Pharmacopoeia) such as "BD BBL SCD Agar Medium RT," "BD BBL R2A Agar Medium RT," and the medium series for food hygiene management, "BD BBL Desoxycholate Agar Medium." [Features] ■ Domestic in-house manufacturing ■ Side printing compatible (to avoid interfering with colony counting, lot and expiration date information is printed on the side of the petri dish) ■ COA (Certificate of Analysis) can be obtained from the web *For more details, please refer to the catalog or feel free to contact us.

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Aseptic test liquid medium

Compliant with the Japanese Pharmacopoeia! A sterile test liquid medium with high transparency, making changes easy to observe.

The "Aseptic Testing Liquid Medium" is a product of the BD BBL/BD Difco brand based on the harmonization of the Japanese Pharmacopoeia (JP), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP). We provide a certificate of analysis compliant with the three pharmacopoeias for each lot. Additionally, due to the high transparency of the medium, the growth of bacteria can be clearly observed. 【Features】 ■ A wide variety of bottle shapes tailored to different uses ■ High transparency medium and clear labels for easy visibility of changes ■ Four types of cap shapes to choose from ■ Expiration date: 12 months from the date of manufacture (stored at room temperature) ■ Sterility assurance: SAL (Sterility Assurance Level) is guaranteed at 10^-6 *For more details, please refer to the catalog or feel free to contact us.

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For airborne bacteria measurement! Gamma-ray irradiated triple-packaging series for environmental monitoring media.

[Free Sample Available] Compliant with the Pharmacopoeia of the Three Regions! We deliver fresh culture media manufactured in our domestic factory! It has a long shelf life of 9 months and can be stored at room temperature!

The environmental monitoring medium "SCD II/SCDLP Plus" can be used for measuring airborne and settled microorganisms in the sterile pharmaceutical manufacturing areas as defined by the Japanese Pharmacopoeia. Additionally, by performing gamma irradiation after the sterile filling of the medium, it can be safely used in isolators and clean rooms. We are currently accepting requests for free samples. If you would like a sample, please download the sample application flyer. 【Features】 ■ Fresh live medium delivered from our domestic factory ■ Compatible with isolators and clean rooms ■ Can be stored at 2–25°C with a long shelf life of 9 months at room temperature ■ Available in both types with and without locking mechanisms etc. *For more details, please download the PDF or contact us.

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Reduce factory inventory by 50% before introducing Microbio μ3D.

Streamlining quality control and reducing costs through advanced microbial testing. Interview on the introduction of a rapid fully automated bacterial colony detection system.

We conducted an interview with Masashi Itakura, Executive Officer and Managing Director of Pigeon, a leading company in childcare products, which was quick to adopt the rapid fully automated bacterial colony detection system "Microbio μ3D." The "Microbio μ3D" continuously monitors the shadows of colonies on petri dishes every 30 minutes using a CCD camera. By detecting changes in shadows not only by area but also by volume, it enables faster detection of colonies growing on the medium compared to visual observation. 【Implementation Results】 - Reduced the determination period for fungi in microbial limit tests from 3-4 days, resulting in a 50% reduction in factory inventory. - Reduced human error in quality inspections and standardized the inspection process. - Streamlined and systematized inspection tasks, allowing a focus on creative work such as product development. *Please download the interview article from our company website. *For product information, feel free to download the PDF or contact us.

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BD BBL Columbia Agar

Compliant with microbial limit tests of JP, USP, and EP. Delivering fresh culture media from our domestic factory.

"Columbia Agar" is used for the isolation and cultivation of bacteria with strict nutritional requirements from various samples, as well as general bacteria. The combination of casein pancreatic digest, pepsin digest of animal tissue, and beef extract allows for good bacterial growth. Yeast extract serves as a source of B-complex vitamins and, along with corn starch, plays a role as an energy source. [Features] - Convenient packaging with 5 sheets in 2 packs - Anaerobic packaging that can be used immediately after opening - Shelf life of 6 months - Refrigerated storage (2–8°C) - Complies with the three pharmacopoeias (JP, USP, EP) *For more details, please refer to the PDF document or feel free to contact us.

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BD BBL Sabouraud Dextrose LP Agar

Effective for 6 months at room temperature! Aerobic culture is possible within 5 days at 22.5°C ± 2.5°C.

Our company handles the "BD BBL Sabouraud Dextrose LP Agar Medium" compliant with the Japanese Pharmacopoeia. It has a shelf life of 6 months when stored at room temperature. Aerobic culture is possible within 5 days at 22.5°C ± 2.5°C. We deliver fresh media from our domestic factory in Japan. 【Composition (per 1L of purified water)】 ■ Casein pancreatic digest: 5.0 g ■ Pepsin digest of animal tissue: 5.0 g ■ Glucose: 40.0 g ■ Agar: 15.0 g ■ Lecithin: 0.7 g ■ Polysorbate: 5.0 g ■ Final pH = 5.6 ± 0.2 *For more details, please refer to the PDF document or feel free to contact us.

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Swab for wipe test 'BD Laspacheck PlusONE'

[Free Sample Offer] You can drop 1cc onto a petri dish without the need for a pipette, improving work efficiency! Suitable for detecting microorganisms and measuring their quantities!

The "BD Laspacheck TM PlusONE" swab for wipe tests is designed to detect and measure the number of microorganisms present on surfaces of important instruments, equipment, food materials, and hands, which is crucial for hygiene management. This product allows for efficient and quantitative understanding of microbial contamination from equipment, environments, and workers in the food manufacturing process. By creating a cap-type hole at the bottom of the main body and improving the design to allow direct dripping onto a petri dish, it enhances work efficiency by enabling 1cc to be dripped onto the dish without the need for a pipette. 【Features】 - Uses large cotton balls for easy wiping - Integrated cap cotton swab for easy wiping operation - Larger cap for easy handling even with gloves on - Soft plastic for easy squeezing of the cotton ball - Can drip directly from the container onto the petri dish - Securely closes with a screw cap - Minimizes splashing of the solution when opening *For more details, please download the PDF or contact us.

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