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"The Basics of Sterilization Knowledge and Manufacturing Standards for Biological Indicators, as well as Sterilization Assurance," is a comprehensive document that covers a wide range of topics from the fundamental knowledge necessary for sterilization assurance to practical applications. It explains the concept of Sterilization Assurance Level (SAL) 10^-6, the selection criteria for biological indicators in accordance with the ISO 11138 series, and the culture conditions. Additionally, it includes examples of calculating D values and Z values for sterilization processes. The content is designed for stakeholders in various fields, including the pharmaceutical industry, medical device industry, and quarantine facilities. **Features** - Explanation of the fundamental knowledge of Sterilization Assurance (SAL) - Introduction of selection criteria for biological indicators based on ISO standards - Presentation of methods for calculating D values and Z values in sterilization processes - Provision of specific guidelines for the design and evaluation of sterilization processes *The document is available for immediate reading via "PDF Download."*

• Sterilizer

We offer a "custom solution for medium performance testing" that adjusts environmental isolates and provides them as freeze-dried pellets that can be stored under refrigeration. In the development of sterile pharmaceuticals, cosmetics, medical devices, and dietary supplements, it is crucial to eliminate microbial risks to ensure safe products. While considering the use of environmental isolates in medium performance testing, please feel free to consult us if you have concerns about the quality and cost of adjustment and storage. 【Features】 ■ Adjustment of environmental isolates for medium performance testing ■ Provision of freeze-dried products that can be stored under refrigeration (2-8°C) ■ User-friendly simple packaging ■ Proven track record in Japan *For more details, please refer to the materials. Feel free to contact us as well.

• Environmental Analysis

This document explains the removal of air from the sterilization chamber. It includes reasons for placing the EZTest biological indicator horizontally and two common methods for removing surrounding air from the sterilization chamber. For any questions, inquiries, or product information, please feel free to contact Leben Japan Co., Ltd. 【Contents (Example)】 ■ Reasons for placing the EZTest biological indicator horizontally ■ Two common methods for removing surrounding air from the sterilization chamber ■ Dynamic air removal ■ Gravity displacement *For more details, please refer to the PDF document or feel free to contact us.

• Other sterilization, disinfection and disinfection equipment

This document introduces the "truth" regarding the execution of sterilization cycles. It explains the claims of dissatisfaction that "no spores should be able to withstand a 212-minute effective ethylene oxide cycle" and the responses to those claims. For any questions, inquiries, or product information, please feel free to contact Leben Japan Co., Ltd. 【Content Overview (Example)】 ■ Important variables that must be controlled in the sterilization process ■ Answers to client dilemmas ■ Sensor systems for controlling and monitoring sterilization cycle performance ■ Steam systems *For more details, please refer to the PDF document or feel free to contact us.

• Other sterilization, disinfection and disinfection equipment

This document provides an explanation regarding the evaluation of isolator decontamination using multiple biological indicators (BIs). It discusses the concept of using three BIs as a proactive measure, rather than as a response to unexpected positive BIs during the VHP cycle. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. [Contents Included (Example)] ■ In the event of undesirable positive BIs ■ Using three BIs as a proactive measure ■ Halvorson-Ziegler equation *For more details, please refer to the PDF document or feel free to contact us.

• Other analytical and testing equipment

This document explains the issues related to Steam-In-Place (SIP) sterilization and new solutions. It covers SIP, which is performed to remove or kill attached bacteria in piping systems, as well as information on bacteria, biofilms, and microorganisms. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. 【Contents (Example)】 ■ Mature Biofilms ■ Mature Biofilms in Process Piping Systems ■ Bacteria in Stainless Steel "Scratches" ■ Biofilm Formation in Dead Legs *For more details, please refer to the PDF document or feel free to contact us.

• High pressure steam sterilizer/autoclave

This document introduces the parameters that affect the performance of hydrogen peroxide BI. It also includes explanations about the potential benefits of using VHP as a decontamination/disinfection medium, as well as information regarding bacterial counts. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. [Contents] ■ Bacterial count ■ Concentration of peroxides and other factors ■ Similar performance impacts with chemical disinfectants *For more details, please refer to the PDF document or feel free to contact us.

• Other quality control and hygiene measures

This document introduces the Process Challenge Device (PCD) announced by SGM Biotech. It includes descriptions of ISO 14161:2000 and a verification set that summarizes a series of four PCD resistances. For any questions, inquiries, or product information, please feel free to contact Leben Japan Co., Ltd. [Contents (Example)] ■ Description of ISO 14161:2000 ■ Verification of ethylene oxide sterilization cycles and routine monitoring ■ A series of four PCD resistances are compiled in the verification set ■ Typical survival curves of biological indicators (BIs) exposed in PCDs evaluated with ethylene oxide resistance evaluation devices *For more details, please refer to the PDF document or feel free to contact us.

• Other analytical and testing equipment

This document presents a review of the revisions related to the ISO 11138 series concerning the manufacturing of biological indicators. It explains the changes in the newly revised AAMI/ANSI/ISO 11138 series. Additionally, it details the manufacturing/performance of biological indicators used for sterilization of healthcare products. For any questions, inquiries, or product-related matters, please feel free to contact Leben Japan Co., Ltd. [Contents (Example)] ■ Biological Indicators, Part 1 ■ Biological Indicators, Part 2 ■ Biological Indicators, Part 3 ■ Biological Indicators, Part 4 ■ Biological Indicators, Part 5 *For more details, please refer to the PDF document or feel free to contact us.

• Other analytical and testing equipment

This document explains why BI survives in a validated cycle. It includes inquiries about EZTest Steam and reviews of data obtained when evaluating the resistance performance of lots. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. 【Contents (Example)】 ■ Inquiries about EZTest Steam ■ Requirements for a 48-hour incubation time with BI ■ Review of data obtained when evaluating the resistance performance of lots ■ Why does the BI test yield positive results at 134°C for 7 minutes? ■ Post-processing contamination is a scenario that needs to be considered *For more details, please refer to the PDF document or feel free to contact us.

• Other analytical and testing equipment

This document introduces an article exploring several reported issues where BI is not possible. It includes Case 1 about the "Bourbon" effect and Case 2 where BI turned yellow but no spores were present after subculturing. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. 【Contents (Examples)】 ■ Case 1: "Bourbon" Effect ■ Case 2: Is it positive? Is that positive? ■ Case 3: Restoration Effect - It is not positive ■ Case 4: A "sensitive" issue with Subtilis ■ Case 5: Who am I? Where did I come from? *For more details, please refer to the PDF document or feel free to contact us.

• Other analytical and testing equipment

This document explains the caramelization (darkening) phenomenon of liquid BI ampoules that have been autoclaved. It includes information on cases where spores did not die off during the culture cycle, as well as glucose and other sugars that may be present in the medium during caramelization. For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. [Content Examples] ■ Does caramelization impair the growth-promoting ability of the media? ■ Does BI function even if the medium is very dark? → Yes *For more details, please refer to the PDF document or feel free to contact us.

• High pressure steam sterilizer/autoclave

This document provides an explanation regarding the appropriate placement of biological indicators (BIs) during the VHP contamination removal cycle. It includes packaged BIs (HMV-091 series with primary packaging) and unwrapped ribbon BIs (SBC-327 series). For any questions, inquiries, or product-related concerns, please feel free to contact Leben Japan Co., Ltd. 【Contents (Example)】 ■ Two main types of BIs used to monitor the VHP cycle ■ Packaged BIs (HMV-091 series with primary packaging) ■ Unwrapped ribbon BIs (SBC-327 series) ■ Post-decontamination processing *For more details, please refer to the PDF document or feel free to contact us.

• Other quality control and hygiene measures

This document introduces the FAQs from MesaLabs. It includes questions such as accidentally leaving a BI ampoule at room temperature overnight, and inquiries regarding the confirmation of bacterial counts during acceptance testing, presented in FAQ format. If you have any questions or concerns, please feel free to contact us. [Content Included (Example)] ■ Handling of BI ampoules ■ Sterilization validation of steam piping ■ Confirmation of bacterial counts during acceptance testing ■ Resistance of spores ■ Facility contamination due to BI *For more details, please refer to the PDF document or feel free to contact us.

• Other Culture

This document explains the reduction of incubation time for biological indicators (RIT), which has been a topic of discussion for many years. It includes guidelines published by the U.S. FDA, information about today's global market, and two applications of biological indicators in the sterilization process. For any questions, inquiries, or product information, please feel free to contact Leben Japan Co., Ltd. 【Contents (example)】 ■ Reduction of incubation time for biological indicators ■ Recognition by SGM (currently Mesa Labs) ■ Well-characterized testing systems ■ Proliferation patterns of self-contained biological indicators ■ Two applications of biological indicators *For more details, please refer to the PDF document or feel free to contact us.

• Other Culture

This document introduces the cultivation period and sterilization guarantee of biological indicators. It discusses what happens to the sterilization guarantee for products that allow for short-term cultivation, as well as information about short-term cultivation for use in medical facilities (hospitals). Please take a moment to read it. 【Contents】 ■ The cultivation period for biological indicators is 7 days ■ What happens to the sterilization guarantee for products that allow for short-term cultivation? ■ What is FDA 510(k)? ■ Can a sterilization guarantee be obtained with short-term cultivation? ■ About the EZTest 7-day cultivation exclusive seal *For more details, please refer to the PDF document or feel free to contact us.

• Other Culture

We would like to introduce the "EZ-Accu Shot" that we handle. It can be used for medium performance testing such as microbial limit testing methods and sterility testing methods listed in the Japanese Pharmacopoeia (JP), and we also handle strains used in medium performance testing for microbial monitoring of pharmaceutical water. In addition, we offer the "EZ-CFU One Step" with a quantity of 10 kits, as well as "EZ-CFU." Please feel free to consult us when you need assistance. 【Features】 ■ Usable for medium performance testing such as microbial limit testing methods and sterility testing methods ■ Also handles strains used in medium performance testing for microbial monitoring of pharmaceutical water ■ Usable for medium performance testing in viable count tests and specific microorganism tests ■ By dissolving the pellet in the attached hydration solution, it is easy to prepare a "microbial solution containing less than 100 CFU of viable count" *For more details, please refer to the PDF document or feel free to contact us.

• Microbiology

This document is published in Spore News regarding the selection of biological indicators. This Spore News provides information on how to initiate the BI selection process, enabling end-users to more accurately determine the appropriate BI type for monitoring unique sterilization cycles. The items are categorized for easy reference, making it a useful resource. We encourage you to read it. 【Contents (partial)】 ■ Steam ■ Porous or hard products ■ Containers for aqueous liquids ■ Containers for heat-sensitive liquids ■ Heat-sensitive hard goods *For more details, please refer to the PDF document or feel free to contact us.

• Other storage and equipment

This document is a product list featuring biological indicators manufactured by MesaLabs, handled by Leben Japan Co., Ltd. It includes standard sterilization assurance indicator strains for obtaining sterilization guarantees, as well as a variety of biological indicators (BIs) such as the test paper type biological indicator "Spore Strips," which can be used for dry heat sterilization at higher temperatures than the spore strip test paper type. [Contents Included] ■ Spore Strips Test Paper Type ■ MesaStrip Test Paper Type ■ DriAmp ■ EZTest ■ Ampoule Type *For more details, please download the PDF or feel free to contact us.

• Microbiology

This catalog introduces standard strains manufactured by Microbiologics, handled by Leben Japan Co., Ltd. It mainly features numerous products applicable to microbiological limit testing methods and sterility testing methods, such as "EZ-Accu Shot(TM)", "EZ-CFU One Step(TM)", and "EZ-CFU(TM)". 【Featured Products】 ■EZ-Accu Shot(TM) ■EZ-CFU One Step(TM) ■EZ-CFU(TM) ■EZ-PEC(TM) ■Epower(TM), etc. *For more details, please download the PDF or feel free to contact us.

• Microbiology