Request Demo
WYSIWYG Web Builder
WYSIWYG Web Builder

Leeuwenbook

Portal Microbiology Laboratory Solution.
What is Leeuwenbook?

Leeuwenhook is commonly known as "the Father of Microbiology". Nowadays Leeuwenbook is a new web and mobile application developed to facilitate handling microbiology lab informations. With portable app you can follow status of received samples, all laboratory tests and generate laboratory reports. Leeuwenbook cover most microbiological examinations like test suitability, growth promotion tests (GPT), Microbiological Limits tests (MLT), Antibiotic bioassay, Sterility tests, Bacterial endotoxins, preservative and disinfectant efficacy test are included. Common laboratory activities like media preparations, reference strains and consumables stock control in addition to assets and instrument logs. Control of samples that out of specifications (OOS) are conducted.

SERVICES


Eliminate waste of time, Capture, organize, manage and collaborate test execution workflows across your organization with ease. With features designed to increase productivity while reducing errors. Leeuwenbook lets you manage the sample life-cycle, optimize laboratory execution, perform data retrieval, interface instruments and systems, and enable security and auditing.
Starting microbiology activities start from preparation of growth media.
Starting microbiology activities start from preparation of growth media.

Microbial culture media preparation is a routine task in the regular detection, count and monitoring of microbial flora in microbiological testing. Microbial culture media preparation is the process of mixing nutrients, agents for buffering and maintaining the osmotic balance, as well as selective inhibitors or indicators to create an agar or broth that supports the growth and the differentiation of microorganisms. Leewuenbook provides recording of all pertaining information for culture media, subculture of Certified Reference Microorganisms (CRMs) and other preparations that support integration of laboratory preparations.

Demonstrate that any residual antimicrobial properties of the product.
Demonstrate that any residual antimicrobial properties of the product.

The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery method have been neutralized using the challenge microorganisms as a kind of biological indicator of neutralization. The method of assessing if neutralization has been successful varies depending on the method employed. The ability of the test to detect microorganisms in the presence of product to be tested must be established (USP 41). Therefore, Leeuwenbook provides integration of pertaining informations of varies suitability methods.

Microbiological Examination of Non-Sterile Products and Materials
Microbiological Examination of Non-Sterile Products and Materials

The microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products. USP tests allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. Leeuwenbook provides integration of pertaining informations of microbial limits tests.

Examine the sterility of pharmaceutical products with innovative laboratory solution.
Examine the sterility of pharmaceutical products with innovative laboratory solution.

Sterility testing is a GMP microbiology testing requirement used to confirm sterile products do not contain viable microorganisms before release and patient administration. Sterility testing methods must be as accurate as possible, due to their importance for medical devices, pharmaceutical products, and formulations, tissue materials, and other products that claim to be sterile or free from viable microorganisms. Compendial methods for the sterility testing of pharmaceutical products requires samples to be cultured in two separate media. Two different types of culture media are used in sterility testing to promote the growth of residual anaerobes, as well as aerobes and fungi. Fluid thioglycolate medium (FTM) is typically used to culture anaerobic and some aerobic bacteria, while soybean casein digest medium (SCDM) is typically used to culture fungi and aerobic bacteria. Samples are incubated for 14 days at 32.5°C and 22.5°C respectively, prior to examination. Any turbidity in the culture media may indicate growth and must be investigated. There are two recommended methods of sterility testing for pharmaceuticals: membrane filtration and direct inoculation.

Estimating active constituents, biological activity and in monitoring the stability of antibiotics.
Estimating active constituents, biological activity and in monitoring the stability of antibiotics.

Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Microbiological assay helps in estimating active constituents, biological activity and in monitoring the stability of antibiotics. Any small change in the antibiotic molecule, which may not be detected by chemical methods, will be revealed by a change in antimicrobial activity. Microbiological assay is very useful for resolving doubts regarding possible change in potency of antibiotics and their preparations.

Powered by ORACLE

Meeting the Expertise requirements recoginizes your company as having cloude applications validated as ruunning on Oracle Cloude.

A responsive web design will automatically adjust for different screen sizes and viewports that look good on all devices. This will set the viewport of your application, which will give the browser instructions on how to change the theme and scaling. Elegant design with fast responsive layout able to make sure that the software is always up-to-date with the latest changes in technology.
https://pixabay.com/users/3

FEATURES

Responsive Cross-Platform


Enhance productivity of your field team and Eliminate human error.
Digital transformation from traditional paperwork into electronic collaboration enhances productivity of your field team and eliminate human error.

Improve communication


Improve communication between QA, QC, production, warehouse and top management.
CORPEX-LIMS facilitate digital management and communication timely between QC and all quality associated  departments.

Enable timely decisions


Ensure compliance with regulatory requirements worldwide. In one platform your organisation can manages product specificatins and quality progress in integrated manner.

Reduce running costs


Reduce your running costs and Eliminate overheads.Cut down on review, approval and delivery times to market for all of your products. Direct communication between all quality associated departments accelerate overall productivity.

Regulatory Complies


Achieving GXP, GAMP5, & FDA requirements and Comply with multiple sets of international regulations agencies.

Document's Management


Automates and effectively manages document control as a core integrated quality suite.

Reporting
Services


From the sample registration to the final reporting, full laboratory management reporting system.

Access Log & Audit Trail


The security administrator authority possesses the ability to manage roles and user security objects.

Full Validation
Package


Where required, we can provide validation scripts (DQ, IQ & OQ)and documentation for your records.

Data acquisition & Integration


CORPEX-LIMS supports real-time instrument interface and file sharing services. Data integrity allow integration between other firmweres.

Virtual Representation


Experience your data, any way, anywhere and view a complete picture of your informations in graphical manner.

Performance Measurements


All activities you make are stored, retrieved and analysed to measure performance in a live manner.
Copyright © CORPEX Informatics 2017-2021. All right reserved.