What We Do?
At M19 Lab, we're assisting various Pharmaceutical manufacturers to ensure high quality products by providing access to advanced Pharma testing products & services.
R&D Solutions
At M19, we understand that Pharmaceutical manufacturers are facing increasingly complex issues from increasing regulatory compliances, performance sustainability & profits. We help you to meet these challenges by deploying our custom-designed Pharmaceutical Lab Products.
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Filter Integrity Analyzer
In the pharmaceutical industry, maintaining the filter's integrity is crucial for product quality and safety. The Filter Integrity Analyzer (FIA) verifies the filter's effectiveness throughout the production line, ensuring sterility in processes such as sterilizing filtration by checking bubble point, forward flow, and water intrusion conditions. It conducts quality control tests, providing real-time feedback to optimize processes and validate cleaning procedures for filter reuse. The FIA also confirms proper filter installation, preventing contamination, and meeting regulatory standards like GMP guidelines.
ASTM F316
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Filtration Efficiency Analyzer
The Filtration Efficiency Analyzer (Model: FEA-50) is a critical tool in the pharmaceutical industry for assessing the effectiveness of HEPA filters in removing particulate matter in various processes. The operating principle involves simulating the conditions under which the filter will be used and measuring the efficiency with which it captures and retains particles. It evaluates the ability of filter media to remove airborne particulate matter, which is crucial for maintaining clean environments in pharmaceutical facilities and ensuring the quality of pharmaceutical products. It helps pharmaceutical manufacturers comply with regulatory standards for air quality management and ensures that filtration systems meet the required performance specifications.
EN 1822, ISO 29463, ISO 16890, ISO 14644
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Surface Area Analyzer
Surface Area Analyzer, also known as a Gas Adsorption Analyzer is indispensable in the pharmaceutical industry for measuring the specific surface area and porosity of pharmaceutical powders, granules, and other porous materials. It provides critical data for ensuring batch consistency, formulation development and manufacturing, contributing to the optimization of drug formulations and the improvement of drug delivery systems. Surface Area Analyzer plays a vital role in characterizing drug delivery systems, such as nanoparticles and microparticles, helping predict drug release kinetics, optimize drug loading, and evaluate carrier stability.
ISO 9277
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Density/Porosity Analyzer
The Density/Porosity Analyzer is utilized in the pharmaceutical industry to measure the true density of various materials such as powders, tablets, and granules. This measurement is crucial for determining the purity, composition, and quality of materials used in pharmaceutical applications, including quality control, tablet compression studies, powder characterization, and granule evaluation, providing valuable insights into the physical characteristics of pharmaceutical materials. By accurately measuring the true density, researchers and manufacturers can ensure the consistency and performance of a wide range of products in pharmaceutical applications.
USP 699
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Liquid Permeability Analyzer
The Liquid Permeability Analyzer (Model: LP-100) is a sophisticated instrument designed to measure the rate at which liquid passes through a filter/membrane under controlled conditions. In the pharmaceutical industry, Liquid Permeability Analyzer plays a crucial role in filter development, QA/QC, and performance evaluation. It provides valuable insights into the designing of filter membranes.
REF. ISO 7231:2023
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Gas Permeability Analyzer
The Gas Permeability Analyzer (Model: GP-100) is a sophisticated instrument designed to measure the rate at which gases pass through filter membranes under controlled conditions. In the pharmaceutical industry, Gas Permeability Analyzer plays a crucial role in filter development, QA/QC, and performance evaluation. It provides valuable insights into the designing of filter membranes.
ISO 7231: 2023
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