INSIGHTS ON CRITICAL ENVIRONMENTS

  • Why Requalify
    Why Requalify?

    Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.

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    ISO Cleanroom Standards

    Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

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    Sterilizing Filtration During Small Molecule Drug Formulation And Filling

    Sterile drug production relies on both prevention and remediation of contamination. A multi-stage filtration strategy reduces microbial load, protects critical filters from fouling, and ensures consistent product quality, process efficiency, and patient safety.

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    Seamless Workflow For Environmental Monitoring

    Learn how connected sampling tools and compliant monitoring software improve data integrity and streamline compressed gas testing workflows, offering a path to reliable environmental monitoring.

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CRITICAL ENVIRONMENT SOLUTIONS

  • Cytiva Microcell Vial Filler
    Used Cytiva Microcell Vial Filler

    Used Cytiva Microcell Vial Filler, catalog# 29754759, speeds up to 300 units per load, 1.0 - 50 mL fill range, gloveless robotic isolator, HMI with stainless steel enclosure, serial# PSV00087, built 2023.

  • Modular cleanroom
    Modular Cleanroom Design And Construction For Pharmaceutical Manufacturing Operations

    Your future cleanroom is the most crucial asset within the entire manufacturing environment. It surrounds critical manufacturing processes where your pharma or biotech company makes its life-changing products. The investment you make in the cleanroom facility should reduce your manufacturing risk and guarantee your performance. AES is the cleanroom expert because it's the only thing we do. Singular focus in providing the most flexible cleanroom technology solutions for over 35 years.

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    Drug Manufacturing Cleanroom Facilities

    In the spectrum of pharmaceutical manufacturing facilities, injectable product manufacturing facilities represent the most sophisticated and challenging to design, build, qualify and operate, particularly when products manufactured in these facilities are rendered sterile when complete, ready to inject directly into a human. For this reason, very careful consideration must be made when developing such a facility.

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    Liquid Particle Counter for USP 788: APSS-2000

    The APSS-2000 Liquid Particle Counter for USP 788 sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards. When it comes to particle monitoring quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.

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    Mobile Clean Room Solutions

    Extract Technology is pleased to add Mobile Clean Room Solutions to our leading portfolio of containment and aseptic systems for the pharmaceutical, biotech and nuclear industries. Our pre-engineered MCRs provide fast, flexible clean room manufacturing space without the considerable time and costs associated with more traditional clean room options.

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FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.

FEATURED PHARMA ONLINE EDITORIAL

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