INSIGHTS ON REGULATORY COMPLIANCE
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![Ecolab - open RABS]( "From Open Cleanrooms To Closed Systems – What Is Driving The Change?")
From Open Cleanrooms To Closed Systems – What Is Driving The Change?Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
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![iStock-1074507482-topical-skincare-skin-]( "Bioequivalence In Topical Generics: Regulatory Considerations")
Bioequivalence In Topical Generics: Regulatory ConsiderationsRegulators are increasingly favoring in vitro methods to prove bioequivalence, though differing guidelines and a new focus on matching reference product structures pose challenges.
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![GettyImages-1465073074 tablets, OSD, pills]( "Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter")
Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering MatterDiscover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.
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![Thermo Fisher - biobased webinar]( "Driving Sustainability In Bioprocessing With Biobased Single-Use Solutions")
Driving Sustainability In Bioprocessing With Biobased Single-Use SolutionsDiscover how biobased materials in bioprocessing enable measurable carbon emission reductions. Learn practical strategies to meet decarbonization goals and adopt greener, operationally sound practices.
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Select The Best Analyte: A Guide To Effective Mycoplasma Testing9/24/2025
As you build a Mycoplasma testing strategy to ensure drug safety, there are three analyte types to choose from: live Mycoplasma, RNA, and genomic DNA, each offering distinct advantages.
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The Impact Of Annex 1 (2022) On Sterility Assurance4/24/2025
Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
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Accelerate Innovation With Compliant Software Solutions9/2/2025
Accelerate your innovation with software solutions that are designed to streamline operations, reduce costs, and speed time-to-market while ensuring compliance and data integrity.
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Maximize Your Laboratory Efficiency10/20/2025
Gain insight into how labs can boost productivity by reducing downtime, minimizing errors, and increasing walk-away time through real-time insights and analytics.
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Building A Connected Quality And Manufacturing Ecosystem In Life Sciences12/27/2024
Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1368058797 vial, fill finish]( "An Introduction To Validation Of Aseptic Fill/Finish And Related Processes")
Discover innovative monitoring solutions for aseptic filling processes, ensuring sterility through equipment, environment, and product validation to optimize safety and regulatory compliance.
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![503B drug compounding]( "Cleanrooms And Equipment For 503B Outsourcing Facilities")
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Culture Media For Biological Indicators")
Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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![MultiWash+ Microplate Washer]( "MultiWash+ Microplate 96- And 384-Well Automated Washers")
Compact microplate washer with maximum flexibility in a minimum footprint
The MultiWash+™ Microplate Washer is an automated, compact, quiet, efficient washer with 20 different wash protocol options. The variations include adjustable speed and volume, adjustable aspiration speed and time, adjustable soak times, and three modes of shaking. Four wash/rinse bottles are included and configurable for both 96- and 384-well plates.
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![GettyImages-1370928101 regulatory compliance]( "Contamination Control Products For Annex 1 Compliant Facilities")
Explore the details of a contamination control strategy, tips for managing disinfectant residues, general guidelines for removing disinfectant residues, and a wide range of products for cleaning and disinfection.
