INSIGHTS ON CRITICAL ENVIRONMENTS
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![Lessons Learned From FDA 483s And Warning Letters – Strengthening GMP Cleanroom Compliance In Life Sciences]( "Lessons From FDA 483s And Warning Letters: Cleanroom Compliance")
Lessons From FDA 483s And Warning Letters: Cleanroom ComplianceLearn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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![GettyImages-1057026794-lab-sterilization]( "6 Reasons To Use Biological Indicators During Your Sterilization Cycle")
6 Reasons To Use Biological Indicators During Your Sterilization CycleUnderstand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.
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![AES - Cleanroom design]( "Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2")
Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.
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![GettyImages-899692706 Project Manager And Chief Engineer Using Laptop In Modern Factory]( "Project Management: Sphere Of Influence")
Project Management: Sphere Of InfluenceThe project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
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An Active Air Sampler For Multiple Applications6/3/2024
Watch to learn about an air sampler designed to monitor microbials in spaces where contamination control is crucial and is ideal for use in regulated settings.
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Advances In Regulations For Viable Environmental Monitoring2/21/2025
Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
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Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation10/23/2024
Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.
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Guide To PUPSIT And Annex 1 In Aseptic Processing12/5/2024
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
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A Modern Environmental Monitoring System That Grows With Its Tasks4/24/2025
Modern environmental monitoring systems are vital for pharmaceutical manufacturing. Explore the benefits of a tool for data collection, analysis, and processing that ensures compliance and adaptability.
CRITICAL ENVIRONMENT SOLUTIONS
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![Cleanroom Mopping GettyImages-1177041874]( "Pharmaceutical Contamination Monitoring Solutions")
Particle Measuring Systems Inc. (PMS) is the technology leader in contamination monitoring around the globe and the inventor of laser particle counting. PMS has expanded into most forms of contamination monitoring, including microbial detection, airborne molecular contamination, as well as traditional particle counting, and is a leading supplier of advisory services related to contamination control. Particle Measuring Systems provides you with the tools and industry experts to detect, analyze, and manage cleanroom contamination.
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![TSI BIOTRAK]( "Biofluorescent Particle Counters — An Environmental Monitoring Solution For Annex 1 And Pharma 4.0")
Biofluorescent Particle Counters (BFPC), like the TSI BioTrak® Real-Time Viable Particle Counter, are an alternative microbiological method that serves as the solution for Annex 1 compliance and Pharma 4.0 implementation.
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![GettyImages-1072249434-lab-tablet]( "The End-To-End Compliance Platform For Pharmaceutical Manufacturing")
Optimize pharmaceutical manufacturing with real-time cleaning data, audit readiness, and automated compliance. This end-to-end compliance platform empowers companies to meet stringent regulatory standards.
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![GettyImages-2198092021-gear-futuristic-blue-highlight]( "Is Now The Time To Upgrade Your ÄKTAprocess™?")
Effectively managing maintenance for bioprocessing systems is challenging. Discover hardware that offers durability and proactive strategies that are essential to mitigate wear and optimize performance.
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![GettyImages-1214112149-lab-team-collaboration-research]( "Vaporized Hydrogen Peroxide Biological Indicators")
APEX Biological Indicator products are designed specifically for the pharmaceutical and medical device industries utilizing H2O2 vapor sterilization. The stainless steel carrier is designed for use with today’s isolator and filling line applications.
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.
