INSIGHTS ON CRITICAL ENVIRONMENTS
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![Asahi Kasei - lab]( "Getting More From Your Buffer Management Strategy")
Getting More From Your Buffer Management StrategyA drug manufacturer was facing challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space, increase efficiency, and become more sustainable.
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![GettyImages-1087219526-scientist-computer-screen-compliance-sterilization]( "How To Choose The Right Bowie-Dick Test Pack For Your Steam Sterilizer")
How To Choose The Right Bowie-Dick Test Pack For Your Steam SterilizerBowie-Dick testing is essential for compliance, but the choice between disposable and reusable systems impacts cost, waste, and efficiency. Learn how to balance sustainability with sterility assurance.
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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-2150276083-lab-mask-tablet-PPE-cleanroom]( "Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 Requirements")
Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 RequirementsExplore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.
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A Data-Driven Approach to Cleaning Validation10/21/2024
Discover how Ongoing Process Verification, guided by PAT and digital integration, ensures consistent cleaning efficacy, reduces risks, and optimizes production efficiency in the pharmaceutical industry.
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Embarking On A Successful Cleanroom Project: Conception To Delivery6/26/2024
Learn how you can obtain comprehensive solutions for cleanroom projects that help you ensure regulatory compliance and operational efficiency.
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Effective Contamination Control6/16/2025
Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product and process quality.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Considerations For Tangential Flow Filtration Process Development5/27/2025
Optimize your TFF process with single-pass technology by joining experts Mike Dango and Michael Brauchle as they share key strategies for scalable, efficient filtration process development.
CRITICAL ENVIRONMENT SOLUTIONS
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![BMT Steripro SPV9612-2AGV cGMP Steam Sterilizer]( "Used BMT Steripro Pharmaceutical Steam Sterilizer")
Brand new BMT Steripro cGMP steam sterilizer, model SPV9612-2AGV. The Steripro SPV9612-2AGV is a high-performance steam sterilizer designed for pharmaceutical and biotech production environments where repeatability is critical. Featuring a polished 316L stainless steel chamber and sanitary piping, it ensures durability and compliance with cGMP standards. Equipped with industrial-grade PLC control systems and high-grade vacuum pumps, it delivers precise and repeatable sterilization cycles with temperature uniformity better than ±0.5°C. Serial# AC22053, built 2022. The unit is already packaged, and installation is included with the sale for seamless setup and operation.
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![Bowie Dick Simulation Test]( "Reusable PCD Designed For Routine Monitoring")
Reusable Process Challenge Device (PCD) designed for routine monitoring of pre-vacuum steam sterilizers.
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![Fast Lane Program]( "Rapid Design-Build Cleanroom Solutions: AES Fast-Lane Program")
Speed-to-market is the number one driver in the pharma/bio industry today ... the faster our clients can build facilities, the quicker they can get treatments into the hands of the patients who need them the most. The AES Fast Lane program is an accelerated Design, Manufacture, and Installation program that fast tracks your cleanroom facility project in seven months.
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![Mobile Clean Room Solutions]( "Mobile Clean Room Solutions")
Extract Technology's self-contained, ready-to-use design provides functional clean room space wherever and whenever it's needed. Whether the need is to expand manufacturing, R&D or processing capacity at an existing facility, a remote location, or around the globe, the company's MCRs can be transported and fully operational more rapidly than other clean room options.
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![express30k]( "Pre-Designed Pharmaceutical Cleanroom: Express 30K, 10 Months Delivery")
Faciflex Express is a pre-designed cleanroom solution that delivers a commissioned cleanroom in as little as 6 months. Pre-designed standard cleanroom layouts are the next generation for snap together installation of modular panel systems. Faciliflex Express has 3 models 5k, 15k, and 30k representing cleanrooms of approximately 5,000, 15,000, and 30,000 square foot.
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.
