INSIGHTS ON CRITICAL ENVIRONMENTS
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Preventive Maintenance Isn't Enough For GMP Manufacturers
Schedule‑based maintenance supports compliance but misses real‑time asset risk. Explore how GMP manufacturers are moving toward condition‑based and predictive strategies to modernize asset management.
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Cleanroom Data Analytics For Setting Up Environmental Monitoring
Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing
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Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits
Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.
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Factory Acceptance Testing (FAT): Pre-Shipment Quality Verification Guide
Quality control begins long before installation. Discover how pre-shipment testing mitigates risk, ensures specification compliance, and streamlines cleanroom project timelines.
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PUPSIT Without The Pain: Practical Solutions For Implementation5/6/2025
Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.
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Smart Manufacturing For Pharma: Modular Automation And MTP8/14/2026
Pharma manufacturers average just 35% OEE. Learn how modular automation, MTP, digital twins, and paperless manufacturing close that gap without sacrificing GMP compliance.
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Contamination In The Shadows: Risks Lurking From Environmental Issues11/17/2025
Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
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0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?2/19/2026
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
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Stay cGMP Compliant: Instrument Requalification In Pharma3/10/2026
Maintaining equipment is an ongoing GxP requirement. Learn what triggers requalification, why it matters for operational continuity, and how proactive evaluation helps prevent costly disruptions.
CRITICAL ENVIRONMENT SOLUTIONS
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Unused IMA Life Nitrogen Dioxide sterilizer, model NO2 Sterilizer 3.5, 316L stainless steel product contact surfaces, with (5) 916mm wide x 916mm deep usable shelves, 270mm shelf spacing, NO2 sterilant storage and dosing system, set up for SIP, Siemens controls with SIMATIC S7-1500 Siemens PLC controller, stoppering with 5 hp hydraulic power pack, (2) Edwards GXS160SF dry vacuum pumps, scrubber system with 5.5 kw blower, 200 cf vapor cooler, buffer tank, chamber certified by Amherst Stainless Fab, rated 7 psi and full vacuum at +200/-76 f, serial# 1535, national board# 1320, IMA Life serial# EFC001, project# SA35-00148, built 2019 and Unused new on shipping skids and crated.
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Used Cozzoli vial washer, model GW24, stainless steel construction, touch screen controls, with Allan Bradley MicroLogix PLC controller, serial# GW24-56.
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Large‑scale reactors and continued investment support dependable commercial API production while improving supply continuity and geographic flexibility.
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The TSI AeroTrak 9303 Handheld Particle Counter offers the most features and flexibility for customers interested in a low cost and versatile handheld particle counter. The Model 9303 features a sturdy yet lightweight high-impact injection-molded plastic design for easy handling. The instrument is easy to configure using an intuitive keypad. The internal memory can store up to 1,500 sample records of particle count data which can be conveniently viewed on screen or downloaded using a USB port.
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A streamlined transfer approach brings monitoring plates into controlled areas without decontamination delays. With plates kept organized and accessible, teams can maintain productivity.
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.
