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    Pathogen Testing in Purified Water: Why Pharma Does It Even When USP, EP and JP Don’t Require It

    Pathogen Testing in Purified Water: Why Pharma Does It Even When USP, EP and JP Don’t Require It

    If you’ve worked with purified water (PW) in pharma or medical device manufacturing, you’ve probably asked this at some point:

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    Why Brevundimonas diminuta Is Used for Microbial Ingress Testing (CCIT)

    Why Brevundimonas diminuta Is Used for Microbial Ingress Testing (CCIT)

    You’ve filled a life-saving injectable into a sterile vial. The cap is on. It looks sealed. But can you be

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    Growth Promotion Test Inoculum and Plate Size: Why 75 CFU Doesn’t Fit Every Plate

    Growth Promotion Test Inoculum and Plate Size: Why 75 CFU Doesn’t Fit Every Plate

    During a microbiology audit, an auditor asked a deceptively simple question: “Why did you use the same inoculum (75 CFU)

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    Pathogen Testing in Purified Water: Why Pharma Tests Beyond USP, EP and JP

    Pathogen Testing in Purified Water: Why Pharma Tests Beyond USP, EP and JP

    If you have worked with Purified Water (PW) in pharmaceutical or medical device manufacturing, you may have asked a fair

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    Water System Qualification: The Right Approach for a Robust, GMP-Compliant System

    Water System Qualification: The Right Approach for a Robust, GMP-Compliant System

    A pharmaceutical water system is a critical GMP utility. It has to deliver water that meets predefined quality requirements, not

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    Hydrogen Peroxide vs Formaldehyde Fumigation in Cleanrooms: Why Pharma Is Making the Switch

    Hydrogen Peroxide vs Formaldehyde Fumigation in Cleanrooms: Why Pharma Is Making the Switch

    For years, many pharmaceutical facilities treated formaldehyde as the “perfect” fumigant. It was cheap, it killed microbes, and it appeared

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    Feller Correction in Air Sampling: Why r and Pr Start Differing

    Feller Correction in Air Sampling: Why r and Pr Start Differing

    During a routine air sampling check, a simple question came up: “Why do r and Pr start differing after 17?”

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    Environmental Isolates in Growth Promotion Testing: Why ATCC Strains Aren’t Enough

    Environmental Isolates in Growth Promotion Testing: Why ATCC Strains Aren’t Enough

    You walk into your facility. Your EM plates look clean. Your media passes growth promotion testing (GPT) with ATCC strains,

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    Why Do Microbiology Reports Say <1 CFU Instead of 0 CFU?

    Why Do Microbiology Reports Say <1 CFU Instead of 0 CFU?

    You open the incubator. You look at the plate. Nothing is growing. Not a single colony. So the obvious question

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    Settle Plate Placement in Cleanroom: Why Location Decides Everything

    Settle Plate Placement in Cleanroom: Why Location Decides Everything

    Picture an aseptic cleanroom on a good day. The HEPA filters are performing efficiently, differential pressures are within limits, and

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