Secciones/Microbiología y CCS

Microbiología y CCS

¿Cómo demostramos la esterilidad — y mantenemos cohesionada la contamination control strategy cuando llega el inspector?

EsterilidadAnexo 1Métodos rápidosCC
Biofluorescence Monitoring In Cleanrooms: A Simple GuideArtículo
Historia principal

Biofluorescence Monitoring In Cleanrooms: A Simple Guide

Hunting contamination used to be a blind search. Biofluorescence monitoring lights it up in real time, seconds, not days, to spot it.

Simantini Singh Deo · 28 jul 2026
CCS: What Inspectors Actually Asked For in the Last 18 Months
Artículo

CCS: What Inspectors Actually Asked For in the Last 18 Months

Contamination control strategy has become the document inspectors judge first. See the 5 questions MHRA and FDA kept asking over the last 18 months.

Mrudula Kulkarni · 11 ago 2026
Gut-Skin Axis: What Happens Before Symptoms Appear
Artículo

Gut-Skin Axis: What Happens Before Symptoms Appear

A single antibiotic course can disrupt gut bacteria for months, affecting the gut-skin axis. Discover the hidden microbiome trajectory.

Dr. Varun Aggarwala · 20 jul 2026
Hospital-Acquired Infection Risk: Hidden Microbial Threats
Artículo

Hospital-Acquired Infection Risk: Hidden Microbial Threats

Hospital-acquired infection risk is shaped by microbial balance, not just single pathogens. Explore the 99% AMR-reduction trial data.

Mrudula Kulkarni · 20 jul 2026
Modern Strategies For Mycoplasma Risk Management: The Silent Contaminant In Biopharmaceutical Manufacturing
Artículo

Modern Strategies For Mycoplasma Risk Management: The Silent Contaminant In Biopharmaceutical Manufacturing

Mycoplasma is invisible to routine checks. Modern risk management combines prevention, rapid detection, and compliant response.

Simantini Singh Deo · 16 jul 2026
From Compliance to Contamination Control: How Annex 1 Is Reshaping Pharmaceutical Microbiology?
Artículo

From Compliance to Contamination Control: How Annex 1 Is Reshaping Pharmaceutical Microbiology?

EU GMP Annex 1 made zero CFU the new Grade A standard. Here's how it's reshaping contamination control, EM programmes, and pharma microbiology.

Simantini Singh Deo · 4 jul 2026
The Sampler That Was Watching the Wrong Air
Artículo

The Sampler That Was Watching the Wrong Air

How a compliant environmental monitoring programme became a blindfold, and what every sterile facility should ask before the next contamination event.

Dr. Nasreen J · 2 jul 2026
Rapid Microbiology Methods (RMMs) In Pharma: Accelerating Quality, Compliance, And Manufacturing Efficiency
Artículo

Rapid Microbiology Methods (RMMs) In Pharma: Accelerating Quality, Compliance, And Manufacturing Efficiency

A 14-day sterility test can outlast a product's shelf life. Here's how RMMs cut detection time and stay FDA, EMA compliant.

Simantini Singh Deo · 29 jun 2026
Turbulence: The Hidden Enemy In Sterile Manufacturing
Artículo

Turbulence: The Hidden Enemy In Sterile Manufacturing

Turbulence is the hidden contamination risk in sterile manufacturing, First Air, smoke studies, isolators and Annex 1 explained.

Simantini Singh Deo · 20 jun 2026
Why Microbial Biofilms Remain One Of Healthcare’s Toughest Challenges?
Artículo

Why Microbial Biofilms Remain One Of Healthcare’s Toughest Challenges?

Biofilms resist antibiotics, evade immune defenses, and persist on medical devices. Here's why they remain one of pharma's toughest challenges.

Simantini Singh Deo · 19 jun 2026