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Pharmaceuticals Industrial revolution
(Commonly Known as Smoke Study in Cleanroom Areas) Airflow Visualization Studies (AVS) are qualitative yet powerful tools used in cleanroom environments to make invisible air movement visible. Instead of relying only on numerical airflow data, this study uses generated smoke or fog to visually demonstrate how air behaves around critical processing zones, equipment, operators, and … Read more
MCQ for Airflow Visualization in Cleanrooms
When you think about Sustainable and Smart Cleanroom Strategies for Next-Gen Pharmaceutical Facilities what should come in your mind Cleanrooms or smart cleanrooms. Cleanrooms exist for a single, non-negotiable reason: to protect patients by controlling contamination risk. That purpose has not changed. What has changed is the context in which cleanrooms must now deliver. In … Read more
Microbiological Analysis in Cleaning Method Validation is more than a cleaning task—it is a critical quality assurance practice that defines the purity, safety, and credibility of every product leaving the production floor. Yet, beyond residues and chemical traces lies another, quieter threat: microbial contamination.This is where microbiological analysis becomes the invisible detective—uncovering what the eye … Read more
Sterile Active Pharmaceutical Ingredient (API) manufacturing is a world where invisible microbes are the enemy, aseptic discipline is the shield, and process integrity is the battlefield. The Media Fill Test (MFT)—often called Aseptic Process Simulation (APS)—is the ultimate “dress rehearsal,” designed to prove that a sterile manufacturing line can function flawlessly before a real API … Read more
Design Basis Document of HVAC genrated when we start designing new fecility for the Pharmaceutical plant. This guide outlines critical cleanroom classifications, regulatory compliance (GMP, WHO, ISO), pressure cascades, and design criteria to ensure air quality, product safety, and operational efficiency in your new plant. M/s. Flair Pharma, Panchkula, HaryanaOSD Block, OSD Liquid Block, LAB Area, … Read more
Top 5 Problems in sterile pharmaceutical manufacturing: Microbial Contamination Root Cause: This most feared adversary creeps in through human error, flawed disinfection protocols, air leakage, or material transfer breaches. Despite sophisticated controls, even a single microorganism can compromise product sterility. Impact: Regulatory Insight: Solution Strategies: Operator-Introduced Errors Root Cause: Despite automation, humans remain the highest … Read more
Discover how ai machine learning batch record review is revolutionizing pharmaceutical quality control. This in-depth article explores how AI and ML automate compliance, accelerate release times, predict deviations, and ensure drug safety, paving the way for the future of pharma manufacturing. For anyone on the floor of a pharmaceutical manufacturing unit, the batch record is the heartbeat … Read more
Encountering an Out-of-Specification (OOS) result is a high-pressure event in any pharmaceutical quality control laboratory. It signals that a product batch may not meet its predefined quality standards, potentially impacting patient safety and triggering regulatory scrutiny. A structured, compliant investigation is not just a best practice—it’s a regulatory requirement. This step-by-step guide will walk you through … Read more
Fumigation Validation is the key validation in the heart of sterile pharmaceutical manufacturing, where microscopic intruders threaten product safety, cleanrooms serve as the ultimate guardians. But even these sanctuaries demand periodic deep decontamination. Among the most powerful tools in the contamination control arsenal is fumigation—a process where a disinfectant in gaseous or vaporized form eliminates … Read more