Imagine this: You’re in the middle of a bustling production line, and everything seems to be running smoothly. Suddenly, an alert goes off, notifying you that the particle count inside your vial filling machine has spiked. Panic ensues. But why is this such a significant issue, and how can you tackle it effectively? Let’s dive…
The Bowie-Dick test is a specific type of test used to evaluate the performance of steam sterilizers (autoclaves), particularly in ensuring that they can effectively remove air from the chamber and achieve the necessary conditions for sterilization Purpose: Procedure: Test Pack Preparation: Placement: Sterilization Cycle: Post-Cycle Evaluation: Interpretation of Results: Importance: Read also: Resource Person:…
What is a DMF? A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is NOT a substitute for an…
Sterile filtration is a vital step in the production of eye drops in the pharmaceutical industry, ensuring that products are safe for use and compliant with regulatory standards. Proper techniques and rigorous testing are essential for maintaining the quality and integrity of the final product. Importance of Sterile Filtration Microbial Contamination Prevention: Eye drops are…
A common question: Why is a 0.22-micron filter considered a sterile filter and why is this specific pore size preferred over smaller or larger microns for sterilization purposes? A 0.22-micron filter is considered a sterile filter because it effectively removes most microorganisms, particularly bacteria, from liquids and gases, ensuring sterility. Here are the key reasons…
When selecting cleanroom garments for use in sterile areas, several key criteria must be considered to ensure compliance with quality and safety standards. Here are the main criteria: Material Selection: Design and Fit: Electrostatic Discharge (ESD) Control: Contamination Control: Sterilization: Compliance with Standards: Cost-Effectiveness: Environmental Impact: These criteria help ensure that cleanroom garments provide a…
This is a natural polysaccharide extracted from red seaweeds (mainly Gelidium and Gracilaria species). Properties of Agar: Agar is essential in microbiology due to its stability, clarity, and inert nature, making it the preferred medium for microbial cultivation: Because of these properties, agar is the most widely used solidifying agent in microbiological culture media. Uses…
Root Cause Analysis (RCA) is essential for identifying and addressing the underlying causes of problems to prevent recurrence. Below are 7 powerful tools that every quality professional should master: ❶ Ishikawa Fishbone Diagram: Organize potential causes into categories for better visualization. ❷ Pareto Chart: Prioritize causes by focusing on the vital few rather than the…
