In the Bacterial Endotoxins Test (BET), incubating reaction tubes at 37°C ± 1 for exactly 60 ± 2 minutes is a key step. But why such specific conditions? Let’s dive in. 1. Optimal Enzyme Activity The heart of BET lies in the Limulus Amebocyte Lysate (LAL) reagent, sourced from horseshoe crab blood. This enzyme reacts…
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:…
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…
Process simulations known as media fills are crucial in the pharmaceutical industry to ensure aseptic manufacturing processes are sterile. These simulations test for contamination by mimicking production with a culture medium. A failure indicates possible breaches in the process line necessitating immediate investigation and action. Steps to Take When a Media Fill Fails By addressing…
The rheological properties effect on the formulation, design & use of IM injectable dosage forms. These formulations may be: As a form of: Aqueous or lipophilic? Aqueous Because after the dosage form injected, the active ingredient is absorbed MORE QUICKLY from an aqueous formulation than its lipophilic counterpart. Suspension or solution (for depot)? Suspension Because…
Smoke Study is used to maintain the aseptic conditions when manufacturing sterile products. When we are manufacturing sterile products, we have to maintain aseptic conditions under the laminar airflow. So, how to ensure that the airflow is proper? We cannot see air, but we can see smoke. Smoke is used as a visual aid, a…
