One of the areas of the most focus in the dissolution world right now is the Apex vessel, which was formerly called the Peak vessel. With all of this new attention, I thought it would be good to answer some of the most common customers I get from scientists about this unique vessel. When should…
What is Viscosity? Viscosity measures a fluid’s resistance to flow, determining how easily it deforms under an applied force. High-viscosity fluids like honey flow slowly, while low-viscosity fluids like water flow quickly. Viscosity is temperature-dependent, generally decreasing as the fluid warms. It’s measured in units such as poise (P) or pascal-seconds (Pa·s). Types of Viscosity:…
Six Sigma is a data-driven methodology aimed at improving business processes by reducing defects, variations, and inefficiencies. It was originally developed by Motorola in the 1980s and later popularized by companies like General Electric. Six Sigma uses a structured approach to problem-solving and decision-making, primarily through two methodologies:- Establish Leadership Commitment : Define Goals &…
The CIP (Cleaning-In-Place) process is crucial in pharmaceutical, food, and chemical industries for cleaning equipment without disassembly. Using cleaning agents and water, it reduces time and ensures product safety. Key Stages of the CIP Process: Common Challenges: Key Considerations: Performance Monitoring: Read also:
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…
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…
When the specifications for the drug substances or drug product are being prepared, The following concepts as per ICH Q6A are important in the development and setting of harmonized specifications. such as, but limited to: 1) Periodic or Skip Testing: Periodic or skip testing is the performance of specified tests at release on pre-selected batches…
Ensuring sterility in pharmaceuticals and medical devices is a non-negotiable aspect of patient safety. Sterility testing not only confirms compliance but safeguards the trust placed in life-saving products. However, the process is intricate, and several factors can impact success. What Can Lead to Sterility Test Failures? For Medical Devices Sterility testing for medical devices presents…
