Is there a requirement to run a leak test of lyophilizer after every cycle in GMP pharmaceutical production? GMP regulations do not mandate leak testing after every lyophilization cycle, but periodic testing is required to ensure equipment integrity and product quality. The frequency is determined by risk assessment, internal procedures, and process criticality. 1.1 European…
Persistent Challenges in Tablet Production If sticking or overlubrication is a permanent problem during tablet production, a useful alternative can be the external lubrication of the punches and dies. It is a standard add-on for modern rotary tablet presses. How Does External Lubrication Work? A nozzle sprays dry lubricant just before the feeder onto punches…
Scaling up the tablet dosage form preparation process, particularly through wet granulation, is a critical task in pharmaceutical manufacturing. As we transition from pilot to production scales, managing liquid addition is crucial to maintaining consistent dissolution profiles and ensuring tablet efficacy. Here’s an expanded view on how to effectively handle this process. Challenges in Scaling…
The pressure limit for a Sterile Injectables Area is crucial to maintain a contamination-free environment. According to WHO guidelines, the recommended differential pressure range for sterile areas is between 10 to 15 Pascal. This pressure difference prevents contamination and cross-contamination, ensuring the sterility of the cleanroom. In a Sterile Injectables Area, a positive pressure difference…
A Contract Manufacturing Organization is a third-party company that provides comprehensive services in the manufacturing of pharmaceutical and biotechnology products. CMOs are integral to the drug development process, as they allow companies to outsource various stages of production, enabling them to focus on other core areas like research, development, and marketing. Key Services Offered by…
Selecting the right processing platform for solid dosage forms is essential for ensuring product quality, efficacy, and manufacturability. This decision-guiding flowchart provides a structured approach to choosing the best processing method based on key formulation parameters. Key Considerations: 1. Solubility: The Biopharmaceutics Classification System (BCS) class determines solubility. For Class II & IV compounds, solubility…
Freeze drying, or lyophilization, is a critical process in the pharmaceutical industry, primarily used to enhance the stability and shelf life of delicate drugs and biological products. This advanced dehydration method allows for the preservation of pharmaceuticals without compromising their efficacy, making it indispensable for high-quality drug production. Understanding the Lyophilization Process Freezing Phase: Initially…
At low moisture levels, termed the (pendular state), the particles are held together by lens-shaped rings of liquid. These cause adhesion because of the surface tension forces of the liquid-air interface and the hydrostatic suction pressure in the liquid bridge. When all the air has been displaced from between the particles, the (capillary state) is…
