Most Expensive FDA approved Drugs 2023

1️⃣ Hemgenix (etranacogene dezaparvovec): Gene therapy that introduces a functional gene into the body. This enables the production of functional factor IX (a protein necessary for normal blood clotting), enhancing the body’s natural clotting ability. 2️⃣ Skysona (elivaldogene autotemcel): ...

What is HVAC ?

It controls Temperature, Humidity and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. The ...

Laminar Air Flow (LAF)

A laminar air flow system is an important concept in controlling particulate pollution in a pharmaceutical industry. It provides an aseptic environment in specific areas to perform various operations during manufacturing. Cleanrooms in the pharmaceutical industry maintain particle-free air using HEPA ...

Filter integrity test

Tests carried out to verify and assure the quality and readiness of the filter membrane regarding the regulatory requirements are called filter integrity tests. If failed, shows that the filter is no longer re-usable, and also the previously filtered batch needs inspection. The machine that performs ...

FDA Guidance for industry states Airlocks

“Air change rate is another important clean room design parameter. For Class 100,000 ( ISO 8 ) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable.” Design requires hard numbers, so there is temptation for the design team to use this statement ...

Classification of Filter Integrity Testing

The FDA set forth guidelines and requirements to conduct and document filter integrity testing. The testing is classified into two categories: A. Destructive Testing B. Non-Destructive Testing A. Destructive Testing Destructive Testing is by and large carried out at the filter manufacturer’s location ...

Airlocks at Pharmaceutical Industry

Airlock helps to protect classified area that may occur during the men and material movement. “Air lock system” in pharmaceutical manufacturing to avid the chance of cross contamination and to separate different process area. Airlocks are closed room having two or more doors between two different ...

Lubricants

Lubricants are the materials used to reduce friction between surfaces. Lubricants are solids or liquid and widely used in engineering and manufacturing industries. These are made up of metals, oils or synthetic compounds. In tablet manufacturing, lubricants are applied to the compression machines dies ...

Lyophilization Process

The lyophilization process involves three main sub-steps: 1. Freezing – Ice formation 2. Primary Drying – Sublimation 3. Secondary Drying – Desorption One of the major advantages of using Lyophilization is that it consumes less heat for drying the product. Also, the harvested powder has enhanced ...

Lyophilization

Lyophilization is a simple dehydration technique where : i. The product mixture is frozen first and then ii. Vacuum is applied to dry the product. Equipment used to conduct the lyophilization process is called Lyophilizer. Freeze-drying or Lyophilization is a method of drying products using low heat ...
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