Steam sterilization and water shower sterilization are both methods used to sterilize equipment and materials, particularly in pharmaceutical manufacturing. Here’s a comparison between the two: Steam Sterilization – Process: Uses saturated steam under pressure to kill microorganisms. The steam penetrates the materials and transfers heat energy, which causes the coagulation of proteins, effectively killing…
Is parametric release an appropriate control strategy for sterile drug products that are not terminally sterilized? No. Parametric release is only appropriate for terminally sterilized drug products. Although both terminally sterilized and aseptically processed drug product batches are required to meet the sterility test requirement (see 21 CFR 211.167(a)) before release to the market,…
Maintaining personal hygiene is of utmost importance in any workplace, especially in industries that involve the handling of pharmaceutical products like ampoules and vials. Ensuring proper hygiene during the ampoule and vial filling process is essential to prevent contamination and ensure the safety and quality of the products. Here are some precautions that workers should…
Sterilization is the practice of “destroying completely all forms of microbial life. Steam autoclaves achieve sterilization by exposing loads to a combination of moisture and heat through direct contact with steam. Microbial death occurs because proteins and nucleic acids in the cell wall rapidly denature at high temperatures. Steam sterilization occurs in three distinct…
Sterilization and depyrogenation are two different processes used in various industries, including pharmaceuticals and healthcare. Here are the differences between them: 1. Definition – Sterilization: Sterilization is the process of eliminating or destroying all forms of microbial life, including bacteria, viruses, fungi, and spores. – Depyrogenation: Depyrogenation is the process of removing or inactivating…
Bubble point integrity testing is a method used to evaluate the largest pore size in a filter or membrane. This test is based on the principle that when a liquid is forced through a filter, it will flow through the larger pores first. As the pressure increases, the liquid will eventually penetrate the smaller pores,…
Terminal sterilization refers to the process of sterilizing a product or substance at its final stage of packaging, usually using heat or radiation. In the pharmaceutical industry, there are several methods of terminal sterilization employed, each with its own advantages and disadvantages. Here are some commonly used methods: 1. Autoclaving – Advantage: Autoclaves…
The frequency of Sterilization In Place (SIP) in the pharmaceutical industry can vary based on the type of sterilization method being used. Here are some common types of sterilization and their associated frequencies: 1. Steam Sterilization: This is one of the most widely used methods in the pharmaceutical industry. The frequency of SIP for…
