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…
Radiation is a non-thermal sterilization method that destroys microorganisms in a product with gamma radiation, beta particles (electron beam), or ultraviolet light. Other than sterile filtration, radiation is the only other sterilization method that doesn’t rely on elevated temperature in order to sterilize. Radiation is an excellent alternative for products that cannot be sterilized with…
Working in a cleanroom under GMP isn’t easy, you have your gowning to consider, your movements, your equipment. Qualifying aseptic operators poses a significant challenge, not because it’s extremely difficult but because it requires great care and attention to detail. Training The more relevant experience the person has, the easier the training and qualification will…
Dry heat sterilization is one of the most practical and preferable forms of sterilization, using blown hot air to eliminate or deactivate all forms of life the setting must be at 160 °C (320 °F) for a duration of two hours, 170 °C (340 °F) for one hour, and up to 190°C (375°F) for 6…
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,…
