SOP for Sterility Test by Open Method

Sterility Test by Open Method Sterility testing is a critical quality control procedure performed to determine the absence or presence of viable microorganisms in a pharmaceutical product, medical device, or other sterile preparations. The test is conducted to ensure that the product meets the required sterility standards and is free from microbial contamination that could … Read more

Alert & Action Limit Determination

Alert & Action Limit Determination:- Determining alert and action limits involves a systematic approach that considers several factors, including process variability, desired performance, and acceptable levels of risk. Here are some general steps for determining these limits: Alert Limit: Alert limits are in-house limits that are defined based on the trend analysis. These limits are … Read more

Qualification/Validation Concept

Qualification/Validation:- Qualification and validation are essential processes in various industries, including pharmaceuticals, medical devices, biotechnology, and manufacturing. They involve systematic activities to ensure that equipment, systems, processes, and methods meet predefined requirements and are fit for their intended purpose. Let’s explore qualification and validation in more detail: Qualification: Qualification refers to the documented process of … Read more

Glossary of Microbiology

Glossary of Microbiology A glossary of microbiology that defines and explains the key terms and concepts used in the study of microorganisms, including bacteria, viruses, fungi, and other microorganisms. It covers topics such as microbial genetics, microbial metabolism, microbial ecology, and infectious diseases. This glossary is useful for students, researchers, and anyone interested in understanding … Read more

Bacterial Endotoxin Test

Bacterial Endotoxin Test in Injectable Plant: Principles, Methods, and Applications Bacterial Endotoxin Test:- Bacterial endotoxins, also known as lipopolysaccharides (LPS), are complex molecules found in the outer membrane of Gram-negative bacteria. They are potent pyrogenic substances that can cause fever, inflammation, and other adverse effects in humans and animals. Injectable pharmaceuticals, such as parenteral drugs, … Read more