Microbial testing of Non-Sterile Products: A Brief Overview of Pharmaceutical Microbiology Basics and History, Microbial Control Strategy, Risk Management for Non-Sterile Standards, and Testing and Acceptance Criteria for Non-Sterile Products. When examining the types of products that carry higher risks, sterile products require a complete absence of microorganisms. This is because they are typically administered … Read more
An uncontaminated environment is essential in pharmaceutical manufacture. Clean rooms created with strict ISO guidelines are engineered with the intent of reducing particulate and microbial contamination in drug manufacturing processes. However, microbial contamination may still be present owing to inadequate cooling, cleaning regimens, or even both. These controlled environments must comply with regulations which means … Read more
Learn about Microbiology incubators including their definitions, Working principle, Working essential components, usage, parts, different types of Incubators, advancement, Limitations, and Application. Incubator/ Definition: incubator is an essential device used in the microbiology section. Its insulated and enclosed design helps to control the environment. It also helps to control the temperature, humidity, and other parameters … Read more
Depyrogenation vs. sterilization these two terms may seem similar but, these are important processes/ methods used in industries such as pharmaceuticals and medical devices to ensure the safety and effectiveness of products. Let’s discuss one by one. What is Depyrogenation? The process of removal or inactivation of pyrogens from a product or surface is known … Read more
Learn About the difference between Positive and Negative Control in microbiology. A positive control is a control group where if you change the dependent variable you’re expected to see a positive response whereas, in a negative control group, whenever you change the dependent variable you would expect a negative response. This demonstrates that the changes … Read more
Human bodies are natural hosts to harmful bacteria, and if we’re sick or infected, dangerous viruses and fungi are as well. We also constantly shed tons of hair and skin cells and breathe out a plume of various microorganisms. So following the Gowning procedure in CleanRoom becomes an important task for working persons. Today Life … Read more
Sterilization is the killing or removal of micro-organisms and their spores from the substance, material, or Preparation required to be used in sterile form or Sterilization is the process by which an object’s surface as a medium becomes free from all harmful microorganisms both in the vegetative and sporing stage are sterilized by removing or … Read more
Learn About Standard operating procedures for the Destruction of Microbial waste by Autoclaving methods along with their Objective, Scope, Responsibility, and procedure. 1.0 Objective: 1.1 To lay down the procedure of the Destruction of microbial waste by autoclaving.2.0 Scope: 2.1 This SOP applies to carry out the procedure of Destruction of microbial wastes by autoclaving in a microbiology laboratory 3.0 Responsibility: 3.1 … Read more
Learn About Standard Operating Procedure for Sterile failure investigation within sterile testing Areas including their, Aim, Scope, Responsibility, Procedure, and Definitions. 1.0 AIM: To lay down the cleaning procedure for the Sterility failure investigation.2.0 SCOPE: This SOP applies to carry out the cleaning procedure for the Sterility failure investigation.3.0 RESPONSIBILITY: Executive – Provide training for Cleaning procedure for the Sterility testing area … Read more
Terms aseptic and sterile are significant concerns, and sometimes it is not easy to understand the differences between the two terms. For example, in the case of environment classification, some people might say the “sterile area”, and others use the term “Aseptic area”. USP General information chapter no. 1116 describes the terms Aseptic and Sterile … Read more
Sterilization processes are critical in the pharmaceutical industry for ensuring the safety and efficacy of medical products. To calculate these Pharmaceutical professionals use two terms, Sterility Assurance Level (SAL) and Log Reduction. Understanding these concepts is key to microbial control, quality assurance, and regulatory compliance. In this post, we explore these terms, their calculations, and … Read more