Cleaning validation is a critical process in ensuring that manufacturing equipment and facilities meet stringent cleanliness standards, particularly in industries like pharmaceuticals, biotechnology, and food production. It is essential to demonstrate that cleaning procedures effectively remove residues of active ingredients, excipients, cleaning agents, and microbial contaminants to acceptable levels. This validation process includes establishing…
Formulation design is crucial to ensure that our products meet quality expectations. By applying QbD principles, we can systematically understand the relationship between critical formulation factors and their impact on Critical Quality Attributes (CQAs). Key elements to consider: 1. Quality Target Product Profile (QTPP): Defines the desired quality characteristics of the final product. 2….
This is one of the most stunning microbiological tests. CCA (Chromogenic Coliform Agar) is a selective and differential medium used primarily for the simultaneous detection and enumeration of Escherichia coli and coliform bacteria in water, food, and environmental samples. Here’s the principle behind CCA: Principle of Chromogenic Coliform Agar (CCA) Selective Components – CCA…
As a QA personnel I have some nightmares like: -How many filing cabinets will require to keep every batch record organized in order to manufacture your products? -Are there numerous papers that require review? -Are any documents missing? Many people view maintaining paper records as a necessary evil. The benefits of switching to digital…
Firstly, atomizing air: It is the air responsible for pumping the solution and controlling the size of the solution spray (droplets of coating solution). Controlling the spray is by increasing or decreasing the force of the air coming out of the gun to pump the solution. Thus, we say that if the air increases, the…
I will talk about the old classic method of Sugar coating: It is to change the bad taste of the to easy of swallowing, and the coating can reach 50% of the weight of the tablet, because there are some products that completely change the shape of the tablet. Stages of the Suger coating…
Firstly, the definition of tablet bed temperature: This is the temperature of the tablets inside the coating machine. Here there is a difference between the inlet air temp and the tablet bed temp: The temperature of the incoming air is what heats the tablets . It comes from the air that is pumped into…
Guns Test It is a test of the accuracy of the guns in terms of the spray rate and to ensure that there is no significant difference between each gun and the other. How is the Guns test done? 1: Cylinders are brought according to the number of guns and of course they are…
