Traditionally, most pharmaceutical companies used hard copy records to keep production batch records commonly known as master production batch records. However, this documentation method has numerous shortcomings. In 1997, Electronic Batch records in Pharmaceuticals were accepted by FDA after EBR …
Validation of Clean Room Pass Boxes
A pass box which is also called a hatch is an equipment which is used to transfer pharmaceutical material from an area of lower cleanliness to an area of higher cleanliness and vise-versa. They, therefore, work as a barrier between areas with different levels of cleanliness.
Occupational Exposure Bands (OEBs) for Chemicals
Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. They are usually classified on th…
Reynolds Number and Its Significance in Purified Water System
Purified water is commonly used in the pharmaceutical industry, science laboratories, laser cutting and automotive use. Purified water finds a considerable amount of usage in the pharmaceutical industry in the form of a raw material, component and solvent in the production of a number of medicatio…
Types of Primary Packaging in Pharmaceuticals
Packaging is one of the most important parts of the pharmaceutical industry. The packaging ensures the protection of drug during the sale, storage, and use. Objectives of packaging are containment, physical and chemical protection, portion control, and security of the drug. Packaging in the pharma…
Site Acceptance Test (SAT)
Site Acceptance Test can determine whether or not systems are meeting the desired and required specifications. The main purpose of site acceptance testing is to give an overall evaluation of a systems compliance and to ensure this compliance meets the requirements of the business involved. Site ac…
Packaging of Pharmaceutical Products
In the healthcare field, pharmaceutical packaging plays a vital role in keeping prescribed drugs and medication safe from all sorts of contamination and bacterial growth. Unlike other goods, pharmaceutical medicines require a much thorough inspection of their packaging so that they are completely …
Factory Acceptance Test - FAT
Any equipment that is being intended to be used in producing various products has to meet certain specifications before it is delivered to a purchaser and installed. The equipment has to undergo what is called Factory Acceptance Test (FAT) so as to ensure its proven quality and compliance. These t…
Top 10 Tips for Microbial Limit Test
The microbial limit test is the quantitative and qualitative assessment of the microbes or microbial contamination test in a sample. This test is performed for:- estimation of the total viable count of fungi and bacteria i.e. Quantitative estimation. Identification of each of the microbes of impor…
Causes and Remedies of Binding in Tablet Manufacturing
Tablet manufacturing involves a series of processes all aimed at the result of a uniform fine piece of art tablet. This article aims at exploring the causes and remedies of binding in tablet manufacturing. The processes include sizing, milling, drying, and compressing among several other procedure…
Differences between Syrups and Suspensions
Do you know that all pharmaceutical syrups are not manufactured equally? If you don’t, then don’t scratch your head. In fact, there is a subtle difference in these products that can cause ineffective use in clinical effects. Pharmaceutical syrup generally can be broken down into different categori…
10 Tips for HPLC Analysis In Pharmaceuticals
HPLC, also known as High-Performance Liquid Chromatography, is one of the most crucial analytical methods in pharmaceuticals. The purpose of HPLC is the separation of each compound that make up a mixture.
It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via…
It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via…
Causes and Remedies of Sticking in Tablet Manufacturing
The tablet production process has become more simplified and more mechanized with the development of technology. However, the complexity of a tablet punching process has increased. But relatively the problems associated with the tablet manufacturing process have not yet been significantly reduced.
Top 10 Tips for Sterility Test
Sterility is a critical test in sterile pharmaceutical manufacturing. there are a lot of chances of errors in this test due to the requirement of highly aseptic conditions during the process. The analyst must be careful about the contamination during the handling of the sample and sterile equipmen…
Difference between Sustained Release and Prolonged Release Tablets
The words sustained release and prolonged release can be used interchangeably because they mean the same thing. But the difference between sustained release tablets and prolonged release tablets is surely evident.
Revalidation of Equipment and Process in Pharmaceuticals
Revalidation in the pharmaceutical industry is very important as it helps to maintain the validated status of the equipment, plant, manufacturing process as well as the computer systems. This procedure is necessary for periodic checking of the validation results according to the revalidation perio…
