Active pharmaceutical ingredients are the main part of every pharmaceutical product because these are the active content in any drug formulation. The presence of impurities in any active pharmaceutical ingredient during product development always remains a concern for product safety and regulatory compliance. Identification and control of these impurities are not only required for regulatory comp…
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Investigation of OOS Results in Analytical Testing
It is important to maintain product quality in the pharmaceutical industry. Product quality, safety and efficacy are ensured by adherence to the regulatory standards and product specifications. Analytical testing by quality control laboratory is the key to ensure the desired quality of pharmaceutical products. Out-of-specification results are critical to deal with during analysis. OOS results are…
Strategies for Resolving Stability Issues in Drug Formulations
The stability of pharmaceutical products plays an important role in the effectiveness of drug products and patient safety. An unstable pharmaceutical product can degrade and produce toxic byproducts those can lead to fatal consequences.
Equipment Failure in Pharmaceutical Manufacturing
Pharmaceutical industry has great expectations and opportunities because medicines play an important role in everyone’s life. The pharmaceutical manufacturing process is complex and time taking. A lot of equipments are required to manufacture a batch of drug products.
Contamination Issues in Pharmaceutical Production and their Prevention
Contamination is one of the biggest problems in pharmaceutical industry, especially in sterile pharmaceutical manufacturing. It is very important to identify the source of contamination to manufacture safe pharmaceutical products.
How to Care for pH Meter Electrodes
pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half-cells built inside the electrodes. These half-cells are coated with silver chloride or AgCl.
10 Tips for HPLC Analysis In Pharmaceuticals
HPLC, also known as High-Performance Liquid Chromatography system, 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 a column full of solid adsorbent substance. There is a difference in the flow rates for each …
It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via a column full of solid adsorbent substance. There is a difference in the flow rates for each …
Tablet Defects in Pharmaceutical Manufacturing
Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw material to final product packaging. The defects may occur due to any human error, equipment malfunction or any environmental factor. In this article, we will focus on tablet defects that occur during manufacturing.
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 importance by culturing on selective media i.e. Qualitative estimation.
Problems Associated with Pharmaceutical Cleanroom Areas
Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to several reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin.
Causes and Remedies of Picking in Tablet Manufacturing
In the pharmaceutical world, tablet picking refers to when a portion of the material in a tablet is removed. In most cases, picking occurs on the upper side of the tablet as opposed to the lower side. Tablet formation should meet various conditions; lubrication, heating, and cooling. These activities should take place at specific intervals and temperatures. If you fail to incline with the conditi…
Manufacturing of Tablets by Direct Compression Method
In the past years, the processing of drugs was mostly achieved through wet granulation or related unit operations. Progressively, other methods emerged that revolutionalized and gradually replaced the old tablet manufacturing methods. Amongst the new techniques, the direct compression method uses the most advanced technology.
Causes and Remedies of Chipping in Tablet Manufacturing
Innovations in the tablet manufacturing process have seen the dawn of machine operations in the manufacture of tablets. While it would have been thought that the machines would produce perfect tablets, but that is far from the truth. Chipping is the breaking of the edges of the tablet during the manufacturing process and for chipping to occur it can be perceived that the tablet has to have alread…
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 procedures. Well, in each of the processes there are possibilities of defects that give rise to associated pro…
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.