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Pharmaceutical Guidelines

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 equipment.

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 period.

Granulation Process in Pharmaceutical Manufacturing

Granulation is a process of producing granules generally. In pharmaceutical manufacturing, granulation process implies the techniques that are, used to combine powdered particles to form relatively bigger ones called granules. This process is used for commercial production of tablets.

Validation of the Effectiveness of UV Light in Water System

UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out.

Steps for HPLC Method Validation

In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the method to provide useful data to ensure that the process or the technique gives satisfactory and consistent results within the scope of the process. The analytical techniques refer to the way of performing the analysis.

Requirements of FDA for Training in Pharmaceuticals

The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirementsThe FDA training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects:

Causes and Remedies of Cracking in Tablet Manufacturing

Cracking is a situation in which small cracks are identified on the top and bottom central surfaces of tablets during the processing of the tablets or during their subsequent use. Hardly are the cracks identified on the sides of the tablets but mainly on the top and bottom surfaces.

Causes and Remedies of Lamination in Tablet Manufacturing

An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. And this is mainly due to the complexities of tablet presses as well as the high demand of quality.

Different Types of Dissolution Apparatus

Drug dissolution testing is usually used on a regular basis in the quality control department of any pharmaceutical company. This method is used to monitor the quality of the capsules and tablets that are produced. A drug can only go into the market if only it passes a dissolution test and is approved.

Difference Between Paddle and Basket Dissolution

When a drug is ingested orally, it takes some time to dissolve in the stomach and get absorbed by the body. The rate at which the drug dissolves inside the stomach affects the drug's concentration in the blood as it gets absorbed. If it dissolves too fast it may cause an over-dosage, and if it dissolves too slowly it may cause an under-dosage.

Causes and Remedies of Capping in Tablet Manufacturing

When the top of a tablet separates from rest of its body, it is called tablet capping. It happens when the air in the tablet is not being released properly. The following are some of the common factors which can cause tablet capping;
1. Formulation related
2. Excipient related
3. Machine related

Difference Between Dynamic and Static Pass Box

In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent air from flowing from one area to another. Pass boxes are made of stainless steel which is powder coated.

Environmental Risk from Microbial Waste

Microbial waste includes any product that emanates from or has been used in tampering with microbes. This includes discarded cultures of microorganisms and infectious agents i.e. bacilli, discarded microbial specimens from pharmaceutical laboratories, pathological or research institutes, live and attenuated vaccines that have been discarded are also considered as waste and lastly, disposable Petri-dishes and all other containers and bottles that have been used in storage and transportation of specimens. Microbial wastes from pharmaceutical premises can either be a solid waste or liquid effluents.

Different Types of Hand Disinfectants Used in Pharmaceuticals

There are different types of hand disinfectants used in pharmaceuticals. These differences can be attributed to the fact that each one varies in its mode of action and the level of activity. It is important to utilize different types of disinfectants in pharmaceuticals because the mode of action in each is needed to prevent the resistance of microbes.

Key Differences between LAF and Biological Safety Cabinet

From a basic point of view, both the Laminar Air Flow and the Biological Safety Cabinets are simply protection compartments but offering different levels of protection. Various aspects of protection offered are dependent on the sample, the environment, and the user as well.

About the Author




Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.
Email: info@pharmaguideline.com

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