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Controlled area in Sterile Pharmaceutical Manufacturing

A controlled (classified) area is an enclosed environment or room with a flawless control over particulate contamination. More specifically, the areas have a controlled contamination level, which is specified regarding the number of particles for every cubic meter, for a specified particle size. The restricted areas are constructed with impeccable humidity, temperature and pressure control to min…

Various Types of Blenders and Their Purpose

A blender is a very important equipment in the pharmaceutical industry, as a medicine is manufactured by mixing a number of drugs and chemicals. This mixing is required to be undertaken in either dry or wet state depending upon the chemical composition and the reactions allowed. There are various types of blenders available in the industry, each one having its own purpose. Some of them are discus…

Possibilities of Contamination in Sterile Products

In pharmaceutical production, the term "sterile products" is usually used to describe parenteral preparations. These are products which are not meant to be administered via oral route or alimentary canal, so do not benefit from the protection of the immune system which the alimentary canal provides. Administration of these drugs is done directly to the blood stream or various body tissu…

COVID-19 SOP for Home in 15 Different Languages

Download and Print COVID-19 SOP for Home in your preferred language.
Download COVID-19 SOP for Home - English (India)
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Importance of Corrective and Preventive Action (CAPA)

Corrective Action and Preventive Action (CAPA) or what can be termed as corrective action are improvements imposed on an organizational process to eliminate undesirable situations and non-conformity. CAPA is characterized by a set of actions that regulations or laws require an organization to adhere to in procedures, documentation and manufacturing activities.

COVID-19 SOP for Home

1.0 Objective: To lay down the procedure for prevention from COVID-19 at home.
2.0 Scope: This procedure is applicable to the home of everyone.
3.0 Responsibility: Every member of the home.
4.0 Accountability: Housewife in the home.

Prevention of Microbial Contamination in Manufacturing

The quality and safety of pharmaceutical products should be a key concern to any manufacturer in order to take care of clients consuming the product as well as maintaining their brand name in the market. Therefore to prevent microbial contamination in pharmaceutical products, there are some key measures or considerations that a manufacturer needs to take care of.

Critical and Non-critical Areas in Pharmaceutical Manufacturing

Appropriate design, positioning and use of critical and non-critical areas in the pharmaceutical manufacturing process are among the key prerequisites for success in this industry. Critical areas include all areas in which any kind of sterile product (including both drugs and equipment) must be exposed to the sterile environment and where activities including sterilization, sterile filling and c…

Different Types of HPLC Detectors

HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column. They are capable of determining the identity and concentration of eluting compounds in the mobile phase. There are specific detectors which respond to a specific compound and their response is not dependent on mobile phase composition.

Concept of GxP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations…

Criteria for Selection of Clean Room Garments in Pharmaceuticals

A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, as well as clothing that enter the GMP clean room, should be of the highest quality to prevent bringi…

Best Weighing Practices in Pharmaceuticals

It has always been a great challenge for many people when it comes to adopting and using the best weighing practices in pharmaceutical industries. This is simply because electronic balances that are used may create the wrong impression sometimes that they are offering guaranteed measurement precision. That's why below, we have compiled the best practices to help you as an individual or organi…

Requirement of Alarm System in Critical Equipments

The general function of an alarm is to warn about any critical condition as a life-threatening danger or any critical environmental condition like building fire alarm etc. But in the pharmaceutical manufacturing facility, the requirement of audible alarm in critical equipment has its great importance because the change in temperature can affect the pharmaceutical product quality or it can alter …

Protective Gears used in Pharmaceutical Sterile Areas

In the health-related area, laboratories need to follow strict measures in order to keep everything flowing. Not only to protect the workers from possible hazards but to protect the patients from possible anomalies in the manipulated substances. In this article, we will tell you more about the laboratory protective gear in the pharmaceutical sterile area and how to use it.

Lux and Light Intensity for Pharmaceutical Areas

Sufficient light is necessary at the workplace to get better work output. Less lighting in working area can result in errors in different ways. None should experience eye-strain during his work.

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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