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Pharmaceutical Guidelines

Jul 16, 2017

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.
Jul 9, 2017

21 CFR and Its Recommendations

The 21 CFR and its recommendations are very important in today's pharmaceutical industry. Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy). It consists of three chapters, each specializing in codes for these organizations.
Jul 2, 2017

Restricted Access Barrier System (RABS) in Pharmaceuticals

The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the intervention recorded. RABS allows for faster start-ups and easier and quicker changeover.
Jun 25, 2017

Fishbone Tool of Investigation in Pharmaceuticals

Fishbone diagrams, also known as Ishikawa diagrams, is a visual form of cause and effect diagram which can help analyze the root causes of a problem. It allows the audience to brainstorm the reasons which might otherwise be directly ignored. These causal diagrams have been in use since 1968 to find root-cause analysis of a specific event. The fishbone diagrams are a part of root cause analysis techniques which are used by pharmaceutical firms to analyze deviations and avoid series of near-misses. In addition to fishbone diagrams, the root cause analysis techniques also include brainstorming and “5 whys” which helps the firm or industry to dig deeper into a problem and then, find a practical solution.
Jun 18, 2017

Duct Designing in HVAC System

Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.
Jun 11, 2017

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 a number of reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin.
Jun 4, 2017

Sampling in Cleaning Validation in Pharmaceutical Industry

Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expect to see a functioning cleaning validation program with appropriate documentation in place during their inspections.
May 28, 2017

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 tissues.
May 21, 2017

ALCOA in Pharmaceuticals : A necessary tool for Quality

Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.
May 14, 2017

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 minimize the generation, introduction, and retention of particulate matter inside the rooms.
May 7, 2017

Basics of HVAC System

Air conditioning has changed over years, HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Heating, Ventilation and Air Conditioning is a system that is used to control the air temperature by controlling the air filtration and the moisture in the air. 
May 1, 2017

Importance of Negative and Positive Controls in Microbial Analysis

In microbiology, there two types of test controls, the positive and the negative control. The positive control is an experiment that involves the repetition of the test using working treatment. It is a duplicate experiment which helps the analyst confirms the correctness of the results of a particular test.
Apr 25, 2017

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 closing take place.
Apr 16, 2017

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 discussed in subsequent paragraphs.
Apr 9, 2017

Performance Qualification (PQ) of Pharmaceutical Equipment

When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Apr 2, 2017

Operational Qualification (OQ) in Pharmaceuticals

Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.