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Pharmaceutical Guidelines

Oct 23, 2017

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.

Oct 15, 2017

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.

Oct 8, 2017

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.

Oct 1, 2017

Self Inspection and Its Implementation in Pharmaceuticals

Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products. It is not limited to finding the faults and follies, and infiltrators within the system but also finding and planning ways to overcome the problems effectively.

Sep 24, 2017

Alarm Challenge Test in Pharmaceuticals

The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and processes used to manufacture drugs are in optimal operating mode.

Sep 17, 2017

Different Types of Chemical Indicators for Sterilization

Chemical indicators have been around for a long time. Hydrangeas bloom blue used in acidic soil and bloom pink for use in basic soil, for example, are perfect indicators for soil conditions. Until 1940 to early 1950s, biological and chemical indicators were never used routinely to monitor sterilization processes. This is because earlier than 1940s; scientists believed that there was no single quality assurance method that would assure that an item is actually sterile and that it only assured that the conditions meant for sterilization have been met. However, this scientific statement is still taken as true today in many sterilization practices.
Sep 10, 2017

Role of RH and Temperature in Dry Powder Injection Manufacturing

Moisture remains to be a great risk to the pharmaceutical industry. Moisture is known to cause deterioration of hygroscopic substances, it activates reactions between containers and the pharmaceutical substances contained in them and it is also known to cause solidification of dry powder injection.

Sep 3, 2017

Safety Guards During Handling of Pharmaceutical Equipment

Working pharmaceutical manufacturing can be very dangerous especially if the right precautions are not followed or the working environment is not up to the standard. In every year, various workers in the pharmaceutical industry globally suffer varying forms of injuries that expose them to various risks and even death while handling pharmaceutical equipment. As such, this makes it very crucial to come up with safety guards in pharmaceutical equipment that will help prevent such injuries.

Aug 27, 2017

Bracketing and Matrixing in Pharmaceutical Stability

The practice of bracketing and matrixing in pharmaceutical stability has been comprehensively covered in various forums interested in the testing of new drug products in accordance with the standards and regulations guiding the industry.

Aug 20, 2017

Mechanism of Drug Release from Oral Dosage Forms

Oral dosage has been a predominant form to provide Active Pharmaceutical Ingredients (APIs) to a patient. The disintegration of the drug through oral dosage forms has been a cause of major bioavailability problems in the past.Therefore, the mechanism is carefully controlled in pharmaceutical products. Oral dosage usually refers to the category of drugs administered to the patient in the form of tablets, capsules and other orally administered forms.
Aug 13, 2017

Biosimilars and their Significance in Pharmaceuticals

The pharmaceutical industry is important for human health for it discovers, produces and markets drugs which most of us use for medicinal purposes. However, they work under laws and regulations that govern them on how to perform their duties. The industry deals with a large number of drugs but this article will focus on biosimilar drugs. Everything about the drugs including their importance is explained below.

Aug 7, 2017

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 organization to be able to use them to lower risks of incorrect measurement.
Jul 30, 2017

Requirement of Active and Passive Air Sampling in Controlled Areas

What would you say if I ask for the causes the most contamination of products during the manufacture of pharmaceuticals? If you’re like me, 'people' was the first thought that came to mind. You and I both are right, in fact; people, raw materials, and water are one of the main contaminants of products according to most microbiologists.

Jul 23, 2017

Preparation Process for Water for Injection (WFI) in Pharmaceuticals

There are basically two types of water preparation in pharmaceuticals.Water for Injection (WFI) preparation process and Purified Water preparation process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection (WFI) system in pharmaceuticals has stricter bacterial control standards than purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection (WFI) preparation process in pharmaceuticals must include distillation or double pass reverse osmosis techniques.

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.