The surprising truth is that there are billions of micro-organisms circulated in the air, most of which are bacteria in nature but the biggest problem is one, identifying them seems to be one of the most major mountains to climb. Many of the pharmaceutical laboratories have tried to identify them through air sampling methods, but quite often results have shown that there are other sources of envi…
Difference between Sterilization and Depyrogenation
To understand the difference between sterilization and depyrogenation, we have to discuss both of them separately, in length to really know the line that separates them. Basically, sterilization is a method that can remove, kill and deactivate microorganisms on a surface like for example the stainless equipment, media etc.
Aseptic Processing Area and Its Maintenance
Good manufacturing practices and regulations are critical areas for having good practices for the pharmaceutical industry. Much care should be taken especially when manufacturing sterile drugs and other biological products using aseptic processing. A critical area is where sterilized drugs, containers and closures may be exposed to the external conditions, therefore must be designed and manufactu…
Importance of Validation in Pharmaceuticals
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is a very common concept in the pharmaceutical industries throughout the world.
Key Differences between LAF and Biological Safety Cabinet
From a basic point of view, both the Laminar Air Flow cabinet 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.
Importance and Maintenance of Pressure Differential in Manufacturing Area
The pressure differential is the difference between atmospheric pressure between the production area and its surroundings. It is measured in Pascal using the magnehelic pressure gauge.
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.
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.
Guidelines for Drug Master File Submission
1. Meaning of a Drug Master File
DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers.
2. Drug Master Files’ Regulatory Basis
It is not a necessity by law to submit DMF, on the other hand, it is submitted at the holder discretion. Upon submission, DMF isn't endorsed or objected; its contents are checked in reference to the applicati…
DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers.
2. Drug Master Files’ Regulatory Basis
It is not a necessity by law to submit DMF, on the other hand, it is submitted at the holder discretion. Upon submission, DMF isn't endorsed or objected; its contents are checked in reference to the applicati…
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 sanitizers in pharmaceuticals because the mode of action in each is needed to prevent the resistance of microbes.
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.
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 requirements. The FDA GMP training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects.
Importance of Data Integrity in Pharmaceuticals
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
Requirements for Good Documentation Practice (GDP)
Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents.
Difference between Fumigation and Fogging
To keep the controlled area from being contaminated in pharmaceuticals, two processes namely fumigation and fogging are used. Both the processes are used for the same purpose, but the difference between fumigation and fogging in pharmaceuticals is great. Moreover, fumigation is banned in few pharmaceuticals because of its negative effects while fogging is a safer option than the former.
