The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. 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 int…
Human Generated Contamination in Cleanroom and its Control
Cleanroom contamination is a major problem in sterile manufacturing and it is difficult to maintain the cleanroom area. People working area is the major source of contamination.
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.
GLP in Microbiology Laboratory
Good Manufacturing Practice (GMP) is a process that ensures that products that are produced by pharmaceutical companies are of quality standards. The GMP is incorporated in the system of production and this result in the minimization or elimination of risks of the final products produced. GMP is integrated into all sequences of production from the raw materials, the premises design, to the equip…
Basics of HVAC System
Air conditioning has changed over the years, the 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.
Mechanism of Drug Release from Oral Dosage Forms
Oral solid 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 f…
Environmental Isolates and Their Library in Sterile Pharmaceuticals
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…
