Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for the compliance of data integrity in firms. These documents clarify the expectations of the FDA from ph…
Working of a HVAC System and Its Functions
Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of good quality. It ensures that there are all the necessary favorable conditions for successful manufacturing. A basic working HVAC system works as explained below:
First, the system collects fresh air from outside the plant from where it is filtered using a fi…
First, the system collects fresh air from outside the plant from where it is filtered using a fi…
Maintenance of Pharmaceutical Clean Area: FDA Recommendation
Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area.
Difference Between HEPA and ULPA Filters
The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are designed to catch and remove tiny, airborne particulate matter such as bacteria, pollutants, and dust…
Isolators and Their Use in Sterile Manufacturing
An isolator can best be defined as an arrangement of physical barricades which are incorporated to a degree that the isolator is capable of being sealed; so as that it can undertake a scheduled leak tests that are based on pressure, to attain stated limits.
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 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.
