Product contamination in aseptic pharmaceutical manufacturing areas can occur by several routes and from several sources but the major route of contamination that cannot be effectively controlled is the airborne one. Process simulation by filling containers with bacteriological medium is an effective method of assessing the expected bacteriological quality of the product. However, these filling tests must be limited in number and are not sufficiently sensitive to show levels much below I contaminant in 1000. An explanation of the mechanisms of airborne contamination in clean rooms are given in this paper and a model is derived which can give a reasonable prediction of the amount of product contamination from a knowledge of the concentration...
The degree of risk from microbial contamination of manufactured products by sources of contaminatio...
During pharmaceutical production the quality of the air in manufacturing areas is monitored by volum...
It is recognized that any contamination control strategy represents a cyclical process, designed to ...
Product contamination in aseptic pharmaceutical manufacturing areas can occur by several routes and ...
Particles present in the air of a manufacturing pharmacy may be deposited or impacted into a contain...
The routes of airborne contamination, during Blow-Fill-Seal (BFS) production, were studied using tra...
This paper describes the fundamental mechanisms of microbial contamination during manufacture of ph...
This paper reports the results from a series of investigations carried out in the U.K. into the impo...
The microbial risk to aseptically manufactured products in pharmaceutical cleanrooms can be assesse...
The manufacture of injectable drugs imposes special requirements to minimize the risk of microbial a...
Analytical methods for hazard and risk analysis are being considered for controlling contamination i...
Results are presented from studies performed in a test chamber on clean room garments used, laundere...
The aim of this work is to develop and validate methods for quantifying endotoxins on surfaces and i...
Aseptic handling is the procedure to enable sterile products to be made ready to administer using cl...
Aseptic handling is the procedure to enable sterile products to be made ready to administer using cl...
The degree of risk from microbial contamination of manufactured products by sources of contaminatio...
During pharmaceutical production the quality of the air in manufacturing areas is monitored by volum...
It is recognized that any contamination control strategy represents a cyclical process, designed to ...
Product contamination in aseptic pharmaceutical manufacturing areas can occur by several routes and ...
Particles present in the air of a manufacturing pharmacy may be deposited or impacted into a contain...
The routes of airborne contamination, during Blow-Fill-Seal (BFS) production, were studied using tra...
This paper describes the fundamental mechanisms of microbial contamination during manufacture of ph...
This paper reports the results from a series of investigations carried out in the U.K. into the impo...
The microbial risk to aseptically manufactured products in pharmaceutical cleanrooms can be assesse...
The manufacture of injectable drugs imposes special requirements to minimize the risk of microbial a...
Analytical methods for hazard and risk analysis are being considered for controlling contamination i...
Results are presented from studies performed in a test chamber on clean room garments used, laundere...
The aim of this work is to develop and validate methods for quantifying endotoxins on surfaces and i...
Aseptic handling is the procedure to enable sterile products to be made ready to administer using cl...
Aseptic handling is the procedure to enable sterile products to be made ready to administer using cl...
The degree of risk from microbial contamination of manufactured products by sources of contaminatio...
During pharmaceutical production the quality of the air in manufacturing areas is monitored by volum...
It is recognized that any contamination control strategy represents a cyclical process, designed to ...