الفهرس 
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Abstract
Aseptic proccssing is a critical method for the preparation of thernrolabilc sterile parcnteral drug products. Sterile 13-lactams antibiotics are extremely deactivated by heat, so the method of choice for their processing is through aseptic filling. The requirements for a properly designed, validated, and maintained filling or other aseptic processing facility are mainly directed to
(1) Cleanroom or aseptic area.
(2) Qualified operating personnel.
Aseptic areas should be designed to encourage separation between each stage of production with ensuring a safe and organized workilow. Highly finished internal surfaces, adequate services within clean room and high level of filtered air supplied by a powerful HVAC system arc the critical requirements to establish aseptic area with an acceptable microbiological quality.
The production of aseptically filled vials within aseptic area requires monitoring of the production environment. The aim is to recognize any deviation froni the standards. The necessity of monitoring environment as a key element for a quality assurance program is widely accepted. A successful monitoring program should address how to determine sampling sites and testing frequency, setting alert/action levels, description of methods for viable and nonviable particulate monitoring, and finally, data analysis and results interpretation.
However bacterial contamination in aseptic filling area is not common, but once it occurs the whole production process become in a crisis. This is due to the danger of contamination of the drug products are filled within this area.
The consequences of contamination may be serious, especially if contaminants arc capable to multiply to high levels. Firstly, the usage of contaminated products leads to a potential health hazard to patients. Through spoilage, active drug constituents may be metabolized to less potent or chemically inactive forms. Secondly, the product may be spoiled. Spoilage of batches usually results in major financial problems for the manufacturer through direct loss of faulty product. Thirdly, the threat damaging publicity of recalls may have serious economic crisis for the manufacturer.
Parenteral penicillins aseptic filling area in Pharco pharmaceuticals Egypt was selected for the monitoring and study in this thesis. Microbiological confonnity of class A/B of cleanroom with the standard specification was canled out using active and passive air sampling techniques, non-viable particles counting and surfaces swapping. The two classes’ results were found to be compatible with the standard requirements.
A total of one hundred and one bacterial isolates amid three standard strains were used. Out of bacterial isolates, thirty-one isolates were collected from class A of aseptic penicillins filling area amid seventy isolates were collected from class B of aseptic penicillins filling area.
Bacterial isolates were identified using macroscopic, microscopic examination and then identity was confirmed by biochemical methods.