Search results for: cleanrooms

Authors: Doris Lacej, Eni Bushi

Abstract:

Cleaning and disinfection procedures are essential for maintaining the cleanliness status of the pharmaceutical manufacturing environment particularly of the cleanrooms and sterile unit area. The Good Manufacturing Practice (GMP) Annex 1 recommendation highly requires the implementation of the standard and validated cleaning and disinfection protocols. However, environmental monitoring has shown that even a validated cleaning method with certified agents may result in the presence of atypical microorganisms’ colony that exceeds GMP limits for a specific cleanroom area. In response to this issue, this case study aims to arrive at the root cause of the microbial contamination observed in the sterile production environment in Profarma pharmaceutical industry in Albania through applying a problem-solving practical approach that ensures the appropriate sterility grade. The guidelines and literature emphasize the importance of several factors in the prevention of possible microbial contamination occurring in cleanrooms, grade A and C. These factors are integrated into a practical framework, to identify the root cause of the presence of Aspergillus Niger colony in the sterile production environment in Profarma pharmaceutical industry in Albania. In addition, the application of a semi-automatic disinfecting system such as H2O2 FOG into sterile grade A and grade C cleanrooms has been an effective solution in eliminating the atypical colony of Aspergillus Niger. Selecting the appropriate detergents and disinfectants at the right concentration, frequency, and combination; the presence of updated and standardized guidelines for cleaning and disinfection as well as continuous training of operators on these practices in accordance with the updated GMP guidelines are some of the identified factors that influence the success of achieving sterility grade. However, to ensure environmental sustainability it is important to be prepared for identifying the source of contamination and making the appropriate decision. The proposed case-based practical approach may help pharmaceutical companies to achieve sterile production and cleanliness environmental sustainability in challenging situations. Apart from the integration of valid agents and standardized cleaning and disinfection protocols according to GMP Annex 1, pharmaceutical companies must be careful and investigate the source and all the steps that can influence the results of an abnormal situation. Subsequently apart from identifying the root cause it is important to solve the problem with a successful alternative approach.

Keywords: cleanrooms, disinfectants, environmental monitoring, GMP Annex 1

Procedia PDF Downloads 177

Authors: HebatAllah Tarek, Zeyad El-Sayad, Ali F. Bakr

Abstract:

Surface coating can permit the bulk materials to remain unchanged, whereas the surface functionality is engineered to afford a more required characteristic. Nano-Ceramic coatings are considered ideal coatings on materials that can significantly improve the surface properties, including anti-fouling, self-cleaning, corrosion resistance, wear resistance, anti-scratch, waterproof, anti-acid rain and anti-asphalt. Furthermore, various techniques have been utilized to fabricate a range of different ceramic coatings with more desirable properties on Nano-ceramics, which make the materials usually used in in-service environments and worth mentioning that the practical part of this study will be applied in one of the most important architectural applications due to the contamination-free conditions provided by it in the manufacturing industry. Without cleanrooms, products will become contaminated and either malfunction or infect people with bacteria. Cleanrooms are used for the manufacture of items used in computers, cars, airplanes, spacecraft, televisions, disc players and many other electronic and mechanical devices, as well as the manufacture of medicines, medical devices, and foods. The aim of this study will be to examine the Nano-ceramics on porcelain and glass panels. The investigation will be included fabrications, methods, surface properties and applications in clean rooms. The unfamiliarity in this study is using Nano-ceramics in clean rooms instead of using them on metallic materials.

Keywords: nano-ceramic coating, clean rooms, porcelain, surface properties

Procedia PDF Downloads 54