Sterile & Non Sterile Manufacturing Operation Manuals
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Indications and the requirements for single-use medical gloves
AIM While the requirements for single-use gloves for staff protection are clearly defined, the conventional medical differentiation between "sterile surgical gloves" used during surgical procedures and "single-use medical gloves" used in non-sterile medical areas does not adequately define the different requirements in these two areas of use. Sterilization of single-use medical gloves is not pe...
متن کاملQuality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction
Pharmaceutical products are classified into two groups according to the microbiological point of view: 1) sterile products and 2) non-sterile products. The sterilized term refers to the products that are free of any microorganisms, their production were done under aseptic conditions, but the production of non-sterile products were not under aseptic conditions; therefore, they are not free from ...
متن کاملFactors governing performance of continuous fungal reactor during non-sterile operation--the case of a membrane bioreactor treating textile wastewater.
White-rot fungi, unlike bacteria in conventional activated sludge system, can degrade wide varieties of textile dyes. Their large scale implementation, however, has been impeded due to lack of appropriate reactor system that can sustain stable performance under non-sterile environment. In this study, contrary to virtually complete decoloration of an azo dye (Acid Orange II, 100 mg L(-1)) in pur...
متن کاملThe Contamination Control Plan in Facility Validation
The contamination control plan is central to good manufacturing practice (GMP) because it describes the procedures and policies designed to create products under controlled conditions. The contamination control plan covers all phases of a facility's status and, therefore, plays a major part in the master validation plan. The author provides an overview of the contamination control plan as it ap...
متن کاملEvaluation of biobutanol production from non-pretreated rice straw hydrolysate under non-sterile environmental conditions.
The study aims to investigate a cost-effective approach to convert non-pretreated rice straw hydrolysate into biobutanol. The influences of the initial cell concentration and incubation temperature on biobutanol production were evaluated under both sterile and non-sterile conditions. Results indicate that 100% glucose utilization could be achieved for initial cell concentrations greater than 21...
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