Controlled environment rooms

Clones of duckweed plants were grown axenically in Stewart s growth medium (17) with asparagine at 132.1 mg/L as nitrogen source. Cultures were maintained in 250-mL Erlenmeyer flasks with 100 mL of medium per flask in controlled environment rooms... 

Frequently, filtration, washing, and drying operations are integrated especially where noxious substances are being handled or when a crystal slurry of an API is being processed to a dry solid in a controlled environment room (CER). In the latter case, all types of combinations of filters and dryers are used (Figure 13). 

Incubation conditions (defined, controlled environment, room temperature, etc.)... 

Many of the fabrication processes for iategrated circuits are similar or coaceptuaHy related to those used ia the manufacture of ptinted wiring boards. However, because of the extremely fine device features, fabrication must be carried out ia clean rooms having strictly controlled environments. Particulate and chemical contamination are minimized, and temperature, humidity, and even vibration are carefully controlled. 

Clean Room and Work Station Requirements, Controlled Environment, Sec. 1-5 Federal Standard 209, Office of Technical Services, U.S. Department of Commerce, Washington, DC, Dec. 16, 1963. 

General Informational Chapter (1116) Microbiological Evaluation of Clean Rooms and Other Controlled Environments... 

USP 24 Testing Chapters (51) Antimicrobial Effectiveness Testing, (61) Microbial Limit Tests and (71) Sterility Tests, United States Pharmacopeial Convention, Inc., Rockville, MD, 2000. USP 24 Informational Chapters (1116) Microbiological Evaluation of Clean Rooms and other Controlled Environments, (1111) Microbiological Attributes of Pharmaceutical Articles, (1151) Pharmaceutical Dosage Forms, (1225) Validation of Compendial Methods, and (1231) Water for Pharmaceutical Purposes, United States Pharmacopeial Convention, Inc., Rockville, MD, 2000. 

A survey of the environmental control and monitoring technology used in several experimental studies indicated significant limitations in experimental control capability. There are seven controlled-environment chambers or clean-room facilities in the United States for human exposure (community air pollution inhalation) from which studies have been reported. Another is under construction at the University of North Carolina in association with the epa at Chapel Hill. There are three chambers in Canada of similar design. 

Samples constructed from adherends which had been alkaline cleaned, lubricated or left untreated exhibited similar joint strength values and durability trends (Figure 10). Adhesive joints placed in the room temperature control environment or the 23 C water bath retained lOOZ and 92% of initial joint strength, respectively. Failure remained cohesive within the adhesive for all of the control samples and for the first 20 days of exposure in the 23 C water bath. After 20 days, some failure began to initiate at both the primer/steel and primer/topcoat interfaces. The adhesive/topcoat interface proved to be more durable than those found between the substrate/primer/topcoat layers. Samples exposed to the more severe salt fog, 60 C water bath and cycle tests were able to retain 70% to 50% of their initial strength over a 60-day exposure period. 

ISO 14644-1. Clean rooms and Associated Controlled Environments, Classification of Air Cleanliness,... 

Areas and surfaces in a controlled environment that are in direct contact with products, containers, or closures and the microbiological status of which can result in potential microbial contamination of the product/container/ closure system should be identified. Once identified, these areas should be tested more frequently than non-product-contact areas or surfaces. Elements that are likely critical product contact points may include compressed air or nitrogen, room air, manufacturing equipment, tools, work surfaces, storage containers, conveyors, gloved hands of personnel, and water. 

A controlled environment such as a clean zone or clean room is defined by certification according to a relevant clean room operational standard. Parameters that are evaluated include... 

Environmental microbial monitoring and analysis of data by qualified personnel will permit the status of control to be maintained in clean rooms and other controlled environments. The environment should be sampled during normal operations to allow for the collection of meaningful data. Microbial sampling should occur when materials are in the area, processing activities are ongoing, and a full complement of operating personnel is on site. 

When appropriate, microbial monitoring of clean rooms and some other controlled environments should include quantitation of the microbial content of room air, compressor air that entered the critical area, surfaces, equipment, sanitization containers, floors, walls, and personnel garments (e.g., gowns and gloves). 

During initial start-up or commissioning of a clean room or other controlled environment, specific locations for air and surface sampling should be determined. 

General information <1116> Microbiological evaluation of clean rooms and other controlled environments. U.S. Pharmacopeia, vol. 25. Rockville, MD U.S. Pharmacopeial Convention, p. 2206-2212 (2002). 

The first component of a successful clinical trial manufacturing program is the area or facility used for the production of clinical trial batches. This facility should have limited access and be segregated from other activities where the danger of cross contamination is removed and the control of materials, product, waste, and personnel flow can be achieved. Preparation of vector batches requires rooms where a controlled environment can be maintained. Here, under class 10,000 and class 100 environments, batches can be produced, purified, and vialed for use in trials. HVAC and other equipment used within the manufacturing facility requires annual calibration, initial installation, and operational qualification, and appropriate preventive maintenance programs. Written procedures for the use, cleaning, and maintenance of the facility, and the equipment must also be written and followed by appropriate personnel. 

In a typical in situ Raman study, CNT samples are heated in a heating stage, operated in air or controlled environment between 20°C and 600°C. Powders must be dispersed in a solvent, such as ethanol, to produce a thin film of CNTs on a glass slide. The samples are then kept in the heating stage and placed under the microscope of the Raman spectrometer. The oxidation process described in this chapter followed two different heating procedures. The first procedure (nonisothermal) includes heating from room temperature up to 600°C at a rate of... 

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