Primary containment

Isolation of radioactive wastes for long periods to allow adequate decay is sought by the use of multiple barriers. These include the waste form itself, the primary containers made of resistant materials, overpacks as secondary layers, buffer materials, concrete vaults, and finally the host rock or sod. Barriers limit water access to the waste and minimize contamination of water suppHes. The length of time wastes must remain secure is dependent on the regulatory limit of the maximum radiation exposure of individuals in the vicinity of the disposal site. 

Diked or Unitized Secondary Containment. Small tanks can have a secondary-containment dam built integrally into the tank. This is essentially within a steel box. These tanks may be either vertically or horizontally oriented in both cylindrical and rectangular shapes. The secondary-containment dikes may be open or closed. Closing the dikes makes access to the primary-containment tank more difficult, but keeps out rainwater. 

Sams, D. W. and M. T rojovsky, Data Summaries of Licensee Event Reports of Primary Containment Penetrations at U.S. Commercial Nuclear Plants, EG G, Septt 1980,... 

Centers for Disease Control and Prevention and National Institutes of Health. Primary Containment of Biohazards Selection, Installation and Use of Biological Safety Cabinets. Washington, DC U.S. Department of Health and Human Services, 1995 (available on http // www.niehs.nih.gov/odhsb/biosafe/bsc/bsc.htm)... 

Closed system The primary containment of a process in a biotechnology clean room. 

Primary containment The enclosing structure around a red zone used in the atomic energy industry, which has a specific leak tiglitness. 

EGSG Idaho s Idaho National Engineering Laboratory reviewed Licensee Event Reports (LERs), both qualitatively and quantitatively, to extract reliability information in support of the USNRC s effort to gather and analyze component failure data for U.S. commercial nuclear power plants. LERs describing failures or command faults (failure due to lack of needed input) for selected components have been analyzed in this program. Separate reports have been issued for batteries and battery chargers, control rods and drive mechanisms, diesel generators, ISC, Inverters, primary containment penetrations, protective relays and circuit breakers, pumps, and valves. 

Storage in the same primary container as will be used on the market, e.g., blister strips for tablets or ovules, tubes for creams, or vials and ampules for injectables. 

Primary container-closure system-related data will need to cover storage, transportation, and use. The choice of materials of construction, their description, and the ability of the container-closure system to protect from moisture and/or light will need to be considered. The compatibility of the container-closure and its contents will need to consider sorption, leaching, and safety. The performance of the container-closure system will also need to be considered in terms of dose delivery from any associated device that is to be supplied as part of the product. Container-closure components will require adequate specifications covering description, identification, critical dimensional tolerances, and test methodology (including pharma-copeial and noncompendial methods). More data are likely to be required for liquid or semi-liquid products than for solid dosage forms. In the latter, product stability data and container-closure system specifications may suffice. 

It is an aerobic, gram-negative, motile, nonsporing, rod-shaped bacterium. It can survive for many months in surface water and up to 3 months in shaded soil. The natural reservoir is soil and water. This is a biosafety level 2 agent. Additional primary containment and personnel precautions may be indicated for activities with a high potential for aerosol or droplet production. 

Laboratory rooms intended for toxic work should be provided with adjacent shower and change facilities. The layout must not require freshly showered personnel to track back through the area that they might have just contaminated. All drains, including those in laboratory floors, should have deep traps and be directed to a toxic sump. Airlocks will help prevent toxic fumes from spreading to non-toxic areas in the event of a failure of a primary containment cabinet. Check valves in the incoming water lines will prevent contamination of potable water supplies when pressure is lost. 

Design and build a robust and well-protected primary containment system following codes, standards, regulations, and other established practices (Security). 

Design and implement a reliable and fault-tolerant basic process control system to ensure the design limitations of the primary containment system are not exceeded. 

Primary containment should be designed and tested to demonstrate freedom from leakage risk. 

The formal validation is often completed after the PAI, where three-batch process validation will be conducted in accordance with the protocol approved during the preapproval inspection. The primary objective of the formal process validation exercise is to establish process reproducibility and consistency. Such validation must be completed before entering the market. The formal validation studies continue through packaging and labeling operations (in whole or in part), so that machinability and stability of the finished product can be established and documented in the primary container-closure system. 

Nuclear Boiler Assembly. This assembly consists of the equipment and instrumentation necessary to produce, contain, and control the steam required by the turbine-generator. The principal components of the nuclear boiler are (1) reactor vessel and internals—reactor pressure vessel, jet pumps for reactor water circulation, steam separators and dryers, and core support structure (2) reactor water recirculation system—pumps, valves, and piping used in providing and controlling core flow (3) main steam lines—main steam safety and relief valves, piping, and pipe supports from reactor pressure vessel up to and including the isolation valves outside of the primary containment barrier (4) control rod drive system—control rods, control rod drive mechanisms and hydraulic system for insertion and withdrawal of the control rods and (5) nuclear fuel and in-core instrumentation,... 

The FDA process validation guidelines [1] refer to a quality assurance system in place that requires revalidation whenever there are changes in packaging (assumed to be the primary container-closure system), formulation, equipment or processes (meaning not clear) which could impact on product effectiveness or product characteristics and whenever there are changes in product characteristics. 

Bringing the correct materials (both product and packaging) to the packaging line and delivery onto the line Packaging line services required to make the line operate Filling the product into the primary container Closing the package (i.e., the primary container)... 

Labeling or identifying the contents of the primary container Adding leaflet(s) as required for all pharmaceuticals Using carton/display outer application (i.e., secondary packaging) if necessary... 

There may be need only to fill, close, and identify the primary container (as used for many sterile filling operations) and then store the filled primary containers for later packaging. This can create many problems for example... 

Containment uses a physical barrier to prevent an uncontrolled release of materials to the environment. The walls of a vessel or pipe serve as the primary containment barrier that encloses harmful materials. Redundant (secondary) containment serves as a safeguard if the primary barrier fails, and is considered a postrelease mitigation measure. Containment can take many forms, depending on factors such as the system or process to be contained, the risks involved with a release, and the cost benefit of the additional secondary containment. 

Medical Sources. All medical encapsulations are done in a facility which consists of a series of five interconnected stainless steel boxes which provide primary containment of process equipment and materials. Interconnections include transfer ports, drop-through tubes, and ventilation ducts. Each containment enclosure has a floor area of 1.52 m x 0.91 m the floor level is 0.76 m above the building floor. A pair of master-slave manipulators serve each containment box. A closed circuit television system and a telescope are provided for close-up viewing of incell operations and can be moved from cell to cell as needed. General arrangement of the facility is shown in Figures 13 and 14. 

Fuel Elements. The fuel element is designed to provide the primary containment for the radioactive fuel and fission products over the three- to four-and-one-half-year operating life of the PWR and BWR fuel. In addition, without significant problems, it has provided the containment of the spent fuel after discharge from the reactors for more... 

Packaging material should be purchased from qualified vendors. Primary containers and closures must be tested to verify that there are no interactions between the radiopharmaceutical and packaging material during storage of the product. 

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