Equipment Procedures and Requirements

Appendix A to Subpart T— Examples of conditions that may restrict or limit exposure to hyperbaric conditions 

Appendix B to Subpart T—Guidelines for scientific diving Subparts U—Y [RESERVED] 

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Content. Have update/upgrade training courses and materials kept pace with changes in equipment, procedures, and requirements ... 

Process Conceptual Design Equipment selection and sizing Inventory of process Single vs. Multiple trains Utility requirements Overdesign and flexibility Recycles and buffer capacities Instrumentation and control Location of plant Preliminary plant layout Materials of construction As above plus equipment suppliers data, raw materials data, company design procedures and requirements... 

In many companies, the scale-up process may include or overlap with the validation process. In any case, demonstration of the process in the production environment at full scale, using the materials, equipment, procedures, and personnel established in production, is required. Often, multidisciplinary teams are arranged to manage the scale-up, and the overall roles and responsibilities for those involved with the product may change. Typically, extensive documentation, including protocols and reports, is involved, as... 

Every in vitro method should be detailed in the developer laboratories using Standard Operating Procedures (SOPs) covering all essential components and steps of the method. The SOP(s) should be sufficiently defined and described and should include the rationale for the test method, a description of the materials needed, such as specific cell types, a description of what is measured and how it is measured, a description of how data will be analyzed, acceptance and decision criteria for evaluation of data, and what are the criteria for suitable test performance. All limitations, e.g., lack of metabolic competences (presence of phase 1 and phase 2 biotransformation activities) or absence of critical transporters, should be included in the in vitro method description. In general, the in vitro method should not require equipment or material from a unique source. This may not be always possible for particular in vitro test systems or other components of the method in which case a license agreement between the provider and a recipient/user may be required. For complex and/or specialized equipment, the equipment specifications and requirements should also be described. Acceptance criteria for measurements carried out on the equipment should also be provided where applicable (e.g., for analytical endpoint determinations, linearity and limits of detection should de detailed) [2],... 

Step 4 deals with identifying alternative facihty, equipment, procedural, and/or persotmel plans that will eliminate or minimize the deficiencies identified in the existing warehouse operation. From these alternative plans of action will come the specific time-phased plan of action to be recommended for meeting the warehouse requirements over the given platming horizon. 

Sensors and AE equipments are already commercially available. In this concern, important aspects are to select proper devices and systems. Depending upon materials and stmctures, selection of sensors, decision of frequency range, techniques to eliminate noises and conditions for system setting may change. Some of standardized procedures and requirements for systems are stated in chapters dealing with applications. 

Diving mode A type of diving requiring specific equipment, procedures and techniques (SCUBA, surface-supplied air, or mixed gas). 

Once pressure equipment and assemblies have been installed and put to work, it is essential that they are used and maintained in a manner that ensures they remain safe throughout their operating life. Criteria, procedures and requirements for ensuring this are contained in the Pressure... 

The source and associated facilities and equipment shall be regularly inspected, tested and maintained in accordance with approved procedures and quality assurance programmes to ensure that components, structures and systems continue to be available and to operate as intended. Modifications to the source and associated equipment shall be conditional on the results of an assessment of their safety implications. Operating procedures shall provide staff with instructions for the conduct of normal operations and for managing foreseeable and reasonably plausible accidents. Lessons learned from operating experience should be considered in order to determine whether equipment, procedures and/or training or related safety requirements need to be modified. 

Oral and Operating exams shall be required. The exam should include plant walkthroughs identifying equipment, procedures, and knowledge required to handle normal and abnormal events. 

The examination is made on an object (i.e. the volume of the component on which NDI information is required), using a procedure and a data organisation (i.e. the definition of the structure of acquisition data). The procedure defines the equipment. The acquisition data is produced by the equipment and arranged according to the data organisation related to the equipment. 

Technical requirements Sound engineering practice, essential requirements tarticle 3t The directive includes a particular technical requirement with respect to equipment which presents only a minor pressure hazard. For such equipment the essential requirements and the certification procedures are not applicable. Instead the so-called sound engineering practice of one of the Member States must be applied. That practice must ensure that design and manufacture takes into account all relevant factors influencing safety during the intended lifetime. The equipment must be accompanied with adequate instruetions for use and must bear the identification of the manufacturer. The CE-marking shall not be applied for such equipment. 

Monitoring by Electromechanical Instrumentation. According to basic engineering principles, no process can be conducted safely and effectively unless instantaneous information is available about its conditions. AH sterilizers are equipped with gauges, sensors (qv), and timers for the measurement of the various critical process parameters. More and more sterilizers are equipped with computerized control to eliminate the possibiUty of human error. However, electromechanical instmmentation is subject to random breakdowns or drifts from caUbrated settings and requires regular preventive maintenance procedures. 

A study of how a sohd dries may be based on the internal mechanism of liquid flow or on the effec t of the external conditions of temperature, humidity, air flow, state of subdivision, etc., on the diying rate of the sohds. The former procedure generally requires a fundamental study of the internal condition. The latter procedure, although less fundamental, is more generally used because the results have greater immediate application in equipment design and evaluation. 

For many years the usual procedure in plant design was to identify the hazards, by one of the systematic techniques described later or by waiting until an accident occurred, and then add on protec tive equipment to control future accidents or protect people from their consequences. This protective equipment is often complex and expensive and requires regular testing and maintenance. It often interferes with the smooth operation of the plant and is sometimes bypassed. Gradually the industry came to resize that, whenever possible, one should design user-friendly plants which can withstand human error and equipment failure without serious effects on safety (and output and emciency). When we handle flammable, explosive, toxic, or corrosive materials we can tolerate only very low failure rates, of people and equipment—rates which it may be impossible or impracticable to achieve consistently for long periods of time. 

If the technical staff from the client company recognizes that a toller may be asked to perform new analyses and make operating decisions based upon the results, the client may help the toller develop the needed procedures and skills required to make these decisions. Typically a round robin laboratory qualification exercise will be performed. Samples of known standards and unknown concentrations of the materials to be analyzed for the toll will be prepared and sent to both laboratories. This can help ensure that equipment calibration is synchronized and that the toller is capable of performing accurate measurements. In some cases, the toller may be the party with the chemical, process, or synthesis specific expertise. 

Tolling presents a special consideration that can make the training step easier. Typically a toller s technical staff, operators and mechanics are knowledgeable in the basic operations and tasks related to the toller s specialty. For example, experienced operators may know operations of the reactors, columns, exchangers, and packaging equipment quite well. The mechanical personnel may be very familiar with the required safe work practices, equipment cleaning procedures and maintenance tasks for standard vessels and piping. 

As with any power equipment, gas turbines require a program of planned inspections with repair or replacement of damaged components. A properly designed and conducted inspection and preventive maintenance program can do much to increase the availability of gas turbines and reduce unscheduled maintenance. Inspections and preventive maintenance can be expensive, but not as costly as forced shutdowns. Nearly all manufacturers emphasize and describe preventive maintenance procedures to ensure the reliability of their machinery, and any maintenance program should be based on manufacturer s recommendations. Inspection and preventive maintenance procedures can be tailored to individual equipment application with references such as the manufacturer s instruction book, the operator s manual, and the preventive maintenance checklist. 

Once the highest steam level is set, then intermediate levels must be established. This involves having certain turbines exhaust at intermediate pressures required of lower pressure steam users. These decisions and balances should be done by in-house or contractor personnel having extensive utility experience. People experienced in this work can perform the balances more expeditiously than people with primarily process experience. Utility specialists are experienced in working with boiler manufacturers on the one hand and turbine manufacturers on the other. They have the contacts as well as knowledge of standard procedures and equipment size plateaus to provide commercially workable and optimum systems. At least one company uses a linear program as an aid in steam system optimization. 

Total enclosure may be in the form of a room with grilles to facilitate air flow this functions as a hood and operates under a slight negative pressure with controls located externally. Entry is restricted and usually entails use of comprehensive personal protective equipment. Ancillary requirements may include air filters/scmbbers, atmospheric monitoring, decontamination procedures and a permit-to-work system (see page 417). 

Contains methods for the safe handling and use of the chemical and for emergency response Identifies the equipment, clothing and procedures required. 

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