Equipment standard operating

Maintenance and calibration of equipment Standard operating procedures... 

Level 1 changes consist of site changes within a single facility where the same equipment, standard operating procedures (SOPs), environmental conditions (e.g., temperature and humidity) and controls, and personnel common to both manufacturing sites are used and where no changes are made to the executed batch records, except for administrative information and the location of the facility. 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Other information may also benefit the PHA. Standard operating procedures for processing equipment, safe work practices, maintenance or job safety analyses, emergency response plans could be appropriate review items for some PHAs depending upon the toll. 

Ambient temperature, altitude and atmospheric conditions at the place of installation of electrical equipment are considered to be the service conditions for the equipment to operate and perform its duties. All electrical equipment is designed for specific service conditions and variations may influence its performance. Below we analyse the influence of such non-standard service conditions on the performance of equipment and the required safeguards to achieve its required performance. 

The vibration characteristics, determined by use of the instrumentation, will serve as the basis for acceptance or rejection of the machine. API standards generally require that the equipment be operated at speed increments of approximately 10% from zero to the maximum continuous speed and run at the maximum continuous speed until bearings, lube-oil temperatures, and shaft vibrations have stabilized. Next, the speed should be increased to trip speed and the equipment run for a minimum of 15 minutes. Finally, the speed should be reduced to the maximum continuous speed and the equipment should be run for four hours. API does not require that the four hours be uninterrupted however, it is generally interpreted that way. The interpretation is one of the many test criteria to be discussed. It would seem that a break in the test at the midpoint is not the same as having it cut short five minutes from the end because the vendor s boiler took an upset that was not related to the compressor test. The ibration during the shop test is normally specified as the API limit of 1.0 mils peak to peak, or the value from Equation 10.1, unfiltcred. whichever is lower. 

When equipment or plant is taken out of service, either for maintenance or for repair, it should not be re-introduced into service without being subject to formal acceptance tests that are designed to verify that it meets your declared standard operating conditions. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Don t use training equipment for operational purposes unless it is certified to current design standards before operational use. 

Control measures for tlie eause of eaeh aeeident ean be developed in terms of equipment, instrumentation, and/or standard operating procedures... 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

Note that some organizations may not use the terminology used in this book and may not distinguish between SOPs and WIs. Standard Operating Procedures provide details of how a series of operations are carried out. An example of a SOP would be the detailed instruction for carrying out a particular analytical method. Work Instructions give details of how a specific operation is carried out. What might be classed as a WI is how to operate a particular instrument, how to estimate measurement uncertainty or how to calibrate a piece of equipment. 

Under the management of change section of the PSM standard employees are required to develop and implement documented procedures to manage changes in the process chemistry, process equipment, and operating procedures. Before a change occurs (except for replacement-in-kind), it must be reviewed to ascertain that it will not affect the safety of the operation. After the change has been made, all the affected employees are trained, and a pre-startup review is conducted. 

Standard colors have been adopted in the industrial world for the identification of physical hazards, marking of safety equipment, and operating modes of typical equipment. These conventions have been incorporated into standards used worldwide for the recognition of such devices and are categorized by the following color coding. 

A HAZOP is performed on all new chemicals following process review, preliminary equipment review, and development of preliminary standard operating procedures (SOP). What-if and checklists are typically used to review a process without process design and chemistry changes. 

There are many regulations regarding the handling and disposal of radioisotopes and these must be fully understood and observed when setting up a radioisotope facility. The hazards must be fully assessed and the laboratory must be equipped and approved for the intended applications. All manipulations must be assessed for specific hazards and standard operating procedures (SOPs) fully implemented. 

Develop and implement a plan of action, including safety considerations, consistent with Standard Operating Procedures and within the capability of the available personnel, personal protective equipment, and control equipment. 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

As with any activity required by regulation, records must be maintained of all equipment inspection, maintenance, testing, calibrating, and/or standardizing operations. The records required by this section of the regulations are necessary... 

Equipment inspection, maintenance, and repair records can be recorded in a logbook especially designed for that purpose. For equipment that is moved from laboratory to laboratory, the logbook should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, on the other hand, may be more efficiently recorded with the associated records of the data acquisition activities. 

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