Laboratory equipment, standard operating procedure

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],... 

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. 

Thus, if quality is established in terms of precision and reproducibility of the results obtained in the studies (i.e. in the respective sets of measurements or experiments), the need to provide for each of the studies a study plan, approved by the head of the laboratory before the experiments or measurements can be started, will not be an important consideration. Certainly, Standard Operating Procedures will have to be observed, and the acknowledged methods will have to be followed, with any deviations to be described and justified. Since it is the quality of the result which counts for the determination of the test facility s quality , and not the way on which it has been obtained, there is no need for a single point of study control in the person of the Study Director. Certainly, a laboratory head will have to be appointed, who has to ensure that the quality of the data obtained in the laboratory remains high, and who has to provide the necessary education and training for the technical personnel in order to enhance and update their technical expertise. If precision and reproducibility are the primary purpose of the test facility s quality concerns, then apparatus, instruments, equipment and computerised systems have to comply to the highest technical standards in terms of validation, maintenance and calibration. 

Supporting Documentation Supporting documentation should address related procedural and operational needs that must be in place to conduct a well-controlled study and produce high-quality data. Critical elements include standard operating procedures for laboratory operations, records of calibration and routine maintenance of laboratory equipment, storage units, and instrumentation, and a description of all circumstances that have the potential to affect sample integrity (e.g., freezer malfunction, instrument failure, etc.). 

Control laboratories and equipment should be kept dean, in accordance with written standard operating procedures and schedules. Records/logs should be kept... 

At various points in the research cycle, as researchers inevitably encounter results that are somewhat different than expected, they will alter the ceteris paribus conditions, the explanatory model, the selection of relevant theories, the boundary conditions of the phenomena under scrutiny, even the standard operating procedures of their laboratory equipment. Essentially anything, whether theoretical or instrumental, that can be bent to its near-breaking point will be bent theory and model will be made to accommodate instruments and experiment design and vice versa, until expectations of acceptable experimental outcomes closely match actual experimental outcomes. 

Per Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1450, Occupational Exposures to Hazardous Chemicals in Laboratories, is a written plan that includes specific work practices, standard operating procedures, equipment, engineering controls, and policies to ensure that employees are protected from hazardous exposure levels to all potentially hazardous chemicals in use in their work areas. The OSHA standard provides for training, employee access to information, medical consultations, examinations, hazard identification procedures, respirator use, and record-keeping practices. 

The process of calibration consists of linking an instrumental response or readout to performance. To calibrate instruments and devices, a trustworthy, traceable standard, procedure, or comparison is mandatory. Forensic laboratories calibrate equipment such as balances and pipets, as well as instruments, via calibration curves. All calibrations are transitory and must be repeated at intervals defined by standard operating procedures (SOPs) or known performance limitations. For example, an analytical balance might be calibrated weekly via NIST-traceable weights, while a calibration curve from a gas chromatograph might require recalibration or a calibration check every 12 hours. Calibration and calibration checks ensure that the device s output is reliable. Typically, the more complex the device, the more often and more detailed the calibration checking must be. 

Master tiles for user, laboratory equipment, EDP devices, analytical methods, standard operation procedures, measuring schedules, sampling locations, limiting values, algorithms, customers, chemicals, literature, addresses, inventory, security instructions Planning of sampling Sample registration... 

Laboratory hierarchy, inventory lists (history and actual state), standard operation procedures and their history, information about products, suppliers, and procurement, supervision of equipment, treatment of failures Completeness of investigation Contract checking, checking of produced or purchased products... 

Procedures used in a laboratory must be recorded for easy reference, down to the smallest detail. An analytical laboratory will often use standard procedures from official publications, but to these must be added references to specific types of equipment used. As a result, a laboratory needs its own procedure manual to use in day-to-day work. Every operation should be described in detail, with references made to official methods where applicable. It takes thought and skill to write such a manual in a manner that will make is useful to all workers. Safety measures, where needed, must be included. Simple operations, such as the preparation of reagent solutions, should be specified. 

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