Testing options for clean laboratories
Testing options for clean laboratories
For the testing objects and parameters involved in the laboratory business, appropriate standard methods should be selected as the testing basis; the selected standard methods must be the latest and effective methods, and the update of relevant testing standards and specifications should be checked regularly to avoid using Abandoned technical standards; clean real...
Text label: clean laboratory testing, laboratory purification
Testing options for clean laboratories
For the testing objects and parameters involved in the laboratory business, appropriate standard methods should be selected as the testing basis; the selected standard methods must be the latest and effective methods, and the update of relevant testing standards and specifications should be checked regularly to avoid using Abandoned technical standards; clean laboratories should establish method work instructions for the selected testing standards or specifications, and the instructions specifically interpret the testing procedures and requirements of standard methods, so that different personnel and different times can perform testing. The process can be kept consistent; especially when some standards are not detailed enough for operation details or there are multiple solutions that need to develop a unified practice in the laboratory, or the relevant pharma machinery personnel cannot understand or interpret the language used in the standards, they should Establish uniform work instructions for laboratories; the areas where laboratories need to establish work instructions also include equipment use, sampling and sample disposal, and data processing. The work instructions for testing technical standards should be updated and changed according to the standards. Modify and update in a timely manner.
To prove that a new standard or test method can be correctly used by the pharma machinery, it is necessary not only to confirm the equipment, environmental conditions, personnel skills and other conditions used, but also to provide the corresponding technical data and original records for verification. These confirmations usually need to be confirmed from five aspects: human, machine, material, method, and environment; the human side should confirm that the laboratory personnel can correctly understand and apply the standard, and establish the work instruction of the test method; the machine side should confirm that the equipment is fully equipped And correctly equipped with the equipment required in the labeling method, and carry out good maintenance and pass the verification and calibration; in terms of materials, the laboratory should be certified to meet the standard detection limit, accuracy, importance and consistency when using the standard method to test. Compared with other laboratories, the test is consistent; the environmental aspect should confirm whether the pharma machinery facilities and environmental conditions meet the test requirements of the test standard. Therefore, when the laboratory method is established and confirmed, it should be as comprehensive and accurate as possible. The experimental steps and test procedures of the detection method, as well as the uncertainty of the test results, the detection limit of the method, the selectivity and accuracy of the method, the linear range, the repeatability The index properties such as robustness, robustness against external influences, and interaction sensitivity against fundamental disturbances from the sample are checked, compared and determined. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean laboratories and sterile laboratories.
In the development of new testing methods by the clean laboratory, it is necessary to ensure that the relevant developers have the ability to complete the development work. Special personnel are responsible for the testing process and method quality at each stage of development. The new development method requires practical inspection records. Verification, preparation of method texts, arrangement and preservation of related technical reports; non-standard methods developed by the laboratory should be confirmed, and the confirmation content also includes calibration using reference standards or reference materials, comparison with the results obtained by different methods, and laboratory testing. Inter-comparison, systematic evaluation of the factors affecting the results, evaluation of the uncertainty of the results, etc., and at the same time understanding the principles and steps of the method from theory to operation practice, and complete the detection limit, recovery rate, linearity and range of the method. , accuracy, precision, robustness and other characteristic indicators to check, compare and confirm, and formulate corresponding work instructions and related technical ability records.
SUZHOU PHARMA MACHINERY CO.,LTD. shows how effective market design can encourage participation, reduce gaming, and aggregate information, in order to improve liquidity, efficiency, and equity in markets.
SUZHOU PHARMA MACHINERY CO.,LTD. endeavors to be valued as an industry leader in client satisfaction, sales growth, product performance, financial strength and profitability.
Even CUSTOM SOLUTION SERVICES are being made fine with advanced equipment.
SUZHOU PHARMA MACHINERY CO.,LTD. can reassign work or shuffle around assigned tasks if one team member is overwhelmed while others are not, more effectively managing resources on the fly. With detailed overviews and reports, manufacturers also can more easily stay abreast of new developments.
SUZHOU PHARMA MACHINERY CO.,LTD. has never compromised on the quality and the services provided to the customer.