3Q verification application
According to the different varieties of production in the pharmaceutical industry, from the dosage form, there are powder injection 1, raw material 1 drugs, solid preparations, etc., and different drugs also have different testing projects, for laboratory instruments, mainly to meet the drug testing for the preparation, so broadly divided into the following picture in several categories. According to the classification of instruments, they are simply divided into 3 categories:
For simple instruments, such as: electric furnace, ultrasonic cleaner, etc. is not required to verify, because the instrument itself is simple, and can not have a direct impact on the test results, so such instruments can be omitted verification.
For general instruments, such as: pH meters, scales and other precision instruments, but the state of the instrument can have a direct impact on the test results, so such instruments need to do 3Q verification, but can be abbreviated to do, sterilizer 3Q certification company, is to do: IOQ, PQ, that is, the IQ (installation confirmation) and OQ (operation confirmation) synthesis of a step to do.
And precision instruments, such as liquid chromatograph, gas chromatograph and other precision instruments, 3Q verification to do the whole, that is: IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation) all do.
IQ / OQ / PQ test protocol
IQ / OQ / PQ kits are available for Axicon verifiers in two forms, one for linear barcode verifiers and the other for 2D barcode verifiers.
Each kit includes a set of accurately manufactured NIST traceable reference test cards and protocol documentation. (NIST is the National Institute of Technology.) When the user performs the test, they can determine if the verifier is working as expected and can be recertified as compliant.
Each card is printed with symbols of known dimensions and characteristics of the exact design, Liaoning Sterilizer 3Q Certification, and these symbols are used in turn to check specific aspects of the verifier’s operation.
Once the test is completed satisfactorily, the user can self-certify that their particular verifier complies with the relevant ISO/IEC standard. For linear bar codes, these are ISO / IEC 15426-1 and ISO / IEC 15416, while for 2D verifiers they are ISO/ IEC 15426-2 and ISO / IEC 15415. (Any verifier that can evaluate linear and 2D symbols must comply with all four standards.)
If a verifier does not meet the requirements of the PQ test, it must be returned to Axicon for repair and factory configuration.
The Need for Reliability Metrics for Instrument Validation
In the past, many countries’ military1 industrial equipment failed to form combat capability after deployment due to high failure rate (i.e., unreliability), high maintenance and security costs, and even dropped in the battlefield. Both developed countries in the world and China have suffered a lot in terms of reliability of military1 equipment. Reliability engineering mainly from the 1950s, in Germany, the United States and other developed countries in the military 1 industry has been rapidly developed and widely used, and since the 1990s began to be gradually introduced by the Chinese military 1 industry, after 15 years of efforts between 1990 and 2005 to promote the application of China’s military 1 equipment quality quickly and significantly improved played a significant role. At present, the world powers (including China) in the process of equipment development, are focused on controlling the reliability level of research and development equipment to meet the standards, and strictly require unconditional multi-level, strict reliability indicators of verification.
For the civil market, a few high security industries also attach great importance to reliability, such as civil aviation, high speed rail, power grid, etc. For many industries, the reliability of the product problem is not so much to cause machine destruction, sterilizer 3Q certification consulting organizations, but the high failure rate of the product on the erosion of corporate brand and reputation is huge, sterilizer 3Q certification consulting center, the pressure caused by the after-sales maintenance guarantee is huge, but also should pay great attention to the reliability of the product. Especially in the field of high 1 end products, the reliability gap is a gap between Chinese manufacturing and international 1 advanced enterprises = the main one, causing even large domestic users to have less confidence in Chinese manufacturing. For example, as of 2016, more than 90% of China’s nuclear magnetic, 80 of CT/radiotherapy equipment, 70% of industrial robots are still dependent on imports, and these high 1 end products China has a large number of supply manufacturers or even no shortage. In many high 1 end equipment and product areas, such a large number of dependence on imports, although gradually in the reversal of the situation, but still abound. This shows that reliability is an important grip on the transformation and upgrading of China’s industrial industry, especially the high 1 end industrial industry.
Therefore, regardless of whether the relevant national industry standards have relevant reliability index requirements or their high or low levels, R&D units, especially the industry, are encouraged to put forward competitive and The reliability index requirements to meet the users’ needs should be taken as an important index for R&D control to enhance the competitiveness and customer trust after the products are marketed.
Sterilizer 3Q certification consulting center – Liaoning sterilizer 3Q certification – Best Force by Best Force Certification Technology (Beijing) Co. “The company is located at Room 901, Greenland Central City Office Building, Gate 4, Xinhua North Street Business Center, Tongzhou District, Beijing, China. Contact: Manager Zhu. Welcome new and old customers to call, write to us, visit us and discuss business. Best Force is looking forward to becoming your long-term partner!