In modern laboratories, today's laboratories have greatly increased the emphasis on public equipment and sequencing certification that has been neglected in the past. Certification of these utilities, such as ultrapure water systems, is also increasing. This article will explore the new pure water system and its certification specifications.
The general laboratory will produce relevant workbooks and records in accordance with the normal work order. Today's pharmaceutical industry requires quality control and drug development in order to meet industry-recognized specifications. In order to facilitate internal and external audits, determine whether the specifications recognized by ISO or NA MA S are met. The certification of the pure water system provides the consistency of the overall operation of the laboratory, enabling the company to meet the requirements of pure water quality specifications from trial production to formal production.
Ensure that the products under test meet the specified specifications. “Certification†is defined as evidence that the quality of the product can be stable to the specified specifications. “To achieve the purpose of certification, the relevant unit must have “Quality Requirements†and “Specified Specificationsâ€. Quality and Procedures test.
The certification of the pure water system is to provide the documents, which are summarized above. It proves that the pure water quality obtained by the user can meet the required quality requirements and can be stable at work. Confirm that the pure water system meets the specified specifications by performing the manufacturer's preset test, maintenance, repair and calibration procedures."
Certification manual
Allow users to meet the certification requirements of pure water machines. The certification manual generally includes: Quality Specification Manual QP Device Specifications IQ Operation Specifications (OQ Performance Specifications (PQ Repair and Maintenance Requirements, Specifications and Certificates. Each pure water system in the laboratory is required to provide an independent certification manual. Certification Manual Must include enough information.
Quality Specification Manual QP
It also lists the quality requirements and implementation process. If there is a deviation in the quality of the product, the purpose of the “Quality Specification Manual†is detailed to specify the procedures required for the quality certification of a product. Required presentations and contingency procedures.
Device specification IQ
In particular, the impact on raw water and the environment. Device Specifications" Check the specified device sequence.
Operating specification OQ
A special sequence, operating specifications should be included to provide documentation on the normal operating sequence of the system, such as cleaning and disinfection.
Performance specification PQ
And in the normal operation in the future, according to the cycle required by the user to execute on time. The Performance Specification provides documentation that the quality of the product is consistent and meets the pre-set quality requirements. Quality testing is performed during the system commissioning phase.
Maintenance contract
There is a need to ensure that the system meets the quality requirements “pure water†from time to time. Therefore, regular maintenance and complete laboratory pure water system certification are required to check for normal operations and to provide inspection documentation. Regular maintenance generally includes routine consumable inspections ( Such as filter elements and ion exchange resins) and replacement. Line water quality probes also need to be regularly calibrated, and the specifications of the calibration box must meet the requirements of the national requirements.
Specification and certificate
Prove that the pure water system can supply pre-set water quality requirements. In addition, a very important part of the quality specification manual is the need to include the manufacturer's certificate of conformity (Certif of Conform and Certif of Calibr and the quality monitoring sequence (Qualiti ControlProcedur). Document. Quality Compliance Certificate (Certif of Complianc can provide documentation that the system can meet requirements such as CE or ETL* after various tests. In addition to the quality specification manual, zui's new pure water system has also been added to the line. The device makes it easier for users to meet Good Laboratori PracticGLP requirements.
Practical application of the certification system
Precision engineered, ELGA PURELA B Ultra pure water system. A device that meets the actual requirements of today's laboratories and is equipped with enhanced certification. Enhanced certification includes the “Quality Specification Manual†consumable recording chip, electronic auto-correction, printable recording, real-time clock and password lock.
Recording chip
The chip not only records the date of production of the filter element, resin type and operation history, but also the recording chip of PURELA B Ultra pure water purification filter (consumable product). It also prevents the user from misplaced the filter element. When the user puts the new filter element into the PURELA B Ultra, the chip is immediately connected to the motherboard. If the inserted filter element is out of specification (such as misplacement or expiration, etc.), the host will issue a warning notice. The bypass box for sterilization is also provided with a chip, and when the sterilization box is placed in the host, the host immediately receives an instruction to perform an automatic disinfection mode.
Electronic automatic correction
The water probe current is compared to the two resistors in the main unit. The PURELA B Ultra has a built-in micro-disposal management system. Then perform automatic correction. In addition, ELGA can also provide an external calibration box for manual calibration.
Record printing
The data required by the user, ELGA provides a printer or computer connection. For example, the quality, time, date, etc., can be printed out according to the time set by the user. These files can also provide the signing position for the user to confirm. The user can also choose to transfer the data to the connected computer for storage.
Real Time Clock
The real time clock can only be changed with a password. The PURELA B Ultra is equipped with a real-time clock using a backup battery. The date and time will be printed on the document in the corresponding water quality presentation.
password
To change the alarm unit, the PURELA B Ultra combination lock is only for authorized personnel. A password lock is required. Other normal operating modes do not require a password, and a password lock is provided to ensure that the system operation meets the pre-set requirements.
Ultrapure water system industrial technology
ELGA uses a variety of industrial technologies to meet the ultrapure water requirements of today's laboratories. To ensure the stability of the quality and the economics of operation. PURELA B Ultra handles different quality incoming waters.
Such as microfiltration, ultrafiltration, reverse osmosis, ion exchange, ultraviolet light and adsorption. PURELA B Ultra also designed “multi-stage monitoring†to ensure the stability of ultrapure water quality. Multi-stage monitoring eliminates water quality changes caused by the consumption of resin cartridges. Most laboratory ultrapure water systems only monitor water quality outside the final water out of the Zui, except for common industrial techniques. Once the water quality is due to the resin filter If it is exhausted and causes changes, the user can only replace the filter element immediately, and the ongoing experiment will be negatively affected by the water quality change. In addition, since the water quality drops below the alarm line, the prompter will have time delay and the user cannot Ensure the stability of the effluent water quality.
ELGA has designed multi-stage monitoring" from a single water quality monitoring to 23 water quality monitoring, due to the many shortcomings of the above single monitoring, and the addition of a second-level maintenance filter. Therefore, the pure water that the user Zui finally obtains ensures Stability, the advantage of the two-stage filter is that the second-stage filter is only responsible for removing a small amount of ions remaining in the primary filter. Multi-stage monitoring will prompt the user to reduce the water quality of the primary filter and prepare to replace it, but because of the second-stage filter Maintenance, the user does not need to replace the filter element immediately and can be replaced after the experiment is completed. And the user only needs to change the existing second-stage filter element to the front stage, and the new filter element can be installed for protection, which not only does not affect the daily work. Can save operating costs.
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