Verification of electronic balances
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September 23 09:05:39, 2022
In the “Good Manufacturing Practices (Revised in 2010)†promulgated by the SFDA (National Food and Drug Administration), relevant regulations, articles and guidelines on equipment have been enacted to restrict the completion of verification work. Through the verification work, the company can confirm that the installation, performance and operation of the equipment can meet the requirements of the user requirements standard (UPS) and the pharmaceutical production management standard (GMP), thereby ensuring the quality of the production and testing process and avoiding risks. For products that involve public health and safety, such as pharmaceuticals, food, cosmetics, etc., because the products are not qualified, it will bring a very large safety risk to the public. Therefore, the production process of these special industries requires a very strict and strict quality system. However, device verification is an important step in ensuring the quality of its products. Let's take the electronic balance verification as an example to briefly explain the device verification.
Electronic balances are a basic but indispensable device in the laboratory. For the validation of electronic balances , METTLER TOLEDO launched a global weighing guide based on risk analysis and management - "Good Weighing Practice TM " in 2008. As mentioned in the GWP® Recommendation, the verification steps for electronic balances are divided into: design validation, installation confirmation, operational validation, and performance verification. The detailed steps include the following:
Design confirmation
Installation confirmation
Operation confirmation
Performance confirmation
Supplier confirmation
Shipping completion confirmation
Initial calibration
User training
Detailed definition of usage requirements
Whether the device is damaged or not
Functional test
Defining test methods
Compliance with regulatory requirements
Is the documentation manual complete?
Indication error test
Defining test tolerances
Confirm that the equipment meets the requirements for use
Environmental confirmation
Offset test
Define test steps
Device function and detailed performance
Hardware installation
Repeatability test
Define test cycle
Prepare IQ and OQ steps
Installation report
Determine the minimum weight
Test information record
In the GWP Recommendation, the device verification content consists of two parts:
(1) Instrument and equipment selection, which can be used as an auxiliary file for user design confirmation;
(2) The daily test section can be used as a reference for user performance confirmation. Based on the customer's actual information, GWP gives the recommended daily test methods, frequency, tolerance and standard weights for testing.
In summary, for electronic balance equipment, users need to write a verification scheme and verify the equipment according to the verification procedure. The electronic balance certification and verification services (IPac and EQPac) provided by METTLER TOLEDO can help users to better. Easily complete the above work, meet regulatory requirements, and meet quality standards.