{"product_id":"qualification-dqiqoqpq-for-labostar-ultraclear-ultrapure-water-systems-w3t227502","title":"Qualification DQ,IQ;OQ;PQ for LaboStar \u0026 UltraClear ultrapure water systems","description":"For the following LaboStar\u003csup\u003e®\u003c\/sup\u003e and Ultra Clear\u003csup\u003e®\u003c\/sup\u003e ultrapure water systems:\u003cbr\u003e \u003cbr\u003e - Ultra Clear TP ED UV TM\u003cbr\u003e - Ultra Clear TP ED UV UF TM\u003cbr\u003e - LaboStar Pro DI\u003cbr\u003e - LaboStar Pro UV\u003cbr\u003e \u003cbr\u003e Creation of a workbook as proof of qualification for the following series:\u003cbr\u003e \u003cbr\u003e - Ultra Clear TP ED UV TM\u003cbr\u003e - Ultra Clear TP ED UV UF TM\u003cbr\u003e - LaboStar Pro DI\u003cbr\u003e - LaboStar Pro UV\u003cbr\u003e \u003cbr\u003e The documents in the workbook form the basis for the operator of the system, for example, to be able to carry out the system qualification independently. It also serves as a template for monitoring institutions such as the FDA (Food and Drug Administration).\u003cbr\u003e The workbook contains the following sections:\u003cbr\u003e DQ IQ OQ PQ.\u003cbr\u003e \u003cbr\u003e Design Qualification (DQ)\u003cbr\u003e \u003cbr\u003e Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used.\u003cbr\u003e \u003cbr\u003e Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used and a comparison is made with the system configuration of the supplier.\u003cbr\u003e \u003cbr\u003e Design qualification (DQ) essentially includes:\u003cbr\u003e \u003cbr\u003e - Creation of specifications for equipment, delivery, assembly, and  operation\u003cbr\u003e - Monitoring of functional suitability by the system control, in particular the interlocks, alarms, and sensors (with certificates if necessary)\u003cbr\u003e - Calculations and logging\u003cbr\u003e - Design programs\u003cbr\u003e - Documentation requirements\u003cbr\u003e \u003cbr\u003e Installation Qualification (IQ)\u003cbr\u003e \u003cbr\u003e Documented confirmation that the water treatment plant, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).\u003cbr\u003e \u003cbr\u003e Installation qualification (IQ) essentially includes:\u003cbr\u003e \u003cbr\u003e - Acceptance reports from the manufacturer for trial operation (FAT)\u003cbr\u003e - Creation of specifications for delivery and assembly\u003cbr\u003e - Conformity of the offer with delivery and execution\u003cbr\u003e - On-site system setup\u003cbr\u003e - Establishment of media connections, e.g.,water\/wastewater\/power\/control cables\u003cbr\u003e - If necessary, integration into the process environment and its connection to other systems\u003cbr\u003e - Initial cleaning and, if necessary, initial disinfection as required and to the extent necessary\u003cbr\u003e - Operating instructions with maintenance instructions and maintenance measures\u003cbr\u003e - Flow charts\u003cbr\u003e - Consumables lists\u003cbr\u003e - Spare parts lists\u003cbr\u003e - Acceptance and handover reports\u003cbr\u003e \u003cbr\u003e Operational Qualification (OQ)\u003cbr\u003e \u003cbr\u003e Documented confirmation that the quality-relevant functions of the water treatment system are reproducibly triggered by the control system and that the system is operating within the planned working range.\u003cbr\u003e \u003cbr\u003e Functional qualification (OQ) essentially includes:\u003cbr\u003e \u003cbr\u003e - Creation of specifications for the operational verification\u003cbr\u003e - Checking the functionality of the plant components, interlocks, alarms, and sensors\u003cbr\u003e - Checking the operating instructions for conformity\u003cbr\u003e - Logging\u003cbr\u003e \u003cbr\u003e Performance Qualification (PQ)\u003cbr\u003e \u003cbr\u003e Documented confirmation that the water treatment plant delivers water of the required quality—purified water (aqua purificata\/ultra pure water)—and that the required performance is achieved.\u003cbr\u003e \u003cbr\u003e Performance qualification (PQ) essentially includes:\u003cbr\u003e \u003cbr\u003e - Creation of specifications for process verification\u003cbr\u003e - Verification of process performance under worst-case conditions\u003cbr\u003e - Determination of regular requalification\u003cbr\u003e \u003cbr\u003e A documentation folder containing all necessary documents for qualification and validation is provided to the user.","brand":"IDL","offers":[{"title":"Default Title","offer_id":57933393658188,"sku":"W3T227502","price":2045.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/4827\/7068\/files\/idl-W3T227502.png?v=1782905781","url":"https:\/\/www.luminixhealth.com\/fr-be\/products\/qualification-dqiqoqpq-for-labostar-ultraclear-ultrapure-water-systems-w3t227502","provider":"Luminix Health","version":"1.0","type":"link"}