Contatore di particelle aeree per il monitoraggio ambientale di routine di camere bianche GMP serie MET ONE 3400+

Il nostro nuovo contatore di particelle aeree portatile della serie MET ONE 3400+ consente agli utenti di caricare la mappa di campionamento SOP (procedura operativa standard) per il monitoraggio ambientale di routine e la configurazione di campionamento specifiche per ogni singola posizione, direttamente nel contatore. In questo modo, la SOP diventa una vera e propria mappa interattiva sullo schermo del dispositivo, che guida gli utenti impegnati nel campionamento giornaliero. Ideale per ridurre i requisiti in termini formativi e gli errori/omissioni dei dati di campionamento.

Importanti funzioni quali la verifica/approvazione del flusso di lavoro, il controllo della versione della SOP e l'esportazione dei record elettronici sono già presenti direttamente nel contatore, senza la necessità di installare software esterni e sono facilmente accessibili da remoto mediante browser Web. L’audit trail sicura e integrata, sulla quale possono essere applicati filtri e strumenti di ricerca, assicura una funzionalità di reportistica rapida durante gli audit. Unita alle funzionalità di Microsoft Active Directory per la verifica di nome utente e password per le procedure di accesso e firma elettronica, garantisce la conformità al Titolo 21 CFR Parte 11.

Caratteristiche

Mappe SOP elettroniche interattive e personalizzate

Utilizzando un browser Web è possibile caricare la propria mappa SOP nel contatore, contrassegnare le posizioni dei campioni e definire i requisiti di campionamento per ciascuno, in base alla procedura operativa.

Monitoraggio interattivo

Le istruzioni a video supportano gli operatori nell'utilizzo della mappa e nell'esecuzione del campionamento in conformità alla SOP. Le icone di posizione diventano verdi dopo il campionamento per consentire all’utente di seguire i progressi a colpo d’occhio.

Record elettronici direttamente dal contatore

MET ONE 3400+ è in grado di fornire record elettronici direttamente dal contatore tramite USB, rete Ethernet cablata o Wi-Fi integrato.

Controllo di versione delle SOP e verifica/approvazione del flusso di lavoro direttamente da browser Web

I responsabili possono verificare i progressi del monitoraggio giornaliero, inclusi tutti i risultati dei campioni, utilizzando un browser Web. La configurazione delle procedure operative standard e il controllo versione da remoto sono disponibili anche per gli amministratori, così come le funzioni di verifica/approvazione da remoto, firma elettronica ed esportazione dei record elettronici per i supervisori, il tutto accessibile mediante browser Web.

Tabella delle specifiche

Performance	ISO 21501-4 unit-to-unit accuracy & reproducibility
Industry Standards	ISO 21501-4 , 21 CFR Part 11, ISO 14644-1, EU GMP (2015), CE, FCC, 802.11, 802.1x
Light Source	Long Life Laser™ Diode
Coincidence Loss	10% at 36,000,000 particles/m³
Throughput	1 cubic meter in 35.3 minutes

Reporting	EU GMP Annex 1, CGMP, ISO 146441-1.2015
Zero Count	ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Counting Efficiency	50% at 0.3 µm (100% for particles > 0.45 µm)
Count Alarms Display and Cycles	Multiple user-defined alert and/or alarm levels for counts, concentration, or environmental sensors
Item Specifications Referenced	C38675

Documenti tecnici

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Title	Description
Achieving Compliant Batch Release – Sterile Parenteral Quality Control {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.
Conducting the ISO 14644-3 Cleanroom Recovery Test with the MET ONE 3400 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This application note reviews the test method and provides guidance on selecting both the “Challenge” and the “Target Cleanliness Limit”. Attention is given to the requirement that the test concentration should not be so high that “residue contamination” becomes a risk.
Cleanroom Routine Environmental Monitoring – FDA Guidance on 21 CFR Part 11 Data Integrity {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper examines the risk of error with SOPs being implemented manually. Technology exists and is commercial available to mitigate this problem and make programs more robust, reducing the impact on data integrity and also supporting the industry's move towards environmental monitoring by production staff in the cleanroom.
Counting Efficiency: MET ONE Air Particle Counters and Compliance to ISO-21501 {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	The one parameter that stands alone as the champion of confusion for defining air particle counter performance is counting efficiency. The purpose of this paper is to present counting efficiency in terms that are easy to understand.
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).
Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Particle testing in cleanroom high-pressure gas lines to ISO 14644 made easy with the MET ONE 3400 gas calibrations	This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.
Quality Control Electronic Records for 21 CFR part 11 Compliance {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
Changes to GMP Force Cleanroom Re-Classifications {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
GMP Cleanrooms Classification and Routine Environmental Monitoring {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.
Environmental Monitoring	Good Manufacturing Procedure (GMP) mandates the air quality conditions for biopharmaceutical production in cleanrooms.
Cleanroom Routine Environmental Monitoring & Data Integrity with the MET ONE 3400+
Maintaining Data Integrity: Understanding FDA ALCOA Guidance	21 CFR part 11 ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T	Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
【カタログ】MET ONE 3400+ {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	GMPに準拠したクリーンルームの環境モニタリングを簡便にし、向上したデータインテグリティ機能を搭載した気中パーティクルカウンター
Facility Monitoring System (FMS) Solutions Product Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure: With new innovative designs specifically tailored to address the requirements of the Pharmaceutical industry, MET ONE particle counters feature full ISO 21501 compliance in advance of ISO 14644 standard adoption for all calibration parameters
MET ONE 3400 Series Portable Airborne Particle Counter {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Product brochure for the enhanced MET ONE 3400 Series, which is the easiest-to-use and easiest-to-integrate portable particle counter for any facility or environmental monitoring program
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring {E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}	Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Cleanroom Routine Environmental Monitoring, 21 CFR part 11 Data Integrity FDA Guidance	Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences \| Published 2017
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).
ALCOA+ Infographic	Guidance on Maintaining Data Integrity Infographic
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity {A0D0EF0B-43F2-431C-BEB0-69F98765BDC4}	Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Certified Calibration Services for MET ONE {9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}	Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
479A MET ONE 3400 {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}

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