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Dal 1972, Particle Measuring Systems è l’esperto globale nel monitoraggio della contaminazione, fornendo all’industria farmaceutica e ad altre industrie del settore delle scienze della vita la competenza per rilevare, analizzare e gestire la contaminazione delle camere bianche in modo da poter soddisfare tutti i requisiti normativi, tra cui ISO 14644-1:2015 e EU GMP Annex 1.

Quando cercate una strategia di controllo della contaminazione per i vostri processi asettici, prendete in considerazione un partner che abbia l’esperienza necessaria per rispondere alle vostre domande, sostenere il vostro progetto dall’inizio alla fine, e poi fornirvi un supporto continuo affidabile e professionale.

In questo breve video, Daniele Pandolfi di Particle Measuring Systems sottolinea l’importanza di questo aspetto e discute le considerazioni da fare nella scelta di un partner.

Particle Measuring Systems ha un team globale di esperti per fornirvi soluzioni complete per il monitoraggio della contaminazione in camera bianca e la gestione dei dati in qualsiasi parte del mondo.

Observe the innovative and unique design for the microbial air sampler, the MiniCapt® Mobile with:

• Flexibility for air and compressed gas viable sampling
• Reduced operator errors from data management and touch screen
• Filtered exhaust eliminates contamination
• Impactor design allows false positive identification
• ISO 14698:2003 compliant

Combine with the BioCapt® Single-Use Microbial Impactor for a fully validated system.

In this brief video, Teresa Riccioni discusses the application of a risk assessment to set appropriate microbiological plate conditions per the new EU GMP Annex 1 draft, Rev 12. It starts with the new Annex 1 draft requirements to use a risk assessment, and then an interpretation on how to apply it and use it in different stages of the manufacturing process.

Particle Measuring Systems vi invita a scoprire la Nuova Era del campionamento microbiologico

Holding an agar plate with isolator gloves can be difficult, even causing drops and spills. Learn how the BioCapt Single Use solves that problem.

Learn more about continuous monitoring or the BioCapt® Single Use Impactor.

Questo video evidenzia i requisiti relativi al Quality Risk Management che sono specificamente menzionati nell’ Annex 1:

• PQS- Manufacture of sterile products
• Utilities Monitoring
• V/NV Environmental and Process Monitoring

In the new working environment it is more important than ever to be able to access data from office locations while working remote. Go paperless in a 21CFR11 environment using Particle Measuring Systems’ PharmaIntegrity™. Watch this video for more solutions.

I vantaggi della batteria del Contaparticelle Portatile Lasair III battery includono:

• Batteria leggera ad alta capacità
• Li-Ion
• Sostituzione a caldo per un uso prolungato
• 3-5 ore di funzionamento con una sola carica a seconda dell’unità
• Design robusto della batteria con un’eccellente capacità attraverso centinaia di cicli di carica
• Caricabatterie stand alone disponibile per un maggiore tempo di funzionamento portatile

As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software.

Learn more about FacilityPro® Monitoring System.

Scoprite le sezioni dell’Annex 1, attualmente in fase di stesura, che trattano le esigenze di monitoraggio e le aspettative future, guardando questo breve video.

Scopri di più sul monitoraggio continuo o sull’impattore Biocapt Single Use

Questo video copre le sezioni 2020.03 (rev 12) dell’Annex 1 relative a metodi microbiologici alternativi e microbiologia rapida. Lo speaker è Frank Panofen, PhD, di Particle Measuring Systems.

Get a quick overview and explanation of the features of the MiniCapt Mobile Active Air Sampler and how you can optionally use it with the BioCapt Single Use Impactor (replacement for settle plates).

The Lasair® III Cleanroom Particle Counter is designed with your unique needs in mind. It sets the standard for portable aerosol particle counters in highly regulated environments. It can be used for both remote and mobile routine cleanroom monitoring. Watch this short video to learn more.

Questo rapido video tutorial vi guida attraverso i passi per creare facilmente ricette per il contatore di particelle portatile Lasair III.

Questo rapido video tutorial vi guida attraverso i passi per creare facilmente ricette per il contatore di particelle portatile Lasair III. Il contatore di particelle portatile Lasair® III definisce lo standard per i contatori di particelle per aria portatili e soddisfa i requisiti della norma ISO 14644-1:2015 e ISO 21501-4. È stato progettato per le camere bianche tenendo conto delle vostre esigenze specifiche.

Particle Measuring Systems provides a central hub for an environmental monitoring system.

Find out more about FacilityPro® Cleanroom Software for Pharmaceuticals or learn about the FacilityPro upgrade.

Informatevi sulle ultime linee guida per i sistemi monouso secondo le ultime linee guida dell’Annex 1. Paola Lazzeri parla anche di come l’impattore microbiologico BioCapt Single Use soddisfa tali requisiti.

Questo video cita tutte le sezioni della più recente bozza dell’Annex 1 che si applicano alla pulizia e alla disinfezione e fornisce linee guida e interpretazioni pratiche.

This short video discusses Using a Risk Assessment strategy to identify microbiological plate incubation conditions and also data interpretation: Applying identified incubation conditions.

This big data documentary was originally published in conjunction with American Pharmaceutical Review. It covers both the data compliance requirements for the Pharmaceutical industry and how to leverage the mass quantities of data that are now available to enhance pharmaceutical products, and ultimately, patients lives.

Learn more about Data Trending Requirements, Data Integrity Regulations, and PharmaIntegrity™ Data Management System for the Pharmaceutical industry.

The APSS-2000 Liquid Particle Counter for USP 788 is a fully contained syringe sampling liquid particle counting system. It provides user flexibility from the many liquid sampling configurations to the comprehensive Sampler Sight software that allows the user to collect, analyze and report data from one simple platform. The software is validatable and 21CFR11 compliant. Learn more from this expert demonstration. Learn more about our APSS 2000.

An industry expert explains the latest guidelines from Annex 1 around Cleanroom Classification, Qualification, and Monitoring. Starting with defining each of these items, through the latest changes, Maurizio Della Pietra guides the viewers through items to consider including identifying sampling points, the need for a risk assessment, and the latest microbial requirements.

Our expert Contamination Control Advisors are available to assist you.

Learn how BioCapt® Single Use  can be an effective and important part of your data integrity program by watching this short video. Learn more about BioCapt Single Use for your cleanroom microbial monitoring.

In this brief video, Daniele Pandolfi discusses the Annex 1 draft and some of the aspects that can be used to understand the current state of regulatory positioning. It covers Trending Relevance (current Annex 1 vs Rev 12 Draft), Environmental Trends (approaches and procedures), and Level Settings (definition and process). The new Annex 1 draft addresses the gaps with data analysis and trends.

Quick overview of environmental monitoring cleanroom software upgrades for the Pharmaceutical / life sciences industries.

Learn about FacilityPro® Cleanroom Software for effective data management.

Learn about the Lasair III Particle Counter touchscreen size & technology.

The Lasair III uses infrared technology, using a matrix of sensors to ensure fast response and the ability to interact with gloves, stylus, etc.

Comparisons to other touchscreen technologies (resistive and capacitive) are also discussed.

Learn why the infrared touchscreen is ideal for cleanroom applications.

The MiniCapt® Mobile Active Air Sampler has a wide variety of accessories available to make it usable throughout your production process and throughout your facility. There is a gas sampling kit, accessories for isolators, the stainless steel head for use on your filling line, and also a single use impactor. Learn more by watching this short video.

Annex 1 requires designing an effective contamination control strategy based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 frequently uses the terms “risk” “justify” and “strategy”, underlying the importance of these concepts.

Paola Lazzeri discusses relevant Annex 1 areas (4.1, 4.32, 9.6, 9.21, 9.24, 9.29, 9.33, 9.38, 9.45), providing insights and highlighting important considerations when creating a contamination control strategy.

You will learn and understand more about:

• Why we should count particles in injectable drugs
• What regulatory requirements are for USP 788-789-729
• Light obsuration technology that’s required
• How to ensure instrument performance and accuracy are to perform (USP 1788 suggested tests)
• See demonstration of APSS 2000 Particle Counter

Useful resources can be found in our Knowledge Center or learn more about 21 CFR11 and Data Integrity Regulations.