ISO 14644-1/2: 2015

Sua fonte completa de informações sobre contagem de partículas em conformidade com a ISO 14644-1:2015

A ISO 14644-1:2015 continua a desafiar gerentes e fabricantes de salas limpas. Aqui fornecemos várias fontes de informação para ajudar a todos, desde os novos na aplicação desse regulamento da ISO até veteranos em campo.

Para obter um resumo da ISO 14644-1:2015, leia o artigo abaixo ou assista ao webinar gravado, à direita.

Leia os artigos abaixo para saber mais sobre as normas de calibração da ISO 21501-4, que são muito relevantes, e como se aplicam a você.

Dúvidas? Leia algumas das perguntas mais frequentes que recebemos (veja o lado inferior direito) ou envie sua dúvida para um de nossos especialistas.

Você precisa de um produto em conformidade com a ISO 14644-1:2015 e com suporte à calibração da ISO 21501-4? Em caso afirmativo, veja nossa lista de produtos na parte inferior.

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Conhecimento/artigos

ISO 14644-1:2015 Revisions Summary
The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

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Understanding ISO 14644-2:2015 Cleanroom Monitoring [Webinar Presentation]
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control.

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Common ISO 14644-2:2015 Questions and Answers
The recently updated ISO14644-2:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise providing you with answers to many of the questions that our customers frequently ask.

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Understanding ISO 14644-2:2015 Cleanroom Monitoring
This document underlines the major changes between the previous version of ISO 14644-2 and the latest, second edition, dated December, 12th 2015. A specific approach to the best practices to be adopted for an efficient and compliant cleanroom monitoring process are discussed.

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ISO 14644-1:2015 Frequently Asked Questions (FAQs)
The newly updated ISO14644-1:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise and have provided an ISO 14644-1:2015 summary paper, an on-demand webinar, and are now providing you with answers to many of the questions that our customers frequently ask.

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Are your particle counters ISO 14644-1 compliant?
Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?

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Produtos em conformidade com a ISO 14644-1:2015 e com suporte à calibração certificada pela ISO 21501-4

Lasair® III 110 Airborne Particle Counter
A true 0.10 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.
IsoAir® 310P Remote Cleanroom Particle Sensor
Real-time remote cleanroom sensor gives quick notification of particle anomalies, detecting 0.5 and 5.0 µm for GMP and FDA compliance.
FacilityPro® Software
FacilityPro Software provides the interface, data management, and reporting for an environmental monitoring…
Airnet® II(s) 2 Channel Air Particle Sensors
Meets the specifications of ISO 21501-4 to measure the size and number of particles suspended in the air for real-time monitoring of defect-causing particles.