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無菌医薬品

Complete Sterility Assurance Solutions

Our complete particle monitoring solutions provide you with the software, knowledge, and quality service for seamless application.

Particle Measuring Systems partners with companies in the Pharmaceutical industry as a complete contamination monitoring solutions provider. Starting with our Advisory Services team, then collecting data with our viable and non-viable particle counters, through to complete validation, data management, and reporting. We have the expertise to help you meet regulatory requirements including ISO 14644-1:2015 and EU GMP Annex 1 to get your product to market.

As one of the world’s leading cleanroom contamination control experts and complete solutions provider, we offer fully integrated and robust monitoring solutions including:

Additionally, we offer a wide variety of expert Advisory Services including:

  • Risk Assessments – avoiding 483s
  • Thermal Validations
  • Crisis Handling – 483 management and response

As a trusted thought leaders in the pharmaceutical cleanroom and other life science industries, our team provides multiple webinarspapers, and training throughout the year to support professionals and cleanroom manufacturers through the necessary regulatory processes.

 

FacilityPro® Environmental Monitoring System

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

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Contamination Control Products

データインテグリティ対応
気中パーティクルカウンタ: Lasair® Pro

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PoE対応リモート気中パーティクルカウンタ:
Airnet® II/IIs 2チャンネル

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ポンプ内蔵・PoE対応リモート気中パーティクルカウンタ: IsoAir® Pro-E

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ポンプ内蔵・Wi-Fi対応リモート気中パーティクルカウンタ: IsoAir® Pro-Plus

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光遮へい型液中微粒子自動測定システム: APSS-2000

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データ管理ソフトウェア: DataAnalyst

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Expert Advisory Services Are Here to Help

 

As a trusted leader in the pharmaceutical cleanroom and other life science industries, we offer a wide variety of expert advisory services, including:

  • — Risk Assessments – avoiding 483’s
  • — Thermal Validations
  • — Crisis Handling – 483 management and response

Learn More