MET ONE 3400 Series

Explore MET ONE 3400 Series Models

Resources + Tools

合規標準常見問題解答產品特點請求報價合規標準 Tech Docs

Explore MET ONE 3400 Series Models Features Content and Resources Technical Documents Related Products

功能特點

Standards

ISO 14644-1 enabled sampling and reporting
ISO 21501-4 unit-to-unit accuracy & reproducibility
Enables 21 CFR Part 11 and EU Annex 1 compliance

Data Management

Industry standard connectivity to data management software
Wireless, Ethernet, serial, and USB communication
Printed or paperless data output

Operation

Easy area, group, and location based configuration of operating parameters
Password protected multi-level access for 21-CFR Part 11-compliant data security

Applications

Cleanroom routine environmental monitoring
Aseptic pharmaceutical production
Continuous environmental monitoring
Cleanroom classification and validation
Process troubleshooting
HEPA filter leak detection

Content and Resources

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使用 MET ONE 3400+ 進行 ISO 14644-3 無塵室回收測試本應用筆記回顧了測試方法，並提供了選擇「挑戰」和「目標清潔度限值」的指導。注意測試濃度不應太高，以免造成「殘留物污染」的風險。

GMP Cleanrooms Classification and Routine Environmental Monitoring 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.

Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing 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.

Changes to GMP Force Cleanroom Re-Classifications 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.

Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.