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製薬用液体充填システムにおけるペリスタルティックポンプのトラブルシューティング

Problem Possible Causes Recommended Solutions Unstable or Inconsistent Flow / Surging 1. Worn or fatigued tubing has lost its elasticity.

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FAT/SATの解説、EU-GMPガイドライン付属書15

FAT = Factory Acceptance Test Testing of equipment and relevant documentation at the vendor’s work shops against the requirements of

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製薬用ラベリング機の特長

Introduction A labeling machine is specialized equipment used in the pharmaceutical industry to apply labels accurately and consistently onto containers such

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医薬品の追跡・トレーサビリティに関するフローチャート

A pharmaceutical track-and-trace flowchart follows a medication from the factory floor through distribution to the end patient, ensuring serialization, aggregation,

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GMP機器要件の解釈およびライフサイクル全体にわたる適格性確認とバリデーション 【パート2】

China GMP Chapter VII: Validation and Qualification Article 138: Enterprises shall determine the qualification or validation activities required to demonstrate […]

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GMP機器要件の解釈およびライフサイクル全体にわたる適格性確認とバリデーション 【 PART -1 】

The core essence of pharmaceutical equipment management lies in ensuring that equipment performance remains consistently stable within qualified parameters, ultimately […]

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