General description
Every bio-manufacturing process involves buffer preparation, pH adjustment, and cleaning. All our respective GMP (IPEC/EXCiPACT) products are manufactured under Excipient GMP conditions and feature low bioburden levels, backed by our Emprove® Program for exceptional quality and documentation support.
As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.
As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.
Application
- As a base for preparing various process buffers.
- Used to adjust the pH of process solutions, buffers, and media in upstream and downstream processing.
- Acts as a cleaning-in-place (CIP) agent for equipment, piping, and vessels due to its strong alkaline properties and low levels of metal impurities.
- Minimizes iron contamination, reducing oxidation risk and interference with downstream purification and analytical steps.
Features and Benefits
- Comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
- Suitable for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance.
- Emprove® products are designed to facilitate compliance with global regulations (e.g., ICH Q7, EU GMP, USP, EP).
- Detailed supply chain and manufacturing information helps ensure traceability and continuity, which is critical for GMP manufacturing.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
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注意喚起語
Danger
ハザードコード
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
保管分類
8B - Non-combustible corrosive hazardous materials
一体何が起きているの?
WGK 1
適用法令
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4800059200: + 4800051002: + 4800050000: + 4800051009: + 4800059916:
jan
劇物
pdsc
名称等を表示すべき危険物及び有害物
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名称等を通知すべき危険物及び有害物
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