CIP Cleaning In Place
Our tailor-made, high quality Cleaning in Place (CIP) solutions help you save time, money, and effort. Instead of preparing your own solutions, simply order the volumes and concentrations you require from our GMP (IPEC-PQG and/or EXCiPACT™) cleaning process solutions plant – then integrate them into your own processes, enabling re-using and protecting your chromatography resins and ultrafiltration devices. Benefit from a long-time original manufacturer of a comprehensive GMP NaOH portfolio in liquid and solid out of our Darmstadt manufacturing site.
Key features include:
- Save time and money with ready-to-use CIP solutions
- Highly basic raw materials for custom DSP buffer preparation
- Sustainable transport management for bulk GMP (IPEC/EXCiPACT) grade CIP cleaning solutions
- Advanced discharge system to increase the safety of handling caustics and acids
Our ready-to-use products can save time and money – and reduce the risk for your employees too.
Products
Transport Management
High quality raw materials supplied globally, in volumes from 1L bottles to 18.000L in tank containers.
Sustainable transport management:
- Resources for proper handling of hazardous goods
- Recyclable and returnable outer containers
All our GMP (IPEC/EXCiPACT) solutions for CIP and buffer preparation are manufactured under Excipient GMP conditions and feature low bioburden levels. Moreover, they are backed by our industry-leading Emprove® Program for exceptional quality and documentation support. To ensure the highest standards of purity and quality, we use raw materials manufactured at least according to Excipient GMP requirements (such as sodium hydroxide pellets), and purified water according to pharmacopoeias. As a result, you can integrate our solutions directly into your biopharmaceutical production process.
Our cleaning in place Emprove® product portfolio includes:
- Citric acid in various concentrations
- Sodium hydroxide solutions: 0.05 N – 50%
- Sodium hydroxide solutions, low iron: 20%/25%
- Hydrochloric acid and acetic acid in various concentrations
- Ethanol 20% (w/w)
- Potassium hydroxide pellets (Ph. Eur., BP, FCC, JP, NF, FCC)
- Sodium hydroxide pellets (Ph. Eur., BP, FCC, JP, NF)
- Ethylene glycol
The Emprove® Program. The Smart Way to Master Compliance and Control.
Ensuring the compliance of your pharma and biopharma products involves the compilation of a vast amount of data, which can be time- and resource-intensive. In order to facilitate and accelerate this process, we developed our Emprove® Program. Beside a selection of filtration and single-use components, it contains more than 500 pharma raw and starting materials addressing different levels of risk.
Each product in the portfolio is complemented with different types of dossiers supporting you with reliable technical, regulatory, and supply information:
- API Information Package
- Elemental Impurities Information
- Material Qualification Dossier
- Quality Management Dossier
- Operational Excellence Dossier
Increase Bioburden Control and Reusability of Your Purification Steps
Every year, biopharmaceutical production facilities use vast quantities of CIP and buffer preparation solutions to clean and store their chromatography resins and TFF cassettes. And every year, more and more companies order our tailor-made products rather than preparing them themselves. They know from experience that our high quality, ready-for-use CIP solutions can save time and money – and allow them to work smarter.
Protect Chromatography Media and Ultrafiltration/TFF Devices
Our high-quality solutions for cleaning and storing of chromatography media such as our Fractogel® and Eshmuno® A resins, as well as ultrafiltration Pellicon® cassettes, are designed to meet the specific demands of our customers in the biopharmaceutical industry. These products fulfill the highest requirements of purity and reliability, and they effectively prevent contamination of your valuable purification equipment.
GMP Grade CIP Solutions
All our solutions are manufactured under GMP conditions and feature low bioburden levels. Moreover, they are backed by our industry-leading Emprove® Program for exceptional quality and documentation support. To ensure the highest standards of purity and quality, we use only pharmaceutical-quality raw materials (such as sodium hydroxide), and highly purified water according to European and US pharmacopoeia (Ph Eur, USP). As a result, you can integrate our solutions directly into your own cleanroom.
Our CIP products include:
- Citric acid
- Sodium hydroxide solutions: 0.05 N – 50%
- Sodium hydroxide solutions, low iron: 20/25/30%
- Hydrochloric acid and acetic acid in different concentrations
- Ethanol 20% (w/w)
- Potassium hydroxide
- Sodium hydroxide pellets (Ph Eur, USP)
- Ethylene glycol
Simplify Approval and Validation Procedures
We also provide technical support regarding packaging and regulatory documentation. To help you stay on top of regulatory changes and simplify your processes, our CIP products are part of our industry-leading Emprove® Program. This powerful, always up-to-date repository of current and anticipated regulatory data supports our high-quality pharmaceutical and biopharmaceutical raw materials and consumables, providing you with comprehensive documentation that can:
- Speed approval preparation and extend compliance
- Facilitate the qualification process
- Support risk assessment
- Increase supply chain transparency
Related Product Resources
- Application Note: Using Ethylene Glycol Emprove® Evolve to increase Eshmuno® A Chromatography Resin Lifetime
Usage of Ethylene Glycol Emprove® Evolve and Eshmuno® A Chromatography Resin.
- Data Sheet: Solutions for Storage and Cleaning of Chromatography Resins and TFF Filters
In purification processes, chromatography media and filtration devices make up a substantial part of material costs.
- Data Sheet: Avoid Product Mix-up with New Encoded Quick Connector
Discharging liquid chemicals from their packaging without compromising their quality and purity can be a critical and time-consuming process step.
- Data Sheet: Contain Your Costs Tank Container Supply Solutions
Buying GMP process solutions in bulk is a great way to cut costs – and with our onestop Tank Container Supply Service, you don’t even need your own tanks to enjoy the benefits.
- Product Guide: Raw Materials for Biopharmaceutical Manufacturing
Our portfolio of ready-to-use and customized material solutions were developed to meet the specific needs of pharma and biopharma production and backed by deep regulatory expertise.
- Mobius® MyWay Single-use Assemblies
The Mobius® MyWay Portfolio offers single-use that’s ready when you are.
- Tech Brief: Holistic Buffer Preparation
Buffers are used throughout processing from media preparation to final filtration, and although reliable buffer preparation is critical, the operation is often considered low added value.
- White Paper: Extractables and Leachables Testing Report
GMP manufactured process solutions in polyethylene containers.
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