GMP Cleaning in Place Solutions
Our tailor-made, top-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 process solutions plant – then integrate them into your own processes, enabling re-use and protecting your chromatography resins and ultrafiltration devices.
Our ready-to-use products can save time and money – and reduce the risk for their employees too.
Downstream Buffer Solutions
Our broad portfolio of downstream chemicals streamlines raw material specification with optimized quality attributes for the full range of downstream needs – then goes a step further by seamlessly integrating supply transparency, documentation, good manufacturing practice (GMP), and change control, all tailored to your risk assessments.
Increase the Bioburden Control and Re-Usability of Your Purification Steps
Every year, biopharmaceutical production facilities use vast quantities of Cleaning in Place (CIP) solutions to maintain the purity their processes demand. And every year, more and more companies order the tailor-made products they need from Merck, rather than preparing them themselves. Why? Because they know from experience that our top quality, ready-for-use products can save time and money – and reduce the risk for their employees too.
Protect Your Chromatography Media and Ultrafiltration / TFF Devices
Merck’s high-quality solutions for cleaning and storing of chromatography media such as our Fractogel®
and ProSep® resins
, as well as ultrafiltration Pellicon® cassettes
, are designed to meet the specific demands of our customers in the biopharmaceutical industry. Our products fulfill the highest requirements to purity and reliability, and they effectively prevent contamination of your valuable purification equipment. All our solutions are manufactured under GMP conditions and feature low bioburden levels. Moreover, our cleaning solutions bear the EMPROVE® Expert
trademark for exceptional quality and documentation support.
GMP Grade Cleaning in Place Solutions
To ensure the highest standards of purity and quality, all our CIP solutions are produced in a cleanroom at our new GMP process solutions plant in Darmstadt, Germany. 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 without further ado.
|CIP High-Level Product Offerings|
|Sodium hydroxide solutions: 0.05 N – 50%
|Sodium hydroxide solutions, low iron: 20/25/30%
|Hydrochloric acid and acetic acid in different concentrations
|Sodium hydroxide pellets, Ph. Eur., BP, FCC, JP, NF, E 524
|Sodium hydroxide, pellets, Ph. Eur., BP, JP, NF
|GMP Solutions Plant in Darmstadt|
|Our GMP solutions plant in Darmstadt sets standards for quantity and quality. The dispersion unit can dissolve up to 10 tons of solid raw materials per day; IBCs are filled in a clean room to ensure the highest standards of purity, dedicated GMP conform tank containers can be filled for bulk supply as well.
Forward-Looking Products and Support
In addition to tailor-made solutions, Merck also provides technical support and full regulatory documentation to simplify approval and validation procedures. Since all our Cleaning in Place products comply with GMP guidelines, you’re well prepared for the future in this increasingly regulated segment.
New: CIP Solutions in Single-Use Bags
We now offer these solutions in single-use bag packaging.