Ecolab, a water, hygiene and energy technologies and services specialist, has launched a cleaning agent for removing stubborn residues of sustained release coatings in the pharmaceutical and nutritional supplement industry.
Cosa Pur 81 is a slightly acidic cleaning product based on surfactants, making it suitable for the removal of alkaline and acid resistant coatings in the production of tablets.
The product is manufactured in a pharmaceutical GMP production facility in accordance with Pharma Good Manufacturing Practice and complies with the requirements of PIC/S and the US FDA. It provides process optimisation for Cleaning in Place (CIP), Cleaning Out of Place (COP) and manual cleaning processes and has been tested and approved by companies including Glatt, L.B. Bohle and Bosch.
Ecolab says the best performance is achieved with reduced temperature (50–80ºC), concentration (2–10%) and contact time (30–60min), which saves energy and means a quicker return to production. For specific sustained release coatings a combination with Cosa CIP 92 may be recommended.
After Cosa Pur 81 has been applied
In addition to the product, Ecolab provides comprehensive documentation to support cleaning validation requirements. This includes an environmental safety assessment, full toxicological profile, BSE/TSE data sheet and statements covering safety, GMO, AOX and organic solvent.
Kristen Gray, Global Marketing Director – Life Sciences at Ecolab, says: ‘Cosa Pur 81 has been designed to give an excellent cleaning performance to meet stringent validation requirements. Customers who use it will be able to demonstrate that they are taking proactive steps to control carryover of products during the production process.’
Cosa Pur 81 comes in a range of options, including a 19kg canister, 200kg drum and a 975kg container. A certificate of analysis is also available for all batches.