GMP, cGMP and ICH regulations have resulted in cleaning validation becoming an essential part of the production of drugs and active pharmaceutical ingredients. Cleaning validation is now just as important as the production process and process validation. It therefore deserves the same careful attention. Regulations, tight deadlines and increasing awareness of costs necessitate efficient and residue-free cleaning processes.
At Borer Chemie and Groesfjeld the cleaning process is at the very center of things. Effective and residue-free cleaning is achieved through the combination of an individual cleaning process and the appropriate choice of a detergent.
In many cases, an efficient aqueous cleaning process can be used to remove residues instead of the costly dissolution of such residues in organic solvents. This is also an important contribution to workplace health and safety and a lower environmental impact.
We have more then 20 years of experience in facilitating cleaning validation in the pharmaceutical- and biotechnology industries in Denmark and Sweden. In close cooperation with Borer Chemie, we actively support you in achieving an efficient and successful cleaning validation.
Documentation is an integral part of process development. We actively support you in the development of cleaning processes with the industry’s most comprehensive documentation package. This includes, amongst others, formulations, PDE-documentation, and validated analytical methods for the verification of removal of possible cleaner residues.
In other to further support you during you cleaning validation, we can offer you comprehensive CLEAN studies in cooperation with Borer Chemie. CLEAN study’s form the basis for your decisions regarding the selected validation process – as the results of the study enable the assessment and classification of potential risks. This allows you to select the optimal cleaners right from the start, thereby avoiding a trial-and-error approach. Click here for more information about CLEAN studies.
deconex® CIP, SURFAX and FORMULA1 cleaners have been specifically developed for use in validated cleaning operations. They enable the effective and residue-free cleaning of batch containers, fermenters, sieves, mixers, tabletting machines, homogenizers, filling equipment, granulators, small parts from production, containers and other production and process equipment.
Our experience tells us that we can help our customers save valuable time and money, especially when we are involved at an early stage.
Please contact us for more information about our products and services for validated cleaning.