Advanced Cleaning Services
We help our customers by making the process of introducing and / or validating new cleaning processes more efficient, thereby saving valuable time and costs.
We focus on ensuring compliance by meeting or exceeding the regulatory expectations regarding cleaning.
Optimization of cleaning processes: We help our customers with highly customized cleaning processes by carefully considering factors such as time, temperature, cleaning methods, material compatibility, water qualities, residues to be removed, cleaning chemicals, and the environment, health, and safety of employees (EHS).
By optimizing cleaning processes we are able to reduce downtime and bottlenecks, improve sustainability, increase employee safety, increase the service life of valuable equipment, reduce water and chemicals consumption, and / or reduce costs.
Troubleshooting cleaning processes: We have more then 2o years of experience in troubleshooting cleaning processes throughout the Danish and Swedish Life Science industry. Therefore we have broad knowledge of the issues that may cause problems in cleaning processes and how to address these issues.
Liaison with the cleaning agent manufacturer: We have a direct line of communication to the technical staff and leadership team at Borer Chemie. These short lines of communication allow us to support our customers with even the most difficult inquiries in a timely manner. We arrange the signing of Non-Disclosure Agreements and the subsequent hand-over of highly confidential documentation on the cleaning agents, such as formulations, PDE-calculations, and validated analysis methods to verify (cleaner) residue-free cleaning. This level of openness is truly unique in the industry and makes cleaning validation a lot less time-consuming.
Assistance with cleaning validation plans and strategy: One of the main observations by the FDA regaring cleaning validation is the lack of a sufficient plan or strategy before cleaning validation is initiated. We are proud to have an experienced and highly professional cleaning validation specialist on our team. We can provide input during these initial stages of the cleaning validation and ensure the validation gets off to a good start. In some cases we can even draft the validation plan and strategy for our customers.
Detailed cleaning studies: We are able to perform cleaning studies both on-site at the customer or off-site. By performing these cleaning studies, we evaluate the cleaning performance of several processes and chemicals on our customers own worst-case residues. Our broad experience allows us to quickly identify the optimal cleaning process. This is especially valuable during cleaning validation, where our cleaning studies can form the basis for the cleaning validation rationale and avoid time-consuming trial-and-error approaches.
In cooperation with Borer Chemie, we also offer their so-called CLEAN studies, which are highly detailed and documented laboratory cleaning studies on the customers own worst-case residues.
Review of cleaning validation documents: We can help our customers during their cleaning validations by sparring with them throughout the validation process and by reviewing the documentation that forms the basis of the cleaning validation, e.g. protocols and reports. We do not perform the validations themselves, but work closely together with the customers validation team, including external validation consultants.
Preparation or review of cleaning SOPs: We help our customers by drafting cleaning SOPs or by reviewing the SOPs created by the customer. We ensure that these are sufficiently detailed to withstand inspection by authorities and that they are clearly understandable by the cleaning operators.
Training: We offer our customers customized training courses ranging from high-level courses about the basics of cleaning to in-dept courses about cleaning procedures or cleaning validation.
We make it easier to become compliant and stay in compliance with relevant regulations.