Cleaning Validation of Medical Device Manufacturing Equipment
Medical device manufacturing equipment requires thorough cleaning between batches and at timed intervals to ensure the cleanliness and safety of manufactured products, and to comply with current Good Manufacturing Practices (cGMP). Cleaning validation can be costly and time consuming, but outsourcing the cleaning validation of your medical device manufacturing equipment can speed up the process, minimize disruption and provide a greater sense of security.
Validation of your cleaning method ensures that your processes, specific to your medical device manufacturing equipment, products, processes and operators, are safe and consistently and repeatedly achieve the required levels of cleanliness.
Cleaning validation of your medical device equipment removes the requirement to verify cleanliness each time cleaning is performed. By validating your processes and then repeating validated methods, you can be confident that you are meeting cleanliness requirements.
Key areas of analysis include the production, facility and equipment systems, packaging and labelling systems, materials and laboratory controls.
We perform residue detection, quantification and identification, method development and validation and residue acceptance criteria development. Our experts develop cleaning methods that include programs to be followed to help ensure the correct procedures are being carried out.
We validate systems to worst case scenarios, i.e. the worst equipment to clean, and residues to remove. Our approach helps speed up the process by simplifying the procedure and extending the same levels of cleaning to all equipment and residues, including those that are easier to remove and clean. Our approach also makes it easier to revalidate your processes when new equipment and residues are introduced.
Our experts will produce a complete list of residues, cleaning agents and other materials that could contaminate your equipment during the manufacturing process. Then we develop the methods that detect the presence of, identify and quantify any residues remaining after your medical device manufacturing equipment have been cleaned.
Making changes to any validated process will often mean a requirement for revalidation. Working with Lucideon means you have a partner that understands the sensitivities of your process. Any changes that require revalidation will be carried out thoroughly, and with as little disruption to your process as possible.
When non-specific methods are required we can help to develop those, complete with the correct processes and documentation that can help to justify these ready for regulatory submission.
Surface contamination investigation
Application of Lucideon's cleaning validation procedure - Validata
Lucideon has worked with Greatbatch Medical to help them gain FDA approval.