Process validation is a strict requirement that helps ensure advanced medical devices, and the electronics inside them, consistently meet set quality standards regardless of when where or how they are made.
Parts cleaning inside a cleanroom, must be done under controlled conditions, then tested and validated. Validated cleaning ensures your parts are free from particulate, oils, and bioburden, making them predictable and reliable. It also helps them meet FDA (Food and Drug Administration), ISO (International Standards Organization) or other market introduction regulatory requirements.
To meet validation criteria, your cleaning process must be consistent, easy-to-use and compatible with your established cleanroom procedures. Vapor degreaser cleaning is a well-engineered cleaning method that is simple, predictable and repeatable, making it easy to qualify and validate for medical device manufacturing.
Dependable, Consistent Cleaning
Vapor degreasers are closed-loop, specially designed cleaning machines that use a specific low-boiling, non-flammable cleaning fluid. Vapor degreasers have two chambers: the boil sump and the rinse sump. In the boil sump, the cleaning fluid heats to its boiling point to generate a vapor cloud. The soiled parts lower through the vapor cloud and into the cleaning fluid. Once cleaned, the parts mechanically transfer to the rinse sump for a bath in more pure, uncontaminated fluid. Then they raise back into the vapor cloud for final rinse and dry. The parts come out clean, dry, spot-free and immediately ready for the next step in the process - whether it’s assembly, coating, marking, sterilizing or packaging.
The cleaning fluid(s) inside the vapor degreaser are chemically engineered for medical device cleaning. They typically have a low surface tension and a very low viscosity. This allows them to easily penetrate and clean inside complex assemblies or intricate shapes, including blind holes and end holes. The fluid dries fast without residue after cleaning. Most vapor degreasing fluids also are very heavy and dense, typically 20-40% heavier than water. This helps dislodge particulate from the parts.
In addition, the fluids are often stable azeotropes. This ensures the chemical makeup of the fluid stays consistent. Even with the repeated cycling from liquid, to vapor, to liquid in the vapor degreaser.
An Environmentally-Friendly Process
Modern vapor degreasing meets local and national air quality regulations and operator safety requirements. In addition, vapor degreasers are efficient. They require very little energy to operate and are compact, taking up very little space in the cleanroom. Plus, they don’t use water, which removes a potential source of bioburden.
Here are some other ways vapor degreasing makes cleaning process validation easier.
Consistent Cleaning with Little Monitoring
Once established and tested, the vapor degreasing process stays constant with little variation. The solvent-based cleaning fluid remains consistent and stable inside the vapor degreaser for thousands of uses. It does not require daily monitoring or acid acceptance testing. This means your cleaning results stay consistent, complying with your product and process validation specifications.
Scalable and Repeatable for Simplicity
Vapor degreasers come is all sizes and shapes from small table-top versions to ultra large versions that hold thousands of gallons of cleaning fluid. But they all work the same way to deliver very similar results. This means vapor degreasers are highly scalable. Large or small batches get cleaned using the exact same repeatable process. There is rarely a need for new equipment when new products are introduced, or if there are changes in batch size or variations in parts geometry.
Easily Documented for Streamlined Record-Keeping
Vapor degreasing methods are clearly defined, dependably repeatable, and easily documented. The simple step-by-step process makes it easy to engineer, easy to audit and simplifies detailed record-keeping. You can keep a complete cleaning history of the batch to demonstrate that all the cleaning steps, as defined by your procedures and instructions, were taken and the cleaning outcome was as expected. All supporting the validation process.
Easy to Use for Qualified, Trained Personnel
The cleaning process should be perfomrmed by qualified and well-trained personne to meet process validation specifications. However, the daily operation of a vapor degreaser is simple and can be trusted to entry-level workers. In many instances, vapor degreasing is easily automated giving you even more consistent cleaning results. Easy automation also simplifies worker training, ensuring there is always a qualified person on-hand to carry out the parts cleaning procedures correctly.
Low Maintenance for Easier Use
Vapor degreasers, when used with modern cleaning fluids, have few moving parts and need very little maintenance. The cleaning fluids are very stable with long service life, and don’t need constant monitoring or daily treatments. They also don’t typically require the air quality reporting required with older chlorinated solvents.
A More Controlled Work Setting
Most vapor degreasers typically have a small footprint relative to the amount of production output. A typical vapor degreaser takes up little space while producing high output. This translates to lower overall operating costs in the expensive cleanroom environment.
Vapor degreasing also helps maintain required cleanroom environmental conditions like temperature and humidity. They don’t generate dust, fumes, heat, or moisture, so they do not require special blowers, fans or any special climate controls to manage cleanroom air quality, ambient temperature or humidity.
Most importantly, solvent-based cleaning fluids, unlike ater, don’t harbor pyrogens. They help provide an environment free of bacteria, viruses, or other pathogens. Vapor degreasing is easier to validate as a cleanroom compatible, bioburden-free cleaning process.
Let MicroCare be Your Cleanroom Validation Partner
When introducing a new product, or changing a process for regulatory compliance, it is important to work with a cleaning fluid supplier with experience in the special requirements associated with medical device manufacturing. MicroCare gives you expert advice to simplify the fluid selection process. We offer individualized consulting, access to our critical cleaning lab for cleanliness testing. We also provide you with cleaning fluid options including off-the-shelf products or customized formulations engineered for your specific soils and substrates.