Technical cleanliness
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Cleanliness analysis refers to the process of assessing and quantifying the level of cleanliness or contamination present on a surface, in a fluid, or within a system. Cleanliness analysis is particularly important in industries where cleanliness standards are critical, such as pharmaceuticals, electronics manufacturing, aerospace, automotive and food processing. Cleanliness analysis involves various techniques and methods. Particle counting is the most common cleanliness analysis technique involving the quantification and characterization of particulate contaminants  present in a fluid thanks to microscopic analysis. Gravimetry is also a cleanliness analysis and involves measuring the weight of contaminants collected on a filter or surface to determine the level of cleanliness. Overall, cleanliness analysis plays a crucial role in ensuring product quality, reliability, and safety accross various industries.

Technical cleanliness refers to the degree of cleanliness or the absence of particles in components, systems or fluids within technical applications. Technical cleanliness standards are established to ensure that components and systems meet specific cleanliness requirements to maintain their functionality, reliability, and performance. Contaminants such as particulates can adversely affect the performance and lifespan of mechanical components, electronic circuits, hydraulic systems, and other technical systems. Achieving and maintaining technical cleanliness often involves implementing rigorous cleaning processes, using appropriate cleaning agents and equipment, establishing cleanliness specifications and standards, and implementing quality control measures throughout the manufacturing and assembly processes.

Several standards and guidelines address technical cleanliness in various industries, particularly in manufacturing. Some of the most commonly referenced standards include: ISO16232, VDA 19, SAE J1726, NAS 1638, IPC TM-650, ASTM E595…The two technical cleanliness most applied standards in the sector are ISO16232 and VDA19. ISO16232 provides guidelines for the assessment of cleanliness levels on components and systems when VDA19 specifies requirements for technical cleanliness in the automotive industry. Both define methods for sampling, extraction, and analysis of contaminants, including particles and residues. Microvision Instruments solutions comply with all procedures required by technical cleanliness standards

Cleanliness analysis is vital in industrial settings for several critical reasons. Cleanliness analysis helps identify and control contaminants (such as dust, grease, and chemical residues) that could compromise the quality and safety of products. This is particularly crucial in industries like pharmaceuticals, food processing, and electronics, where even minor impurities can have significant impacts. Regular cleanliness analysis ensures that the cleanliness standards are constantly met, which is essential for maintaining uniform product quality and meeting customer expectations. Cleanliness analysis also helps ensure compliance with the regulations, avoiding legal issues and fines. Also, regular cleanliness analysis can prevent larger issues that require costly repairs or replacements, thereby saving money in the long run.

Performing industrial cleanliness analysis involves a series of systematic steps to assess and maintain the cleanliness of industrial environments, equipment and products. First step is to define cleanliness analysis criteria dertermining the relevant industry standards and regulatory requirements. Second step is to collect samples before to perform cleanliness analysis by combining an optical instrument for image acquisition and a cleanliness analysis software solution to count and characterize particles. Finally, results will have to be compared to standards and compiled into a report. Filtrex is the dedicated Microvision Instruments solution for cleanliness analysis. Contact us for more information about cleanliness analysis.

The Food and Drug Administration (FDA) plays a central and multidimensional role in regulating industries in the United States and globally, serving as an international reference for other regulatory bodies and all companies working with the United States (including exports). The FDA established the FDA 21 CFR Part 11 standard to regulate industries involved in food, drugs, medical devices, cosmetics, and other products that impact public health, ensuring user safety with the rise of digital processes to guarantee the same traceability with electronic records and electronic signatures as their paper counterparts. To support these companies, Microvision Instruments has developed specific software that allows full compliance with the FDA 21 CFR Part 11 standard. While using the image analysis software dedicated to specific issues (Filtrex, IMULAB…), the FDA 21 CFR Part 11 dedicated software compiles all electronic records and rigorously controls access to ensure that only authorized personnel can access electronic records and critical system functions. Every modification made to a record is tracked and timestamped, with the identity of the operator who made the change. All these records are available in an audit trail. The INTEGRITY software thus allows you to perform your image analyses in compliance with the FDA 21 CFR Part 11 standard.

The frequency of cleanliness testing depends on several factors. Different industries have specific regulations and standards that dictate cleanliness testing frequency. The type of product being manufactured or handled will influence cleanliness testing frequency. Products with high levels of contamination risk may require most frequent testings. A risk assessment can help determine the appropriate cleanliness testing frequency based on the potential consequences of contamination. It is important to consult relevant industry standards and regulations to determine the specific cleanliness testing requirements for your industry and products. Some additional factors can also be considered: changes in production processes, environmental factors or incident investigation may influence the cleanliness testing frequency.

Cleanliness testing is essential for ensuring the reliability and performance of components and products, particularly in critical industries like aerospace, automotive, and medical device manufacturing. Common contaminants found in components after cleanliness testing include particulate matter, organic contaminants, inorganic contaminants and ionic contaminants. Cleanliness testing in the industry usually focuses on particles. Dust, dirt, metal chips, fibers, and other solid particles can lead to component failures, reduced product life, and increased maintenance costs. By conducting regular cleanliness testing, manufacturers can minimize the risk of product failures, improve product quality and enhance customer satisfaction.

The automotive industry has stringent cleanliness testing standards to ensure the reliability and performance of vehicles. ISO 16232 is the primary international standard for cleanliness testing in the automotive industry. It provides guidelines for determining particulate contamination on functionally relevant components and systems. It covers various aspects, including extraction methods, analysis methods (techniques for measuring and characterizing the particles) and documentation (requirements for recording and reporting cleanliness testing results). VDA 19 is the German standard, developed by the German Association of the Automotive Industry (VDA), it is closely related to ISO 16232. It provides more detailed guidance and examples for cleanliness testing, particularly for fluid systems. Many automotive manufacturers have their own internal cleanliness standards that are even stricter than ISO 16232 or VDA 19. These standards may be tailored to specific components or systems. Cleanliness testing is crucial in the automotive industry for several reasons. Contamination can cause malfunctions, premature wear, and failures in automotive components, leading to vehicle breakdowns and safety issues. Even small amounts of contamination can affect the performance of sensitive systems, such as fuel injection or braking systems.  Contamination can accelerate corrosion and wear, reducing the lifespan of components. By ensuring cleanliness, manufacturers can reduce warranty claims and improve customer satisfaction. Automotive manufacturers and suppliers must comply with relevant cleanliness standards to ensure the quality and reliability of their products. This involves implementing cleanliness testing measures throughout the manufacturing process, conducting regular cleanliness testing, and documenting the results. It’s important for automotive professionals to stay updated on the latest requirements and best practices to ensure compliance and maintain high levels of cleanliness in their products.