Technical Cleanliness

In the automotive and electronics industries, components must be free of unwanted particulate contamination. It can lower the product performance and lifetime. Industries spend considerable effort finding efficient ways to maintain technical cleanliness and keep production cost-effective.

Standards help suppliers and manufacturers obtain reliable cleanliness results. In the automotive industry, they are VDA 19 and ISO 16232. In the electronics industry, a common reference is the ZVEI Guideline.

Particulate contamination in pharmaceutical products can be a major risk for patients. To ensure product quality and safety, pharma companies need innovative solutions for root cause analysis concerning technical cleanliness.

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What is technical cleanliness?

Technical cleanliness concerns the fabrication of products and their components in various industries. The product quality can be quite sensitive to contamination. As a result, industries like automotive, aerospace, microelectronics, pharmaceuticals, and medical devices have stringent requirements for cleanliness.

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What is ISO 16232?

In the automotive industry, one of the main standards is ISO 16232 which gives the accepted definitions and ranges of common parameters, e.g., particle class in terms of size, threshold values for particle identification, image settings, etc., used for cleanliness analysis.

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What is VDA 19?

For cleanliness analysis in the transportation industry, it has become the established practice to follow guidelines, such as VDA 19.1 (German Association of the Automotive Industry), for the quantitative determination of particulate contamination on product components.

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Technical Cleanliness Electronics

Technical Cleanliness: Electronics

In the electronics industry, component cleanliness is important, because particle contamination can increase the risk of failure, e.g., conducting particles can cause shorts in PCBs. Now with e-mobility, there are also electric vehicles with batteries and electronic parts. A common reference for electronics cleanliness is the ZVEI guideline.

For a cost-effective cleanliness analysis, suppliers and manufacturers must determine efficiently the conductive properties of particles that indicate the potential to cause damage. Automated analysis is key for achieving an efficient process, where normally optical microscopy is applied. Determining the particle composition efficiently with a single solution is a big advantage.

Example: Production of electronic boards

Technical Cleanliness: Automotive and Transportation

In the automotive industry, residual contamination in systems often have an effect on performance and lifetime. A common standards and guideline for automotive cleanliness are ISO 16232 and VDA 19.

To achieve efficient, cost-effective cleanliness analysis, suppliers and product manufacturers must agree on what should be measured to indicate the particle’s potential to cause damage, especially high-risk “killer particles”.

Automated particle analysis is instrumental for an efficient process. Optical microscopy is the broadly applied method. The goal is to find and eliminate the source of contamination. A solution which allows it to be identified efficiently is a big advantage.

Example: Cylinder block from an engine

Technical Cleanliness Pharmaceuticals

Technical Cleanliness: Pharmaceuticals

Particulate contamination in pharmaceutical products can come from many different sources. Such contamination can be a risk to patients as they may cause sepsis, inflammatory response, organ dysfunction, phlebitis, and pulmonary arteritis. A standard used in pharma industries is USP 788.

Identification of the particulate contamination is done with optical microscopy. During visual analysis of particles, it can be sometimes difficult to determine the source of the contamination. Elemental/chemical analysis allows the composition to be known, so finding out where they come from (root cause analysis) takes less time and effort. A visual- and chemical-analysis solution offers significant advantages.

Example: Pharmaceutical production of a liquid for intravenous infusion

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Example of a steel particle which could be found during cleanliness analysis of parts and components.

Automotive & Transportation

Example of a steel particle which could be found during cleanliness analysis of parts and components.

Example of a copper particle which could be found during cleanliness analysis of components.

Electronics

Example of a copper particle which could be found during cleanliness analysis of components.

Example of a steel particle which could be found during cleanliness analysis of parts and components

Pharmaceuticals

Example of a glass particle which could be found during cleanliness analysis for a non-regulated pharma application.

Example of a steel particle which could be found during cleanliness analysis of parts and components.
Example of a copper particle which could be found during cleanliness analysis of components.
Example of a steel particle which could be found during cleanliness analysis of parts and components

Frequently Asked Questions Technical Cleanliness

In the electronics industry, a common reference for cleanliness standards is the ZVEI Guideline (ZVEI = German Electrical and Electronic Manufacturers’ Association) entitled “Technical Cleanliness in Electrical Engineering”.

This international standard specifies the code to be used in defining the quantity of solid particles in the hydraulic fluid used in a given hydraulic-fluid power system. The purpose of this code is to simplify the reporting of particle count data by converting the numbers of particles into broad classes or codes, where an increase in one code is generally a doubling of the contamination level.

This standard applies to fresh mineral and synthetic oils with and without additives. Part of the oil sample is filtered through a membrane filter and the residue on the filter is washed oil-free with solvent. The particles on the filter are determined by number and size using an optical microscope. The particle counts are given separately for particle sizes which are coded values according to ISO 4406.

It is a standard concerning particulate matter testing methods applied to injectable fluids and liquids which are used in health care. Examples are intravenous (IV) solutions, injections of medications, etc. Particulate matter refers to undissolved particles that are not intentionally present in injectable fluids which can cause unwanted toxicity or side effects.

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