Cleanroom Manufacturing of Thermoformed Plastic Parts – High Hygiene Standards

Cleanroom manufacturing of plastic thermoformed parts – Key points at a glance

• Cleanroom manufacturing prevents particle contamination and guarantees the highest level of product purity.
• Thermoformed plastic parts produced in cleanrooms are used in the medical, electronics, aerospace and automotive industries.
• International standards such as ISO 14644 and EU GMP define the permissible particle levels.

→ Enquire about cleanroom thermoformed parts now!

What is Cleanroom Manufacturing?

Cleanroom manufacturing, cleanroom production or cleanroom technology enables the manufacture of high-quality, bespoke components for use in sensitive environments such as the medical technology, electronics and aerospace industries.

What is the purpose of cleanroom manufacturing?

Cleanroom manufacturing is designed to ensure that products are not contaminated by particles in the ambient air. A cleanroom is an area with a low concentration of airborne particles. Airborne particles are particles that float in the air and are sometimes invisible to the naked eye.

What is a Cleanroom?

A cleanroom is a specially designed space that is continuously monitored and regulated to ensure the highest level of purity and precision in production. Cleanroom manufacturing follows strict standards for air quality, particle concentration, and environmental conditions.

What are the Requirements for a Cleanroom?

A critical aspect of cleanroom manufacturing for thermoformed plastic parts is the use of specialized materials. These materials must meet the stringent requirements of the thermoforming process while also complying with cleanroom purity standards. Some requirements include:

• The use of low-particle-emission plastics
• Special coatings or treatments to minimize contamination
• Strict adherence to hygiene protocols

What is allowed in a cleanroom?

In einen Reinraum dürfen nur Personen, Materialien und Ausrüstungen, die den festgelegten Reinheitsstandards entsprechen. In der Reinraumproduktion zu arbeiten, schließt spezielle Reinraumkleidung, Werkzeuge und Filtereinrichtungen ein.

The Thermoforming Process in Cleanroom Manufacturing 

In plastic deep-drawing, plastic sheets or films are shaped into a three-dimensional form. The plastic is formed in a cleanroom under controlled conditions to ensure that no harmful particles or contaminants enter the manufactured plastic parts.

Significance for sensitive applications

Cleanroom manufacturing is particularly important for implants, electronic components and aerospace components. Even the tiniest particles of contamination can have serious consequences in these contexts, which is why strict safety precautions must be observed.

Why Manufacture Thermoformed Plastic Parts in a Cleanroom?

Reliable functional safety is important in sensitive areas such as medicine and pharmaceuticals, electronics, and food. Specific plastic products are manufactured in cleanroom production to prevent airborne dirt particles from interfering with the production of supplier parts.

Advantages of plastic thermoformed parts manufactured in cleanroom production

• Optimal cleanliness: The controlled cleanroom environment ensures that the cleanroom products manufactured are free of contamination.
• Versatile applications: Thermoformed parts manufactured in cleanroom production are used in sensitive areas such as medicine, electronics, and aerospace.
• Improved reliability: The elimination of contamination in the cleanroom increases the reliability and performance of the thermoformed parts.

Regardless of cleanroom production, the manufacture of plastic parts using the thermoforming process enables exceptional precision and tight tolerances. Thermoformed parts are therefore ideal for demanding applications that require complex geometries.

Cleanroom production is essential for these end markets in plastic thermoformed parts.

• Semiconductor manufacturing
• Optical and laser technology
• Aerospace
• Life sciences
• Medical treatment and research
• Manufacture of sterile implants, wound dressings, thermoformed trays, and other medical assemblies
• Germ-free production of pharmaceuticals and food

Cleanroom production for the automotive industry

Cleanroom production is also becoming increasingly important for the automotive industry. It enables automotive manufacturers and suppliers to ensure that parts and components are manufactured to the highest cleanliness standards. Cleanliness requirements are particularly critical in sensitive vehicle parts such as ABS or direct injection systems. These components are extremely sensitive to contamination, especially particle residues.

VDA 19: Technical Cleanliness in the Automotive Industry

VDA 19, or more specifically VDA 19.1, is a guideline developed specifically for the automotive industry to ensure the technical cleanliness of functionally critical automotive parts. This guideline was established to meet the need for industry-wide standards and testing methods.

Application of VDA 19 in the production process

VDA 19.1 defines requirements for clean manufacturing and the inspection of components. It is applied at various stages of the production process, such as:

• Initial sampling of components
• Outgoing and incoming inspection
• Quality control for manufacturing processes involving cleanliness
• Monitoring of process steps

Combination of cleanroom manufacturing and VDA 19

The combination of cleanroom manufacturing and the requirements of VDA 19 provides a clear framework for the production of high-quality, technically clean automotive parts. This helps minimize failures and enhance vehicle safety.

Most important cleanroom classes according to various standards

• For semiconductor technology ISO 14644-1 and 2
• For aerospace technology also ISO 14644
• In food technology according to standard VDI 2083
• In the pharmaceuticals guideline EU-GMP with Annex 1

Classes in cleanroom manufacturing

The cleanroom classes with all their conditions are listed here again with all the most important cleanroom guidelines:

Purity classes according to ISO 14644-1

• Cleanroom classified according to ISO 1-9
• Cleanroom classes may only contain a particle count between 0.1 µm and 5 µm

Cleanliness classes according to EU-GMP guideline Annex 1

• GMP guideline defines cleanroom classes according to A, B, C, and D
• Here, only the maximum permitted particles per cubic meter are differentiated according to sizes greater than or equal to 0.5 µm and greater than or equal to 5 µm

VDI Guideline 2083 – Definition and function of a cleanroom

• Defines how a cleanroom is defined, how it works, and what needs to be considered
• The guideline deals exclusively with permissible concentrations of particles in the air at the so-called clean workplace
• As with DIN EN ISO 14644, only particles in the size range between 0.1 µm and 5 µm are considered

How can formary guarantee sterile conditions for cleanroom production?

formary has access to a network of partners that enables cleanroom production and additional hygiene levels, allowing us to meet all hygiene standards for thermoformed parts. Use the configurator to request your individual thermoformed part under cleanroom conditions now.

Cleanroom production for plastic thermoformed parts – a summary

Cleanroom manufacturing of plastic thermoformed parts plays a key role in industries that demand the highest quality standards and cleanliness requirements. Working in a cleanroom not only ensures the production of hygienic and clean parts, but also helps improve the reliability and performance of products in sensitive applications.
Through its specialized supply network, formary ensures that, for every industry requiring high hygiene standards, the appropriate manufacturers design and produce the thermoformed parts.

Do you have any further questions? Feel free to give us a call at +49 7191 9525170!