Clean Room: Intralogistics According to Hygiene Regulations

Numerous medical products, but also products from the food, chemical and pharmaceutical industries are produced in cleanrooms. Both the production environments and the associated intralogistics must meet strict hygiene regulations.

Clean Room Intralogistics

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Especially for industries with high hygiene requirements montratec has developed the montrac® Cleanroom Shuttle MSH4 CR, which is particularly used for the production of sensitive products in the computer, semiconductor, medical technology and pharmaceutical industries as well as in laboratories.

What is a clean room?

A cleanroom is a room in which there is only an extremely low concentration of airborne particles. Airborne particles are substances and particles that float freely in the air of the room and that the human eye is usually unable to detect.

Clean rooms are always necessary where airborne particles could lead to contamination of products - this applies, for example, to medical technology, but also to laboratories, space technology, semiconductor production, or even the food and pharmaceutical industries.

Clean rooms are needed not only in medical research but also in the germ-free production of pharmaceuticals and foodstuffs.

But which products are manufactured in a clean room?

Maximum sterility is required not only in the production of sterile drugs, but also in the manufacture of dressings and wound dressings. The same applies to the production of implants, medical devices, but also components for the semiconductor industry and other sensitive products that must not be contaminated by particles under any circumstances. Even the smallest contamination of dressing material or wound dressings could lead to infection, which must of course be avoided.

In semiconductor manufacturing, on the other hand, particles from the ambient air would disrupt the structure of the highly sensitive circuits.

Furthermore, pressure as well as humidity and temperature must be kept at a constant level in the clean room in order to create consistent production conditions at all times. People themselves are often the cause of contamination of the room air.

Therefore, in addition to the use of special work equipment and tools, specific work clothing - also known as cleanroom clothing - must be worn. This, in turn, must be adapted to the respective cleanroom class; in addition, overcoats for the shoes, head hoods, and frequently also a mouth guard are required.

When an employee moves from one cleanroom to the next, he or she usually also has to change clothes. In addition, personnel and material locks including appropriate filter and ventilation systems as well as special floor mats ensure that no contamination occurs.

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Regulations for cleanrooms: Cleanroom classes ISO 1 to ISO 9

In order to assign a clean or ultra-clean room to a clean room class ISO 1 (= purest clean room class) to ISO 9, which is based on ISO 14644, particle measurements are carried out during operation according to specified standards and rules. In addition, there are industry-dependent cleanroom d efinitions that differ in the respective standard.

For example, the main standard for aerospace and semiconductor technology is based directly on ISO 14644, while food technology is governed by VDI 2083, a set of rules issued by the Association of German Engineers based on ISO 14644. According to VDI 2083, contamination with microorganisms must be avoided in food production.

Cleanroom production in the pharmaceutical industry, on the other hand, must comply with the EU GMP Directive incl. Annex 1, which stipulates that the drugs produced in the cleanroom must be sterile.

In general, cleanrooms are assigned to cleanroom classes ISO 1 to 9 according to their size (from 0.1 - 5.0 µm) and the number of particles (per cubic meter).

While cleanroom-certified equipment in semiconductor manufacturing must comply with the classifications ISO 1-5, the regulations for the food industry are not as strict; here, the cleanliness level of the machines lies between ISO 6 and ISO 9.

For comparison: According to the literature, 1 m3 of air at the North Pole contains up to 10,000 particles of size 0.5 µm, while in the cleanroom of class ISO 3, a maximum of 35 particles of this size are permitted; for cleanroom class ISO 1, even only 10 particles with a maximum size of 0.1 µm are permitted.

Efficient cleanroom intralogistics: certified shuttle system for cleanroom classes ISO 5 and 7

In cleanroom production, both the production conditions and the internal material flow are subject to the strictest hygiene and cleanliness requirements. Contamination from intralogistics systems is primarily caused by abrasion.

One example of an efficient intralogistics solution in the cleanroom is the montrac® monorail and transport shuttle system from montratec. With the power rail integrated in the monorail and the thus internal, contactless power supply, montrac® is already well suited for production in the cleanroom. The rubberized drive and support rollers of the montrac® cleanroom shuttle, which are optimized for minimum abrasion and have only punctual contact surfaces on the monorail, ensure the desired minimum particle emissions.

The Cleanroom Shuttle, which was specially developed for cleanroom production, allows loads of sensitive products weighing up to 30 kg, depending on the model, and achieves travel speeds of 30 m/min.

Due to the purely electrically driven components and the resulting minimal particle emission, the Cleanroom Shuttle is certified by the Fraunhofer Institute for cleanroom classes ISO 5 and 7. It is used in the cleanroom in particular for the production of battery drives and digital displays for e-mobility as well as in the electronics, semiconductor and medical technology industries, among others, for the production of hard disks, wafers and medical products.

Conclusion

Cleanrooms require special precautions to meet the required hygiene and cleanliness standards - regardless of whether they are used in aerospace and medical technology or in the food, chemical, pharmaceutical or semiconductor industries.

Based on ISO standardization 14644, cleanrooms are classified according to the number (per cubic meter) and size of air particles in cleanroom classes ISO 1 to 9. Depending on the industrial sector, classifications according to EU-GMP or VDI guideline 2083 are also possible. What they all have in common is that air purity can basically be classified by the permissible concentration and size of air particles.

Only intralogistics systems with minimal particle emissions have a chance of being certified for cleanroom production.

One example of this is the intelligent monorail and transport shuttle system montrac® with the montrac® Cleanroom Shuttle specially developed for the in-house transport of hygiene-sensitive products - certified by the Fraunhofer Institute for cleanroom classes ISO 5 and 7.

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