Hi mechatronics fans!

Welcome to this new post in our Sinadrives blog.

February 2022

In today’s post we’re going to discuss positioning applications in cleanrooms. We’re going to explain what a cleanroom is, the type of applications that require cleanroom certification and how to ensure that the positioning application meets the certification requirements.

A cleanroom is an engineered space with a controlled concentration of particulates. Accordingly, cleanroom classifications determine maximum concentration limits (i.e., particles/m³ of air), quantified by the number of particulates and their size. The most common classification system is the ISO 14644-1: 2015 cleanroom standard. Other standards include the Federal Standard 209E or the EU GMP. The equivalences between the different standards are displayed in the table below:

The system is applied in all applications where particulate contamination can impair product quality, purity or useful life. For example, in the pharmaceutical sector, an excessive number of particulates can have a negative impact on the purity of medicines. Meanwhile, in the semiconductor sector, particulates can reduce the useful life of components such as chips, LEDs or touch screens. Other areas where cleanroom standards may be applied are the optical sector (manufacture of eye lenses, objective lenses, microscopes), the food industry or the life sciences and laboratory sector.

Generally speaking, these sectors, based on their experience, have already established which type of classification applies to each specific process and have implemented the corresponding procedures and compliance standards.

Now let’s look at the steps that must be followed to ensure compliance with the regulations in applications involving positioning and automated movements.

If our goal is to design a machine that must comply with the cleanroom standard, first of all we have to establish which ISO classification we must comply with. The lower the ISO class number, the more demanding we must be in our component selection. As a general rule, we must follow the steps below:

• Determine the applicable ISO cleanroom regulations and class number.
• Determine which materials we must and must not use.
•  Determine which components we must and must not use.
• Determine whether the selected components and materials are ISO certified and whether their classification is equal to or lower than the initially defined target.
• If the selected components do not comply with the regulations or are not certified, we must certify them independently.

In general, components that offer frictionless movement are the most suitable ones. Friction generates wear and tear that entails the emission of particulates that pollute the air. For example, a linear motor drive does not generate friction or particles and is certainly the most suitable for cleanroom applications.

Over the past decade, linear motors have become the first choice for the building of industrial machines that must comply with cleanroom standards. Make the most of this advantage and ensure a fast, successful ISO standard classification process with the linear modules manufactured by SINADRIVES.

All linear guides generate particulates. Friction guides generate them through the wear and tear of plastic or bronze, while roller linear guides generate oil or grease particulates that become detached from the guide during motion. Special low-emission greases exist to minimize these particulates, in compliance with the ISO standard. As a rule, these special greases are white, and they are suitable for this type of application.

It should be noted that in order to control the emission of particulates, the grease must be of the highest possible quality, and re-greasing intervals and the recommended temperature of use must be respected.

The SINADRIVES company currently manufactures three certified solutions for the ISO3 category: the families of linear modules equipped with the MLS, MLE and MLL linear motors. These families have been certified by official laboratories and comply with the ISO3 category.

All the linear units of the MLS, MLE and MLL family operate by means of a linear motor as a transmission element, recirculating roller linear guides with special shutters and a specific grease. This means that the modules can be integrated directly in machine assemblies, which in turn enables the manufacturer to attain the desired emission level in a straightforward manner.

If you have an application that requires certification and compliance with the ISO standard, please contact our technical team (Hyperlink). We will be pleased to advise you with no obligation.

Todas las unidades lineales de la familia MLS, MLE y MLL funcionan a través de un motor lineal como elemento de transmisión, guías lineales de recirculación de bolas con obturadores especiales y una grasa especial. Todo esto permite que estos módulos puedan ser integrados directamente con la maquinaria, lo que a su vez permite al fabricante alcanzar los niveles de emisiones deseados de manera sencilla.

Si tiene una aplicación donde se requiere una certificación y cumplimiento de la normativa ISO aquí puede contactar nos nuestro equipo técnico. Le asesoraremos de manera gratuita.

As for the components that are going to be used, special attention must be paid to elastic and flexible elements from which particulates may become detached through internal friction; that is, cables, chain covers for cables, elastic covers, seals, rubber saws, etc. All these elements are considered “dirty” and do not offer emission stability during their useful life.

Surface treatments such as lacquering or painting are not advisable, since they can generate dirt particles. It is advisable to use surface treatments such as anodizing for aluminium parts, while steel parts should be stainless steel.

All parts must be free of burr, chips, dust, grease residues and oil. It is advisable to carry out a thorough cleaning process with special material such as cleanroom cloths and wipes. Avoid using fast-deteriorating elements that are not suitable for ISO-certified environments.

Some examples of the measurement of our equipment are shown below:

If you decide to use our certified components, you do not have to certify your entire machine assembly, provided that you have not incorporated other non-certified moving parts in the assembly.

Should you have to certify an element independently, you will have to hire the services of an accredited laboratory in order to complete the certification process. The duration of the process can vary depending on the type of element or assembly (about 2-3 days). The certification process is expensive and requires meticulous preparation of the element to be tested. As in all certification processes, the equipment may not pass the test or attain the required classification. This can be very discouraging and entails costs that will never be recovered.

From a practical point of view, using certified components always gives the machinery manufacturer a significant advantage: a lot of time is saved and unpleasant surprises are avoided. Ensure the successful completion of your project by using certified components; you will save time and money. Our specialists are on hand to answer your queries.

If you have an application in which you’re keen to improve the performance of your machine, be it in terms of speed, dynamics, precision or simply reducing maintenance needs, please contact us.

Our specialists in Direct Drive technology and Linear Modules with linear motor technology will be happy to advise you free of charge.

Draw your own conclusions. Decide which innovation you want to implement in your machine to be competitive. We can help you.

Your SINADRIVES Team.