Pure 4.0 The Pure Areas are changing their future perspective

Digitization in the cleanroom, provided by Becker Cleanroom Technology.

Particle measurement device

Air intakes

Paul Jochem

Industry 4.0 reflects the guiding principle of intelligent self-organizing production. The fourth industrial revolution anticipates and offers, for example, numerous possibilities in the analysis, assessment, and control of processes as well as workflows. These need to be identified, channelled, and utilized. Only in this way can correctly maintained processes achieve an increase in throughput value.

With digitalization, not only will value-added processes change, but new business models and perspectives for employees will also emerge.

Especially for small and medium-sized enterprises, intelligent digital production methods offer great opportunities.

The driving force behind this development is the rapidly increasing digitalization of economy and society. It fundamentally changes the way production and work will be carried out in Germany in the future.

Following the steam engine, assembly line, electronics, and IT, now intelligent factories (so-called "Smart Factories") define the fourth industrial revolution.

In our version of Pure 4.0, we talk about solutions for the digitalization of production and processes under pure conditions. We refer to "Pure 4.0" as clean production and purity-specific automation systems.

Intelligent value chains are created, which also include all phases of a product's lifecycle.

When we use the term "Pure" in our field, we mean: purity, cleanroom conditions, cleanroom, clean air, (...).

What do these terms mean:

- Pure: Unadulterated, pure, particle-free, free from disturbances, etc.
- Purity: Under workplace air purity, the particulate purity is understood, i.e., the absence of disturbing airborne contaminants, which can occur in the form of dust, fog, or microorganisms.
- Cleanroom conditions: All parameters of a clean workplace. The following parameters are defined: air purity, airflow conditions,
climate conditions (...).
- Cleanroom: An area separated by airflow technology or mechanically, where the particulate purity of the air corresponds to a specific cleanliness class.
- Clean air: (or Reinstluft): Air that is supplied after appropriate treatment (filtration), e.g., in a cleanroom.

All these are terms derived from the adjective "Pure".

When examining the so-called 4.0, we currently get two definitions: Industry 4.0, Digitalization 4.0. I believe that companies and their employees who deal with cleanroom technology in some way should know what the term "Pure 4.0" entails. Since we have examined the character of the term "Pure" as described above, this term deserves a unique feature.

After in-depth discussions within the CleanRoomNet network, we decided to support our cleanroom colleagues in the pharmaceutical industry, pharmacists working under pure conditions, cosmetic manufacturers, and all those processing their portfolios according to GMP and VDI guidelines (...), during these so important changes.

We want to show you possibilities of digitalization, provide assistance, and explain added values that make your participation in our event on June 18, 2019, indispensable. Take the opportunity to discuss with us and our speakers the advantages and disadvantages of digitalization so that you and your company do not have to jump on a moving train. We support you in this.

Take advantage of the free offer and benefit from the expertise of our network partners and our speakers at the event. Through our presence at cleanroom trade fairs, events organized with Saaris Healthcare Saarland, and Saarbrücken University over several years, you have been able to get an idea of the topics we deal with. With the brochures "A Locking Concept" for GMP users, as well as our brochure: "Thinking About It," we offer you a guide for your cleanroom. So you have reference works that are indispensable for your work in the cleanroom.

How does Pure 4.0 affect cleanroom technology?

In the 4.0 revolution, production is integrated with state-of-the-art information and communication technology. Digital monitoring solutions, efficient controls, traceability, and error detection are facilitated.

However, Industry 4.0 is still in its infancy in pharmaceutical production.

Although digitalization of cleanroom technology offers many possibilities, such as: what is already possible now and where the future is headed.

- Permissible particle concentration exceeded?
- Relative humidity above the limit?
- Too high temperature endangering active ingredient stability?
- (...)

If critical situations arise in the cleanroom, the staff team could benefit from digital monitoring: direct alarm, overview of the situation, quick reaction, and timely countermeasures can potentially prevent damage to the batch and save costs. However, integrating modern procedures into the established analog structures of a pharmaceutical company is not always easy. For example, in monitoring sterile drug production, sterile filling, or sterilization packaging, mostly analog data are generated. The key measurement is the number of airborne particles in a predefined volume.

Continuous monitoring also includes the differential pressure between different cleanroom zones and, of course, the cleanroom against the surrounding unclean area. Another important parameter is often the relative humidity. A rule of thumb suggests that in places where the medication or another product remains for more than 24 hours, temperature monitoring should also be performed. Whether determined via resistance measurement or other methods, the data are primarily analog.

From analog to digital!

In traditional companies, data transmission is largely done via analog cables. The digital alternative offers significantly more advantages: while an analog cable only transmits one signal, a digital cable can transmit many signals simultaneously.

In measurement technology, this principle enables capturing many data points at various locations and transmitting them through a single cable out of the cleanroom to visualize process data.

The fully digital connection of sensors to the monitoring system offers several additional benefits. When signals are transmitted digitally, not only does the susceptibility to interference decrease, but measurement results become more reliable. This is because an analog signal no longer needs to be converted into digital, eliminating translation errors.

The core messages of networked companies are:

- Production-relevant processes can be interconnected and coordinated across company boundaries.
- Current data are continuously collected from processes, enabling flexible fine control of processes based on situation-specific operational information.
- Increased flexibility facilitates quick adaptation of production processes to market developments and short-term changes.
Additional benefits include improved utilization of production facilities, minimized risk of penalties, increased efficiency of resource management, and cost reductions in logistics.

Added value:

- Demand-oriented, flexible optimization of value-added processes based on various criteria (time, costs, quality, resource consumption, ...).
- Traceability of production and logistics processes for each individual product. Significantly easier error detection and correction. Automatic service requests (maintenance, repair).
- Increase productivity by up to 50%, reduce energy consumption by up to 60%.

There are already possibilities for control systems to automatically shut down machines if particle concentrations are too high; the control room is then informed later.

The variety of possibilities has no upper limit!

Particle measurement device:

- Particle count
- Measurement cycle
- Filling volume
- Warning limits
- Danger limits
- QM action plan if limits are exceeded
- User manual

Air intakes:

- Manufacturer
- Maintenance plan
- Temperature
- Service hotline / repair information
- Functionality
- Connections
- Switching

The driving force behind this development is the rapidly increasing digitalization of economy and society. It fundamentally changes the way production and work will be carried out in Germany in the future.

Originally, our event was to take place at Dr. Theiss Naturwaren in Homburg. However, unforeseen technical reasons prompted us to consider an alternative venue.

At this point, I would also like to sincerely thank, on behalf of my network partners, the managing director Giuseppe Nardi of Dr. Theiss Naturwaren and his team for providing their premises.

Sources:

Federal Ministry of Education and Research: Future Vision "Industry 4.0", Handbook of Cleanroom Practice Hauptmann-Hohmann, GMP, VDI 2083, EN ISO14644-1

Here is our event program and contact details enabling participation:

Event date: June 18, 2019

Start: 2:00 PM – 6:00 PM

Location:
CFK - Center for Leisure and Communication of Lebenshilfe gGmbH
Zum Nassenwald 1
66583 Spiesen-Elversberg

Participants:
An event for cleanroom operators and planners, across industries.
"Pure 4.0" – from cleanroom planning with BIM to cleanroom 4.0. What is already possible today, and what will the future bring?

Program:
2:00 PM  Welcome of participants  
2:10 PM  Keynote: Introduction to Technology Connection Industry 4.0 for Cleanrooms; Dr. Dirk Werth, Managing Director and Scientific Director, AWSi August Wilhelm-Scheer Institute for Digital Products and Processes, Saarbrücken
2:40 PM  Use of BIM Technologies: Status and Outlook, the research project HoloBIM: Augmented Reality meets BIM, AR and BIM in Cleanroom 4.0.
a demonstration of application scenarios, L. Kuhn, EUROKEY GmbH + Team
3:40 PM  State of the Art: Network partners present ideas of the future, speakers from: Becker Cleanroom Technology, WZB gGmbH, and ELPRO GmbH
4:25 PM  Coffee Break
4:40 PM  State of the Art: Network partners present ideas of the future, speakers from: TÜV SÜD, SLKB GmbH, and Klima Becker Full-Service GmbH
5:25 PM  Topic selection for further workshops with moderation: Which topics are of interest to you as participants; goals for new workshops, Dr. Thomas Siemer, Saaris  
5:45 PM  Presentation of possible funding programs, Dr. Thomas Siemer, Saaris

Following the event, there will be a get-together with finger food buffet.

Registration deadline until June 14, 2019, via FAX to Saaris at 0681/5846125

Registration link: http://www.saaris.de/termine/veranstaltungen

CleanRoomNet and its speakers offer you high-quality, future-oriented information on current changes and topics around the future in the cleanroom. The focus of the statements is particularly on digitalization.