Cleanroom technology from INNEXIS
Because demanding industries require individual concepts and precise solutions
We implement tailor-made cleanroom solutions that function safely and reliably throughout Germany, especially for pharmaceutical and biotechnology companies. Our GxP team of experts will support you with their specialist knowledge and a great deal of passion during the planning, implementation and commissioning, qualification of your cleanrooms and, of course, during ongoing operation.
Your benefits with cleanroom technology from INNEXIS
- Nationwide cleanroom customer service
- Special pharmaceutical expertise
- Excellently trained and certified employees
- Cleanroom certifications in accordance with DIN EN ISO 14644
- Compliance with GMP guidelines
- Complete assumption of project management on request
- Planning, implementation, commissioning, maintenance and qualification / requalification from a single source
Please send us an inquiry with your special requirements and we will promptly send you an offer with your individual cleanroom solution.
Your head start:
Our in-depth industry expertise
The special cleanroom requirements in the pharmaceutical industry
In order to meet the different needs of our customers in the pharmaceutical industry, cleanrooms are operated in compliance with special standards such as DIN EN ISO 14644 and the EU GMP guidelines.
Each cleanroom is divided into different cleanliness classes depending on the subsequent application. DIN EN ISO 14644 divides these into the classes ISO 1 to ISO 9. The more critical the product or process, the lower the required ISO class. In the pharmaceutical industry, special GMP cleanroom classes apply, which range from class A to D in the EU guidelines on Good Manufacturing Practice. Class A is the highest cleanliness level, while class D allows the highest permissible particle concentration.
The standards define important specifications for the following cleanroom criteria:
- Air quality
- Concentrations of particles and germs
- Room air movement
- Air exchange rate
- Monitoring
- Cleaning and disinfection
- Training of employees
By complying with all rules, we always reduce the risks of contamination of cleanrooms to a minimum.
We offer our cleanroom technology services both in our Pharma & Life Science Parks and throughout Germany for pharmaceutical companies or the biotechnology industry.
Controlling air movement - the principle of laminar flow
Laminar flow or low-turbulence displacement flow (TAV) is a key principle in cleanroom technology when it comes to air movement within a room. Laminar flow refers to a uniform, flowing air movement in which the air flows parallel to each other in one direction. This supply air flow takes place via a terminal HEPA filter such as a filter fan unit (FFU). The airflow itself is generated by an integrated fan and cleaned by a high-performance filter before being fed into the cleanroom.
Laminar airflows (= directed airflows) are mainly used in cleanrooms where sensitive processes or products need to be protected from contamination. The filtered air (= clean air) prevents particles from entering the cleanroom and protects not only the sensitive products but also the people in the cleanroom.
The term Flow generally describes the movement of air within a room, which can be either laminar or turbulent. Turbulent flow is characterized by an irregular, swirling air movement caused by obstacles or changes in the air flow.
Our team of experts works with all common laminar flow modules on the market, regardless of manufacturer - including maintenance and commissioning.
Effective and energy-efficient - Turbulent dilution flow (TVS)
Turbulent dilution flow (TVS) is a process in cleanroom technology that is used to remove particles from the air. It uses the principle of turbulence to achieve effective mixing of the air and improved particle separation.
The TVS works by generating turbulent flows in the air. Special nozzles or nozzle plates are used to spray the air in different directions, creating turbulence in the air. The turbulence causes intensive mixing of the air and thus effective distribution of the particles.
In contrast to laminar flow, which is used in cleanroom technology for the production of clean air, TVS ensures a more turbulent flow with increased particle separation. Due to the higher air exchange rate, larger particles can be separated, which improves the air quality and reduces the particle concentration.
Another advantage of TVS is its energy efficiency. Compared to other methods of airborne particle separation (e.g. electrostatic filters or HEPA filters), TVS requires less energy to clean the same amount of air. This is because the principle of turbulence does not require any additional energy for particle separation.
In summary, turbulent rarefaction flow is an effective and energy-efficient method for separating particles in the air, which is often used in cleanroom technology. By generating turbulent flows, it effectively removes particles and thus ensures a cleaner and safer environment.
You can expect these services from INNEXIS
Planning
Everything has to be just right in a cleanroom: Air conditioning and ventilation technology, GMP-compliant (German) systems and sterility. Thanks to years of cooperation with internationally successful pharmaceutical and biotechnology companies, we are very familiar with all the requirements and possibilities of cleanroom technology. We will be happy to consult with you on the planning of your new cleanroom or the modernization of your existing cleanroom and work with you to develop a tailor-made concept.
Construction, conversion or modernization
Whether new construction, conversion or modernization - our competent employees at INNEXIS are comprehensively trained in all relevant standards and guidelines. We work on a daily basis in accordance with DIN EN ISO 14644, VDI 2083, VDI 6022 or the Good Manufacturing Practice guidelines and are familiar with all the specific requirements of the pharmaceutical industry. Our support ranges from the organization of the entire construction phase with all trades to the qualification of your cleanrooms.
Project management
If required, INNEXIS can also take on the complete project management for a conversion or the installation of a new cleanroom in existing buildings. Your advantage: the entire process remains in one hand. Naturally, we plan in such a way that ongoing operations are affected as little as possible. Our engineers and technicians always work in accordance with the latest pharmaceutical regulations.
Qualification
Qualification is an essential step in ensuring that the specific requirements for the construction and commissioning of cleanrooms are met. This includes various measurements, flow visualizations and inspections of the cleaning and disinfection processes. Our GxP experts are specially trained and certified for this. They have years of experience in cleanroom qualification and documenting the results.
Ongoing operation
A cleanroom must be regularly maintained and requalified to ensure consistently high quality throughout the entire life cycle of the room. We take on this task as well as repairs and conversions. We work flexibly so that you are restricted as little as possible in your work. During operation, our experts take care of all required cleanroom measurements and offer your company flow visualizations if required.
Nationwide deployment
INNEXIS offers all services relating to cleanroom technology to companies in the Pharma & Life Science Parks as well as pharmaceutical and biotechnology companies throughout Germany. From development, construction and qualification through to commissioning, we are there for you with our expertise and our external customer service and are quickly on site. No matter where you are and where you need our technical support, repair or maintenance.
Our expert contacts for your questions
We support you with specialist knowledge, experience and individual solutions for all questions relating to our services. Whether you would like a quote from INNEXIS, use our services or are looking for a long-term partnership - we are always happy to help. Get in touch with us directly. We look forward to supporting you!
Tests and measurements in cleanroom technology
In a cleanroom, various parameters must be continuously monitored, tested and measured to ensure that air purity and other environmental conditions are always within the specified limits. The most important parameters in cleanroom technology include
- Filter integrity
- Particle concentration (cleanliness class determination)
- Illuminance
- Flow visualization
- Recovery time
- Air flow and air velocity at terminal HEPA filters
- Air exchange rate
- Microbiological contamination (bacteria, yeasts, germs, fungi, viruses)
- Temperature and humidity
- Differential pressure between cleanroom and adjacent environment
- Sound pressure level
- CO2 concentration
- Chemical contamination (e.g. non-condensable gases)
These tests ensure compliance with the high cleanroom standards and contribute to safety and quality.
INNEXIS cleanroom knowledge: Frequently asked questions
What is a clean or ultra-clean area?
A clean or ultra-clean area is a specially defined space in which air quality, temperature, humidity and particle content are strictly controlled in order to eliminate contamination as far as possible. Such areas are typical for the pharmaceutical industry, biotechnology, medical technology or semiconductor production. The requirements are often based on standards such as ISO 14644 or the GMP (Good Manufacturing Practice) guidelines. These standards define cleanliness classes that specify the maximum number of particles of a certain size that are permitted per cubic meter of air.
What is a cleanroom and how does it work?
A cleanroom is a special room in which the concentration of particles in the air, contaminants (impurities), bacteria, viruses, germs or chemicals is kept at a very low level. This effectively protects sensitive processes or products from contamination.
How can cleanroom technology be explained simply?
Cleanroom technology includes all the measures required to ensure and maintain the air quality in a cleanroom. This includes, for example, controlling air movement and circulation, cleaning the air, monitoring air quality and training employees in cleanroom operation.
What cleanroom standards and classifications are there?
We differentiate between cleanroom and cleanliness classes according to DIN EN ISO 14644 and EU GMP guidelines (Annex 1). While the DIN EN ISO standards define basic requirements and classification criteria for cleanrooms, the EU Guide to Good Manufacturing Practice contains specific requirements and recommendations for the pharmaceutical industry. Both are important to ensure that a cleanroom meets the respective standards.
What specific hygiene regulations apply to cleanrooms?
Continuous monitoring of cleanroom conditions is essential to ensure compliance with the specific requirements. To this end, we recommend implementing a monitoring system to permanently control particles, room pressure, temperature and humidity in the cleanroom. In addition, all persons entering the cleanroom must follow certain rules to ensure that the cleanliness of the room is not compromised. This includes, for example, wearing protective clothing or adhering to hygiene measures.
What criteria do I use to choose the right cleanroom class?
The choice of class depends directly on your product and its sensitivity. Ask yourself the following questions: How sensitive is my product to particles? What regulatory requirements apply to my industry? What risk of contamination does my manufacturing process pose? In the pharmaceutical industry, for example, we work with the EU GMP system from grade A to D. While Grade A stands for aseptic core zones with maximum purity, Grade D is suitable for secondary areas. INNEXIS analyzes your production processes and recommends the most economically viable classification that also meets all safety requirements.
Which technical components form the heart of a cleanroom?
Three systems work together: Firstly, the air purification technology with multi-stage filter systems that capture even sub-microscopic particles. Secondly, flow management, which directs clean air through the room and removes impurities immediately. Thirdly, the air conditioning system, which precisely controls temperature and humidity. Added to this are pressure cascades between the zones, which prevent contaminated air from entering critical areas. At INNEXIS, we design these systems to be energy-efficient while offering maximum process reliability.
What legal requirements do I have to observe?
The regulatory landscape is complex: internationally, the ISO 14644 series is regarded as the reference standard for classification and testing. In Germany, VDI 2083 provides additional detailed technical regulations. Pharmaceutical companies must also comply with the GMP guidelines of the European Commission, which go well beyond mere particle limits. They require documented qualification and monitoring programs, risk assessments and continuous proof of process control. We know these requirements from years of practical experience and integrate them into your cleanroom planning right from the start.
At what intervals are inspections required?
The inspection frequency depends on the criticality of your processes: We inspect highly critical areas for sterile production every six months, less critical zones annually. However, continuous monitoring is carried out between these formal qualifications. Particle measuring systems, pressure sensors and microbiological controls provide continuous data. In the event of deviations, conversions or after maintenance work, unscheduled inspections are essential. We establish a monitoring system for you that recognizes trends at an early stage and documents regulatory evidence seamlessly.
Why are people the biggest risk factor in cleanrooms?
Every person releases millions of skin flakes, hairs and microorganisms every minute - even when at rest. This release increases with movement. This is why, paradoxically, people are the biggest source of contamination in cleanrooms. The solution lies in three pillars: first-class protective clothing that functions like a barrier; sophisticated airlock concepts that intercept contaminants as soon as they enter; and, above all, intensive training for your employees. We develop practical training programs that raise your team's awareness of critical behaviour and make correct working practices routine.
GMP is a top priority at INNEXIS
GMP is the abbreviation for "Good Manufacturing Practice" and describes a set of rules laid down by national or international regulatory authorities. It applies to all companies that manufacture pharmaceutical or medical products.
The specifications include guidelines on cleanroom technology and hygiene, quality assurance, documentation and the tracking of all relevant processes and products. This set of rules ensures that medicines and medical products are always of high quality and reach the market safely.
At INNEXIS, all employees have in-depth knowledge of the current GMP regulations and regularly take part in the necessary further training to guarantee you the best possible service.
Everything for your cleanroom - directly available!
Cleanrooms require the utmost precision and care. Do you need new workwear, safety shoes or suitable safety goggles? You can find your personal protective equipment in various sizes in our online store - conveniently and reliably available to order.
This ensures that you always have what you need. And best of all: your order will arrive at your doorstep in a flash so that you can continue working safely and comfortably.