Clean room technology

Nowadays, adherence to stringent clean room classification prerequisites is a must in almost all high-tech and growth sectors. A host of related guidelines and laws must be considered to ensure the optimal performance of your assets.

TÜV SÜD’s clean room experts work at the cutting-edge of clean room design, governing the future of contamination control and clean room technology, drawing up the codes and standards for effective clean room construction. Production of modern technology would be impossible without contamination control and monitorable clean room standards. The more our daily lives become defined by technology, the higher the demand for contamination control i.e. via monitoring the types of particles within in a clean room’s air composition.

A clean room’s equipment and high purity media systems must be planned, projected, certified and periodically re-certified according to national and international clean room standards and industry guidelines and regulations – this is where TÜV SÜD can help.

What is a clean room and clean room certification?

A clean room is designed to control the internal environment of a room via observing the types of particles prevalent in the air. This means that the number of airborne organisms, chemical vapors and contaminants present within the room are tightly monitored.

More often than not, a clean room is entered and left via an airlock, requires staff to go through an extensive clean room training program before being allowed access and necessitates that all in-room equipment doesn’t produce any contaminants.

A clean room is often a prerequisite in the pharmaceutical, biotechnology, microelectronic, optoelectronic, micro and nanotechnology manufacturing and food industry sectors. With a clean room class certification, your clean rooms would comply with the class criteria and function optimally.

How can our clean room standards experts benefit your business?

• Take advantage of the extensive know-how - where TÜV SÜD experts can advise on national and international contamination control and clean room class standards.
• One-stop certification – TÜV SÜD takes care of all your clean room certification and recertification needs, ensuring that your assets comply with the various rigorous clean room classification requirements.
• Reduce your workload – TÜV SÜD helps you streamline your work processes, thus easing the workload of your employees.
• Save on time – our TÜV SÜD experts know exactly which tasks require prioritization and what steps must to be taken to realize them, significantly accelerating your operational processes.
• Gain solutions – through our clean room design experts, attain answers to complex questions such as:
  • How can clean room construction be both cost-effective and competitive despite the enormous expenditures involved?
  • How can effort-intensive class certification, qualification or recertification be realized in a cost-effective manner?
  • How can necessary supplier resources be guaranteed?
  • How does an organization remain up-to-date with the latest findings in contamination control and clean room technology?   

What clean room services does TÜV SÜD offer?

TÜV SÜD provides clean room services in the following sectors and industries:

• Pharmaceutical
• Food
• Biotech  
• Medical device
• Active substance production
• Laser technology
• Microelectronics
• Optoelectronics
• Aerospace
• Multimedia technology

Other clean room services include:

• Training
  We can train your employees with regards to ensuring adherence to clean room class standards in the following ways:
  • Protection of the environment and employees
  • Handling of new technologies
  • New regulations and standards
• Clean room class certification / re-certification
  We offer class certification and re-certification services in the following areas:
  • Clean rooms
  • Clean workplaces, isolators, enclosures
  • Supply of ultra-pure media
  • Filter integrity and filtration efficiency
  • Filter pressure drop
  • Clean room compatibility of components
  • Systems and manufacturing equipment
• Clean room certification / re-certification for pharmaceutical facilities
  TÜV SÜD conducts class certification as per VDI 2083 and ISO 14644/ISO14698 and other guidelines/codes and standards, e.g. in the pharmaceutical industry additionally as per WHO GMP, PIC GMP, FDA. We offer clean room class services in the following areas:
  • Clean room design qualification
  • Installation qualification
  • Operational qualification
  • In the hospital sector, we provide additional certification services as per the VDI 2167 and DIN 1946, Sheet 4, VDI 6022
• Clean room design and clean room construction
  Our clean room experts can assist you in the following areas:
  • Monitoring of clean room construction
  • Assessment of installation
  • Support in supplier selection
  • Supplier evaluation
  • Auditing
  • Measuring technology acceptance

Clean room services specific to the microelectronics, pharma and life sciences sectors

In the microelectronics, pharma and life sciences sectors, the design and construction of production plants and machinery must satisfy the most stringent requirements. As a plant manufacturer or owner/operator, you must be particularly uncompromising in fulfilling purity criteria.

To strike a balance between quality, cost-effectiveness and safety, considerations should be given to statutory regulations, investment costs, the costs of ongoing production, but also production performance, maintenance and user-friendliness. Our interdisciplinary project teams can advise you with their expert know-how in hygienic plant design and GMP and FDA compliant production and assist you with the planning and construction of your plants by providing specific technical expertise and practice-focused, cost-effective solutions.

TÜV SÜD microelectronic, pharma and life sciences clean room services:

• Project studies and process advisory
• GMP project support (RA/VMP/QMP/SOP)
• Support during construction
• Support with FAT and SAT for machines and installations
• Plant certification (DQ/IQ/OQ)
• Certification of GMP compliance for special machinery
• Approval testing in accordance with the building code of fire and lightning protection systems, lift systems and electrical engineering systems
• Seminars and training courses
• Energy-efficiency analyses
• Risk assessments for installations and machinery
• Monitoring of planning
• Quality assurance during construction