the cleanroom

On this page we wish to give you an overview of how a cleanroom is produced, in which areas of application cleanroom technology is now indispensable and how humans - the biggest source of contamination - should conduct themselves appropriately in the cleanroom.
How is a cleanroom actually produced?
The various areas of application of cleanroom technology require individual solutions for every individual customer. No cleanroom can be constructed in exactly the same way as another!
For this reason, each project is individually divided into 5 construction phases.

Phase 1: planning
For the successful and on schedule implementation of a cleanroom project, the planning phase is definitely the most important.
Especially where a GMP-compliant cleanroom is involved, the complete planning process must be carried out in the form of a DQ (= design qualification).
First a detailed as-is analysis must be carried out. The customer's problem is examined and then detailed specifications and requirements are drawn up. Without these, the construction of a cleanroom could not be co-ordinated.
Here the requirements are but also the basic conditions are exactly defined, such as: the number of persons involved in the work process etc., .
In addition, a comprehensive analysis of weaknesses and risks can be very beneficial for the customer and prevent later additional costs.
Later maintenance and qualifications as well as intensive cost planning may also play an important role in this phase.

Phase 2: development
Engineers and technicians now develop on an individual solution for the previously defined requirements.
Flow systems and flow equipment required to comply with the purity class are defined, suitable air lock systems as well as wall, floor and ceiling systems are defined and finally the electrical and all other components of cleanroom technology are co-ordinated with each other. Air conditioning technology and later equipping of the cleanroom are precisely planned here.

 

Phase 3: implementation
In agreement with the user, the cleanroom is installed by qualified specialists, Material air locks and air showers  (personal air locks) are integrated and all furniture and flow boxes, as well as cleanroom lamps and fan filter units are installed.
After completion of all on-site work, the cleanroom is cleaned and all  technical cleanroom equipment is put into service to flush the system.
A ventilation engineer must now set all specific values. These include: air quantity, air flow rates, pressure stages for adjacent rooms, temperature, humidity etc.
When this construction phase is complete,
phase 4 begins: commissioning
Inspection and acceptance of the complete technical cleanroom equipment (IQ = installation qualification) checks whether all requirements defined in the planning and development phases have been delivered and installed correctly and without damage.
Then OQ (=operation qualification) is carried out, which serves as documented verification  that the cleanroom plant or cleanroom system can be operated in accordance with the specifications. For this, the room is measured "at rest" (= without activity).
Then the PQ (= performance qualification) is carried out. This involves measuring the cleanroom "in operation" (= with activity).
If the technical cleanroom equipment also fulfils all requirements here, the system can be approved for production.

 

Phase 5: maintenance and re-qualification
Depending on requirements, a cleanroom must be subjected to constant or regular monitoring.
In particular in the case of pharmaceutical applications, the installation of a monitoring system which monitors the room 24 hours a day and documents the measured values, may be advantageous.
Other applications require regular maintenance and re-qualification.
It is recommended to consider maintenance intervals right from the beginning and to conclude
a maintenance agreement with a trusted company.

Who actually needs cleanroom technology?
In the last few years, cleanroom technology has firmly established itself in numerous industries and will also become increasingly important in future for progressive companies, who wish to safeguard and further improve their competitivity and their market advantage.
Cleanrooms, cleanroom systems but also flow boxes and mini-environments are nowadays used for various purposes. numerous applications in medical technology, pharmaceuticals, the food industry but also electronic and optical components require a controlled production environment.
However, cleanroom technology has also established itself just as firmly in research laboratories, biotechnology, laser and solar technology as well as microchip production.
Individual solutions, from asmalla small, mobile table-top device, to workplace devices and flow boxes,cleanroom tents and CleanoFlex systems to complete cleanrooms of all sizes and purity classes, enable versatile, interesting options for all applications.

code of behaviour in the cleanroom

Conduct in the cleanroom
"The greatest source of risk for the cleanroom is the human who works in it"
His or her movements set particles in motion, which come off skin, hair and clothing.
This contamination can be contained by precisely formulated rules of conduct .
Depending on the purity class and requirements, the following rules can easily be tightened.
However, the efficiency ultimately depends on the implementation and the sense of responsibility of the employees . In addition to all rules, an appeal should be made, to the sense of responsibility of the employees and improve understanding!

Exemplary regulations:

1.) Entering the cleanroom:

• Only necessary and trained personnel may enter the cleanroom!
• The complete cleanroom may never be entered with normal outdoor shoes!
The specially provided cleanroom shoes or overshoes are to be used.
• Specially provided cleanroom clothing must be worn!
This clothing must be put on wherever possible without contact with the floor.
In some rooms, gloves, a beard cover and a hood must be worn. It must be ensured that no hair protrudes from underneath the beard cover or hood. 
• Wearing of make-up is not permitted!
• No food or drink may be taken into the airlock and cleanroom area!
• All doors must be kept closed at all times!
2.) Conduct in the cleanroom:
• Persons should conduct themselves as calmly as possible. Rapid, hasty movements and unnecessary walking around are to be avoided!
• No fibre pens may be used for writing!
• Only cleanroom-compatible paper may be used!
• Materials, equipment and tools may only be brought in with the approval of the person responsible for the cleanroom!
• The materials, equipment and tools in the cleanroom must not be removed from the cleanroom!
3.) Leaving the cleanroom:
• Undressing is carried out only in the changing area!
• Disposable clothing must be disposed of in the bins provided!
• Reusable clothing must be hung up in the lockers provided!