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Cleanroom
High-tech production facilities cannot do without cleanrooms.
The air in clean / clean rooms must be thoroughly cleaned and constantly monitored for the presence of dust and aerosol particles, microorganisms and chemical compounds. The decisive factor for cleanliness is a countable concentration of particles that does not exceed fractions of a micrometer.
For some industries, in addition to cleanliness, strictly defined and stable values of temperature, pressure, humidity and lighting must be maintained.
Usage
The use of cleanrooms is relevant to many areas of industry and scientific development. Relocation of technological processes to a dust-free environment increases the service life of various products and significantly reduces the possibility of their failure.
Processes and operations such as research, production of food or its individual components, surgical procedures, production of optics, electronic circuit boards or medical equipment are carried out in clean rooms.
Cleanliness classes
Cleanliness classes DIN EN ISO 14644-1
Feb. / 2016
ISO 14644-1 applies to a wide range of industries, including healthcare, pharmaceuticals, food processing, medical devices, and aerospace. This international standard defines air cleanliness classes for cleanrooms and controlled environments based on the amount or concentration of airborne particles. A fine dust test procedure is required in conjunction with the calculation of the measurement points.
Clean room classes GMP - Good Manufacturing Practice
Design and construction of pharmaceutical facilities are regulated by GMP standards and requirements. GMP is one of the most important laws defining the requirements for the production and quality control of pharmaceuticals. The requirements of the standard also apply to personnel, premises, equipment as well as documentation.
GMP applies to the production of:
- pharmaceutical preparations
- biopharmaceuticals
- veterinary medicinal products
- Medical devices
- Medical instruments for diagnostics
- active substances
According to GMP, cleanrooms are classified into A, B, C and D cleanrooms depending on the permissible content of aerosol particles.
Class A - intended for high risk operations requiring aseptic conditions ensured by an area with unidirectional air flow.
Class B - Clean Zones - space surrounding the Class A area.
Class C and D clean zones - designed for less demanding production operations.
Construction
The design of cleanrooms determines the type of tasks performed in them. This can be as simple as ventilating the work area with filtered air at a single workstation or as complex as a multi-stage ventilation system, separate airlocks and special wall, ceiling and floor coverings.
A ventilation system is required for an area of any cleanliness level.
To produce the required conditions, various methods are used to prevent unwanted particles from entering the air and to remove contaminants already in the air. This can be further supplemented by various enclosure designs, floor and ceiling designs, sealed windows and doors, special fixtures, transfer windows, airlocks, laminar enclosures and cladding elements that prevent dust accumulation at the joints.
Since humans are usually the largest source of particles and other contaminants, appropriate work clothing, special work equipment and tools, and the appropriate work technique help to maintain the specified cleanroom class. For example, there is special lint-free cleanroom paper, cleanroom clothing, head hoods and shoe covers.
Requirements for a clean room
Regardless of the specific application, the following requirements apply to cleanrooms:
- maximum sealing
- material with smooth surface for easy cleaning
- high strength and durability of the material
- resistance to all aggressive cleaning and disinfecting solutions
The entire structure should have a minimum number of protrusions, holes or depressions that make cleaning difficult.