Planning of Clean Rooms
Cleanrooms are used in various industries, including pharmaceuticals, biotechnology, medical device reprocessing or microelectronics, to minimize contamination risks.
Generally, the requirements follow the ISO classes according to DIN EN ISO 14644-1 for particles and Annex 1 of the EU GMP Guidelines, supplemented by microbial limit values (e.g., ISO 8 / Zone D – ISO 7 / Zone C – ISO 5 / Zone A/B), e.g., for the sterile production of pharmaceuticals. For non-sterile applications, the ZLG, for example, provides recommendations for microbial limit values.
The planning of such clean rooms is always an individual process in which, in addition to the intended use – when converting existing buildings – the local conditions must also be taken into account. This includes the arrangement and design of the personnel and material airlock systems, which are assigned to the cleanliness zone plan/ hygiene zone plan.
The following guidelines and standards are among the basis:
| > EU-GMP–Leitfaden und Annex 1 > FDA Aseptic Guideline > VDI Richtlinie 2083, Blatt 1–15 > VDI Richtlinie 6022 > DIN EN ISO 14644-1 > DIN EN 779 > DIN EN 1822 |
This requires a high level of expertise and a deep understanding of the technical, regulatory and practical requirements necessary for a controlled environment. Suppliers of wall and ceilings for clean rooms offer modular systems. With its specialist knowledge, practical know-how and experience, P³ supports its customers in selecting the right components.
The key to functional cleanroom design is the integration of technical components such as air conditioning (filter boxes, outlets, return air shafts, etc.), electrical systems (lights, switches, displays, etc.), safety systems (room detectors, gas sensors, etc.), monitoring (sensors, alarms, etc.) and airlock systems (pass-throughs, locks, buttons, emergency openings, etc.).
Analysis of needs and costs
The establishment and operation of the clean room are associated with costs: In addition to the one-time investment in the room system and technology, there are also running costs. A clean room should therefore be dimensioned in such a way that it meets the requirements of the user without taking up an unnecessarily large amount of space. Due to their modular design, clean rooms can be expanded and adapted according to requirements. Keep this in mind when planning, in case production is expected to increase in the foreseeable future.
Degrees of air purity
The air in clean rooms is divided into particle cleanliness classes (DIN standard EN ISO 14644-1), which differentiate between particle density and size. In the pharmaceutical sector, the GMP guidelines of Annex 1 also define the limits of permissible bacterial load.
Venting solutions
Which ventilation system is suitable depends on the ISO specifications. The design in a way that the deposition of particles is prevented and are discharged to the outside. To do this, entrances must be positioned in such a way that they cannot be blocked during operation. Air conditioning units control the temperature and room humidity; in most applications, a constant level is required here.
Access for staff and goods
Clean rooms are generally entered via locks that can be locked from both sites. They help to equalize pressure, bring materials in and also let staff change into protective clothing so that as few particles from outside as possible are carried into the clean room.
Materials
There are also guidelines for the cleaning of clean rooms, especially with regard to the cleaning agents to be used. The choice of material for horizontal and vertical surfaces should be easy to clean and resistant to chemicals.
Air locks and furniture
Airlocks are critical elements in cleanroom technology, enabling the safe and effective operation of clean rooms through their ability to control contamination and support pressure levels. Of particular importance are electronic locking systems, which ensure important aspects of door functionality, such as mutual locking, recovery times, etc. Airlocks facilitate the flow of personnel and materials for clean rooms (bidirectional or one way flow).
Furniture in clean rooms should offer little deposit opportunities for particles. Seating furniture should be resistant to abrasion. Surfaces made of plastic and stainless steel have proven especially effective thanks to their durability and easy cleanability.