FAQ

ISO 14644-1 defines cleanroom classes from ISO Class 1 (highest cleanliness) to ISO Class 9 (lowest cleanliness), based on the maximum permissible particle concentration in the air. Here are the limit values for some selected classes:

These values indicate the maximum permissible number of particles per cubic meter of air. For example, ISO class 5 allows up to 3,520 particles with a size of ≥0.5 µm per cubic meter.

A cleanroom is subject to stricter particle concentration controls than a controlled environment. Controlled environments provide a environment with less stringent requirements, suitable for processes that do not require the highest standards of cleanliness.

A cleanroom is a controlled area in which the concentration of airborne particles is minimized. This serves to protect sensitive processes or products from contamination.

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VDA 19 is a guideline issued by the German Association of the Automotive Industry that defines standards for the technical cleanliness of automotive parts. It deals with the particle contamination of functionally relevant components and defines methods for testing technical cleanliness. In the context of controlled environments, VDA 19 describes requirements for clean production in order to minimize particle contamination during production. The environment in which such production takes place is referred to as the cleanliness area and is divided into different levels:

• ‍Clean zone (SaS1): Controlled areas with specific cleanliness requirements.
• ‍Controlled environment (SaS2): Areas with increased cleanliness standards, but not as strict as cleanrooms.
• ‍Cleanroom (SaS3): Areas with the highest cleanliness requirements according to ISO 14644.

This classification helps to implement appropriate particle control measures in production.

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GMP Annex 1 is an annex to the EU GMP guidelines that sets out specific requirements for the manufacture of sterile medicinal products. A central aspect of this is the classification of cleanrooms, which are divided into different classes depending on the required cleanliness:

• Class A: Areas with the highest requirements, such as laminar flow workbenches for aseptic processes.
• Class B: Background areas for Class A zones, typically cleanrooms for aseptic preparation.
• Class C: Cleanrooms for less critical steps in the manufacture of sterile products.
• Class D: Areas for the manufacture of products that are later sterilized.

The particle concentration requirements in these classes are defined both at rest and in operation. For example, in Class A, a maximum of 3,520 particles ≥0.5 µm per cubic meter of air may be present, both at rest and in operation.

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Media such as electricity, data lines or compressed air can be flexibly integrated into the sphairlab rooms as required. For this purpose, there are closable inlets that sphairlab inserts into the shell close to the floor. Of course, additional inlets can be integrated as required. Exhaust air from fume cupboards etc. can also be routed out of the sphairlab using this technology.

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The use of high-performance filter technology and sophisticated air routing ensures that the air quality is constantly maintained at the required cleanliness level. The filter technology is tailored to the cleanroom class or your individual requirements.

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A precisely operating air recirculation system generates a constant overpressure that keeps the textile cover static and ensures even distribution of the filtered air. Exhaust air flaps discharge the contaminated air close to the floor into the room environment. This ensures the air changes recommended by the standard.

The assembly time of a sphairlab cleanroom varies depending on the model and size. The delivery time is around 8 - 12 weeks. The actual assembly of a sphairlab cleanroom on site can take anywhere from several days to a few weeks, depending on the size and complexity of the cleanroom tent.

sphairlab offers solutions for cleanroom classes 5 to 8 in accordance with ISO 14644-1 and for cleanroom classes B to D in accordance with GMP. We also offer cleanrooms in accordance with VDA 19 or rooms that do not have to comply with any standards.

The cleanrooms are equipped with long-life LED lighting, which ensures optimum illumination of the work areas.

sphairlab offers flexible cleanroom and cleanroom solutions, including machine enclosures, which are individually adapted to the customer's needs. Textile materials are used for the walls, ceilings and air ducting. These materials make it possible to manufacture cleanrooms more cost-effectively, ensure rapid availability and offer a high degree of flexibility in terms of design and use.

sphairlab uses high-quality, certified textiles and films that are individually cut to size and offer a wide range of design options. The textiles are woven from a lint-free continuous filament and are flame-retardant.

The cleanrooms from sphairlab can be individually designed to meet specific requirements and offer a modern, functional design. Surfaces can be designed to be transparent or opaque if the cleanroom needs to be darkened. All materials can also be printed.

The solutions from sphairlab are characterized by their flexibility, mobility and cost efficiency. By using textile materials and an intelligent overpressure system, cleanrooms can be set up quickly and relocated to other sites if necessary.

sphairlab is aimed at companies in sectors such as medical technology, academic research and industrial manufacturing that require flexible and efficient cleanroom solutions.

Yes, sphairlab uses existing structures such as existing halls or rooms to realize cleanrooms without costly construction measures.

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Yes, sphairlab has already successfully implemented projects in various industries. Details of specific application examples can be found on the sphairlab website.

Yes, the mobile cleanroom solutions from sphairlab can easily be moved to different locations.

Yes, sphairlab also offers rental solutions that are particularly suitable for temporary projects or changing locations.

Yes, the mobile and flexible cleanroom solutions from sphairlab are ideal for temporary projects and can be set up and dismantled quickly.

By using textile materials and utilizing existing infrastructure, the costs for sphairlab cleanrooms are often lower than for traditional cleanrooms, without compromising on quality. The exact costs depend on the individual requirements, as sphairlab designs the cleanrooms precisely to the needs of the users. Contact us and receive a non-binding offer for your requirements! You can reach us at +49 (0) 163-2518059 or info@sphairlab.com.

The costs vary depending on the specific requirements and project scope. For an individual offer, we recommend contacting sphairlab directly. Contact us and receive a non-binding offer for your needs! You can reach us at +49 (0) 163-2518059 or info@sphairlab.com.

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