Orbital shakers in GMP cleanrooms: design choices that reduce particles

Cleanroom orbital shaker selection starts with particle emission control

A cleanroom orbital shaker must support strict maximum particle counts in the room. Personnel are the biggest particle source, however equipment is the second. Poor design can increase passive dispersion and actively generate new airborne particles during operation. Since clarified rules emerged in 2016, equipment suitability must be assessed under normal operating conditions. Therefore, measuring released airborne particles is essential for compatibility. For relevant solutions, see Shaking and Mixing.

Cleanroom orbital shaker: request ISO 14644 and VDI 2083 test proof

Not all orbital shakers are suitable for ISO Class 5 cleanrooms. Therefore, you should request documentation proving testing per ISO 14644 and VDI 2083. Testing includes visual inspection and then emission measurements. Particle counts for sizes ≥ 0.1 µm per m³ are assessed. Results are evaluated against allowable concentrations from 0.1 µm to 5.0 µm. With this data, ISO class compatibility can be established. The image caption on page 2 highlights particle hot spots such as edges, seals, and openings.

Materials and construction drive cleanability and shedding risk

The standards emphasize optimal design to achieve low particle emission. Therefore, stainless steel is preferred due to lower electrostatic properties. This reduces particle sticking on surfaces. In contrast, plated, painted, or coated steel can shed particles. These surfaces are also more burdensome to clean and sterilize. The photos on page 2 also show rounded corners and a touchscreen interface as cleanability-friendly elements.

Sealed electronics and fewer wear components reduce new particle generation

Beyond materials, internal architecture matters. A sealed electronic system helps reduce risks during spraying and wiping. Moreover, fewer components such as seals or ball screws reduce active airborne particle generation. Consequently, the shaker contributes less to the whole-room particle count. Support this with routine checks via preventive maintenance.

Fast disassembly enables frequent cleaning and better reproducibility

A cleanroom shaker should be easy to clean and disinfect. Therefore, platforms and clamps should be easy to remove. Hidden areas, such as under the platform, must be accessible for cleaning. This reduces particle accumulation and contamination hiding places. Infrequent or delayed cleaning can negatively affect reproducibility. Therefore, align SOP execution with service and maintenance. For more guidance, see Shakers and mixers for laboratories.