New Cleanroom for the Pharmaceutical Industry: ISO 14644-1 Class 8 with Special Requirements

sphairlab recently installed a new cleanroom for a company in the pharmaceutical industry. The room complies with ISO 14644-1 Class 8 and is used as an airlock to support the cleanliness requirements of the existing cleanroom.

Challenge: Integration and Safety Requirements

The customer needed an airlock that could be seamlessly integrated into its existing cleanroom. Integrating the double-leaf door of the existing cleanroom posed a particular challenge. Additionally, non-combustible materials were required, a requirement that went beyond our standard flame-retardant materials.

Solution: Custom Design and Material Selection

sphairlab developed a custom cleanroom solution featuring hardwall partitions, as is typical for airlocks. The room, measuring 3.5 m in length, 2.5 m in width, and 2.9 m in height, was precisely tailored to the customer’s spatial conditions. A double-leaf door was installed on one side, while the other side was seamlessly connected to the existing cleanroom door. To integrate the existing door,installation work had to be carried out inside the cleanroom, which required one of our employees to wear cleanroom clothing. To meet the stringent fire safety requirements, non-combustible aluminum-steel composite panels were used. In addition, the cleanroom was equipped with calibrated pressure monitoring and an interlocking door system.

Result: A fabric-free sphairlab

The new cleanroom was successfully installed in less than a week and meets all of the customer’s requirements. Thanks to its seamless integration into the existing cleanroom and the use of high-quality, non-combustible materials, it offers a safe and code-compliant airlock solution. The calibrated pressure monitoring and interlocking door system ensure maximum safety and control, while the hardwall walls guarantee the stability and airtightness typical of airlocks.