Portable Softwall Cleanrooms

Deiiang Portable Softwall Cleanrooms are designable and testable for ISO 5 to ISO 8 classes of airborne cleanliness, in accordance with ISO 14644-1. Tests could include counting particles, checking the integrity of HEPA filters, measuring airflow and verifying the differential pressure. Compliance will depend upon the approved design, method of installation, operational state and site conditions. Project-specific test reports and records of approvals would be provided.

As-built handover could include the classification of airborne particles as defined in ISO 14644-1, testing the integrity of HEPA filters by an approved aerosol method, testing the airflow of each FFU (Filter Fan Unit) and face velocity, airflow rate, differential pressure, temperature, relative humidity, and smoke visualization. Tests are performed using calibrated apparatus and the reports and calibration certificates are included in the handover package.

Class selection is dependant on the process, contamination risk, product requirement, level of occupancy, and applicable regulations. ISO 5 is normally used for higher sensitive particle processes. Configurations from ISO 6 to ISO 8 are used progressively for less critical processes. Deiiang evaluates room dimensions, equipment heat load, personnel, and surrounding environment and advises on the quantity and grade of HEPA filters, airflow rate, layout of FFUs, and the number of filters. The user is responsible for confirming regulations.

Particles are controlled through the use of a ceiling-located fan filter unit (FFU). This unit distributes air through a set of HEPA H13 or H14 filter(s). Airborne particles in the controlled zone are diluted using positive pressure and airflow that moves downwards. This airflow pressurizes the control zone and provides a means for particles to move to designated low level return paths or to the curtain gaps. The precise performance of the cleanroom is evaluated after construction since the cleanliness of the controlled area can be affected by human activity (including door opening and closing) as well as the equipment and background activity in the vicinity.

In order to control static, antistatic PVC curtains can be utilized for applications that require ESD control. To achieve ESD control, the curtains, frame and associated equipment should be bonded and grounded as per the approved ESD-control plan and surface-resistance performance should be as per the specifications. Curtains can also be cleaned using appropriate, low-lint materials and approved cleaning agents. Curtain system material data and test records can be made available upon request.

The cleanroom can be relocated and/or expanded. This involves modulating the length and width of the cleanroom and/or moving the cleanroom to a new location. Before securely relocating the cleanroom, safety procedures must be implemented to disconnect electric supplies from the FFUs, frame and casters. After the cleanroom has been relocated and/or expanded, it is necessary to perform an inspection, clean the cleanroom and assess the airflow to ensure that the specified ISO classification and performance of the cleanroom are not compromised.

Softwall systems mostly control particles. They rely on the host facility for temperature and humidity control. Additional control over temperature, humidity, and dehumidification and humidification systems is available, but would be sized based on a site heat-load and moisture-load assessment. Softwall enclosures are not completely sealed. Therefore, the degree of achieved stability is dependent on the room, the process, and how frequently the enclosure is accessed.

Curved airflow distribution units (FPUs) and cleanroom curtains need to be cleaned on a regular basis. The pre-filters, filters, gaps between the curtains, curtain thermal breaks, and position and clearance of the curtains need to be inspected. The casters and brakes need to be checked, along with the wiring, lighting, and grounding. HEPA filters need to be checked and the airflow of the FPU needs to be inspected. The curtain fabric needs to be classified. HEPA integrity and airflow, pressure drop, and protective seals tests need to be done in accordance with the site quality plan and to validate the cleanroom after major repairs and filter replacement.

Deiiang can provide replacement/spare parts of all the components of the supplied system, including FPUs, curtain sections, luminaires, control parts and caster assemblies, control parts, and FPU components. Preventive maintenance, safety checks, and remote technical support can be done according to the service contract. Spare parts and maintenance schedules are included in the installation manual.

Yes. Depending upon the agreed project scope, the documentation package can include approved drawings, equipment specifications, filter certificates, material data sheets, operation and maintenance manuals, instrument calibration certificates, airborne-particle results, HEPA integrity reports, airflow and pressure records and a summary of the commissioning. For regulated applications, documented responsibilities should be agreed upon prior to the manufacturing of the equipment.

A portable softwall cleanroom provides localized control of particles, but this does not provide suitability for aseptic or sterile processing. These processing activities require a documented strategy for controlling contamination, microbial control, qualified cleaning and disinfection, personnel control, and a Commitment to fulfill GMP or regulatory requirements. Deiiang can provide the enclosure to support a defined process. However, this must be confirmed by a project specific assessment and a qualification program.

Deiiang provides design of cleanrooms, construction, selection of filters, guidance for cleanroom installation, performance testing, and documentation. Recommendations are provided based on the process risk, size and occupancy of cleanrooms, equipment to be housed in the cleanroom, and the conditions of the client's facility, rather than a generic design. Customers can evaluate careful acceptance criteria and documented performance prior to being handed over to the client.