What are the requirements for the cleanliness of the construction site for the installation of pure steam pipelines? ​

Pure SteamIt is used for SIP online sterilization of equipment and disinfection and sterilization of sterile appliances. Ra of the inner wall of the pipeline is ≤ 0.4 μ m. If construction dust, oil stain and metal debris fall into the pipe, it will cause steam pollution and microbial breeding. It is divided into three types of cleaning standards: prefabrication area, clean area on-site installation area, and ordinary sandwich construction area. Detailed rules for temperature and humidity, isolation, and personnel management and control are provided.

1、 Pipeline prefabrication workshop (cutting, cutting, prefabrication welding)

Air cleanliness standards

Static control ISO8 level (10000 level): particles ≥ 0.5 μ m ≤ 352000 particles/m ³, no obvious dust; It is strictly prohibited to work on the same site as cutting and polishing carbon steel and cast iron, and to prevent cross contamination of stainless steel pipes by iron filings.

Environmental temperature and humidity: temperature between 5-35 ℃, relative humidity between 40% and 65%; The local humidity in the argon arc welding area is 60% to 90%, and the ambient wind speed is less than 2m/s. It is windproof and rainproof to avoid oxidation and blackening of the weld seam, which may result in residual oxide skin inside the pipeline.

Ground and venue: Lay rubber/anti-static PVC soft cushions, with no dust, water, or engine oil accumulation on the ground; The pipes should be stored at a height of 50-100mm above the ground, and the pipe openings should be sealed with clean plastic plugs as they are cut. The entire process should be sealed and protected.

Tool control: exclusively for pipe cutting machines, flat mouth machines, and grinding wheels, without mixing carbon steel processing tools; Wipe the tool with isopropanol to remove oil and dust before use.

2、 Installation in GMP cleanroom (B/C/D cleanroom piping)

1. Cleanliness matching requirements

Installation in D-level clean area: on-site static compliance with ISO7 level (10000 level);

Installation of B/C level sterile area: After temporary construction enclosure, the local ISO5-6 level (hundred/thousand level) will be maintained. During construction, the clean area will have a positive pressure of 5-10 Pa relative to the non construction walkway to prevent the backflow of dirty air from the outside and the introduction of dust.

2. Environmental hard indicators

1) Temperature and humidity: 18-26 ℃, RH45%～60%， Wipe the floor and fence with 75% alcohol before and after daily construction for disinfection;

2) Partition isolation: Use dust-proof curtains and temporary color steel plates to build independent construction buffer enclosures to isolate ordinary civil engineering and electrical operations; The entrance is equipped with sticky dust mats and a temporary changing area.

3. Personnel Cleanliness Management

Construction personnel shall replace their one-piece clean clothes, dust-free gloves, and masks, and enter the site after being exposed to air for at least 30 seconds; Do not wear jewelry or watches, and do not touch the inner wall and sealing surface of the pipeline with bare hands.

3、 Technical mezzanine and suspended ceiling construction (non clean area, general standard for mezzanine)

The interlayer does not have GMP cleanliness level, but follows low dust operation standards:

The construction of sandwich civil engineering, insulation, and steel structure should be completed in advance and cleaned for dust removal. Pure steam piping can only be carried out 72 hours after completion;

Install a mobile negative pressure dust removal device during homework, collect cutting and polishing dust in real time, and prevent dust from drifting into open pipes;

Pipeline opening and sealing shall only be welded on the same day, and the pipe mouth shall be immediately sealed upon shutdown.

4、 General mandatory control points (applicable to all construction sites)

Pollution source ban

Hot work for rust removal, cement polishing, painting, and mechanical cutting of carbon steel are prohibited in the construction area; Oil stains, coatings, and construction waste should be kept away from the pipe stacking area to prevent volatile substances from adhering to the pipe wall and forming organic pollution in the later stage.

Pipe protection

Finished pipe fittings and valves have no damage to the factory protective film, and unpacking is only done at the moment of construction; After unpacking, if the inner wall is contaminated with dust, it should be wiped with anhydrous ethanol, dried with clean and dry air, and then assembled.

Temporary protection upon completion

All pipe openings that were not welded and completed on that day were sealed and blocked; Before the system pressure test and purging, the entire process should be sealed to prevent environmental dust from entering the pipeline.

5、 Quality hazards caused by non-compliance

Excessive dust on site → Welding slag and particulate matter retained in pipelines → High temperaturePure SteamWash off and contaminate sterilized products; Environmental oil pollution exceeds the standard → organic residue on the pipe wall → high-temperature carbonization breeds heat sources and endotoxins, resulting in GMP acceptance failure and pure steam quality exceeding the standard.