What are the requirements of automatic sandblasting machine for medical products?

Medical products (especially implants, orthopedic/dental instruments) are selected by automatic sandblasting machine, the core of which is clean material, fully enclosed negative pressure, precise and controllable, verifiable and traceable, in line with ISO 13485 and clean workshop requirements, and general industrial machines can never be used.

First, material and structure: medical grade clean without dead ends.

Fuselage/cavity: 304/316L stainless steel must be used, with polished inside and outside, no weld/dead angle/burr; Carbon steel plastic spraying is prohibited (easy to rust and chip off).

Detachable and easy to clean: the cavity, spray gun, abrasive bin and pipeline are quickly disassembled without tools, which is convenient for sterilization and verification; There is no dust groove inside and no bolts exposed.

Sealing and negative pressure: totally enclosed+continuous negative pressure (-5~-10Pa) to prevent dust from overflowing and polluting the clean workshop; Door-controlled interlock, stop immediately after opening the door.

No peeling on the surface: all seals, pipelines and filters are medical grade (such as silicone rubber and PTFE), and there is no precipitation or chip drop.

Second, gas path and abrasive: no oil, no water and no residue.

Quality of gas source: oil-free, water-free and sterile, dew point ≤-40℃, oil content ≤ 0.1 mg/m, with three-stage filtration+activated carbon+sterilization filtration.

Abrasive specifications: medical grade only-white corundum (high purity Al₂O₃), glass beads (lead-free soda-lime-silica), alumina and zirconia; Quartz sand, river sand and ordinary steel sand are prohibited.

Abrasive recovery and screening: closed-loop recovery+multistage screening (≥3 grades) to eliminate broken/polluted particles; Prevent mixing, residue and cross-contamination.

Anti-residue design: the spray gun nozzle is wear-resistant tungsten carbide with accurate angle; The cavity is streamlined and has no dead angle of sand accumulation; Equipped with high pressure blowback+self-cleaning.

Third, process control: precise, stable and repeatable

Programmable parameters: pressure (0.1–0.8 MPa), time, distance, angle and rotation speed can be accurately controlled, and the program can be stored/called/traced.

Roughness consistency: Ra/Rz tolerance ≤ 0.2μ m; Equipped with on-line roughness monitoring (optional), suitable for medical materials such as titanium alloy, PEEK, cobalt chromium molybdenum and zirconia.

Uniformity: multi-axis linkage (3–6 axes), automatic positioning of spray gun, workpiece rotation/translation; No blind area, no spray, no missed spray.

Batch stability: continuous production parameter drift ≤ 1%; The abrasive flow is stable, and the pressure fluctuation is ≤±0.02MPa.

Fourth, dust removal and environmental protection: adaptation of clean workshop

Efficient filtration: the dust removal system is equipped with H13/H14 HEPA+activated carbon, and the dust emission is ≤ 0.3 mg/m, 99.97% @ 0.3 μ m..

Quiet and low vibration: noise ≤65dB, vibration ≤0.1mm, suitable for class 10,000/class 100,000 clean workshops.

Dust does not dye back: negative pressure+independent exhaust, filtered air will not be discharged to the workshop to prevent secondary pollution of the workpiece.

V. Compliance and Verification: Meet the requirements of ISO 13485/SFDA.

Complete documents: provide verification documents of DQ/IQ/OQ/PQ, material certificate, abrasive MSDS and filter integrity test report.

Traceability: PLC has a data log to record the parameters, time, operator and equipment status of each batch; Support audit trail.

Safety compliance: in line with ISO 13485, YY/T 0287 and JB/T 14168；; CE/FDA certification (export demand).

Sterilization compatibility: the external surface of the equipment can be autoclaved at 121℃ or wiped with 75% alcohol; Electrical protection IP65.

6. Automation and adaptation: Seamless docking of production lines

Automatic loading and unloading: adapt to manipulator/assembly line, quick change of workpiece positioning fixture+error prevention.

Intelligent monitoring: touch screen+remote monitoring, fault alarm (abnormal pressure, gun blocking, filtration failure), automatic shutdown protection.

Small batch and multi-variety: one-button program switching, rapid tooling replacement, adapting to implants, dentistry, orthopedics, minimally invasive instruments and other categories.

VII. Absolute prohibitions

Carbon steel fuselage, common paint/plastic spraying

Open cavity, no negative pressure and dust overflow.

Ordinary abrasives (Shi Ying, river sand, steel sand)

The parameters are uncontrollable and there is no data traceability.

No verification document, unknown material