What should be paid attention to when installing injection manipulator in injection molding of medical supplies?

The core of the manipulator for injection molding and installation of medical supplies is cleanliness and compliance, stable precision, safety interlock, material and seal adaptation, and strictly follows GMP and ISO 13485 requirements.

First, clean environment and compliance requirements (medical industry first)

Cleanliness level matching: the installation area must meet the cleanliness standards of Class 100,000 (ISO 8) and above; The manipulator body, fixture and cable must be dust-free, oil-free and debris-free, and wiped and disinfected with a dust-free cloth and isopropanol before installation.

Material and seal:

Parts in contact with products/clean areas: 304/316 stainless steel, medical-grade PEEK, food-grade silica gel, carbon steel/ordinary rubber is strictly prohibited.

Protection grade: IP54 and above for arm and control cabinet, dustproof, waterproof and corrosion-proof; Clean-grade polyurethane sheath for cables to avoid precipitates.

GMP and verification: Installation and debugging documents, I/O linkage records and calibration certificates shall be complete; The accuracy of repeated positioning is ≤±0.02mm, and IQ/OQ/PQ verification is required for key processes.

Second, pre-selection and space matching

Load and stroke:

Rated load ≥ actual grab weight ×1.2 (including product+nozzle+fixture).

Travel coverage: X axis ≥ pull rod spacing, Y axis ≥ outside of safety door, Z axis ≥ mold opening travel+picking height.

Installation method:

Horizontal machine priority side hanging type (not occupying clean passage); Overhead clearance height ≥ standby height+300mm.

Manipulators of adjacent machines are in the same direction, with a distance of ≥800mm, and there is no interference in their actions.

Space and channel:

There is no interference of columns, beams and conveyor belts within the range of motion; Maintenance channel ≥80cm.

Ground bearing: C25 concrete ≥150mm thick; Heavy machinery (> 500kg) is used as reinforced concrete foundation.

Three, electrical and pneumatic installation specification

Electrical system:

Power supply: three-phase 380 V 5%, 50Hz；; Control 220 v; Grounding resistance ≤4Ω, independent grounding electrode.

Signal linkage: hard interlock with I/O of injection molding machine (after mold opening, ejection, safety door and emergency stop); When the fault occurs, both parties stop the machine synchronously and give an alarm.

Cable: clean shielded wire is used in clean area, and the trunking is sealed to prevent dust accumulation; The control cabinet is far away from heat source/dust.

Pneumatic system (medical grade):

Air source: 0.5–0.7 MPa stable, dry, oil-free and sterile; Equipped with three-stage filtration+dryer+sterilization filter.

Fixture: vacuum sucker (medical silica gel) or stainless steel jaw; The pressure sensor monitors the clamping force, and the error is less than or equal to 5%, so as to prevent the product from being pinched.

Four, mechanical installation and precision calibration

Base and fixing:

The side hanging bracket is fastened diagonally with 8.8-grade high-strength bolts, and the torque reaches the standard; The flatness of the mounting surface is ≤ 0.1 mm/m.

Horizontal calibration: adjust it to **≤0.02mm/m** with a precision level, and it will run without jitter.

TCP and precision calibration;

Tool center point (TCP) calibration: three-point method/laser tracker, with deviation ≤ 0.005 mm.

Repeated positioning accuracy: No-load/Full-load shall be measured 10 times, ≤±0.02mm, and the records shall be filed.

Anti-collision and safety:

Full-stroke manual teaching, confirm that there is no interference with the mold, pull rod and safety door; Enable servo anti-collision (torque overload shutdown).

Safety door interlock: when the door is opened, the manipulator stops immediately; The emergency stop button has two circuits, one for the control cabinet and one for the operation box.

Five, the main points of exclusive debugging of medical products

Pick-up and attitude:

Thin-walled/transparent parts: vacuum sucker is used, and the adsorption area is ≥ 1/3 of the product, so as to prevent deformation/scratch.

Insert/precision parts: secondary positioning+visual verification to ensure position accuracy.

Action sequence: mold opening → ejection → taking parts → turning (if necessary) → placing parts → resetting, which is synchronous with injection cycle and ≤ cycle.

Cleanliness and pollution prevention:

Oil-free design: servo motor/guide rail has no oil lubrication or food-grade grease to prevent oil mist pollution.

Debris control: clean the fixture/sucker regularly; The moving parts are sealed and dustproof to prevent dust from falling off the product.

Failure and traceability:

Alarm function: stop the machine immediately if it is not in place, the parts are dropped, the air pressure is abnormal, and the screen displays the fault code.

Data traceability: linked with MES of injection molding machine, recording the picking time, batch and yield to meet the requirements of medical traceability.

VI. Acceptance and Daily Maintenance

Acceptance criteria:

Idle for 2 hours: no abnormal sound, jitter and oil leakage; Accuracy is up to standard.

Trial production for 24 hours: yield ≥99.9%, no scratches/deformation/pollution.

Complete documents: installation drawing, wiring diagram, calibration record, verification report and operation SOP.

Daily maintenance (clean area):

Daily: clean the fixture/sucker and check the air pressure and interlock; Wipe the surface of the manipulator with a clean cloth and isopropanol.

Weekly: lubricate the guide rail (no oil/food grade), calibrate TCP, and check the bolt torque.

Monthly: comprehensive cleaning+disinfection, backup parameters and check safety interlock.

Seven, taboo and red line

Ordinary carbon steel, rubber and oil-bearing parts are prohibited from entering the clean area.

Do not do TCP calibration during installation or force mass production when the accuracy is not up to standard.

Not hard interlocking with injection molding machine, only software linkage.

The air source is not filtered and sterilized, and directly connected to the pneumatic fixture.