How to install five-axis servo manipulator in medical supplies injection workshop?

Complete installation scheme of five-axis servo manipulator in medical supplies clean injection workshop (suitable for GMP/ISO13485, 10,000-class/100,000-class clean area)

The core differences of medical workshop are dust-free and oil-free construction, air source sterilization and filtration, clean wiring, hard safety interlock, full-process verification documents, additional A/B rotation axis calibration and anti-rotation interference design for five axes.

First, the pre-installation preparation (clean area front, top priority)

1. Site environment and foundation acceptance

1) Clean area standard

Class8 (class 100,000) /Class7 (class 10,000) injection clean area, shut down before installation, and completely disinfect with ozone/alcohol; The installer shall wear dust-free clothes, shoes and gloves, and the tools shall be wiped with isopropanol in advance to remove oil and dust.

The manipulator body, fixture and guide rail are packed cleanly in the factory, and the unpacking is only in the clean area; Ordinary carbon steel fittings and butter exposed parts are prohibited from entering the clean area.

2) Ground and load bearing

C25 concrete on the ground is more than or equal to ≥150mm, and the flatness error is less than or equal to 2mm/m; A heavy-duty five-axis manipulator (≥600kg) is used as a reinforced concrete embedded base, embedded with anchor bolts, and equipped with shockproof stainless steel shim (to prevent vibration and dust).

The distance between machines is ≥800mm, there is no interference from columns, pipelines and safety doors within the rotation radius of the manipulator, and the maintenance channel is ≥80cm.

3) Pre-configuration of power and air source (special for medical treatment)

Power supply: three-phase 380 V 5% independent circuit, independent grounding electrode, grounding resistance ≤ 4 Ω; The control cabinet IP54 is clean and dustproof, away from the mold temperature machine and the heat source of the barrel.

Compressed air: the main pipeline is equipped with three-stage precision filtration+freeze dryer+sterile sterilization filter, and the output is clean, oil-free and water-free, with a stable air pressure of 0.5–0.7 MPa; All 304 stainless steel pipes in the gas circuit are prohibited from precipitating contaminated products from ordinary plastic hoses.

4) Equipment matching check

Check the clamping force, mold opening stroke and bulk modulus of the injection molding machine, and the five-axis stroke covers the action of taking parts+rotating disk/insert; More than 15% redundancy is reserved for the load (lightweight sucker for medical thin-walled parts).

Confirm that the injection molding machine has a standard I/O manipulator interface, and a special isolation signal module is required if there is no interface (to prevent interference).

2. Clean pretreatment of tools and materials

Tools: torque wrench, precision frame level meter, laser locator, dust-free paper, 75% isopropanol, clean cable tie, stainless steel bolt (grade 8.8), silicone gasket, clean shielded cable.

Manipulator accessories: five-axis servo host, control cabinet, teaching device, A/B rotating shaft module, medical silicone sucker/316 stainless steel jaw, clean drag chain, and sterile tracheal connector.

Second, the mechanical body installation (five-axis servo special, clean and dust-proof construction)

Step 1: Hoist in place and fix it with the base (cross the top-mounted/side-mounted mainstream)

1) Hoisting: Dust-free slings are used in the clean area, and wire ropes are prohibited from directly contacting the fuselage; Immediately after unpacking, wipe the whole machine with a dust-free cloth to remove ex-factory antirust oil and dust.

2) Fixed mode

Top loading (mainstream of horizontal injection molding machine): reinforce the bearing capacity of the top beam of injection molding machine, fasten the base with bolts above 6 o'clock, and install stainless steel shock pad;

Side-hanging type: fixed on the support seat outside the fixed template, all 8.8-grade stainless steel bolts, diagonally locked in stages, with standard torque of 35-50 nm.

3) Horizontal calibration (key to five-axis accuracy)

The base of the precision level meter is X/Y bidirectional, and the horizontal error is ≤ 0.3 mm/m; Laser calibration Z axis vertical, A/B rotation axis rotation center verticality ≤0.1mm/m, to prevent the deviation of rotary pickup from scratching medical thin-walled parts.

Step 2: Assemble the five-axis arm body and the rotating shaft module.

1) Assemble the main transverse X axis, the pulling Y axis, the upper and lower Z axes, the rotating A axis and the turning B axis in sequence (five-axis core double rotating module); Fill the slide block of guide rail with food medical grade dust-free grease, and ordinary butter is strictly prohibited.

2) Install a clean and closed towing chain, with cables and windpipes built into the towing chain, and there is no exposed dust dead angle; Both ends of the towing chain are sealed and dustproof to prevent debris from falling off the mold and products.

3) Installation of end fixture: medical silica gel sucker/316 stainless steel clamping jaw, with pressure detection sensor installed to prevent the needle cylinder, catheter and shell medical parts from being pinched; The fixture has no dead angle, which is convenient for daily wiping and disinfection.

Step 3: Mechanical interference preview (five-axis required)

Manually push each shaft to the limit travel, completely simulate the full range of A-axis rotation of 90 and B-axis turnover of 60, check: the interference of tie rod, mold, hot runner, safety door, conveyor belt and charging barrel, mark obstacles and adjust the installation position.

Three, electrical system installation (clean wiring+injection molding machine hard interlock, medical safety mandatory requirements)

1. Control cabinet layout and main power supply access

1) The control cabinet is placed in the buffer room outside the clean area/in the dust-free area on the side of the machine to avoid high temperature and dust; The bottom of the cabinet is sealed, and the cable goes in and out.

2) Connect 380V three-phase power, and separate leakage protection switch; The 24V control loop is isolated independently, and the single-ended shielded wires of all motors and encoders are grounded to eliminate electrostatic dust adsorption (10 ~ 10Ω is required for antistatic medical parts).

2. Wiring specification for clean area

The cable adopts PU clean shielded cable, adopts closed stainless steel trunking, and the joints of trunking are sealed with silica gel; The cable is fixed with white clean tie, and there are no sharp edges and corners of bare metal.

Five-axis and more than two groups of rotating shaft servo power lines and encoder signal lines are routed separately, and strong and weak current are isolated in layers to avoid rotation positioning drift caused by signal interference.

3. I/O hard wiring interlock of injection molding machine (GMP mandatory, only software linkage is prohibited)

8 channels of core 24V interlocking signals must be connected one by one, and the on-off test shall be conducted:

Injection molding machine → manipulator: signal of mold opening completion, signal of safety door closing, and ejector pin returning to position.

Manipulator → injection molding machine: parts are taken, there is no arm signal in the mold, and the machine stops due to failure.

Two-way intercommunication: global emergency stop and alarm output.

The communication is equipped with Profinet/RS485, which synchronizes the five-axis rotation posture sequence and adapts to the multi-cavity and insert implantation process.

4. Safety circuit wiring

The emergency stop, safety light curtain, soft limit and hard limit of the whole machine are connected in series; If it is triggered at will, all servos of the manipulator will stop immediately, and synchronous locking of the injection molding machine is prohibited.

Four, pneumatic system installation (special medical sterile gas source)

1) The main air source is connected to the sterile filter, and all the 304 stainless steel quick-plug connectors of the trachea are sealed without leakage; The pipeline runs away from the high temperature area of the mold to prevent the pipeline from precipitating.

2) The shunt is equipped with a miniature pressure regulating valve, so that the suction cup/gripper pressure can be adjusted independently, and the pressure is stable at 0.5–0.6 MPa; Each road is equipped with a small oil-water separation cup, which discharges pollutants every day.

3) After the gas path is assembled, ventilate with no load for 30 minutes to purge the impurities in the pipeline, and then connect the manipulator body to prevent particles from entering the clean area and polluting the products.

V. Power-on, servo origin calibration and single machine debugging (five-axis and two-axis focus)

1. Insulation inspection before power-on

Use multimeter to measure the insulation between power line and ground ≥1MΩ, and confirm that there is no short circuit or wrong wiring; Switch on the power supply after the air pressure is stable and there is no leakage.

2. Servo return to origin and five-axis precision calibration

1) The servo is powered on, and the five axes of X/Y/Z/A/B perform mechanical origin regression in turn, and confirm that the hard limit and soft limit of each axis are effective, and the alarm pops up normally.

2) The repeated positioning accuracy of laser locator calibration: the linear axis is ≤±0.05mm, and the angle error of A/B rotation axis is ≤ 0.1, which meets the requirements of high-precision medical parts retrieval.

3) Manually test the single-action and compound linkage of each axis independently, without jitter, abnormal sound and servo overload; The rotating shaft starts and stops at a uniform speed without inertia deviation.

3. Functional test of end fixture

Air leakage detection of vacuum sucker and pressure feedback test of clamping jaw; Install a real blank alarm, stop immediately if the product is not sucked, to prevent the empty mold from closing and damaging the mold.

Six, injection molding machine linkage teaching and machine test run (clean no-load first)

1) empty mold teaching (no product)

Calibration in sequence: in-mold safety point, taking down point, suction confirmation point, rising and withdrawing point, A-axis rotation posture, B-axis turnover angle, conveyor belt placing point and intermediate transition avoidance point; Run in one step at low speed all the way, and repeatedly confirm that there is no collision.

2) Timing linkage debugging

Match the timing of mold opening and closing and ejection of injection molding machine, optimize the speed of five-axis rotation, and do not lengthen the injection cycle; Set interlocking logic: the manipulator does not completely exit the mold cavity, and the injection molding machine cannot close the mold.

3) Verification of trial production with materials

Continuously run 30–50 molds, and observe: no parts are dropped, no scratched products and no dust falls; The temperature rise of servo motor is ≤40℃, and the air pressure and current are stable.

Seven, clean area ending, disinfection and GMP verification document delivery

1. Clean the site.

1) Dismantle construction waste, packaging and iron filings, and move them out of the clean area; Slot and base gap shall be completely wiped and disinfected with dust-free cloth and isopropanol.

2) The exposed metal parts shall be sprayed with clean antirust coating, and all lubricating points shall be covered with dust covers; Arrange cables and windpipes, and fix them neatly without messy dust dead ends.

3) Post safety warnings, emergency stop signs and equipment operation instructions, and reserve maintenance operation space.

2. Complete set of verification data (IQ/OQ necessary for medical device production)

1) Mechanical installation records: base level calibration data, bolt torque records, and rotating shaft accuracy test report;

2) Electrical wiring diagram, I/O interlock test record form and grounding resistance test sheet;

3) Air source cleanliness detection and air pressure stability record;

4) Five-axis repeated positioning accuracy calibration certificate and continuous trial production operation record;

5) Equipment maintenance manual, clean maintenance specification and spare parts list.

Eight, medical workshop installation special taboo (GMP red line)

Ordinary butter, carbon steel screws and recycled rubber pipes are prohibited from entering the clean area;

Hard-wire interlocking shall not be omitted, and only communication signals shall be used for linkage;

Dust-free protection is not done during installation, and construction dust remains on guide rails and molds;

The five-axis rotation space is not reserved, and the pull rod and the safety door collide during operation;

The air source is not sterilized and filtered, and the compressed air pollutes medical plastic parts;

Direct mass production without calibration of accuracy leads to batch scratches and poor dimensions.

Nine, daily cleaning and maintenance supporting (installation synchronous planning)

Wipe the guide rail and towing chain with dust-free cloth every day; Weekly replenishment of medical grade grease;

Replace the filter element of sterile air source filter regularly and record it;

The fixture is wiped and disinfected with 75% alcohol per shift, and there is no dead angle of material accumulation;

The control cabinet is periodically purged to dissipate heat, so as to keep the pressure difference in the clean area stable.