2, the scope of application: applicable to the daily cleaning of the drawing and filling machine.
3, the responsible person: the person in charge of the process, quality control, job operators.
4, the content of the regulations:
4.1 cleaning conditions and frequency:
4.1.1 implementation conditions: after the end of each shift; equipment maintenance; more than the cleaning of the period of validity of re-use.
4.1.2 Cleaning period: 48 hours.
4.2 Cleaning scope:
4.2.1 Filling and sealing machine exterior: panel, fixed tooth plate, drive tooth plate, hopper, pulling components, filling components.
4.2.2 Medicine delivery system: reservoir bottle, piston, pump, buffer ball, silicone tube, tee, needle and so on.
4.3 Cleaning location: in situ cleaning, movable (disassembly) equipment should be in the cleaning room.
4.4 Cleaning tools: rags, brushes, tweezers.
4.5 Cleaner and its preparation: water for injection.
4.6 Cleaning procedures:
4.6.1 Machine exterior, after the end of the day's work, use tweezers to pick up the glass chips stored in the crevice. Transmission tooth plate, fixed tooth plate, panel, lower hopper, discharge hopper, etc. with a rag to wipe clean, if there is a medicine sticking to the injection of water to wipe clean repeatedly.
4.6.2 Conveying liquid system
4.6.2.1 Remove the storage bottle, piston, pump, buffer ball, tee and other glass products, rinse with water injection, drain and soak with 1% sodium hydroxide solution (or vibration) for 15 minutes, then rinse the wash solution with water injection, and then rinse with water injection 3 times.
4.6.2.2 Remove the silicone tubing and needle, and rinse them out repeatedly with water for injection.
4.6.2.3 Put the rinsed parts and silicone tubing in the designated location in the cleaning room or in a container with a lid for proper storage and spare.
4.6.2.4 Before the next shift of work, use 0.1Mpa, 121 ℃ steam to sterilize the parts and silicone tube for 15 minutes, after installation, rinse with water for injection for 5 minutes.
4.6.2.5 New reservoir bottle, piston, pump, buffer ball, tee treatment method, according to 4.6.2.1 method.
4.6.3 After cleaning, wipe the surface of the equipment with a clean rag.
4.6.4 Disinfect the equipment with a disinfectant at regular intervals as specified.
4.7 Cleaning, drying and storage of cleaning tools: Follow the "Clean Area Cleaning Procedures".
4.8 Evaluation of cleaning effect: clean, no foreign matter.
4.8 Evaluation of cleaning effect: clean, no foreign matter.