SOP for Collapsible Tube Filling Machine

Standard operating procedure of Collapsible Tube Filling Machine.

1.0 AMAÇ:

To set forth the Operating Procedure of Collapsible Tube Filling Machine used for filling semi solid dosage forms such as creams, ointments, gels, and pastes into aluminum, laminate, or plastic tubes.

2.0 KAPSAM:

This Procedure covers the Operating Procedure of Collapsible Tube Filling Machine used in the semi solid production section of the plant.

3.0 SORUMLULUK:

Tube Filling Operator & Production Executive

4.0 SORUMLULUK:

Production Department Head.

5.0 İŞLEM:

5.1 Tour the tube filling area and examine the machine body. Confirm that the “CLEANED” tag is secured on the unit before start of work.

5.2 Enter the start up details in the Equipment Usage Sheet. Fill in the operator name, the product name, the batch number, the date, and the clock in time.

5.3 Lift off the “CLEANED” tag and put up the “UNDER PROCESS” tag in its place.

5.4 Secure the Line Clearance approval from In Process Quality Assurance (IPQA). The run must wait until the approval paper arrives at the machine.

5.5 Safety Points:

5.5.1 The tube hopper holds product at an elevated temperature for creams and ointments. The jacket runs at 40 to 70°C depending on the product grade. Do not touch the hopper wall with bare hands during operation.

5.5.2 The crimping jaws close with significant force. Keep fingers clear of the jaw zone at all times. The jaws can clamp shut in under half a second.

5.5.3 The orientation station has sharp edges and spring loaded fingers. Never reach into the orientation pocket while the turret is rotating.

5.5.4 Hot air sealing units produce air at 250°C or higher. The hot air nozzle stays hot for several minutes after shutdown. Mark the area with a hot surface sign.

5.5.5 Be aware of pinch points around the tube tray and the indexing chain. Loose hair, lab coat sleeves, or jewelry can get caught in moving parts.

5.5.6 Do not clean the electrical panel with any wet cloth. Water entry can short the control board and trigger false alarms.

5.5.7 Trip hazards are common near the tube tray load point. Keep the floor around the loader clear of empty cartons and packing waste.

5.5.8 The required PPE for this machine is a lab coat, heat resistant gloves for hopper handling, safety glasses, closed toe shoes, and a hair net. Add a dust mask when the product generates airborne particles.

5.5.9 Perform the safety tests below on a weekly basis and file the results:

5.5.9.1 Flip the main isolator and check that the HMI screen goes blank within five seconds.

5.5.9.2 Press the emergency stop mushroom head. The turret must lock in place within a quarter turn.

5.5.9.3 Lift each safety cover one at a time. Opening any cover should trigger the interlock and halt the drive.

5.5.9.4 Verify that the two hand anti tie down control on the tray loader works as designed.

5.5.9.5 Sign the Weekly Safety Log after each complete round of checks.

5.6 Machine Setup:

5.6.1 Tube Loader and Tray:

5.6.1.1 Empty tubes arrive from the supplier in fiberboard trays. Each tray holds between 144 and 288 tubes depending on the tube size.

5.6.1.2 Transfer the tray onto the loader bed at the rear of the machine. Align the tray so the tube necks face toward the pickup arm.

5.6.1.3 The pickup arm uses vacuum cups to lift one tube at a time from the tray. Check the vacuum gauge on the side panel. A reading below 400 mm Hg means weak suction.

5.6.1.4 Confirm that the tube diameter in the tray matches the recipe setting on the HMI. A size mismatch will cause the arm to drop the tube during transfer.

5.6.1.5 Remove any deformed or dented tubes by hand before they enter the turret. Damaged tubes cause jams in the orientation station.

5.6.2 Tube Orientation and Eye Mark Reader:

5.6.2.1 Printed tubes carry an eye mark that sets the alignment of the front design. The machine must orient each tube so the artwork faces the right direction before the seal step.

5.6.2.2 The orientation station uses an optical sensor to find the eye mark. The sensor lens must be clean and free of product residue.

5.6.2.3 Teach the sensor the eye mark pattern at the start of each batch. Hold one correctly oriented tube under the sensor and press the Learn button.

5.6.2.4 Test orientation on five tubes in manual mode. Each tube should end up with the artwork facing forward before the filling step.

5.6.2.5 Adjust the rotation speed of the orientation cup if tubes come out misaligned. A slow rotation can miss the eye mark. A fast rotation can overshoot the target position.

5.6.3 Product Hopper and Jacket:

5.6.3.1 The product hopper is a jacketed stainless vessel with a capacity of 20 to 50 liters. The jacket circulates warm water to keep semi solid products at the fill temperature.

5.6.3.2 Connect the water jacket lines to the temperature control unit. Set the target temperature based on the product bulletin for your batch.

5.6.3.3 Load the product into the hopper through the top lid. Use a clean stainless scoop or a product transfer pump. Do not overfill past the maximum level line.

5.6.3.4 Start the hopper stirrer at slow speed. The stirrer breaks up any lumps and keeps the product consistent during the run.

5.6.3.5 Allow 15 to 30 minutes for the product to reach fill temperature before the first tube enters the machine. A cold product cannot fill evenly.

5.6.4 Fill Nozzle and Dosing System:

5.6.4.1 The fill nozzle enters the tube through the open back end. The nozzle lowers into the tube, dispenses the dose as it rises, and withdraws with a suck back action.

5.6.4.2 Set the fill volume on the dosing screen. The range runs from 2 grams to 150 grams depending on the machine model and nozzle set.

5.6.4.3 The suck back function pulls product up into the nozzle at the end of each fill. This action prevents tail strings and product drips on the outer tube.

5.6.4.4 Match the nozzle diameter to the tube opening. A nozzle that is too wide will scrape the tube walls. A nozzle that is too narrow will splash product at high speed.

5.6.4.5 Center the nozzle over each tube cup on the turret. An offset nozzle will bend or puncture the tube during the fill stroke.

5.7 Sealing Methods:

5.7.1 Aluminum Tube Crimping:

5.7.1.1 Aluminum tubes are sealed by folding and crimping the open end. The crimp forms an airtight closure that prevents product leakage and air ingress.

5.7.1.2 The first fold flattens the tube end. The second fold doubles the flat section. The crimp jaw then presses a pattern into the folded area.

5.7.1.3 Set the crimp pressure between 40 and 60 bar depending on the tube gauge. Too little pressure gives a loose crimp that can open during transport.

5.7.1.4 Clean the crimp jaw faces with a soft brush before each run. Dried product on the jaw face transfers to the crimp pattern and causes visible smears.

5.7.1.5 Check the crimp appearance on the first 10 tubes. The folds should be parallel and free of cracks, splits, or uneven crimp lines.

5.7.2 Plastic and Laminate Tube Heat Sealing:

5.7.2.1 Plastic and laminate tubes are sealed by heat rather than crimping. Hot air softens the open end before two jaws press the softened plastic together.

5.7.2.2 Set the hot air temperature on the sealing station. The range sits between 250°C and 450°C depending on the laminate grade.

5.7.2.3 Adjust the hot air dwell time to match the tube wall thickness. A thin wall seals in 0.5 seconds. A thick wall may need up to 2 seconds.

5.7.2.4 The sealing jaws close right after the hot air step. Set the jaw pressure so the plastic fuses fully without squeezing out of the seal zone.

5.7.2.5 Inspect the seal bead on each tube. A clean uniform bead shows a good seal. A thin or torn bead points to too much heat or pressure.

5.8 Coding and Batch Print:

5.8.1 Every filled tube must carry the batch code and expiry date. The code goes on the crimp for aluminum tubes and on the seal bead for plastic tubes.

5.8.2 Load the correct type characters into the coding holder before the run starts. Double check each character against the batch record.

5.8.3 Pull the first five tubes after the coding step. Read the code under a 10x magnifier to check for clarity and correct content.

5.8.4 A blurred or missing code on any tube requires a stop of the line. Identify the root cause before any further tubes run through.

5.8.5 Log the code check result every hour during the run. A sudden drop in code quality often points to worn type characters or a misalignment of the coding holder.

5.9 Machine Control Panel:

5.9.1 The machine control panel holds a color HMI, an emergency stop, a main start button, and a mode selector switch.

5.9.2 Power up the panel with the key switch. The HMI loads the operating system in about 45 seconds.

5.9.3 Sign in with your operator ID. The system records every action under your ID for audit purposes.

5.9.4 The HMI main screen holds these working areas: Run, Setup, Teach, Alarms, Reports, and Service.

5.9.4.1 Run: holds the Start, Stop, Jog, and Hold buttons plus the live cycle counter.

5.9.4.2 Setup: stores the recipe data for each tube size and product type.

5.9.4.3 Teach: guides the operator through vision system training for each new artwork design.

5.9.4.4 Alarms: lists current and historical faults along with clearing instructions.

5.9.4.5 Reports: prints shift reports, batch summaries, and preventive maintenance due lists.

5.9.4.6 Service: holds engineer level functions such as axis calibration and sensor zeroing.

5.9.5 A graphical machine layout shows the live position of every station on the turret. Green means ready. Yellow means in process. Red means fault.

5.9.6 The cycle rate indicator shows tubes per minute in real time. The target rate for most products runs between 60 and 120 tubes per minute.

5.9.7 Log off the panel at shift end. An inactive session will auto log off after 10 minutes to protect the settings.

5.10 Running the Batch:

5.10.1 Confirm that the hopper temperature, stirrer speed, and jacket flow all show green on the Run screen.

5.10.2 Load the recipe for your product from the Setup area. Cross check each parameter against the Batch Manufacturing Record (BMR).

5.10.3 Run a dry cycle of ten tubes with the fill nozzle raised and the dosing system paused. Inspect the tube loading, orientation, and sealing stations for any issue.

5.10.4 Lower the fill nozzle and start the dosing system once the dry cycle passes. The first few tubes may come out underfilled until the nozzle clears any air.

5.10.5 Weigh the first ten filled tubes on a calibrated balance. The average weight must fall within ±2% of the target fill weight.

5.10.6 Continue the batch once the weight check passes. Pull six sample tubes every 30 minutes for in process checks.

5.10.7 Record each in process sample weight in the In Process Check Register. Flag any sample that drifts toward the upper or lower limit.

5.10.8 Watch the crimp or seal quality in real time through the inspection window. A change in seal appearance often precedes a full defect.

5.10.9 Do not walk away from the machine during a run. A jammed tube or a feeder issue can escalate in minutes if no one is watching.

5.11 Defect Handling:

5.11.1 The machine uses a reject arm at the end of the turret. The arm pushes defective tubes into a labeled reject chute.

5.11.2 Common defects on a tube filler include:

5.11.2.1 Underfilled tubes that fall below the weight limit.

5.11.2.2 Overfilled tubes that bulge at the seal point.

5.11.2.3 Crooked seals where the crimp or hot air jaws missed the tube edge.

5.11.2.4 Missing or blurred batch codes on the seal area.

5.11.2.5 Wrong artwork orientation after an eye mark reader miss.

5.11.3 Segregate the reject tubes by defect type within the shift. Do not mix different defect groups in one bin.

5.11.4 Underfilled tubes with good seals can be topped up through the back and resealed after QA review. This requires a formal rework request.

5.11.5 Tubes with bad seals or broken crimps must be discarded. Squeeze the product out into a recovery drum and send the empty tubes for disposal.

5.11.6 Complete the Defect Register at shift end. A rising defect rate in any one category needs root cause analysis within 24 hours.

5.12 End of Shift:

5.12.1 Press Stop on the Run screen. Allow the machine to finish the tubes already in process before the next step.

5.12.2 Close the hopper outlet valve. This step prevents product from draining into the fill nozzle during shutdown.

5.12.3 Drain any leftover product from the hopper into a labeled recovery container. Send the container to the semi solid store room for disposition.

5.12.4 Turn off the hopper heater and the jacket circulation pump. The hopper will cool to ambient over the next hour.

5.12.5 Return the fill nozzle to its home position using the Jog control on the Run screen. A nozzle left in the down position can drip on the turret overnight.

5.12.6 Remove the remaining empty tubes from the loader and place them back into their original supplier tray. Return the tray to the tube store room with the correct label intact.

5.12.7 Switch off the main power at the panel and lock out the disconnect if the machine will sit idle for more than one shift.

5.12.8 Fit the “TO BE CLEANED” tag on the machine.

5.12.9 Clean the Collapsible Tube Filling Machine as per the defined cleaning SOP.

5.13 RECORDS:

5.13.1 Equipment Usage Sheet.

5.13.2 Batch Manufacturing Record.

5.13.3 In Process Check Register.

5.13.4 Weekly Safety Log.

5.13.5 Defect Register.

5.13.6 Cleaning Record.

6.0 KISALTMALAR:

6.1 Standart İşlem Prosedürü (SOP): Standart İşletme Prosedürü.

6.2 IPQA: Süreç İçi Kalite Güvencesi.

6.3 QA: Kalite Güvencesi.

6.4 Kişisel Koruyucu Ekipman (PPE): Kişisel Koruyucu Ekipman.

6.5 HMI: İnsan Makine Arayüzü.

6.6 BMR: Parti Üretim Kaydı.