{"id":16907,"date":"2026-07-31T01:29:51","date_gmt":"2026-07-31T01:29:51","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=16907"},"modified":"2026-04-30T02:44:19","modified_gmt":"2026-04-30T02:44:19","slug":"sop-for-liquid-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/es\/sop-for-liquid-filling-machine\/","title":{"rendered":"SOP for Liquid Filling Machine"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"16907\" class=\"elementor elementor-16907\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Standard operating procedure of Liquid Filling Machine.<\/p><figure id=\"attachment_16926\" aria-describedby=\"caption-attachment-16926\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-16926\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine.jpg\" alt=\"SOP for Liquid Filling Machine\" width=\"1000\" height=\"832\" title=\"\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine-500x416.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine-300x250.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine-768x639.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/07\/SOP-for-Liquid-Filling-Machine-14x12.jpg 14w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-16926\" class=\"wp-caption-text\"><em><strong>SOP for Liquid Filling Machine.<\/strong><\/em><\/figcaption><\/figure><h2><strong>1.0 OBJETIVO:<\/strong><\/h2><p>To describe the Operating Procedure of Liquid Filling Machine used for precise volumetric filling of liquid products of varied viscosity into primary containers.<\/p><h2><strong>2.0 ALCANCE:<\/strong><\/h2><p>This Procedure applies to the Operating Procedure of Liquid Filling Machine installed in the liquid section of the production department.<\/p><h2><strong>3.0 RESPONSABILIDAD:<\/strong><\/h2><p>Filling Operator &amp; Production Technologist<\/p><h2><strong>4.0 RESPONSABILIDAD:<\/strong><\/h2><p>Production Head.<\/p><h2><strong>5.0 PROCEDIMIENTO:<\/strong><\/h2><p>5.1 Walk through the filling area and inspect the machine frame. Make sure the &#8220;CLEANED&#8221; status tag is fixed to the unit before any work starts.<\/p><p>5.2 Fill out the Equipment Usage Register. Log your name, the product code, the date, and the exact time the shift began.<\/p><p>5.3 Peel off the &#8220;CLEANED&#8221; status tag and mount the &#8220;UNDER PROCESS&#8221; status tag in its place.<\/p><p>5.4 Request a Line Clearance from In Process Quality Assurance (IPQA). Do not proceed until a signed and dated clearance reaches you.<\/p><h3><strong>5.5 Safety Requirements:<\/strong><\/h3><p>5.5.1 Many liquid products contain alcohols, essential oils, or volatile solvents. Keep all ignition sources such as lighters, mobile phones, and sparking tools away from the filling area.<\/p><p>5.5.2 Slippery floors are a major hazard around liquid fillers. Wipe up any spill the moment it happens and use the yellow wet floor sign until the area dries.<\/p><p>5.5.3 Do not pressurize the product tank above the rated limit shown on the tank nameplate. Over pressure can rupture a fitting and spray product at high force.<\/p><p>5.5.4 Keep the CIP return lines clear at all times. A blocked return line can build up pressure during the clean cycle and damage the tank.<\/p><p>5.5.5 Never reach into the fill heads while the pistons or pumps are moving. The drive force on each piston can pinch or crush a finger without warning.<\/p><p>5.5.6 Wear chemical resistant gloves and a splash apron when you handle product concentrates or cleaning agents. Flush any skin contact under running water for at least 15 minutes and report to the first aid station.<\/p><p>5.5.7 Lift heavy product drums with a trolley or a second person. A full 200 liter drum can weigh over 200 kg and cause a back injury if handled alone.<\/p><p>5.5.8 Standard PPE for this machine includes a lab coat, nitrile gloves, safety glasses, closed shoes, and a hair net. Add a face shield when you work with hot or caustic products.<\/p><p>5.5.9 Complete the safety circuit audit below every week and document it:<\/p><p>5.5.9.1 Isolate the machine with the main disconnect and confirm that all live lights turn off.<\/p><p>5.5.9.2 Strike the emergency stop mushroom. The pumps, drive, and conveyor must all halt in one motion.<\/p><p>5.5.9.3 Open each guard door in turn. The machine should drop into a safe hold state each time.<\/p><p>5.5.9.4 Test the low level probe in the product tank by drawing off some liquid. The line must pause when the probe goes dry.<\/p><p>5.5.9.5 Sign the Safety Audit Log after each weekly review.<\/p><h3><strong>5.6 Filling Technology Selection:<\/strong><\/h3><h4><strong><b>5.6.1 Piston Volumetric Filling:<\/b><\/strong><\/h4><p>5.6.1.1 The piston filler draws a fixed volume on each stroke. This method suits thin liquids and medium viscosity products up to 5000 cPs.<\/p><p>5.6.1.2 Set the stroke length on the adjuster dial. One full turn usually changes the dose by 1 mL, so move the dial in small steps.<\/p><p>5.6.1.3 Piston fillers give very repeatable doses with less than 0.5% variation between bottles. Select this mode for oral suspensions, syrups, and cough mixtures.<\/p><h4><strong><b>5.6.2 Peristaltic Pump Filling:<\/b><\/strong><\/h4><p>5.6.2.1 The peristaltic pump uses rollers to squeeze a silicone tube. The product only touches the tube, not the pump itself.<\/p><p>5.6.2.2 Select this mode for sterile products, small batch runs, or any product that must not contact metal parts.<\/p><p>5.6.2.3 Replace the silicone tube at the intervals listed on the preventive maintenance chart. A stretched tube gives inaccurate fills.<\/p><h4><strong><b>5.6.3 Gravity and Pressure-Time Filling:<\/b><\/strong><\/h4><p>5.6.3.1 Gravity fillers rely on head pressure from a tank mounted above the fill heads. This approach suits thin water like liquids that foam easily.<\/p><p>5.6.3.2 The fill volume is controlled by a timed valve rather than a metered stroke. The valve opens for a set duration to release the dose.<\/p><p>5.6.3.3 Keep the tank level constant during the run. A falling level drops the head pressure and shrinks the fill volume bottle by bottle.<\/p><h4><strong><b>5.6.4 Flow Meter Filling:<\/b><\/strong><\/h4><p>5.6.4.1 The flow meter filler uses a mass or magnetic flow sensor on each fill line. The sensor counts the exact volume that passes through the nozzle.<\/p><p>5.6.4.2 This mode gives the highest accuracy and adjusts automatically when product density changes. Select this mode for high value products or regulated fills.<\/p><p>5.6.4.3 Calibrate each flow sensor at the start of every batch. A two point calibration at 10% and 90% of full scale is sufficient for most products.<\/p><h3>5.7 Product Tank and Feed System:<\/h3><p>5.7.1 The product tank is a jacketed stainless steel vessel mounted on load cells. The load cells give a live weight reading of the product on hand.<\/p><p>5.7.2 Connect the product supply line to the inlet port on top of the tank. Tighten the tri clamp by hand first, then finish with a wrench to the torque on the label.<\/p><p>5.7.3 Set the tank jacket temperature as required by your product. Hot syrups need the jacket at 40 to 50\u00b0C to keep the viscosity low during the fill.<\/p><p>5.7.4 Start the tank agitator at low speed. Gradually raise the speed to the value listed on the batch record. A quick ramp up can splash product onto the tank lid.<\/p><p>5.7.5 Confirm that the low level and high level probes are active. The machine will pause the fill if either probe loses contact with product.<\/p><p>5.7.6 Check the product transfer pump for leaks at the seal. A wet seal housing points to a worn mechanical seal that needs replacement.<\/p><p>5.7.7 Bleed all air from the feed lines before the first fill. Air pockets in the line cause short fills and bubble formation in the finished product.<\/p><h3><strong>5.8 Nozzle and Drip Control:<\/strong><\/h3><p>5.8.1 The fill nozzles are the final stage before product enters the container. Each nozzle must be matched to the product viscosity and the container mouth size.<\/p><p>5.8.2 Fit the diving nozzle head for foamy products. The nozzle dives below the liquid surface during the fill so the product pours without splash or foam.<\/p><p>5.8.3 Set the dive speed to match the fill rate. A slow dive causes overflow. A fast dive creates bubbles at the product surface.<\/p><p>5.8.4 Confirm that the anti drip valve closes fully at the end of each cycle. A leaky valve drips product between fills and contaminates the outer bottle.<\/p><p>5.8.5 Inspect each nozzle tip for product buildup at the start of each shift. Dried residue can block the flow path and cause a short fill.<\/p><p>5.8.6 Swap nozzle sets whenever you change container size. Using a small nozzle on a wide mouth bottle leads to splash marks on the inside wall.<\/p><h3><strong>5.9 Product Changeover:<\/strong><\/h3><p>5.9.1 A product changeover requires a full clean of all contact parts. Skipping any step risks cross contamination between products.<\/p><p>5.9.2 Drain all remaining product from the tank through the bottom outlet. Collect any recoverable product in a labeled container for QA review.<\/p><p>5.9.3 Rinse the tank, the feed lines, and the nozzles with purified water for three minutes. The rinse water must run clear at the drain point.<\/p><p>5.9.4 Engage the CIP cycle from the main control panel. The cycle will run hot caustic wash, rinse, acid wash, rinse, and final water for injection rinse.<\/p><p>5.9.5 Verify the conductivity reading of the final rinse water. A reading below 1.3 microsiemens per cm confirms adequate removal of cleaning agents.<\/p><p>5.9.6 Swab test a sample of three contact surfaces after the CIP cycle. Send the swabs to microbiology for bioburden testing.<\/p><p>5.9.7 Replace the nozzle set, tubing, and gaskets if required by the changeover matrix. Some products need new contact parts even after a full clean.<\/p><p>5.9.8 Do not load the new product until QA releases the machine for use. The release comes after satisfactory results from the swab test and the rinse conductivity check.<\/p><h3><strong>5.10 HMI Navigation:<\/strong><\/h3><p>5.10.1 The Human Machine Interface uses a 15 inch color touchscreen mounted at operator level. The screen links to the PLC via a fiber optic cable for fast data transfer.<\/p><p>5.10.2 Power up the interface with the secondary enable button after the main panel comes on. The boot sequence takes about 60 seconds.<\/p><p>5.10.3 Log in with your unique user ID and password. The system assigns access rights based on your role: Operator, Technologist, Supervisor, or Engineer.<\/p><p>5.10.4 The home screen displays five tiles: Batch Setup, Fill Control, CIP\/SIP, Data Trend, and Audit Trail. Tap any tile to enter that section.<\/p><p>5.10.4.1 Batch Setup: holds the product code, batch number, target volume, and line speed for the current run.<\/p><p>5.10.4.2 Fill Control: shows the live fill status of each head along with the pause, resume, and abort controls.<\/p><p>5.10.4.3 CIP\/SIP: runs and monitors the automated clean and steam cycles between batches.<\/p><p>5.10.4.4 Data Trend: plots fill volume, temperature, and tank level over the last 24 hours.<\/p><p>5.10.4.5 Audit Trail: shows a tamper proof log of all operator actions, parameter changes, and fault events.<\/p><p>5.10.5 The alarm bar at the top of the screen turns amber for warnings and red for critical faults. Address red alarms before the run continues.<\/p><p>5.10.6 Log off the HMI at the end of your shift. The screen will lock within 60 seconds if no activity is detected.<\/p><h3><strong>5.11 Production Run:<\/strong><\/h3><p>5.11.1 Confirm the tank level, jacket temperature, and agitator speed all read green on the Batch Setup screen.<\/p><p>5.11.2 Run five test fills in Manual mode into labeled beakers. Weigh each beaker on a calibrated balance and compare to the target.<\/p><p>5.11.3 Adjust the fill parameter on the HMI if the average weight falls outside the \u00b11% tolerance. Re test until all five samples land within tolerance.<\/p><p>5.11.4 Switch the machine to Auto mode once the test fills pass. Tap Start on the Fill Control screen to begin the run.<\/p><p>5.11.5 Watch the first 30 filled containers at the outfeed. Inspect each one for fill level, bubble formation, and nozzle drip marks.<\/p><p>5.11.6 Pull an in process sample of five containers every 30 minutes. Weigh each sample and log the result in the Batch Production Record.<\/p><p>5.11.7 Monitor the Data Trend screen for any drift in fill volume. A steady decline suggests a filter is clogging or a pump seal is wearing.<\/p><p>5.11.8 Report any out of spec sample to the shift supervisor at once. Do not adjust fill parameters mid run without supervisor approval.<\/p><h3><strong>5.12 Rejects and Recovery:<\/strong><\/h3><p>5.12.1 The machine has two reject stations along the outfeed conveyor. Each station pushes off containers that fail a specific check.<\/p><p>5.12.2 The first station uses a check weigher. Any container that falls outside the upper or lower weight limit drops onto the reject tray.<\/p><p>5.12.3 The second station uses a fill level camera. The camera rejects containers with air bubbles, foam heads, or low meniscus.<\/p><p>5.12.4 Sort the rejected containers within one hour of production:<\/p><p>5.12.4.1 Low fill containers can be topped up by hand and returned to the line after reinspection.<\/p><p>5.12.4.2 Over fill containers must be emptied back into the recovery tank for blending into the next sub batch.<\/p><p>5.12.4.3 Visually defective containers are set aside for QA disposition.<\/p><p>5.12.5 Record the reject count by category in the Reject Log at shift end. A rising reject trend needs investigation within 24 hours.<\/p><h3><strong>5.13 Shut Down Steps:<\/strong><\/h3><p>5.13.1 Press Stop on the Fill Control screen. Let all containers on the conveyor clear the line before the next step.<\/p><p>5.13.2 Drain the remaining product from the tank into a labeled recovery drum. Cover the drum and send it to the quarantine area.<\/p><p>5.13.3 Turn the jacket heater off and let the tank cool to room temperature.<\/p><p>5.13.4 Flush all product lines with purified water for two minutes to clear residual product.<\/p><p>5.13.5 Drop the machine into Safe Hold mode from the HMI. This mode depressurizes the system and parks all pistons at home position.<\/p><p>5.13.6 Switch off the main power at the disconnect and lock it out if the machine will remain idle overnight.<\/p><p>5.13.7 Attach the <strong>\u201cPARA SER LIMPIADO\u201d<\/strong> tag on the machine.<\/p><p>5.13.8 Clean the Liquid Filling Machine as per the defined cleaning SOP.<\/p><h3><strong>5.14 REGISTROS:<\/strong><\/h3><p>5.14.1 Equipment Usage Register.<\/p><p>5.14.2 Batch Production Record.<\/p><p>5.14.3 Safety Audit Log.<\/p><p>5.14.4 Reject Log.<\/p><p>5.14.5 CIP Cycle Record.<\/p><p>5.14.6 Cleaning Record.<\/p><h2><strong>6.0 ABREVIATURAS:<\/strong><\/h2><p><strong>6.1 Procedimiento operativo est\u00e1ndar:<\/strong> Procedimiento operativo est\u00e1ndar.<\/p><p><strong>6.2 IPQA:<\/strong> Aseguramiento de Calidad en Proceso.<\/p><p><strong>6.3 GARANT\u00cdA DE CALIDAD:<\/strong> Seguro de calidad.<\/p><p><strong>6.4 EPI:<\/strong> Equipo de protecci\u00f3n personal.<\/p><p><strong>6.5 CIP:<\/strong> Clean In Place.<\/p><p><strong>6.6 SIP:<\/strong> Steam In Place.<\/p><p><strong>6.7 HMI:<\/strong> Interfaz hombre-m\u00e1quina.<\/p><p><strong>6.8 PLC:<\/strong> Programmable Logic Controller.<\/p><p><strong>6.9 cPs:<\/strong> Centipoise.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Standard operating procedure of Liquid Filling Machine. 1.0 OBJECTIVE: To describe the Operating Procedure of Liquid Filling Machine used for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16926,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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