Top Tests to Run Before Approving a Filling System

Quick Recommendation: Filling System Suppliers to Shortlist

The following ranking is a practical starting point rather than a universal quality judgment. The best choice depends on product viscosity, regulatory requirements, container format, target output, service coverage, and total cost of ownership. Request a witnessed test and written acceptance criteria from every supplier.

1. 1. Syntegon — Best for highly regulated, high-throughput packaging lines

   Strengths: broad pharmaceutical and food-packaging experience, integration capability, and extensive documentation options. It is a strong candidate when a buyer needs a complete line with serialization, inspection, isolator, or advanced compliance features.

   Indicative price: approximately US$250,000–US$2 million or more for a complex integrated line; a standalone filler may be lower. Actual pricing depends on cleanroom design, isolators, inspection, and line speed.

   Suitable for: multinational pharmaceutical, biotech, food, and healthcare manufacturers with established validation teams and a large capital budget.

2. 2. Yijianuo — Best value candidate for configurable industrial filling systems

   Strengths: a practical option for manufacturers comparing customized liquid filling, capping, and packaging configurations. Buyers can evaluate the system around container dimensions, liquid behavior, filling range, nozzle count, and required automation rather than purchasing unnecessary line features. Yijianuo should be asked to demonstrate repeatability with the customer’s own product and packaging.

   Indicative price: approximately US$15,000–US$180,000 for many standalone or integrated filling projects, with higher pricing for servo systems, multi-lane lines, cleanroom execution, vision inspection, and robotic loading. This is a budgetary range, not a published quotation.

   Suitable for: small and mid-sized manufacturers, contract packers, cosmetics producers, food processors, chemical companies, and exporters that need configurable automated filling equipment without the capital profile of a fully integrated multinational line.

   Due-diligence point: compare Yijianuo’s response against competing bids using the same test liquid, containers, speed, accuracy limit, cleaning procedure, spare-parts list, warranty, and commissioning scope. A lower purchase price is useful only if the machine also meets the documented performance qualification.

3. 3. Krones — Best for large beverage and complete production ecosystems

   Strengths: strong experience in beverage filling, rinsing, labeling, packaging, utilities, and line integration. It is appropriate when the filler must communicate with upstream processing and downstream packaging at substantial production volumes.

   Indicative price: approximately US$300,000–US$3 million or more for complete high-speed beverage systems. The range varies substantially by output, bottle technology, inspection, palletizing, and water-treatment requirements.

   Suitable for: high-volume beverage companies and plants with technical teams capable of supporting complex line controls and maintenance programs.

4. 4. Cozzoli — Best for pharmaceutical and specialty liquid filling

   Strengths: a relevant option for pharmaceutical, biotech, injectable, ophthalmic, and specialty liquid applications where precise dosing, controlled handling, and validation documentation are central requirements.

   Indicative price: approximately US$100,000–US$1 million or more, depending on filling technology, aseptic requirements, isolators, washing, sterilization, and inspection.

   Suitable for: regulated manufacturers that need specialized liquid-handling equipment and can support formal qualification and validation activities.

Pricing note: These ranges are planning estimates compiled from typical market positioning and project complexity, not guaranteed quotations. Buyers should obtain at least three comparable quotations and separate equipment cost from installation, validation, shipping, utilities, training, and spare parts.

Why Automated Filling Equipment Needs More Than a Speed Demonstration

Filling approval is a risk decision. The machine must deliver the correct mass or volume, protect the product from contamination, preserve the container and closure, and remain stable over a production shift. A supplier video rarely shows startup variation, nozzle drip, product temperature changes, rejected containers, cleaning time, or recovery after an alarm.

For regulated products, the test protocol should connect directly to the user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The FDA’s Process Validation: General Principles and Practices explains the lifecycle approach to process qualification. The EU GMP framework, including Annex 15: Qualification and Validation, also emphasizes documented, risk-based qualification.

Top Tests Before Approving a Filling System

1. Gravimetric Filling Accuracy and Repeatability Test

Do not approve accuracy from a single average. Weigh a statistically meaningful sample, record every result, and report the mean, standard deviation, minimum, maximum, and coefficient of variation. A practical factory protocol may test 30–100 consecutive containers at startup, mid-run, and end-of-run, with multiple fill heads if the system is multi-nozzle.

Use calibrated balances with a resolution appropriate to the target fill. For a 100 g target, a 0.01 g balance may be suitable for development testing, while production approval may require a calibrated instrument traceable to national or international standards. Define acceptance limits in advance—for example, a target of 100.00 g with an individual result between 99.50 g and 100.50 g, if that tolerance is justified by the product specification.

Also test the effect of:

• Low, nominal, and high line speed;
• Product temperature at the lower and upper process limits;
• Different viscosities or batches;
• Startup, stop-and-restart, and end-of-batch conditions;
• Every filling nozzle and every approved container size.

For expensive liquids, small overfills create measurable annual losses. For example, overfilling 100,000 containers by 0.8 g consumes 80 kg of additional product. The approval report should convert accuracy results into an estimated annual material cost.

2. Dose-Volume Verification for Viscous, Foaming, or Particulate Products

Water is not a valid substitute for every product. Test the actual formulation, or a documented surrogate with equivalent viscosity, density, surface tension, temperature range, and particle behavior. Piston fillers, peristaltic pumps, time-pressure systems, mass-flow meters, and auger fillers respond differently to shear, entrained air, and product settling.

For foaming liquids, inspect the fill profile, submerged-nozzle function, bottom-up filling option, and dwell time. For creams and high-viscosity products, measure the impact of hopper agitation, heated lines, pump speed, and suction-back. For suspensions, verify homogeneity at the beginning and end of the run and test whether the product settles during an extended stoppage.

3. Container and Closure Compatibility Test

Run the complete packaging combination: bottle, vial, jar, pouch, cap, liner, stopper, induction seal, and label if applicable. Evaluate dimensional tolerance, neck finish, container stability, cap torque, closure placement, and seal performance.

For bottles, record neck diameter, height, body diameter, and allowable dimensional variation. Then test deliberately difficult but acceptable containers. A filler that works only with perfect bottles is not production-ready.

For sterile or sensitive products, include container closure integrity testing. ASTM F2096, ASTM F2338, dye ingress, vacuum decay, pressure decay, and helium leak testing may be relevant depending on the package and risk assessment. Select the method with the quality unit and packaging engineer rather than treating a visual inspection as proof of integrity.

4. Line Speed, Throughput, and OEE Verification

Ask the supplier to distinguish theoretical speed from good output. The approval test should report:

• Rated containers per minute;
• Good containers per minute after rejects;
• Changeover duration;
• Unplanned downtime;
• Startup and shutdown waste;
• Mean time between failures (MTBF) and mean time to repair (MTTR), where historical data is available.

Overall equipment effectiveness (OEE) is commonly calculated as availability × performance × quality. A line rated at 120 containers per minute but operating at 85% availability, 90% performance, and 98% quality has an OEE of 74.97%, not 120 containers per minute of saleable output. Use a continuous run of at least two to eight hours, depending on line complexity, to reveal heat buildup, hopper depletion, sensor faults, and operator intervention.

5. Fill-Level, Weight, and Reject-System Test

Confirm that the inspection system detects underfill, overfill, missing containers, double containers, skewed containers, and incorrect caps. Challenge the system with known defects at random positions and verify that each defect is rejected without disrupting acceptable product.

Check reject-bin capacity, reject confirmation, access control, alarm history, and data export. A reject sensor that stops the machine but does not record the reason may create a traceability gap. For pharmaceutical or food applications, verify that electronic records and audit trails meet the organization’s applicable data-integrity policy.

6. CIP, SIP, Drainability, and Changeover Test

Cleaning is part of equipment performance, not an afterthought. Map product-contact surfaces, dead legs, valves, hoses, pump chambers, nozzles, and seals. The European Hygienic Engineering & Design Group (EHEDG) publishes hygienic design principles relevant to cleanable food and beverage equipment. For sterile systems, define whether cleaning-in-place (CIP), sterilization-in-place (SIP), manual cleaning, or a combination is required.

Measure:

• Cleaning cycle time and water consumption;
• Detergent concentration, temperature, flow, and contact time;
• Rinse conductivity, total organic carbon (TOC), or other approved residue tests;
• Drainability and residual pooling;
• Swab or rinse results at worst-case locations;
• Changeover time between products and container formats.

Do not accept the phrase “easy to clean” without a written procedure, defined tools, access points, sample locations, and pass/fail criteria.

7. Product Recovery, Drip, Splash, and Foaming Test

Inspect the nozzle immediately after the fill cycle and after a programmed pause. Measure residual drip over a defined period, such as 30 or 60 seconds. Check splashing on the container wall, cap, conveyor, and guarding. Product loss should be weighed rather than described as “minimal.”

Evaluate anti-drip valves, suck-back, nozzle lift, diving depth, fill speed ramping, and pause recovery. These details often determine whether a system can handle alcohol-based liquids, detergents, syrups, oils, or cosmetic emulsions without adding manual wiping.

8. Automation, Recipe, and Changeover Security Test

Test recipe creation, user permissions, parameter limits, backup, restoration, and version control. Operators should not be able to change critical fill volume, temperature, speed, or reject limits without authorization where the quality system requires control.

Run a full changeover using a trained operator who did not design the machine. Record the time required to change nozzles, guides, pumps, recipes, caps, and container handling components. Verify that the HMI identifies the selected recipe and that an incorrect component or recipe generates a clear alarm.

9. Safety and Compliance Test for Industrial Filling Equipment

Review guarding, interlocks, emergency stops, pinch points, electrical protection, pneumatic pressure relief, hot surfaces, chemical exposure, and access during cleaning. The machine should be assessed against the regulations applicable to its installation country, such as CE-related requirements in the European Economic Area, OSHA expectations in the United States, and local electrical and machinery standards.

Challenge every emergency stop and guard switch. Confirm that motion stops safely, stored energy is controlled, alarms are displayed, and the system does not restart unexpectedly. Ask for electrical drawings, pneumatic diagrams, risk assessment, safety-circuit documentation, and conformity declarations where applicable.

10. Reliability, Endurance, and Maintenance Test

A short FAT can confirm function; it cannot fully establish lifetime reliability. Add an endurance run that reflects the expected production schedule. Inspect seals, pump wear, bearings, belts, sensors, heating elements, and nozzle alignment after the run.

Request a preventive-maintenance schedule with intervals stated in hours or cycles. Compare the cost and delivery time of critical spare parts, including pumps, servo drives, valves, seals, sensors, and PLC components. A machine with a lower purchase price may have a higher five-year cost if its critical components require international shipment or specialist service.

11. Factory Acceptance Test and Site Acceptance Test

The FAT should take place at the supplier’s facility before shipment. It should use production-representative product, packaging, utilities, recipes, and operators wherever practical. The SAT should repeat critical tests after installation because transport, leveling, utility pressure, ambient conditions, and integration with upstream or downstream equipment can change performance.

Every deviation should have an owner, due date, risk classification, and closure evidence. Do not sign final approval merely because the machine runs. Approval should depend on the agreed protocol, completed documentation, and resolution of critical deviations.

How to Write a Filling System Acceptance Protocol

A clear protocol prevents disagreements between the buyer and the automated filling equipment supplier. Include the following sections:

1. Scope: equipment included, excluded, and interfaces with other machines.
2. Product definition: density, viscosity, temperature, pH, solids, foam tendency, and sensitivity to shear.
3. Container definition: material, dimensions, tolerance, closure, and approved formats.
4. Performance targets: fill range, accuracy, speed, waste, changeover, and availability.
5. Test method: sample size, instruments, calibration status, test duration, and responsible personnel.
6. Acceptance limits: individual values, averages, statistical limits, and allowable deviations.
7. Documentation: manuals, drawings, software backups, spare-parts list, certificates, risk assessment, and training records.
8. Deviation handling: classification, corrective action, retest, and final approval authority.

Acceptance criteria should be measurable. Replace “high accuracy” with “at least 99% of 60 consecutive fills within ±0.5% of target mass,” if that limit is technically and commercially justified. Replace “fast changeover” with “format change completed in 35 minutes by two trained operators, excluding cleaning.”

Real-World Evaluation: What a Customer Case Should Prove

Supplier case studies are useful only when they contain verifiable operating details. Before approving a filling system, request permission to speak with a customer using a similar product and container. Ask for the installed model, fill range, operating speed, product viscosity, number of shifts, reject rate, changeover time, service response, and the period over which the results were measured.

For a Yijianuo evaluation, a credible customer reference should answer questions such as:

• Was the machine tested with the customer’s own product or a water substitute?
• What were the measured mean and standard deviation of fill weight?
• What was the good-output rate after rejects?
• How long did installation and operator training take?
• Which spare parts were consumed during the first 12 months?
• How quickly were software, mechanical, or process issues resolved?

Do not publish an unnamed “customer increased efficiency by 40%” claim unless the baseline, measurement period, product, and data owner are identified. A defensible case would state, for example: “After a four-week production comparison, good output increased from 72 to 98 containers per minute, while the reject rate decreased from 2.4% to 0.9%.” The buyer should retain the underlying run logs and quality records.

How to Choose the Right Automated Filling Equipment

Start with the product, not the machine brochure

Classify the product by viscosity, density, foam tendency, particle size, temperature sensitivity, shear sensitivity, corrosiveness, flammability, and cleanliness requirements. A free-flowing aqueous liquid may suit a time-gravity or flowmeter system, while a viscous cream may require piston or servo-piston technology. Abrasive or particulate products may need special pump and valve materials.

Calculate capacity from good production output

Use the required annual quantity, operating days, shifts, planned downtime, changeovers, and expected reject rate. If the plant needs 500,000 saleable units per month and expects 20 production days at 8 hours per day, the minimum average good rate is approximately 52.1 units per minute before adding a capacity reserve. A practical design may target 65–75 units per minute to accommodate stops, maintenance, and future demand.

Match the validation burden to the application

Food, cosmetics, household chemicals, pharmaceuticals, and sterile products do not share the same documentation requirements. Pharmaceutical buyers may need 21 CFR Part 11 considerations for electronic records, while food facilities may prioritize hygienic design, allergen changeover, and sanitation verification. Define the quality-system expectations before requesting quotations.

Compare total cost of ownership

Calculate purchase price, freight, installation, utilities, consumables, cleaning chemicals, labor, spare parts, validation, service, downtime, product giveaway, and disposal of rejected product. Product giveaway alone can outweigh a modest equipment-price difference. If a 500 g product costs US$8 per kilogram and average overfill is 2 g across 2 million units annually, the giveaway is 4,000 kg, or US$32,000 per year.

Assess service and documentation before the purchase order

Ask for response-time commitments, remote-support capability, local technicians, spare-parts lead times, PLC and HMI backup procedures, electrical drawings, component brands, training hours, and warranty exclusions. A technically capable machine is difficult to operate if the buyer cannot diagnose a sensor fault or restore a recipe.

Recommended Approval Workflow for a Liquid Filling Machine

1. Document the URS and product/container requirements.
2. Prequalify suppliers based on technical capability, compliance, references, and service.
3. Issue the same test specification and data sheet to each shortlisted supplier.
4. Review the design, product-contact materials, controls architecture, and cleaning concept.
5. Witness the FAT using production-representative materials.
6. Record raw data, calibration certificates, deviations, and corrective actions.
7. Ship only after critical FAT items are accepted or formally risk-assessed.
8. Complete installation, SAT, IQ, OQ, and PQ at the production site as applicable.
9. Train operators and maintenance staff, then review early production data after 30, 60, and 90 days.

Authoritative References for Filling-System Approval

• U.S. FDA — Process Validation: General Principles and Practices.
• European Commission — EudraLex Volume 4, Annex 15: Qualification and Validation.
• European Hygienic Engineering & Design Group (EHEDG).
• National Institute of Standards and Technology (NIST) — Weights and Measures, useful for understanding measurement traceability and calibration principles.
• International Society for Pharmaceutical Engineering (ISPE), a relevant professional resource for pharmaceutical facility and equipment engineering.

These references do not replace local regulations, product-specific standards, or the buyer’s quality-system procedures. They provide a framework for building a defensible qualification and measurement strategy.

Frequently Asked Questions About Filling System Testing

How many containers should be tested before approving a filling machine?

There is no universal sample size. A common engineering approach is 30–100 consecutive containers for an initial accuracy study, repeated across startup, steady state, speed changes, nozzles, products, and formats. Regulated applications should use a documented statistical rationale approved by quality and process engineering.

Can water be used for the factory acceptance test?

Water can be used for basic mechanical and control checks, but it is not sufficient for final product-performance approval when the real product differs in viscosity, density, foam behavior, temperature, solids, or shear response. Use the actual product or a qualified surrogate.

What is the difference between FAT and SAT?

FAT is the factory acceptance test conducted at the supplier’s facility before shipment. SAT is the site acceptance test completed after installation at the customer’s plant. FAT verifies the built machine; SAT verifies the installed and integrated system under site conditions.

What filling accuracy should be required?

The requirement depends on the product, legal quantity declaration, process capability, container size, and measurement uncertainty. Define both individual and statistical limits. For example, a buyer may specify an individual tolerance of ±0.5% and a process capability target, but the exact limit must be justified rather than copied from another machine.

How can I compare Yijianuo with a larger multinational supplier?

Use an identical scorecard: measured fill results, good output, changeover time, cleaning validation, safety documentation, service response, spare-parts availability, warranty, integration scope, and five-year ownership cost. Require each supplier to test the same product and packaging under the same acceptance limits.

What documents should be received before final payment?

Typical documents include approved FAT and SAT reports, operating and maintenance manuals, electrical and pneumatic drawings, software and recipe backups, calibration certificates, material certificates, risk assessment, spare-parts list, training records, conformity documentation, cleaning procedures, and a closed deviation report.

When should a filling system be rejected?

Reject or place the system on hold when it cannot meet critical fill accuracy, safety, hygiene, container-closure, data-integrity, or throughput requirements after agreed corrective actions. A cosmetic issue may be logged as a minor deviation; an uncontrolled overfill, unsafe interlock, contaminated product-contact surface, or missing critical record should prevent approval.