| Safety | Machine risk assessment | Documented risk assessment based on ISO 12100, covering filling, crimping, propellant charging, cleaning, maintenance, and abnormal operating conditions. | Review the signed risk assessment, hazard register, safeguarding layout, and residual-risk instructions. | Identifies mechanical, pneumatic, electrical, chemical, pressure, and flammable-propellant hazards before commissioning. | High |
| Safety | Explosion and ignition control | For flammable propellants, use appropriately classified equipment, bonding and grounding, ventilation, gas detection, and ignition-source control according to the site classification. | Check hazardous-area drawings, electrical certificates, grounding-resistance records, ventilation calculations, and gas-detector test reports. | BOV aerosol production may involve flammable propellants and requires controls that prevent ignition and limit vapor accumulation. | High |
| Safety | Emergency-stop and interlock system | Emergency stops should be clearly accessible; guards, doors, pressure switches, and access panels should stop or place the relevant section in a safe state. | Perform documented functional tests for every emergency stop, guard switch, access door, and reset sequence. | Prevents continued operation when an operator enters a hazardous zone or when an unsafe condition occurs. | High |
| Safety | Safety-related control performance | The required performance level should be determined by risk assessment; safety circuits should be designed and validated according to ISO 13849-1 or an equivalent standard. | Request the safety-circuit calculation, validation report, component list, and proof-test procedure. | Confirms that safety functions are capable of achieving the required risk reduction throughout the machine life cycle. | High |
| Safety | Pressure protection | Filling circuits, manifolds, and pressure vessels must have suitable pressure ratings, pressure relief, isolation, and controlled depressurization. | Compare design pressure with operating pressure; inspect relief-device certificates, pressure-test records, and piping diagrams. | Protects operators and equipment from overpressure during propellant filling, blockage, thermal expansion, or valve failure. | High |
| Quality Control | BOV component verification | Verify valve, bag, actuator, gasket, can, and dip-tube specifications before production; use part-presence and orientation checks where practical. | Review approved component drawings, incoming-inspection records, barcode or recipe controls, and rejected-part records. | Incorrect BOV components can cause leakage, poor product delivery, loss of pressure, or container failure. | High |
| Quality Control | Product and propellant dosing accuracy | Define the accuracy and repeatability required by the product specification; a common starting point is a validated target of approximately ±1% for liquid dosing and tighter limits where formulation performance requires it. | Conduct gravimetric studies over multiple cycles, operators, shifts, and machine speeds using calibrated instruments. | Accurate dosing supports consistent net content, spray performance, product efficacy, and regulatory labeling. | High |
| Quality Control | Crimping and valve-seat quality | Crimp diameter, crimp height, valve alignment, and insertion depth must remain within the container and valve supplier’s validated limits. | Use calibrated crimp gauges, dimensional checks, destructive tests, and periodic sectioning or pull-out tests as defined in the control plan. | Improper crimping is a major cause of leakage, valve malfunction, and inconsistent dispensing. | High |
| Quality Control | Leak detection and pressure testing | Include a validated leak or pressure-decay test after filling and crimping; acceptance limits must be based on container, valve, and product characteristics. | Review the test method, sensitivity study, calibration records, challenge samples, and automatic reject verification. | Detects leaks that could cause product loss, poor shelf life, flammable-vapor release, or customer safety issues. | High |
| Quality Control | In-process inspection coverage | Monitor container presence, BOV orientation, fill level, crimp condition, code readability, actuator presence, and reject confirmation. | Check the PLC inspection list, sensor challenge tests, reject-bin-full alarm, and sample inspection frequency. | Prevents defective units from moving to secondary packaging and provides early warning of process drift. | Medium |
| Quality Control | Recipe management and changeover | Password-controlled recipes should record product, container, valve, dosing, crimp, speed, and inspection settings; changeover parts should be uniquely identified. | Test recipe access levels, parameter limits, electronic change logs, barcode controls, and first-off approval after changeover. | Reduces setup errors and prevents incorrect settings from being used on a new product or container format. | Medium |
| Quality Control | Data integrity and traceability | Record batch number, recipe version, operator, machine status, alarms, inspection results, rejects, and critical process values with protected timestamps. | Review audit-trail functions, user permissions, backup procedures, data export, and retention controls. | Supports investigations, recalls, continuous improvement, and regulated manufacturing documentation. | High |
| Compliance | Machinery safety documentation | Supply a technical file or equivalent documentation package, including manuals, drawings, risk assessment, safety validation, and declarations required by the target market. | Use a document checklist before purchase and verify that manuals cover installation, operation, cleaning, maintenance, and emergency procedures. | Demonstrates that the machine has been designed and documented for safe use and regulatory review. | High |
| Compliance | Electrical and control-system compliance | Electrical equipment and control panels should be designed and tested against applicable requirements such as IEC 60204-1 and local electrical codes. | Inspect schematics, short-circuit ratings, protective devices, panel labels, insulation tests, grounding tests, and conformity documents. | Reduces electrical shock, fire, electromagnetic-interference, and unplanned-downtime risks. | High |
| Compliance | Pressure-equipment requirements | Pressure vessels, gas circuits, and safety accessories must be assessed under the pressure-equipment rules applicable to the installation country, such as the EU Pressure Equipment Directive where relevant. | Review vessel categories, material certificates, welding records, relief-device certificates, and inspection requirements. | Confirms that pressure-containing components are suitable for their fluid, pressure, temperature, and service conditions. | High |
| Compliance | GMP and hygienic design | For pharmaceutical, medical, or sensitive personal-care products, use cleanable product-contact surfaces, suitable materials, controlled lubrication, and documented cleaning procedures. | Review material certificates, surface-finish specifications, cleaning validation or verification, lubrication controls, and sanitation instructions. | Reduces contamination, cross-contamination, and batch-release risks. | High |
| Compliance | Materials and chemical compatibility | Product-contact materials, elastomers, seals, and lubricants must be compatible with the formulation, propellant, cleaning agents, and expected temperature range. | Request material declarations, compatibility data, extractables or leachables assessment where applicable, and supplier change-notification controls. | Prevents swelling, embrittlement, corrosion, contamination, leakage, and changes in product performance. | High |
| Performance | Validated production capacity | Select a rated speed that meets demand while allowing time for inspection, cleaning, changeover, maintenance, and rejects; validate output using the actual product and container format. | Run a factory acceptance test and site acceptance test using production-equivalent materials and documented performance criteria. | Nominal speed alone does not guarantee sustainable output or acceptable quality. | Medium |
| Performance | Overall equipment effectiveness | Measure availability, performance, and quality separately; establish an agreed baseline rather than relying only on the machine’s maximum cycle rate. | Collect downtime, micro-stop, speed-loss, reject, and changeover data during a representative production trial. | Provides a realistic view of usable capacity and operating cost. | Medium |
| Maintenance | Critical spare parts and serviceability | Identify safety-critical, long-lead, and wear parts; provide preventive-maintenance intervals, lubrication points, troubleshooting steps, and changeover tools. | Review the spare-parts list, maintenance schedule, mean-time-to-repair assumptions, and technician training plan. | Improves uptime and helps prevent unsafe temporary repairs or extended production interruptions. | Medium |
| Acceptance Testing | Factory and site acceptance testing | Define measurable FAT and SAT criteria for safety functions, dosing accuracy, crimp quality, leak detection, reject handling, alarms, data records, and changeover performance. | Use signed test protocols with traceable instruments, approved samples, deviation records, and final corrective-action closure. | Confirms that the installed machine meets the agreed specification before routine production. | High |
