Knowledge article
Factory Acceptance Test Inputs for Packaging Equipment
Define samples, run conditions, acceptance criteria, documentation, and deviation handling before the FAT begins.
Define the FAT boundary
A factory acceptance test should answer a defined question: does the assembled equipment conform to the approved purchase and technical scope under the agreed factory conditions? It is not a substitute for site acceptance, process validation, or qualification in the installed environment. State the machine boundary, software version, included options, test location, utilities, participants, and documents that form the baseline. If the machine is incomplete or temporary components are used, record that condition before testing begins.
Freeze the approved references
Freeze the approved references before writing test steps. Typical inputs include the purchase order, technical agreement, user requirement clauses in scope, approved layouts, product-path drawings, electrical and pneumatic diagrams, component lists, format drawings, software functional description, risk controls, and supplier specifications. Give each document a revision. The FAT protocol should trace tests to these references and distinguish inspection, functional challenge, performance demonstration, and document review. Unapproved sales material should not become an acceptance criterion by accident.
Control samples and components
Control samples and packaging components as test inputs. Identify product or placebo, formulation or relevant physical properties, container and closure suppliers, dimensions, lot numbers, film or label roll data, cartons, leaflets, coding consumables, storage, conditioning, and quantity. Provide enough material for setup, nominal running, challenges, format changes, and repeat tests. Agree how unused and rejected material is handled. If a substitute is used, document why it represents the production material and which conclusions remain open for site testing.
Build an operating-envelope test matrix
Build a test matrix around the operating envelope. Include normal startup, nominal output, agreed minimum and maximum formats, dose or count extremes, controlled stops, restart, replenishment, changeover, and cleaning access where relevant. For connected lines, test handshakes, accumulation, blocked and starved conditions, and reject tracking. State the run duration and whether speed is a brief demonstration or a sustained acceptance value. A single easy format at one setting does not verify a multi-format machine.
Define measurements and acceptance
Define every measurement before collecting data. State instrument, calibration status, sample size, sampling interval, calculation, rounding, acceptance limit, and treatment of startup or rejected units. Examples include fill mass, count accuracy, seal integrity, torque, code quality, label position, carton appearance, line output, and reject performance. Avoid vague terms such as 'good result' or 'no problem'. For visual criteria, use approved examples or a defect catalogue so buyer and supplier classify the same condition consistently.
Challenge safety and alarms
Challenge safety, alarms, and error handling deliberately. Verify guards, interlocks, emergency stops, reset behaviour, safe access, stored energy controls, overloads, missing-component logic, low-level warnings, sensor faults, reject-bin conditions, and utility loss that are included in scope. Record expected and actual machine response. A safety test should not be improvised by creating an uncontrolled hazard; the protocol must identify the safe challenge method and authorized participants. Any bypass used for setup must be removed or controlled before release.
Review controls and deliverables
Review controls and deliverables while the responsible people are available. Check recipes, user roles, language, alarm history, counters, reports, date and time, backup and restore, interfaces, and supplied software media or licenses. Inspect manuals, drawings, certificates, calibration records, spare and wear parts, change parts, tooling lists, and recommended consumables against the order. Mark draft documents as draft and assign final due dates. A successful machine run does not close missing documentation that the site needs for installation or operation.
Manage deviations to closure
Use a deviation log with ownership and disposition. Each difference should identify the requirement, observation, evidence, product or safety impact, temporary control, responsible party, target date, and whether retesting is required. Classify deviations using the project procedure rather than hiding them in meeting notes. Buyer and supplier should sign the factual observation even if commercial responsibility is still under discussion. Closure may be accepted at the factory, by documented evidence before shipment, or at site only when that route is explicitly approved.
Release the machine with site actions
End with a release decision and site-action list. Summarize tests passed, tests failed, open deviations, incomplete formats, software and document versions, removed trial materials, preservation, packing, lifting, shipping restraints, reassembly, and utilities needed at site. Identify FAT results that must be repeated after installation and inputs still required for SAT or qualification. Shipment authorization should reference this record. The objective is not a ceremonial signature; it is a controlled transfer from factory testing to installation and final verification.
Turn the requirement into an equipment shortlist.
Share your material, format, capacity, utilities, and destination standard for a model-level review.
Request a technical discussionContinue the technical review
Related equipment
16-channel Vision Counting Machine
YOKO-16SJ is a 16-lane vision counting machine for tablets, hard capsules, softgels, and compatible discrete products. Its catalogue reference is 4,200 bottles per hour with an adjustable count from 8 to 9,999 units per bottle. Product geometry, translucency, overlap, dust, bounce, feed stability, bottle handling, inspection logic, and the required counting challenge must be evaluated with actual samples before the sustained line rate is confirmed.
- Reference range
- 4200 bottles/hr
Automatic Gummy Counting Machine
The YOKO-T16SP automatic gummy counting machine is intended for gummy counting and hard-candy counting. Selection is reviewed against gummies and hard candy, target output, utilities, and line interfaces. Final configuration is defined in the quotation and technical agreement.
- Reference range
- 180,000 (3g) pcs/hr
Automatic Alu/Alu Strip Packing Machine
The YOKO-RP-F automatic Alu/Alu strip packing machine is intended for tablet blisters and capsule blisters. Selection is reviewed against PVC and PVDC, target output, utilities, and line interfaces. Final configuration is defined in the quotation and technical agreement.
- Reference range
- 4800 / 1800-4800 / 66000 pcs/hr
Automatic Blister Packaging Machine
YOKO-P-F is an automatic blister-packaging family with seven reference models. The published range covers forming areas from 105 × 70 to 310 × 160 mm, forming depths up to 35 mm, and listed outputs from 1,200 to 9,600 blister cards per hour depending on model and format. Selection should begin with the product, cavity layout, web materials, barrier requirement, registration, feeder, inspection, coding, and cartoning interface.
- Reference range
- Model-dependent; see technical specifications
Automatic Horizontal Cartoning Machine
YOKO-WZH-N is a horizontal cartoning family with eight reference configurations. Published production ranges extend from 600 to 6,000 cartons per hour depending on model and product format, with carton-board references of 250–400 g/m². A reliable selection requires the actual product presentation, carton and leaflet drawings, loading method, closure style, coding, inspection, reject logic, buffer strategy, and sustained upstream rate.
- Reference range
- Model-dependent; see technical specifications
Automatic Horizontal Cartoning Machine
The YOKO-WZH-A automatic horizontal cartoning machine is intended for pharmaceutical cartons and blister cartoning. Selection is reviewed against paperboard cartons and leaflets, target output, utilities, and line interfaces. Final configuration is defined in the quotation and technical agreement.
- Reference range
- 50-100 / 30-120 / 180 / 320 cartons/min