BEFORE SHIPMENT · PHARMACEUTICAL EQUIPMENT PROCUREMENT
A blister packing machine FAT should demonstrate the approved product, packaging materials and configured functions against an agreed acceptance protocol. Build the test scope before comparing quotations, so the offered machine and the evidence required to accept it describe the same project.
Freeze the product and pack drawings, assign a pass criterion to each requirement, challenge relevant faults, measure accepted output over a defined interval, and close deviations with an owner and evidence. Your quality team approves the limits and the connection to site qualification.
For procurement, production engineering and quality teams buying standalone blister machines or a connected blister-to-carton line.
What should a blister packing machine FAT prove?
A factory acceptance test is an equipment acceptance activity at the supplier’s facility. It should establish what the supplied configuration can demonstrate before shipment, including the agreed materials, controls, inspection functions and line interfaces. The purchasing specification needs to identify which requirements are tested at the factory and which need site conditions or connected systems.
Before finalizing the acceptance plan, review the blister machine supplier evidence and responsibility checklist. Confirm who provides the configuration records, trials, interface information and remaining site work.
A witnessed machine run is useful when its setup and result are traceable. Record the machine configuration, software or recipe version, tooling, product identity, material lots, instruments and approved protocol. A successful run of an easy format cannot establish performance across an untested SKU matrix.
Dimensions, fragility, feeder behavior, cavity layout, forming web, lidding web, registration and finished-card criteria.
Required accepted packs per hour, run duration, permitted rejects, agreed test methods and measurement boundaries.
Who provides samples, test equipment, integration, documents, deviation review and remaining site tests.
Select representative and difficult formats with the buyer’s team. Consider feeding behavior, material variation, deep or close-fitting cavities, registration demands and changeovers. Agree the needed sample quantity from the planned tests rather than sending only a few ideal packs.
The 15-point blister machine FAT checklist
Use these areas to build a project-specific protocol. For each requirement, add the test method, the buyer-approved pass criterion, who executes and witnesses it, and the record to retain. An item absent from the quotation needs a scope decision before it becomes an acceptance obligation.
| Test area | What to demonstrate | Evidence to retain |
|---|---|---|
| 01 · URS and as-built scope | Compare the approved requirement list with machine drawings, selected components, tooling, options and software functions. Record changes before testing. | URS references, configuration list, approved drawings and a deviation register with named owners. |
| 02 · Web supply and tracking | Run the approved web at the agreed reel and operating conditions. Review tension, alignment, material availability, registration and stop/restart behavior. | Material lots and reel specification, setup values, observations, alarms and restart samples. |
| 03 · Forming | Review the finished cavity geometry, appearance and material condition across the nominated settings. Thermoform and cold-form routes need their own tooling and sample checks. | Approved cavity drawing, method, sample locations, settings, measured results and defect records. |
| 04 · Product feeding | Run representative products and orientations. Review missed or double fills, product damage, feeder adjustments and recovery from a controlled interruption. | Product/sample identity, feeder setup, challenged conditions, observations and affected pack disposition. |
| 05 · Heat sealing | Use the actual forming/lidding material pair. Assess the agreed settings and stop-state protection; test seal attributes by the buyer-approved method. | Material lots, temperature/pressure/timing basis, test method, sample plan, results and deviations. |
| 06 · Indexing and cutting | Compare registration, finished-card dimensions, perforations and coding clearance with the approved drawing. Include relevant operating conditions and restarts. | Measured samples, setup or recipe identity, cut criteria, registration results and rejected samples. |
| 07 · Inspection capability | Challenge only the configured inspection tasks, such as missing product, print or code checks. Distinguish what is detected from what remains outside the quoted scope. | Defect definitions, prepared challenge samples, detection results, setup and inspection exclusions. |
| 08 · Physical rejection | Follow the challenged defective unit from detection to its removal. Review timing, reject confirmation where specified, collection and recovery after a relevant fault. | Challenge log, detected/removed units, reject destination, reconciliation and failure response. |
| 09 · Alarms and safety functions | Use an approved safe procedure to demonstrate the quoted guards, stops, material alarms and protection functions. Confirm recovery and reset behavior. | Function list, test procedure, observed response, alarm records and outstanding corrective work. |
| 10 · Recipe and user functions | Check the quoted recipes, permissions, parameter ranges and retained records. Evaluate electronic-record features against the agreed intended use and applicable requirements. | Function specification, permission tests, sample records, backup/restore tests where included and open items. |
| 11 · Coding and identification | Confirm batch/expiry content, location, legibility and registration. Where code verification or serialization is supplied, agree its specific checks and interfaces. | Approved artwork, code requirements, sample codes, verification results and applicable interface evidence. |
| 12 · Cleaning and access | Review accessible product and material paths, residue collection, approved cleaning methods and change-part handling. Confirm quoted material documentation. | Access review, cleaning procedure scope, relevant material records and any features needing site assessment. |
| 13 · Changeover | Observe a defined SKU-to-SKU change, including clearance, feeder/tooling setup, recipes and first-piece approval. Use agreed starting and ending conditions. | Change-parts list, operator/tools, elapsed time, setup record and accepted restart samples. |
| 14 · Sustained run and interfaces | Measure accepted output, rejects, waste, stops and interventions over one stated period. Challenge specified upstream/downstream handoffs or document simulation limits. | Run record, counts, stop reasons, signal matrix, recovery results and tests deferred to site. |
| 15 · Documents and deviations | Review the agreed document index, test results, training and service scope. Resolve or formally assign remaining work before authorizing the agreed shipment stage. | Signed report, document revision list, deviation disposition, retest evidence and handover responsibilities. |
Temperature uniformity, seal-test values, detection rates, changeover times and safety performance depend on the actual machine, packaging system, intended use and approved methods. Do not turn an illustrative checklist into a universal numerical specification. Your quality and engineering teams should approve suitable limits and sampling.
Engineering insight: measure accepted packs over the same elapsed run
A cycle count describes machine motion; a finished-card count describes packs produced. Accepted packs describe the conforming output released from the test boundary. Specify the boundary and the timing rule before comparing supplier results.
Assume a defined 60-minute run produces 8,400 finished cards, of which 240 are rejected. Accepted cards = 8,400 − 240 = 8,160. Accepted output = 8,160 ÷ 60 = 136 cards/min, or 8,160 cards/hour. Rejected share = 240 ÷ 8,400 ≈ 2.86%. These are arithmetic examples, not HIJ test results or passing FAT limits.
If that elapsed period contains five minutes of unplanned stops, retain the five minutes in the stated elapsed-run result. Dividing by the 55 running minutes gives about 148.36 accepted cards per running minute, which answers a different question. Report both only with clear labels. The accepted hourly rate above already includes those stops; applying another allowance for the same stops would double-count them.
For a carton containing two blister cards, 8,160 accepted cards/hour can supply 4,080 cartons/hour before grouping and cartoning losses. A faster cartoner cannot create additional accepted cards. Check the downstream count recipe, inspection, carton feed and shared recovery sequence with the upstream result.
Count reconciliation also needs a boundary. Explain how samples removed for testing, partly completed packs, process scrap and startup material are treated. An OEE claim requires defined availability, performance and quality calculations; this simple accepted-output example is not an OEE result.
Apply the protocol to the actual HIJ platform
DPP-260 / DPP-360K flat-plate scope
The supplied combined technical document describes positive-pressure thermoforming, a flat sealing arrangement, adjustable traction, modular station changes and missing-product detection/rejection. Mechanical and servo arrangements are described; the final configuration list is controlled by the contract. Confirm the exact model and supplied functions before assigning tests.
Review the DPP-260 blister machine configuration and reference specification. Test the chosen materials, feeder, tooling, inspection and changeover scope together.
DPH380B roller-plate scope
The DPH380B source describes roller heat sealing, servo-controlled motion and material/temperature protection. Its motion rate and possible finished-pack output have different units. FAT conditions must name the material route, pack drawing and inspection functions rather than reuse another platform’s results.
Compare the documented platform through the HIJ blister packing machine range. Agree the seal-process and registration evidence for the actual quoted setup.
PBL-400S-400SF integrated line
The provided project file covers glass pre-filled syringes and ampoules, forming, loading, inspection, sealing, punching, leaflet handling and cartoning. Its 8,000 pieces/hour project basis is not a universal accepted-carton rating. Review unit conversion and the complete pack definition in the test protocol.
Use the PBL blister-cartoning line scope and cartoning FAT checklist to connect the primary and secondary acceptance tasks.
HIJ can review a standalone machine or a connected line against your product, materials and requested evidence. The inclusion of a control, inspection function or document must be confirmed in the project offer.
Close the report and define what remains for the site
Agree the document index before the purchase order: controlled drawings, manuals, utilities, selected components, relevant material records, test instruments, FAT protocol/report, parts and tooling lists, software functions and training scope. Qualification-support documents are included only when named in the offer.
Use the blister machine price and quotation scope guide to define the cost boundary for tooling, trials, witnessing, documents and site work. Resolve required items outside the base offer before treating quotations as equivalent.
A deviation register should identify the requirement, observation, impact assessment, corrective action, owner, due stage and verification record. A corrected fault needs appropriate retest evidence. Keep shipment authorization and the handling of open items consistent with the contract and the buyer’s approval process.
Some interfaces or conditions cannot be fully exercised at the supplier’s facility. Identify any simulated upstream discharge, unavailable customer system or different site utility. Record the boundary of the factory result and agree the remaining connected tests for site acceptance. This is more useful than implying that an isolated machine run established complete-line performance.
For drug manufacturing, FDA’s Process Validation guidance describes a lifecycle including process design, qualification and continued verification. FAT evidence can inform your equipment review; the customer’s quality team determines how to use it in site qualification and process validation. This drug guidance does not cover medical devices or dietary supplements.
Request electronic-record functions from a documented intended-use assessment. Identify which records the system creates, how access and changes are controlled, how records are retained, and what remains in the customer’s systems. Assess applicable requirements separately; a PLC brand or a generic “Part 11 ready” label does not demonstrate the agreed functions.
Prepare a blister machine and FAT review request
Start with what you have. A product and blister drawing, intended forming/lidding materials and accepted-output target help HIJ assess the configuration. Add the proposed test areas, downstream interfaces and document needs for a comparable quotation.
Optional project brief
These fields prepare a message for review. The existing inquiry form collects contact details when you choose to submit.
Review the message before submitting. Copying or opening the form does not send an inquiry.
Blister packing machine FAT: buyer questions
Resolve these questions before agreeing the machine scope and test protocol.
What is a blister machine FAT?
It is the agreed equipment acceptance test at the supplier’s facility before shipment. It uses approved products, packaging materials and test methods to check the configured machine and retain evidence against the purchase requirements.
Who decides the FAT acceptance limits?
The buyer’s engineering and quality teams agree the limits with the supplier and approve the protocol. Values depend on the product, packaging system, intended use and quoted functions. A web checklist is a planning aid, not an approved test specification.
How long should the production trial run?
Agree duration from the risks, formats, functions and representative operating conditions that need to be demonstrated. Include the count and timing boundaries, planned stops, sampling and permitted rejects. There is no single run duration established by this guide for every project.
What samples should I send?
Provide representative products, production forming and lidding materials, approved drawings and any downstream cartons or leaflets. Agree quantities from the trial plan, including challenges, setup, changeovers and samples taken for examination.
Does vision inspection prove seal integrity?
Only if the quoted inspection method is suitable for that specific task and demonstrated against agreed defects. Product-presence or code cameras answer different questions. Confirm the seal-test method separately with the buyer’s quality team.
Does a successful FAT complete IQ, OQ or PQ?
Factory testing provides evidence within its documented conditions. Site installation, qualification and process validation remain in the customer’s approved plan. Record what can be used, what needs reassessment after transport/installation and what must be tested at the site.
Can blister and cartoning equipment be tested together?
Yes, where the agreed project and available equipment allow connected testing. Define the product count, material flow, control handshakes, inspection, rejection and recovery. Record any simulated interfaces and remaining site work.
What affects the machine and FAT quotation?
Product feeding, tooling, material routes, inspection, coding, interfaces, document scope, trial formats, sample quantity and service responsibilities affect the offer. Request a current configuration-based quotation with included and optional items identified.
Sources and scope of this guide
This is an editorial procurement framework from HIJ Machinery. Equipment examples use the supplied DPP-260/360K, DPH380B and PBL-400S-400SF technical documents. The output calculation is illustrative and has no claimed personal author or customer-test attribution.
Read the blister machine buying guide for the wider selection process, or review complete-line planning when several equipment suppliers and interfaces are involved. The final specification, acceptance protocol and commercial scope are project-specific.
