FAT and SAT for Packaging Machines: What to Require in the Acceptance Protocol and Documentation Pack

Start with a written, approved acceptance protocol

Before you schedule any test, insist on a written protocol that names the critical process steps, the acceptance criteria and the number of runs, and that is reviewed and approved by your quality unit.

GMP guidance treats that approved protocol as the documented starting point for validation activity, and the same documentary logic transfers to FAT/SAT acceptance¹. The protocol is what makes every later test auditable: without pre-agreed criteria, a test result is an opinion.

The companion document matters as much as the protocol. Qualification is described as proceeding through Design Qualification, Installation Qualification and Operational Qualification before process validation, with a validation report that cross-references the protocol, summarises results, comments on deviations and recommends corrective changes¹⁰.

Any variation from the protocol is documented with justification¹⁰. Ask your vendor to accept the same structure: protocol first, report second, deviations written down rather than settled verbally.

For your RFQ, that means the acceptance protocol is a deliverable in its own right, not an annex the vendor fills in after the machine is built. You decide the criteria; the vendor signs up to them.

Reject quotes that do not commit to tested output on your product

A rated maximum speed is not an acceptance figure. Buying guides state that rated speeds are often achieved under ideal test-material conditions that do not reflect real production runs, and advise requesting documented specifications including tested output rates on your actual product¹¹.

The same guides present a trial run with your own product and film, even at added cost, as cheaper than discovering compatibility or accuracy issues after installation¹⁶. So rule out any quote that offers only a catalogue speed.

What you want in writing is a tested output rate and accuracy figure produced on your product, your container and your film, with the test conditions recorded. That converts a marketing number into a verifiable acceptance criterion you can hold the vendor to at FAT and again at SAT.

One peer guide offers example numeric acceptance targets for dosing repeatability, reject rate and process capability that you could use as a negotiating starting point¹⁹. Treat them as a starting point only: no source establishes packaging-machine-specific tolerances for output rate, fill or pack accuracy, seal integrity or reject rate.

Acceptance criteria for the trial run

The only numeric targets in this evidence set come from one peer compliance guide, and they are described there as examples rather than universal limits¹⁹. Use them to open the negotiation, not to close it.

Conformity, material and calibration documents, and what to test rather than certify

At installation you should collect the paperwork that proves the machine matches what you ordered and what you specified. A peer compliance guide describes IQ as verifying machine arrival against the purchase order — model, serial, firmware .

And collecting certificates of conformity, the CE declaration under Machinery Directive 2006/42/EC, and material documentation for contact parts¹⁹. Where solvents are present in the process, ATEX documentation is additionally required alongside the CE declaration¹⁹.

Some safety elements should be verified by test, not by certificate. The same guide describes OQ as running the machine empty and with a non-production surrogate to exercise functions including safety interlocks and HMI alarms¹⁹.

For robotic packaging cells operating near human workers, compliance with ISO 10218 and ANSI/RIA R15.06 is expected, together with guarding, light curtains or safety-rated monitored stopping, and risk-assessment documentation²⁵. A general buying guide for tray sealers lists emergency stop buttons and safety guards among the features to look for⁵.

Each source names a different standard set for a different equipment type, so map the applicable standard to your own machine rather than copying a list. ISO 12100, ISO 13849 and 21 CFR Part 11 are not addressed by any source in this set.

The acceptance documentation pack to attach to the purchase order

Across a GMP guidance document and two peer equipment guides, the recurring documentation set for equipment acceptance includes a protocol-and-report pair, material and calibration certificates, conformity declarations, and records of control parameters^10,19,33. Attach this list to the PO so it is a contractual deliverable.

• ✓Acceptance protocol with critical steps, acceptance criteria and run counts, approved by your quality unit
• ✓Validation or acceptance report cross-referencing the protocol, with deviations and conclusions
• ✓FAT and SAT reports as named deliverables in the documentation pack
• ✓Material certificates for product-contact parts, plus finish and passivation reports
• ✓Calibration records for sensors and instruments
• ✓Certificates of conformity and CE declaration; ATEX documentation where solvents are present
• ✓Records of control parameters and sensor calibrations captured during OQ

Service, spares, training and warranty questions to settle before you sign

These items determine whether the machine stays productive after handover, and buying guides list them as questions to settle before purchase rather than after^31,33.

• ✓What is the expected lead time for spare parts, and is local service available?
• ✓What training is included, and how long until an operator reaches full proficiency?
• ✓What warranty and service contract options exist, and what do they cover?
• ✓What consumables does the machine require, and what do they cost annually?
• ✓Can you speak directly with a reference customer running a similar product line?
• ✓What is the local service network, and is remote PLC/HMI support available?

What you must write yourself: test split, responsibility and milestones

The sources describe IQ/OQ/PQ as a qualification sequence and separately list FAT/SAT reports as documentation. But no source maps FAT to a specific qualification stage or defines which tests occur at the factory versus on site^10,19,33.

That allocation is yours to write into the contract, along with the pass/fail criteria for each stage. The responsibility split is equally open.

No source states who supplies product and utilities for the test, who witnesses it, who pays travel costs, or what minimum run length and sampling make a test run valid.

What the sources do support is using your own product and format in the acceptance run and treating repeatable acceptance testing as a selection criterion^16,31. Market reporting notes that German and Japanese manufacturers place greater weight on safety records and repeatable acceptance tests before replacing established machinery.

And that German plant teams emphasise machinery safety and control documentation before changing a validated line^18,28. Commercial milestones are the third gap.

No source covers payment milestones, retention, witness or retest costs, or the lead time from purchase order to FAT and SAT. Write those terms yourself and have them reviewed before the PO is issued.

Changeover time: two figures the sources disagree on

Changeover time is a specification item to confirm for all current SKUs, and the two figures below come from different kinds of source, so they are not directly comparable^13,27.

What the sources do not establish

• No source defines which tests are performed at the factory (FAT) versus on site (SAT) for packaging machines, or the pass/fail criteria for each.
• No source specifies PLC/HMI software backup or as-built drawings as FAT deliverables.
• No source names a formal deviation or non-conformance log, or a final release certificate, as SAT deliverables.
• No source gives packaging-machine-specific tolerances for output rate, fill or pack accuracy, seal integrity, reject rate or changeover time.
• ISO 12100, ISO 13849 and 21 CFR Part 11 are not addressed by any source in this set.
• No source covers payment milestones, retention, witness or retest costs, or lead time from purchase order to FAT and SAT.
• No source defines who supplies product and utilities, who witnesses the test, who pays travel, or what constitutes a valid test run.
• No source specifies operator or maintenance training records, or warranty terms, as formal SAT deliverables.
• The GMP and legal sources in this set are pharmaceutical, food-safety or unrelated regulatory texts and do not describe packaging-machine FAT/SAT procedures.