Short answer: Before you accept an Ampoule Filling Machine, inspect it twice — once at the supplier's factory (FAT) and once on your site (SAT). The FAT proves the machine is built and functions to specification; the SAT proves it performs after installation and integration. A written protocol, agreed in advance, turns both into objective acceptance decisions instead of a handshake.

What Is the Difference Between FAT and SAT?

The factory acceptance test happens at the builder's plant, before shipment, on the actual machine with your reference ampoules and product sample. The site acceptance test happens at your facility, after installation and utilities connection, and links directly into commissioning and qualification. Skipping either stage does not save time — it simply pushes problems into validation, where they cost far more to correct.

What Should You Prepare Before the FAT?

• A signed user requirement specification and an approved FAT protocol.
• Representative ampoules across the size range and a sample of the real product.
• Agreed acceptance criteria for fill accuracy, seal quality and output.
• Calibrated reference balances and the test methods to be used.
• A named acceptance team with the authority to sign off.

Which Tests Belong in the FAT?

At minimum, verify mechanical function at low and high speed, gravimetric fill accuracy at the extremes of ampoule size, seal quality by visual and leak checks, and all safety interlocks and alarms. Confirm the HMI, recipe handling and audit trail behave as specified. Record actual numbers, not pass/fail ticks, because the numbers are what you compare against your URS and reuse at the SAT.

How Do You Verify Materials and Cleanability?

Confirm product-contact surfaces, typically 316L stainless steel, and the surface finish stated in your URS. Inspect welds, crevices and drainage, because these drive cleanability and the effectiveness of CIP/SIP. Ask for material certificates and check that the design supports the cleaning validation you will run later. A machine that is hard to clean will not stay in compliance, however good its performance test looks on the day.

What Must Be Verified at the SAT?

At site, re-run the critical function and fill-accuracy tests after installation, confirm the machine integrates with upstream and downstream equipment, and check utilities such as compressed air, gas and power quality. Confirm safety systems, complete operator training, and hand over the records that feed IQ and OQ. Only after a clean SAT should you move towards performance qualification and routine production.

How Do You Handle Deviations Found During FAT or SAT?

Record every deviation, agree a corrective action and retest. A conditional acceptance with a defined open-item list is common when the deviation does not affect safety or performance, but each item needs an owner and a due date. Close the loop before qualification, and keep the deviation log with the acceptance records; auditors will ask for it.

How Do You Plan the Acceptance Timeline?

Build the FAT and SAT into the project schedule from the start, with time reserved for retest if a deviation is found. A realistic plan allows for travel, for representative ampoules to arrive, and for the site to have its utilities ready before the machine ships. An Ampoule Filling Machine that is accepted late pushes every downstream activity — qualification, validation, first commercial batch — to the right, so treat the acceptance dates as fixed gates rather than movable targets. Assign a single owner for the acceptance file, witness and sign the FAT with the supplier, and keep the FAT and SAT records together. That way the qualification team starts from complete, dated evidence instead of chasing test results after the fact.

What Is the Single Most Useful Habit?

Test what the machine will actually do in production, record real numbers, and resolve every deviation before you sign. A disciplined FAT and SAT is the cheapest insurance you can buy for an Ampoule Filling Machine that must run sterile from day one.

Frequently Asked Questions

Can I accept the machine without a FAT?

You can, but you take on far more risk. Findings discovered at site are costlier to correct than at the factory.

Should fill accuracy be tested with water or product?

Test with water for a repeatable baseline, then confirm with the real product, because viscosity changes the dose.

What if a FAT test fails?

Record it, agree a corrective action and retest. A conditional acceptance with open items is common if the deviation does not affect safety or performance.

Who should sign the acceptance protocol?

A named team with engineering, QA and production representation, holding the authority to accept or hold the machine.

To plan an acceptance protocol around a specific machine, review this 20ml ampoule filling machine or browse the full Ampoule Filling Machine portfolio. Send your ampoule sizes, output and compliance requirements for a tailored FAT/SAT plan.