Publish Time: 2026-10-30 Origin: Site
A laboratory centrifuge may arrive, power on and complete a demonstration run without establishing that every contractual requirement has been met. The equipment may still need configuration checks, site verification, documented performance results or resolution of outstanding deviations.
For laboratory buyers, the commercial risk is not simply receiving a machine that does not operate. It is accepting equipment before the delivered configuration, agreed performance and handover requirements have been adequately verified.
Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment qualification and final acceptance address different stages of this process. Their scope and responsibilities should be established before the purchase order is finalized.
A well-defined procurement project connects the original requirements to the final equipment handover. Each stage should have a clear purpose, responsible party and documented outcome.
Illustrative procurement sequence. The actual order and extent of qualification activities depend on the equipment, project requirements and applicable quality system. PQ may follow as a separate activity where required.
Factory Acceptance Testing is performed at the supplier's facility before delivery when required by the project or purchase agreement. Its purpose is to evaluate the equipment against the agreed technical requirements while the equipment is still under the supplier's control.
For a centrifuge, the FAT protocol should be built around the actual order rather than a generic demonstration of a similar machine.
Not every centrifuge purchase requires a formal FAT. The need depends on equipment complexity, project risk, the laboratory's quality requirements and the commercial agreement.
The European Commission's EudraLex Annex 15, for example, describes vendor evaluation before delivery as applicable to equipment, particularly where novel or complex technology is involved. It also recognizes that some documented tests may not need to be repeated on site when transport and installation cannot affect the tested functionality.
A successful FAT confirms only the requirements and test scope that were actually evaluated. It does not automatically establish that the equipment is correctly installed or accepted for its intended laboratory environment.
Site Acceptance Testing takes place after the equipment has reached its intended location and the relevant installation work has been completed.
Unlike FAT, SAT addresses conditions that cannot be fully established at the supplier's factory. The objective is to confirm that the delivered equipment can operate under the agreed site conditions.
| Site verification area | What should be established | Why it matters |
|---|---|---|
| Equipment identity | Delivered model, serial number and ordered configuration. | Connects the installed machine to the purchase record. |
| Installation conditions | Location, clearances and installation requirements against the applicable manual. | Confirms that the installation is suitable for the equipment. |
| Electrical supply | Actual site supply against the model's specified voltage and frequency. | Prevents an incorrect electrical configuration from being overlooked. |
| Operating functions | Agreed controls and functions after installation. | Establishes that the installed equipment operates as intended. |
| Refrigeration | Specified temperature-control checks under the agreed conditions. | Addresses the requirements of refrigerated workflows. |
| Documentation | Installation records, test reports and outstanding actions. | Supports the formal handover decision. |
The SAT protocol should not simply repeat every FAT test without considering whether repetition is necessary. Tests should be selected according to the effects of transportation, installation and site conditions, together with the requirements of the purchase agreement.
For example, a site power-supply check addresses a condition that cannot be confirmed solely through a factory demonstration. Conversely, a factory test that is demonstrably unaffected by transportation or installation may not require full repetition.
This distinction is particularly important for laboratories operating under formal quality systems. A supplier's FAT report does not automatically satisfy the laboratory's own equipment qualification requirements.
| Activity | Primary question | Typical focus |
|---|---|---|
| FAT | Does the equipment meet the agreed pre-delivery requirements? | Supplier-site testing and documented results. |
| SAT | Does the equipment meet the agreed requirements at the intended site? | Installation-dependent and site-specific checks. |
| IQ | Has the equipment been correctly installed? | Equipment identity, installation and required documentation. |
| OQ | Does the equipment operate as intended within the specified range? | Functional testing and operating limits. |
| PQ | Does the equipment perform effectively and reproducibly in the intended process? | Actual or appropriately simulated operating conditions. |
Documents that the installed equipment and relevant components comply with the approved installation requirements.
Documents that the equipment performs as intended throughout its anticipated operating range.
Documents that the equipment and associated systems perform effectively and reproducibly under the intended process conditions.
These definitions are consistent with FDA/ICH Q7A and the qualification framework in EU GMP Annex 15.
However, IQ/OQ/PQ should not be treated as a mandatory package for every centrifuge purchase. The required extent depends on intended use, risk assessment, the laboratory's quality system and applicable regulatory requirements.
A research laboratory may require documented installation and functional checks without requiring a formal PQ protocol. A GMP-regulated manufacturing environment may require a more extensive, risk-based qualification programme.
FAT and SAT provide equipment and site evidence. IQ/OQ/PQ address qualification requirements. One activity may contribute evidence to another, but the responsibilities and acceptance criteria must remain defined.
One important detail in centrifuge procurement is the difference between the maximum capability of a centrifuge platform and the operating limits of an individual rotor.
A test report that records only the main centrifuge model may be insufficient when the order includes multiple rotor assemblies. The rotor identity and its rated operating conditions should be connected to the relevant test record.
The YT18R has a published maximum platform speed of 21,000 rpm and maximum RCF of 30,910 ×g. Its rotor range includes configurations with substantially different rated speeds and capacities.
This means a single platform-level maximum cannot be used as the acceptance speed for every supplied rotor. The test protocol must identify the actual rotor and applicable operating limits.
View YT18R Product Specifications →| Rotor | Configuration | Maximum rotor speed | Published maximum RCF |
|---|---|---|---|
| G18-1 | Swing rotor, 4 × 800 mL | 4,000 rpm | 3,450 ×g |
| G18-14 | Fixed rotor, 12 × 1.5–2 mL | 21,000 rpm | 30,910 ×g |
| G18-30 | Fixed rotor, 24 × 50 mL | 4,000 rpm | 2,970 ×g |
Manufacturer-published YT18/YT18R rotor specifications. These values describe individual rotor limits, not factory or site acceptance test results.
For a multi-rotor order, the purchase and acceptance records should identify each supplied rotor, the associated accessories and the applicable test scope.
See the GlanLab rotor compatibility and spare-parts guide for further information about rotor identification and replacement configuration.
A test result is useful only when the requirement being tested, the test method and the acceptance limit are clear. A report that simply states PASS without identifying these elements gives the buyer limited information about what was actually verified.
The acceptance record should allow another qualified reviewer to identify what was tested, how it was tested, which equipment configuration was involved and why the result was accepted.
Calibration may provide supporting evidence for specified measurement parameters, but it does not establish that the entire centrifuge delivery meets every contractual requirement.
A calibration result for a measuring parameter does not, by itself, confirm the correct rotor configuration, installation conditions, delivered accessories or completion of the agreed acceptance tests.
Metrological traceability also applies to measurement results, supported by a documented chain of calibrations and associated measurement uncertainty. Possessing a calibration certificate alone does not automatically establish the traceability of every subsequent measurement.
For the detailed distinction between calibration, verification, adjustment and routine performance control, refer to the separate Centrifuge Calibration and Preventive Maintenance Guide .
A failed test should not be removed from the record simply because the equipment passes after adjustment or repair. The original result is part of the equipment's acceptance history.
The project should define how non-conforming results are recorded, investigated, corrected and reassessed before the final acceptance decision.
Preserve the original test result and identify the requirement that was not met.
Determine whether the issue relates to equipment, configuration, installation or test conditions.
Document the corrective action and repeat the relevant test under the approved method.
Evaluate the evidence and obtain approval from the designated responsible parties.
Acceptance criteria should not be changed retrospectively simply to make a failed result appear acceptable. Any proposed change needs documented justification and approval under the applicable project or quality procedures.
EU GMP Annex 15 also requires results that fail predefined acceptance criteria to be documented as deviations and investigated. It describes controlled authorization for progression to a subsequent qualification stage where outstanding deviations have been assessed and documented.
This does not mean that a critical safety or performance failure can automatically be accepted conditionally. The decision must follow the applicable quality requirements and contract.
One of the most important commercial details is the difference between authorization to ship, successful site installation and final acceptance.
These events may occur on different dates and should not be treated as interchangeable milestones.
For international equipment procurement, these definitions are particularly important when installation, testing or training involves more than one party.
The purchase agreement should identify which responsibilities belong to the equipment supplier, which belong to the local installation or service provider, and which remain with the laboratory's own quality and technical personnel.
The acceptance plan should begin with the exact equipment configuration and the laboratory's intended application.
GlanLab publishes model specifications, rotor configurations and relevant technical information for its centrifuge range. These records provide a starting point for defining which product requirements need to be checked during procurement and delivery.
GlanLab's support information also identifies technical support for centrifuge use and problem analysis, after-sales support, OEM/ODM services and order records.
The availability of formal FAT, SAT, on-site installation, IQ/OQ/PQ documentation or independent calibration must be confirmed against the actual model, project requirements and agreed order scope. These services should not be assumed to be automatically included in every purchase.
Provide the centrifuge application, exact model or required performance, rotor package, vessel configuration, voltage and frequency, destination country, and any required acceptance or qualification documentation. This gives GlanLab a defined basis for reviewing the equipment configuration and confirming the applicable supply and support scope.
No. A formal FAT is not automatically required for every centrifuge purchase. Its scope should reflect equipment complexity, project risk, contractual requirements and the laboratory's quality system.
Not necessarily. FAT addresses the agreed pre-delivery test scope. Site-dependent installation and operating requirements may still need verification before final acceptance.
No. SAT is a site acceptance activity, while IQ and OQ are equipment qualification activities. Some evidence may be shared where justified, but their scope and approval requirements are not automatically identical.
No. Calibration evidence addresses specified measurement parameters. Final acceptance also considers the delivered configuration, installation, agreed functions, documentation and other contractual requirements.
The failed result should be recorded, investigated and addressed through documented corrective action. Relevant tests should then be repeated under the approved procedure, with the final decision authorized by the responsible parties.
The required scope depends on the purchase agreement and intended use. The protocol should identify each rotor and its applicable operating limits, then define which configurations and functions require testing. A platform's maximum speed should never be treated as the rating of every rotor.
European Commission — EudraLex Volume 4, Annex 15: Qualification and Validation, particularly the sections addressing risk-based qualification, FAT/SAT, IQ, OQ, PQ and deviation management.
U.S. FDA / ICH — Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: equipment qualification terminology and definitions.
National Institute of Standards and Technology (NIST) — Metrological Traceability: Frequently Asked Questions and NIST Policy.
GlanLab — Published YT18R technical specifications, matched rotor configurations and official Support information.
Share your application, required centrifuge model or performance, rotor configuration, electrical requirements and destination market. If your project requires FAT, SAT, installation verification or qualification documentation, include those requirements in your enquiry so the applicable technical and service scope can be reviewed before ordering.
GlanLab can help review the centrifuge configuration, published technical specifications and available support arrangements for your project.
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