Which test and documentation packages are customary for FAT/SAT on mixing plants?
For Factory Acceptance Tests and Site Acceptance Tests of mixing plants, technical test protocols, evidence of manufacturing and assembly quality, and documentation on the control system, safety and process function are compiled. The scope and depth of testing depend on process risk, sector, degree of automation, plant complexity and regulatory requirements. A mixer for a simple powder recipe generally needs a different test package than an automated mixing plant for pharmaceuticals, food, chemicals, battery materials or potentially explosive areas.
The FAT and SAT should be based on an agreed specification. This includes, for example, the User Requirement Specification, functional and design specification, P&ID diagrams, safety concepts, automation description and, where applicable, a risk analysis. For every test, the test step, test method, measuring equipment, acceptance criterion, result, deviation and approval should be clearly documented.
Typical base documents
Design and manufacturing documentation usually comprises P&ID diagrams, design drawings, layout plans, parts lists, component lists, electrical circuit diagrams and pneumatic diagrams. For product-contact components, material certificates to EN 10204, material data, surface records and welding documentation can be required.
The scope of the welding documentation depends on the material, pressure rating, process risk and contractual requirements. It can include welding procedure specifications, welding procedure qualification records, welder qualifications, weld seam lists and results of non-destructive testing. For hygienic or pharmaceutical applications, roughness measurements, passivation evidence and endoscopy or borescopy records for permanently piped areas can additionally be required.
Mechanical evidence relates, for example, to dimensional accuracy, alignment, clearance, the mixing tool, seals, bearings, discharge elements, inspection doors and moving components. Depending on the design, idle running, smoothness of operation, noise generation, vibration, torque or power consumption are also tested and documented.
For pressure or vacuum plants, pressure tests, leak tests, vacuum tests and, where applicable, leak-tightness evidence form part of the test package. The test method, test pressure, test medium, hold time, permissible leakage rates and the safety requirements during testing must be defined in advance.
Electrical, control and safety
The package for electrical systems and automation typically includes checked circuit diagrams, terminal diagrams, cable lists, I/O lists, wiring diagrams, software version status and a description of the control architecture. Where required, evidence relating to network structure, interfaces, operator interface, recipe management, data capture and higher-level systems is added.
In the FAT, control functions are usually tested by means of a simulation or on the fully assembled apparatus. This includes I/O tests, functional tests of drives and valves, operating modes, sequential steps, alarm messages, interlocks, recipe sequences, operator messages and interfaces. If signals from the real plant are not yet available, testing can take place via simulations or test rigs. The scope must be documented transparently.
Electrical protective measures are tested in accordance with the agreed standards and at the final installation site. This can include protective-conductor testing, insulation measurement, testing of the emergency-stop function, safety circuits, earthing, equipotential bonding and, where applicable, tests of explosion-protected components. Requirements for design, risk assessment, technical documentation and conformity assessment apply to machinery. The EU Machinery Regulation 2023/1230 applies directly in all member states of the European Union from 20 January 2027.
SIL evidence is only required where safety instrumented functions with a defined safety integrity level are part of the safety concept. In that case, the safety requirements specification, the SIL verification, the relevant test protocols and the results must document that the safety function achieves its specified integrity level.
Typical FAT content
The Factory Acceptance Test takes place at the manufacturer's premises prior to delivery. It checks whether the plant has been manufactured in accordance with the agreed specifications and fulfils the intended functions. The FAT can combine mechanical, electrical, control-related and safety-relevant tests.
An FAT package generally contains a test plan approved in advance. This describes the test object, test steps, acceptance criteria, measuring equipment used, responsibilities and documentation format. Typical content includes visual inspection and document review, functional testing of the mixing tool, testing of drives, seals, valves and sensors, as well as tests of the control logic, alarms, interlocks and safety functions.
The FAT ends with a test report. Open items, deviations and rework are documented in a punch list. Every deviation should receive a clear assessment, responsibility, deadline and closure confirmation. Not every open item prevents delivery. This depends on its impact on safety, quality, function and further assembly.
Typical SAT content
The Site Acceptance Test takes place after transport, installation and connection at the operator's site. It confirms that the plant has arrived undamaged, has been correctly assembled and functions under the real conditions at the site of use.
The SAT usually includes checking the mechanical installation, utility connections, electrical connections, earthing, interfaces to peripherals and control systems, as well as testing safety-relevant functions. Loop checks verify that sensors, actuators and control signals are correctly connected in the installed state. Interlock tests verify that protective and interlock functions respond correctly under actual operating conditions.
Depending on the project, overall functional tests and performance evidence can take place in the SAT. For mixing plants, these can be tests of mixing time, mixing quality, homogeneity, temperature control, heating or cooling performance, vacuum behaviour, cycle time or residual discharge. Whether product, a substitute medium or a simulated process is used for this must be clearly regulated in the test strategy.
The handover documentation can include, among other things, the plant log book, the final technical documentation, operating and maintenance instructions, spare-parts lists, declarations of conformity, certificates, software versions, test reports and training records. It should clearly distinguish between provisional documents, as-built documentation and items still open.
Regulated applications
In regulated sectors, the FAT and SAT can be part of an overarching qualification plan. EU GMP Annex 15 allows a Factory Acceptance Test to be supplemented by a Site Acceptance Test after receipt and installation of the equipment at the operator's premises. Suitable FAT results can be used for later qualification activities if this is justified on a risk basis and transport and installation do not affect the functions already demonstrated.
Additionally, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification can be required. Typical supplementary documentation includes a traceability matrix, risk analyses, change control documents, deviation reports, calibration certificates, cleaning evidence and, where applicable, data integrity evidence for GMP-relevant computerised systems.
A complete FAT and SAT package is therefore not merely proof of function. It creates a traceable link between specification, design, manufacturing, testing, installation, deviation management and the structured handover of the mixing plant.
How amixon® supports FAT and SAT and the qualification of pharmaceutical mixing plants
From the URS to a qualifiable plant
In pharmaceutical powder processes, apparatus design, mixing quality, cleanability, documentation and process safety directly influence the later qualifiability of the plant. amixon® develops precision mixers, agglomerators, vacuum mixer dryers and synthesis reactors on the basis of the operator's User Requirement Specification and manufactures the apparatus at the Paderborn site.
Depending on the agreed scope of supply, amixon® provides qualification-relevant documentation. This can include technical drawings, P&ID diagrams, parts lists, material certificates for product-contact components, surface specifications, welding documentation, operating instructions, maintenance documentation and test protocols. This documentation creates a traceable basis for the traceability matrix, FAT and SAT, as well as for the operator's DQ, IQ and OQ documentation.
DQ, IQ and OQ with amixon® support
amixon® supports operators in the Design Qualification, Installation Qualification and Operational Qualification of the delivered plant. Test planning, documentation and execution are aligned with the operator's User Requirement Specification, risk analysis and validation concept.
For automated mixing plants, project-specific functions for recipe management, user rights, interfaces, electronic records and audit trails can be taken into account. ERP integration, barcode capture or electronic batch documentation can also be incorporated into the automation concept where agreed. Responsibility for assessing the GxP relevance, data integrity, the validation of computerised systems and formal approval remains with the operator.
Requirements from EU GMP and FDA 21 CFR Part 11 can be taken into account on a project-specific basis. The specific execution is defined in the User Requirement Specification, functional specification, risk analysis and the agreed acceptance documentation.
FAT at the Paderborn works
The Factory Acceptance Test takes place on the fully assembled apparatus at the Paderborn works. It is based on the agreed test points from the User Requirement Specification, the technical specifications and the FAT test plan. The tests can cover, among other things, mechanical functions, the mixing tool, drives, seals, discharge elements, control sequences, alarm messages, interlocks, safety functions and project-specific performance characteristics.
The results are documented. Open items and deviations can be tracked in a punch list with responsibilities, deadlines and closure confirmation. The FAT results, once assessed by the operator, can feed into the later IQ and OQ as technical evidence, provided this is envisaged in the qualification concept.
SAT and handover at the site of use
After transport, installation and connection at the operator's premises, amixon® can accompany the assembly and the Site Acceptance Test. The SAT checks whether the plant is correctly installed at the site of use and fulfils the agreed functions under the real conditions.
Depending on the project, the SAT can include checking mechanical and electrical connections, utility supply, control interfaces, safety functions, loop checks, interlock tests and overall functional tests. Agreed performance evidence such as mixing time, mixing quality, temperature control, vacuum behaviour, product discharge or cleaning sequences can also be part of it.
The Performance Qualification with the later product and the release of the routine process are the operator's responsibility. amixon® can provide technical documentation, process data and documented results from pilot-plant trials as a well-founded starting basis for PQ planning and scale-up.
Hygienic design and cleaning
amixon® mixers can be configured with a top-mounted mixing tool, product-contact areas designed for easy cleaning, and large Clever-Cut® inspection doors. The Clever-Cut® access points support visual inspection, manual cleaning and inspection of the mixing chamber.
Depending on the process task, integrated spray lances as well as WIP, CIP or SIP concepts can be provided for. A cleaning-friendly design can support cleaning validation. The specific cleaning performance and validatability, however, depend on the product, recipe, cleaning medium, plant configuration and the operator's validation strategy.
For certain applications, requirements from GMP, EHEDG, FDA or 3-A Sanitary Standards can be incorporated into the design. Which evidence is required is bindingly defined in the User Requirement Specification and the agreed scope of supply.
Pilot plant III for demanding processes
Before making an investment, the mixing task can be trialled with the operator's original product. The amixon® pilot plants form a practice-relevant bridge between laboratory and production. They serve the development, optimisation, trialling and scale-up of mixing, drying and synthesis processes under realistic conditions.
The new amixon® pilot plant III in Paderborn extends these options in particular for demanding vacuum, high-temperature and synthesis processes. Among other things, synthesis reactors with a usable capacity of 200 litres are available there, which can be operated at temperatures up to 350 degrees Celsius under vacuum and at pressures up to 25 bar gauge pressure.
In the pilot plants, mixing quality, product protection, energy input, discharge, cleanability and reproducibility can be assessed. The results are evaluated and documented together with the operator. They support apparatus design, the selection of process parameters, the planning of the FAT and SAT, as well as later process development and qualification.