Scope and compliance boundary
This guide explains how a buyer can organise an equipment-evidence review. It is not a conformity assessment, legal opinion, hazardous-area classification or approval of a specific machine. The responsible manufacturer, importer, duty holder and competent project specialists retain their respective obligations for the actual market, installation and operating case.
What does ATEX marking prove on a filling machine?
ATEX-related marking identifies the assessed equipment duty and limits; it does not prove that the machine is suitable for every flammable liquid, every Zone or the buyer’s complete filling process. The marking must be read with the instructions, declaration, certificate information where applicable, area-classification inputs, product conditions and the assembled machine scope.
In Great Britain, equipment intended for use in potentially explosive atmospheres is covered by the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016. HSE also makes clear that workplace duties under DSEAR remain separate. A useful project therefore joins equipment evidence to the approved workplace classification without treating either document set as a substitute for the other.
Check the intended use, not only the Ex symbol.
The review should establish where the machine is intended to operate, the gas or vapour conditions addressed, temperature limitations, ambient and process limits, excluded uses, installation conditions and any external protective or control measures relied on for safe operation.
Match each project input to the equipment evidence
| Project input | Equipment evidence to review | Acceptance question |
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| Approved hazardous-area information | Intended equipment location, marking, category or protection information, ambient limits and installation instructions. | Does the declared equipment duty match the actual zone, extent and operating assumptions at every machine interface? |
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| Product and release scenario | Intended product duty, process limitations, material schedule, temperature limits, extraction or ventilation dependencies and cleaning restrictions. | Are normal filling, start-up, shutdown, drainage, sampling, cleaning and credible fault conditions inside the agreed scope? |
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| Complete assembled machine | Equipment schedule, electrical and non-electrical assessments, drawings, control narrative and declarations for the supplied assembly. | Is the evidence for the complete machine rather than a list of individually protected components? |
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| Site interfaces | Utility requirements, earthing and bonding points, extraction permissives, product-feed limits, guarding interfaces and cause-and-effect schedule. | Which conditions are supplied by Lancing and which must be designed, installed and verified by the site? |
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| Acceptance and handover | FAT records, SAT open points, inspection instructions, operating limits, maintenance information and change-control triggers. | Can the buyer trace each requirement to a drawing, test, instruction or named site action? |
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What documents should a buyer request for an ATEX filling-machine project?
The document list should cover product conformity, machine operation, installation interfaces and project acceptance, while clearly distinguishing statutory documents from contract-specific evidence. Not every project uses the same certification route or document title, so the purchase specification should name the required outcome and responsible party rather than copying a generic checklist without review.
Product and conformity layer
- Applicable declaration or incorporation document for the supplied scope.
- Marking schedule and equipment identification.
- Instructions and stated limits of intended use.
- Certificate details where the conformity route requires them.
- Manufacturer and responsible economic-operator information appropriate to the market.
Project and integration layer
- General arrangement and hazardous-area interface drawings.
- Product-contact material and seal schedule.
- Control narrative, permissives and cause-and-effect schedule.
- Utility, extraction, earthing and product-feed interface register.
- FAT evidence, SAT actions, operating checks and maintenance requirements.
Use a traceable review sequence
- Freeze the input basis. Record the current SDS, product temperature, container and closure range, area-classification information, output target and site interfaces.
- Define the supplied assembly. List the filler, pumps, hoses, enclosure, scale, conveyor, capper, labeller, sensors and external systems that are inside or outside the manufacturer’s scope.
- Check marking against location. Review each relevant equipment item and the assembled machine against the approved installation drawing and intended operating modes.
- Trace conditions to controls. Connect extraction, earthing, guards, product pressure, container presence and other required conditions to the control narrative and fault response.
- Test what can be tested at FAT. Demonstrate the agreed supplied functions and record what must wait for the final installation, site utilities and representative process.
- Close the SAT evidence. Verify installed interfaces, site-specific tests, operator information, inspection requirements and remaining actions before production release.
Common documentation mistakes
Component certificates presented as a machine conclusion
Protected motors, sensors or enclosures can support the design, but their individual documents do not by themselves establish the suitability of the assembled filling machine or its process interfaces.
The site classification arrives after machine design
Late zone information can force changes to equipment location, controls, extraction interfaces and installation. The approved basis should be available before the machine duty is frozen.
FAT evidence is treated as SAT evidence
Factory testing cannot prove the final earth, ventilation performance, room classification, connected product supply or every site procedure. Those boundaries should be explicit.