In a pharmaceutical packaging area, the conveyor is part of the controlled environment. It must not shed particles, it must be cleanable, and its design must be documented in a way that satisfies an auditor who has never seen it before.
Key takeaways
- Use stainless steel and FDA-compliant belting, with smooth, crevice-free surfaces.
- Design for cleaning: access, drainage and no trapped product.
- Minimise particle generation from belts, bearings and guides.
- Document materials, finishes and cleaning procedures with the equipment.
Materials and finish
Frame: 304 or 316 stainless steel, with welds ground smooth and passivated. Avoid painted mild steel, which can chip and trap particles. Fasteners should be stainless and should not have exposed threads where product can accumulate.
Belt: FDA-compliant PU or silicone, with a sealed edge and a splice that does not trap residue. For blister packs and small cartons, a flat belt with a low-friction surface is common. For vials, a cleated belt or a pocket belt may be needed.
Cleanability
The conveyor should be accessible for cleaning without tools. Use quick-release belt tensioners, removable guide rails and a frame that can be wiped down. Avoid horizontal surfaces where dust collects, and provide drainage if the area is washed.
Bearings should be sealed and should not require lubrication that can migrate to the product. If lubrication is necessary, use a food-grade or pharmaceutical-grade lubricant and document it.
| Item | Typical specification | Audit evidence |
|---|---|---|
| Frame | 304/316 stainless, Ra <0.8 µm | Material certificate, finish report |
| Belt | FDA-compliant PU/silicone | Material declaration |
| Bearings | Sealed, no re-lubrication | Supplier datasheet |
| Guides | UHMWPE or stainless | Material certificate |
| Fasteners | Stainless, captive | Drawing |
Particle control
Every moving part generates particles. Belts rub on pulleys, bearings rotate, guides slide. In a Grade C or D area, the particle generation may be acceptable; in a Grade A/B area, it may not. Choose low-shedding belts and sealed bearings, and keep the conveyor out of the critical zone if possible.
If the conveyor must be in a critical zone, use a design with minimal moving parts and a smooth surface. Avoid exposed chain and lubricated drives.
Cleaning validation
Define the cleaning procedure, the detergent, the contact time and the acceptance criteria. For a conveyor, the critical areas are the belt surface, the belt underside, the pulleys and the guide rails. Swab or rinse samples should be taken from these areas.
Document the procedure and the results. An auditor will ask how you know the conveyor is clean, and “we wipe it down” is not an answer.
Documentation
Provide a documentation package with the equipment: drawings, material certificates, surface finish reports, belt declaration, bearing datasheets, cleaning procedure and spare-parts list. The package should be in English and should match the equipment as installed.
If the conveyor is part of a validated line, the documentation should be included in the validation report. Changes to the conveyor after validation need a change control record.
Frequently asked questions
Can I use an aluminium conveyor in a cleanroom?
Anodised aluminium can be used in some areas, but stainless is preferred for pharmaceutical packaging because it is easier to clean and does not chip.
Do I need a drainage slope?
If the area is washed, yes. The frame should drain and should not trap water. If the area is dry-cleaned, drainage is less important.
How often should the belt be replaced?
Inspect monthly for edge fraying, cracks and splice wear. Replace when the surface is damaged or the belt no longer meets the cleaning validation.
Send your cleanroom class and cleaning procedure to our engineers through the contact page; we will specify the conveyor and the documentation package.
