Cleanroom & GMP logistics

The August 2023 revision of EU GMP Annex 1 sharply tightened material requirements in pharma and biotech cleanrooms. Any transport or storage aid used in Grade A/B must be low-particle, disinfectant-resistant and fully qualifiable. Our rotomoulded containers and trolleys are one-piece, with no welds, rivets or voids — exactly the target Annex 1 §4.14 describes.

For ISO 14644-1 classification the key question is how many ≥ 0.5 µm particles an aid emits in use. Wooden pallets are effectively excluded from Grade B/C; welded stainless trolleys shed metallic particles under friction. PE surfaces at Ra < 0.4 µm (on request) are within the validatable range — we can provide particle-abrasion data to ISO 14644-13.

A frequently missed point is electrostatic charging. Standard PE can accumulate up to 5 kV through friction and actively attract particles. For cleanroom applications we therefore supply ESD-conditioned PE with a surface resistance of 10⁶–10⁹ Ω — IEC 61340-5-1 compliant and validatable for electronics and pharma production.

VHP fumigation (vaporized hydrogen peroxide, typically 35 % H₂O₂) is the standard approach for room and surface decontamination in isolators and Grade A cleanrooms. Many plastics become brittle or discolour under VHP; our dedicated PE grades are validated for 500+ VHP cycles with no measurable mechanical degradation or migration.

The boxes and trolleys are equally resistant to isopropanol (70 % IPA), peracetic acid and quaternary ammonium compounds — the usual wipe disinfectants in cleanroom hygiene. That covers combined regimes where wipe disinfection is daily and VHP fumigation weekly or monthly.

For isolator use and RABS (restricted access barrier systems) we supply boxes with sealed lids and no undercut geometry, so no H₂O₂ residue can collect in gaps. That shortens the aeration phase after decontamination and hence line downtime.

For pharma applications the qualifiability of the aid matters as much as the aid itself. Every cleanroom product can be supplied with a full qualification package: DQ (design qualification), IQ (installation qualification) and OQ (operational qualification) templates, material certificates (USP Class VI for product contact), migration analyses and cleaning validation.

For customers with 21 CFR Part 11 needs we provide unique laser-engraved serial numbers, Data-Matrix codes and documented batch traceability down to PE raw material. That supports track-&-trace requirements in regulated supply chains.

We pay particular attention to long-term resistance under gamma sterilization. For single-use bioprocess containers we offer a PE that retains > 85 % of its initial tensile strength after 50 kGy gamma — well above industry standard and enabling robust single-use logistics.