Pharma & Life Science

The revised EU GMP Annex 1 (in force since August 2023) significantly tightens contamination control requirements in cleanrooms. At its core is the Contamination Control Strategy (CCS), which systematically assesses every source of possible contamination — including transport and storage containers — and minimises risk. Containers used in Grade A/B must be smooth, non-shedding and fully sterilisable.

Rotogal pallets and boxes made of rotationally moulded LMDPE offer exactly these properties: a closed, pore-free surface, no bolted joints, no wood fibres and no coating that might detach. For Grade C/D our standard qualification is sufficient; for Grade A/B we supply particle measurement protocols per ISO 14644-3 on request and support with cleaning and wipe-down procedures.

Particularly relevant: Annex 1 now explicitly requires an assessment of transport routes between cleanroom zones. Anyone using wooden pallets or metal wire-mesh cages here has to document and mitigate risk extensively. With our closed plastic variants, a whole strand of that assessment falls away.

Since the pandemic and the breakthrough of mRNA technology, supply chains at −70 °C to −80 °C have become standard for biologics, cell and gene therapies. The challenge: power failures, vehicle breakdowns or unexpected customs delays — every one of those scenarios threatens product integrity. A temperature excursion often means the total loss of a batch with damages in the six- to seven-figure range.

The Rotogal dry ice box BHS-500.2 was developed for exactly this scenario: 80 mm PUR insulation, rotationally moulded LMDPE outer shell, 400 kg dry ice capacity. At full load the sublimation rate is only about 10 % over 48 hours — enough to bridge cold-chain interruptions of up to 72 hours or run entire regional distributions with reduced grid dependence.

For validation purposes we supply temperature profile records, IQ/OQ supporting documents and, if needed, project-specific data logger integration. The box can be fully integrated into track-and-trace systems in combination with in-mould RFID tags — including CSV-compliant documentation per 21 CFR Part 11.

ISO 15378 — the GMP-aligned quality management standard for primary packaging materials — extends ISO 9001 with specific requirements for materials that may come into contact with medicinal products. Secondary components in the immediate primary-packaging environment (pallets, boxes, transport containers) fall under the same duty of care in practice.

USP Class VI is the highest biocompatibility standard of the US Pharmacopeia for plastics in direct or indirect patient contact. It covers systemic toxicity, intracutaneous reactivity and implantation tests — a certification that goes well beyond typical food contact requirements. For critical primary-packaging environments we offer material variants with USP Class VI approval.

For your supplier qualification we deliver documented: material certificate, declaration of conformity, batch traceability, migration reports on request, particle measurements (per project), cleaning and sterilisation recommendations. Audit visits at our plant in Wilsum are always welcome — we'll walk you through production and quality processes personally.