Cleanroom manufacturing GMP C/D

The revised Annex 1 to the EU GMP guide, in force since 2022, shifts sterile manufacturing to a Contamination Control Strategy (CCS) — a holistic risk assessment that treats materials, equipment, personnel and processes as equals. For transport containers and pallets that means: documented suitability, a defined cleaning and airlock protocol, complete traceability.

Rotogal containers are made from cleanroom-qualified HDPE, with moulded-in serial ID and a declaration of conformity included. For A/B airlocking we have developed a standard protocol: pre-cleaning with IPA 70 %, intermediate rinse with WFI-grade DI water, final drying under laminar flow — yielding particle levels that remain unremarkable even in an adjacent class A during operation.

For plants creating their CCS document for the first time or adapting to Annex 1, we supply a container risk assessment with evaluation of sources, cleaning efficacy and maintenance intervals — as an annex to your QA documentation.

Class C corresponds to ISO 7 in operation and ISO 8 at rest — a maximum of 352,000 particles ≥ 0.5 µm per m³. A container brought into the room must not raise this concentration to a critical level. With plastics, particle emission results mainly from surface abrasion and electrostatic attraction of ambient particles.

Rotogal HDPE has a measured emission value in airflow of under 1 particle per cm² surface per minute (ISO 14644-3 at-rest) — that is an order of magnitude below room limits even in class C in operation. Critical factors: surface quality (Ra ≤ 0.8 µm, polished inner face), wall abrasion resistance and the material compound, which releases no unbound additives.

For plants with high sensitivity (e.g. parenterals production) we offer an LPC test (Liquid Particle Count) as additional individual check — containers are rinsed with WFI, the rinse water analysed for particle count and an LPC certificate supplied.

In GMP C/D, surfaces are routinely wiped with isopropanol 70 %, hydrogen peroxide 5–6 % or peracetic acid formulations, occasionally NaOCl solutions. Conventional plastics show visible wear after 500–1,000 cycles, cracking at joints or discolouration — turning the cleaning agent into a particle source.

Our HDPE compound is chemically stable against these media: no effect on surface roughness, no discolouration, no cracking. Ageing tests over 5,000 cleaning cycles (typical 4-year cleanroom use) yield surface metrics within the as-new specification.

For the standard airlock routine (three IPA wipes in the pass-through system) we supply an SOP template that you can adapt to your local cleanroom rules — incl. a proposed colour-coding scheme for cleaned / prepared / inducted status.