Why our airlocks are the first thing we show an auditor

Any plant can be clean on the day of a visit. Segregation is either designed into the building or it is not, and no amount of preparation adds it.

Two doors, not one

Every manufacturing area here has a separate material airlock and a separate personnel airlock — MAL and PAL. People and materials enter through different doors, gowning happens in one of them, and the two flows do not cross.

It sounds like a detail. It is the difference between a controlled area and a room that is cleaned regularly. A single shared entry means every material pallet travels through the space where people change, and every gowning event happens where materials wait.

Dedicated air, per area

Each area has its own air handling unit rather than sharing one across the site, with terminal HEPA filtration in the core processing area. The reason is containment: a shared AHU is a path between two rooms that are supposed to be independent, and a cross-contamination investigation that has to consider the ductwork is one nobody wants to run.

Manufacturing runs at class 100,000 and class 10,000 as the step requires. Applying the tighter class everywhere would cost more and mean less — the classification should follow the exposure, and an auditor who sees one number applied uniformly asks why.

Surfaces, because they are the record

Clean-room partitioning and coved epoxy flooring throughout, and all product-contact parts in SS 316 on CE-certified machinery. Epoxy coving is not a finish choice: a coved junction can actually be cleaned, and a square one collects what the mop misses. Ten years on, the floor is the most honest document in the building.

Why it is the first thing we show

Because it is the part that cannot be arranged for a visit. Photographs of the corridors are on the facilities page for the same reason — the doors, the coving and the airlock signage are visible in them, and they are the same doors on any day of the year.