We already have a Contamination Control Strategy.

A document isn’t a system. The question isn’t whether the strategy exists - it’s whether the controls in it actually talk to each other on the floor. If your garment data, cleaning records and consumable certificates live in four places, your CCS describes four controls. It doesn’t connect them. The gap between them is still open.

Each of our controls is validated and performing.

Individually, they may well be. But contamination events rarely come from a single failed control - they come from the handoff between two good ones. A validated cleaning regime and a validated garment programme still leave a gap if no one owns what happens between them. How strong each control is tells you nothing about the space between them.

Moving contamination control to one partner feels like a big step.

It’s a fair concern - changing how something this critical is managed carries its own risk. So you don’t switch everything at once. We map where your routes are covered and where they’re exposed, start where the gap is widest, and bring the rest across at a pace your operation sets.

CONTAMINATION CONTROL

Control every route contamination takes, not just the ones you can see.

Contamination reaches your product through your people, your surfaces, your air, and everything you bring into the room. Each route needs its own control - and a gap in one undoes the rest. We manage every control as a single strategy, so nothing falls between suppliers. The risk that used to sit with you now sits with us.

Talk to a Specialist

2,500+

customers in life sciences & semiconductor

cleanroom textile facilities across Europe

1,650+

specialists in cleanroom management

1M+

garments processed to ISO 5–ISO 8 each year

40+

years of experience in cleanrooms

THE STAKES

The strongest control in your cleanroom doesn’t decide whether you have an event. The weakest one does.

Garments from one supplier. Cleaning from another. Consumables from a third, training from a fourth. Each does their part well — and contamination still gets through, because it doesn’t respect the boundaries between them.

Contamination pressure 3 unowned handoffs

e.g. Garments

Supplier A, B, C

e.g. Validated

No owner

e.g. Garments

Supplier A, B, C

e.g. Validated

No owner

e.g. Garments

Supplier A, B, C

e.g. Validated

No owner

e.g. Garments

Supplier A, B, C

e.g. Validated

Your product Deviation · no single failed control

Scroll to see all four controls →

The gap

Every control is validated and performing. Contamination doesn't go through them, it goes between them.

WHERE CONTAMINATION GETTHE DIFFERENCE

Contamination gets in five ways. Cover four, and the fifth still finds you.

Almost every contamination event traces back to one of five entry points. Close all five, and you’re in control. Miss one, and the rest can’t make up for it. Here’s each one, the control it needs, and how we cover it.

Your people

People are the largest source of contamination in any cleanroom - skin, hair, movement, breath. Two things keep that in check: what your team wears, and how they behave once they’re in the room.

Your surfaces

Every surface is somewhere contamination lands - and somewhere it transfers from, to product, to people, to the next surface. Keeping it in check takes disciplined cleaning and disinfection, using materials validated to do what the label claims.

Your air

Particles and micro-organisms travel in the air and settle where you least want them. Two controls matter: removing what’s already in the room, and limiting what your people and garments add to it.

What you bring in

Every glove, wipe and disinfectant you bring in is either a control or a contamination risk - depending on whether it’s validated, sterile and right for your grade. An unqualified consumable isn’t a barrier. It’s a way in.

The everyday routine

A control only works if it’s applied the same way, every shift, by everyone. Most events aren’t caused by the wrong procedure. They’re caused by the right one, applied inconsistently.

THE ANSWER

Five controls, run by four suppliers, isn’t a strategy. It’s four strategies with gaps between them.

Every one of those controls can be bought separately. Most are. But when garments, cleaning, consumables and training each sit with a different supplier, no one owns the space between them - and that space is where contamination gets through.

Garments & gowning

Validated laundering and sterilisation, item-level lifecycle control, and gowning qualification evidence - the record your file needs, supplied with the garment.

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Cleaning & disinfection

Documented, audit-ready and mapped to your classified areas. A cleaning process inside your quality system, not a service you supervise.

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Consumables

Validated supply, vendor-managed to your usage, so the right qualified item is on the shelf - delivered with the bioburden, particle and sterility data your validators need in hand.

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Training & Competency

Role-based training that turns gowning and behaviour protocols into consistent floor habits, with the competency records to prove it.

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On-site service

A team embedded at your facility, closing the gap between delivery and the point of use, where most contamination risk actually enters.

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WHAT IT INVOLVES

What contamination control looks like when one partner owns every route.

We manage all five controls as one coordinated strategy. One quality system across every route in. One point of accountability when a question crosses a boundary. One view of whether your controls are working together - not four reports that each look fine on their own.

Bringing every control under one strategy changes what you can see, what you can prove, and who carries the risk. Four things change first.

One quality system, everywhere contamination can get in

Garments, cleaning, consumables and training all run to a single validated standard - so the control on one route holds to the same rigour as the control on the next. No weak link, because there’s no separate system to become one.

Evidence that connects

When your cleaning records, garment lifecycles, consumable certificates and training logs live in one place, you can show an inspector how your controls work together - not just that each one exists. Certificates and documentation, available 24/7, not assembled the week before.

One conversation, not four

When a question crosses a boundary - a contamination trend that touches both garments and cleaning - you have one QA-to-QA contact who can see the whole picture. Not four suppliers pointing at each other.

Patterns you can act on

Looking across every route at once surfaces the trend no single supplier would catch: the rise in one area that predicts an event in another. That’s the line between reacting to contamination and preventing it.

^↓30^%

fewer contamination events

^↓25^%

fewer audit findings

^↓50^%

fewer handling errors from trained teams

7^-log

minimum sterilisation reduction, revalidated annually

ISO 14644-1
ISO 9001
ISO 14001
ISO 50001
ISO 45001
GMP-aligned
EcoVadis Gold

Pharmaceutical manufacturing

Annex 1 doesn't ask whether each control exists. It asks whether your whole contamination control strategy is governed, evidenced and enforced — including the routes your suppliers cover. We close all five and document them as one strategy, so the supplier side of your CCS holds up under inspection. Including biologics, cell and gene therapy, generics and CDMOs.

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Medical device manufacturing

The routes you outsource are still processes inside your ISO 13485 system and your MDR technical file - and a notified body can audit them unannounced, assessing your critical suppliers directly. We close all five as one documented programme, so the evidence is there on demand rather than assembled after the request.

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Semiconductor manufacturing

Most fabs control the air and the tools tightly, then leave everything arriving through the gowning room to procurement. That's the open route - and at shrinking geometries, one particle is enough to scrap the die. We run people, surfaces and materials to the same validated standard as the sources you engineered, with electrostatic control built in.

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FAQ

Think your controls have this covered? Three assumptions worth pressure-testing.

Let’s find the routes you haven’t closed.

Bring us your current setup - who covers what, and where the boundaries sit. We’ll walk your five routes in, show you where contamination could still get through, and what closing the gap would take for your site. No commitment.

Talk to a Specialist

Control every route contamination takes, not just the ones you can see.

The strongest control in your cleanroom doesn’t decide whether you have an event. The weakest one does.

Contamination gets in five ways. Cover four, and the fifth still finds you.

Five controls, run by four suppliers, isn’t a strategy. It’s four strategies with gaps between them.

What contamination control looks like when one partner owns every route.

One quality system, everywhere contamination can get in

Evidence that connects

One conversation, not four

Patterns you can act on

The difference, measured

The routes are the same. What’s at stake changes by sector.

Think your controls have this covered? Three assumptions worth pressure-testing.

Let’s find the routes you haven’t closed.