ANNEX 1 COMPLIANCE

Your garment programme is now Annex 1 evidence. We keep it audit-ready by default.

Since the 2023 revision, inspectors treat cleanroom garment management as a qualified GMP process - with documented lifecycle limits, validated laundering, and evidence they can ask to see at any moment. We manage that whole system as a documented part of your contamination control strategy. The risk that used to sit with you starts to sit with us.

Book an Annex 1 Risk Review

THE SHIFT

The question is no longer whether your garments are right. It's whether you can prove it.

For years, garment supply was a procurement decision. Now it's a contamination control decision - and inspectors evaluate it as one. They don't ask whether you use the right garments. They ask whether the garment lifecycle is governed, documented and enforced, with the evidence available in real time.

	Missing lifecycle documentation Limits defined on paper, but not tracked at individual-garment level. The policy exists; the enforcement can't be shown.
	Supplier documentation gaps Your laundry supplier can't produce a site-specific audit pack during inspection. The finding still belongs to you.
	Continuity built for logistics A garment stockout in Grade A/B is a contamination control deviation, not a late delivery.
	Sustainability that can't be filed Group-level ESG averages don't hold up in supplier qualification. Auditable data is programme-specific.

Gowning qualification

Visual and microbial assessment at defined body locations, repeated annually, with APS participation as a condition of Grade A/B access.

Annex 1 · 7.4

Garment selection

Material qualified for particle shedding and barrier performance across its full life - with the sterilisation cycle count considered separately from the laundering count.

Annex 1 · 7.15

Laundering & sterilisation

Validated parameters, deviation records, CAPA history and a revalidation schedule - all available to you for inspection without notice.

Annex 1 · 7.4

Lifecycle control

Both cycle counts tracked per garment and enforced at item level, not assumed from the batch.

Annex 1 · 7.13, 7.15

Inspection readiness

Your CCS names the laundry supplier as a critical service provider - and that supplier keeps a site-specific audit pack ready.

Annex 1 · 2.5

Sustainability evidence

Programme-specific data you can file - CO₂ per cycle, energy intensity, repair rate, retirement records - not a portfolio average.

Programme-level

Want to see where you stand? The 30-day checklist walks your team through all six, item by item - each with what "good" looks like and the Annex 1 reference.

Get the checklist

WHAT A PARTNER SHOULD DO

We don't deliver garments. We carry your Annex 1 garment risk.

Most laundry suppliers hand back clean garments. That leaves the hardest part with you - proving, on demand, that every garment in use is qualified, tracked and within its limits. We work differently. We manage the garment lifecycle as a documented part of your contamination control strategy. QA to QA, not sales to procurement.

That changes what you're buying: not a service you have to supervise, but a partner who carries the regulatory risk alongside you and can stand behind the evidence when an inspector asks. It comes together across three areas.

PILLAR 1
Risk Ownership

The documentation, lifecycle control and audit pack that make you audit-ready by default.

See how

PILLAR 2
Continuity

Supply engineered around your batch-release logic, because a stockout is a compliance event.

See how

PILLAR 3
Sustainability

Evidence at garment-cycle level, in a format your QA and procurement teams can actually use.

See how

Documented limits, enforced per garment

Reuse and sterilisation limits set from qualification data and tracked on every individual garment - so you can produce the retirement record for one item, not just the policy.

Validated processes, evidence attached

Laundering and sterilisation validated to defined parameters, revalidated on schedule, with deviations and CAPA visible to your quality system - not handled quietly on our side.

A site-specific audit pack, kept current

Your validation summaries, lifecycle documentation, deviation history and CAPA records maintained for your site - ready to produce during inspection, without prior notice.

One named QA contact

A quality contact who knows your site and is reachable during inspection hours. When a question comes up mid-audit, you know who to call - and they already have the answer.

You own

Your gowning procedures, and how they're followed on the floor
How garments fit into your wider contamination control strategy
Training and behaviour

We own

✓ Validated laundering and sterilisation, documented every single cycle
✓ The garment lifecycle — qualification, reuse limits, retirement — with the evidence behind each decision
✓ Audit-ready documentation, prepared before the audit, not assembled during it

2 CONTINUITY

A garment shortage can hold a batch.
So continuity is engineered in.

We know how this feels from your side. A sterilisation cycle fails on Monday, a Grade A campaign starts Wednesday, and the question isn't about delivery - it's whether you can release the batch. A stockout of qualified garments is a contamination control gap, not a late order. We plan for it that way.

Built around your production

Stock levels and recovery times calibrated to your batch-release schedule and campaign durations - how critical each area is to you - not to a standard delivery frequency.

Criticality-based, tier by tier

Grade A/B garments get the highest tier of protection: defined minimum stock, a recovery-time objective agreed with your quality team, and a qualified backup pathway.

Recovery with redundancy

A network gives us the backup capacity to recover from a disruption; proximity keeps us close when you need us fast.

An emergency pathway that stays qualified

When an unplanned event needs garments outside the normal cycle, both sides already understand the qualification that applies. No improvising under pressure.

3 SUSTAINABILITY

Sustainability you can actually put in your QA file.

Your procurement and QA teams are increasingly asked to evidence a supplier's environmental performance - and most of what suppliers provide can't be used. A group-level carbon figure can't be traced to your programme, so it can't go in a supplier-qualification file. The fix isn't a better narrative. It's better data.

Here's the part that tends to surprise people: the same lifecycle controls that make you Annex 1-compliant already generate the evidence. Every governed stage produces both a compliance record and a sustainability metric.

Programme-specific, not portfolio-averaged

CO₂, energy and water per laundering and sterilisation cycle - for your garment types and specifications, from metered process data.

Repair-first, with the records to prove it

Repairs-to-retirements ratio, average cycle extension, material kept in service - drawn from individual garment records, not estimated.

End-of-life you can substantiate

Retirement quantities by garment type and their disposition pathway - evidence, not a group recycling policy.

In a format your QA file accepts

An annual, programme-specific report structured for supplier review and qualification documentation.

1	A validated process, documented and available Laundering and sterilisation validated to defined parameters and revalidated on schedule, with change control shared both ways.

2	A site-specific audit pack, kept current Not a generic portfolio document assembled before each audit - maintained continuously for your programme.

3	A named QA-level contact Reachable during inspection hours, answering process and lifecycle questions from records.

4	Continuity calibrated to your criticality Recovery timelines aligned to your Grade A/B recovery-time objectives, not set unilaterally.

5	Garment-cycle-level sustainability data Programme-specific, in a QA-file-ready format - usable in supplier qualification and annual reviews.

6	Answers to the questions an inspector asks The evidence behind every "ask your partner" question, produced in real time rather than followed up on later.

Let's look at your garment programme together.

Bring us your current setup. We'll show you where the exposure sits and what audit-ready by default would take for your site.

Book a Free Assessment

Your garment programme is now Annex 1 evidence. We keep it audit-ready by default.

Validated

ISO 4-7

Item-level

ISO 14001 & 50001

The question is no longer whether your garments are right. It's whether you can prove it.

The sites facing the hardest findings aren't the ones who ignored this.

Six domains. A gap in any one becomes a finding.

We don't deliver garments. We carry your Annex 1 garment risk.