EU GMP Annex 1 Compliant Cleanroom Clothing

Annex 1 is the EU guideline for the manufacture of sterile medicinal products, published in EudraLex Volume 4. The revised version came into operation on 25 August 2023. It sets the gowning requirement for each cleanroom grade, and it requires clothing that limits shedding and retains particles released by the operator. Because the PIC/S GMP Guide carries the same text, a specification written to Annex 1 is recognised across member inspection regimes.

Grade A and Grade B require dedicated garments worn under a sterilised suit. Headgear must be sterile and enclose all hair, including facial hair. Sterilised footwear covers the feet, garment sleeves tuck into a second pair of sterile gloves, and trouser legs tuck inside the footwear. The clothing must minimise shedding of fibres and particles and retain particles shed by the body.

Grade C requires at minimum that head, beard, and moustache are covered, with garments that shed few fibres or particles. Grade D requires hair and, where relevant, beard coverage with general protective clothing. Sterility for Grade C and Grade D follows the contamination control strategy, so gloves and a facemask may be added for specific activities that the CCS flags as a contamination risk.

ISO 14644-1 classifies air cleanliness by particle concentration. Grade A and Grade B correspond to the ISO Class 5 limit, Grade C to ISO Class 7, and Grade D to ISO Class 8, at the 0.5 micrometre and larger threshold at rest. Grade A also applies tighter limits in operation during critical operations. Always confirm the operating limits against Annex 1 Table 1 for your facility.

We prepare garments for gamma, electron beam, and ethylene oxide sterilisation, and for steam sterilisation where the fabric and construction suit it. The route is chosen with your quality unit, and the cycle is validated by an accredited sterilisation partner with a stated sterility assurance level.

Yes. We build both. Single use sterile garments are common for Grade A and Grade B critical operations. Reusable garments run through a validated cleanroom laundering and sterilisation cycle with a tracked maximum number of processing cycles, because repeated processing degrades barrier and particle shedding performance.

Particle shedding measures how many particles and fibres a garment releases when the operator moves, which is what contaminates the critical environment. Bacterial filtration efficiency measures how well the fabric blocks microorganisms, which is the barrier the garment provides. Annex 1 needs both, because a garment must both shed little and block well.

Annex 1 places the garment programme inside the contamination control strategy described in Chapter 2. The CCS ties together the facility, the change rooms, personnel training, gowning procedures, environmental monitoring, and the garment lifecycle. Your quality unit treats the garment as an audited element of that system, so the documentation we supply is written to slot into it.

Yes. We apply branding with cleanroom grade methods and materials, such as low shedding woven labels or cleanroom compatible transfers. We avoid decoration that adds exposed edges, traps particles, or introduces unsecured conductive islands on static dissipative garments.

The minimum order is 12 pieces per design for most cleanroom styles, with higher minimums for some sterilised programs. Standard production runs take 10 to 14 working days after sample and artwork approval, plus the accredited sterilisation and testing cycle where the order requires it.