Annexe 1 des BPF de l'UE • Habillage pour salle blanche de catégorie B
Procédure d'habillage en salle blanche BPF de catégorie B : exigences de l'annexe 1 + exemple en 42 étapes
Publié initialement le 6 juin 2021 • Mis à jour le 17 août 2026
Réponse rapide : L'annexe 1 des BPF de l'UE exige que le personnel de catégorie B suive une procédure écrite d'habillage et de lavage des mains, utilise des vêtements de protection propres et stérilisés appropriés à la zone et complète la qualification de port aseptique avec une réévaluation périodique au moins une fois par an. Le règlement définit les principes de contrôle et les attentes vestimentaires ; ça fait pas prescrire une séquence universelle de « 42 étapes ». La séquence détaillée ci-dessous doit donc être traitée comme un exemple de SOP d’installation et adaptée à la procédure validée et à la stratégie de contrôle de la contamination (CCS) de votre site.
Grade B is the background cleanroom for Grade A aseptic preparation and filling when an isolator is not used. Because personnel are a significant contamination source, gowning is part of the facility’s broader contamination-control system rather than a stand-alone dressing routine.
What Does EU GMP Annex 1 Require for Grade B Gowning?
| Exigence | Annex 1 reference | Signification pratique |
|---|
| Written gowning and hand-washing procedure | 7.10 | The facility should define and control the sequence used to minimize garment contamination and transfer of contaminants into clean areas. |
| Aseptic-gowning training and qualification | 7.3–7.4 | Personnel entering Grade A/B areas should be trained and periodically reassessed at least annually using visual and microbial assessment. |
| Clean, sterilised protective garments at each entry | 7.13, 7.15 | Grade B clothing includes sterile head covering, facemask, eye covering, sterilised footwear and sterile gloves, with garment configuration appropriate to the process. |
| Prevent contact with garment outer surfaces and the floor | 7.13 | Garments should be packed and folded so the operator can don them without touching the outside surface or allowing the garment to touch the floor. |
| Garment cleanliness and integrity checks | 7.11 | Garments should be visually checked before and after gowning, with replacement when damage is identified. |
| Gowning in an appropriate change-room grade | 7.14 | The changing environment and pre-gowning clothing should be controlled so they do not introduce contamination into the gowning area. |
Is a 42-Step Grade B Gowning Procedure Required by Annex 1?
No. Annex 1 specifies contamination-control principles, personnel qualification, garment requirements and gowning controls, but it does not publish a mandatory 42-step sequence. A detailed step count is normally facility-specific and should reflect room layout, garment design, barrier benches, disinfectant practice, transfer flows, risk assessment and the approved CCS.
The sequence below is retained as a practical example SOP. It should not replace your site’s approved gowning procedure.
Important: If your facility’s validated SOP differs from this example, follow the validated SOP. Do not add or remove gowning steps solely to match a published checklist.
42-Step Example Gowning Protocol for Grade B Entry
- Enter the Grade B buffer/change area according to the site entry procedure.
- Remove lower-grade work shoes and place them in the designated location.
- Enter the sterile gowning room or designated higher-cleanliness changing zone.
- Disinfect hands using the approved hand-disinfection method.
- Select the correct size of sterile gown, eye protection and sterile footwear.
- Place packaged gowning items on the designated clean surface or isolation bench.
- Disinfect hands again before opening sterile garment packaging.
- Open the sterile gown package without contacting the outer garment surface.
- Handle the gown only by approved inner contact points.
- Open the zipper or fasteners while avoiding contact with the garment exterior.
- Orient the garment for donning without allowing it to touch the floor.
- Insert one leg carefully while maintaining control of the garment.
- Insert the second leg without allowing the garment to contact uncontrolled surfaces.
- Raise the upper garment while using a mirror where provided.
- Insert arms into sleeves using the garment’s approved donning features.
- Position the hood/head covering so all hair, including facial hair where applicable, is enclosed.
- Adjust the garment using only permitted contact points.
- Close the primary zipper or front fastening.
- Secure collar or neck fasteners as designed.
- Disinfect gloved hands as defined by the site SOP.
- Remove the sterile mask from its package by permitted handling points.
- Position the mask without touching unapproved surfaces.
- Fit the mask to cover the required facial area with no obvious gaps.
- Disinfect gloved hands.
- Remove sterile eye coverings or goggles by the strap or designated handling point.
- Position and secure eye protection in front of a mirror where provided.
- Disinfect gloved hands.
- Open the sterile footwear package and handle the footwear from the permitted inner surface.
- Open footwear closures fully before insertion.
- Insert the first foot into the sterilised boot or over-boot.
- Secure leg and footwear fasteners according to garment design.
- Close the footwear zipper or closure using approved pull tabs.
- Secure any final snap or closure.
- Cross the barrier bench with the first fully gowned foot onto the cleaner side.
- Keep the second foot from contacting the cleaner floor before footwear is applied.
- Don the second sterilised boot/over-boot using the same controlled method.
- Perform a mirror check for exposed skin, loose closures and incorrect gown positioning.
- Perform any approved garment-surface disinfection step only if specified by the validated site SOP.
- Don the outer sterile glove layer where required by the gown configuration and site procedure; ensure sleeves are correctly contained.
- Disinfect outer gloves according to the site procedure.
- Confirm gowning is complete and all required checks have been passed.
- Enter the Grade B area through the personnel airlock using the approved door-opening and interlock procedure.
Five Principles That Matter More Than the Exact Step Count
- Use a controlled written procedure. The sequence should be defined, trained, version-controlled and followed consistently.
- Protect the sterile garment exterior. Avoid touching outer surfaces and prevent the gown from contacting the floor.
- Control transitions. Barrier benches, personnel airlocks and hand/glove disinfection steps should support movement from lower to higher cleanliness.
- Verify gown integrity and fit. The garment must be clean, intact, correctly sized and correctly worn.
- Qualify the operator, not just the garment. Grade A/B access depends on training, gowning assessment and ongoing qualification.
How Often Should Grade B Gowning Be Requalified?
EU GMP Annex 1 states that compliance with aseptic-gowning procedures should be confirmed by assessment and periodic reassessment at least annually. The assessment should include both visual and microbial evaluation. Facilities may use a more frequent schedule based on risk, trends, deviations or internal quality requirements.
How Gowning Fits Into the Contamination Control Strategy (CCS)
Annex 1 requires a facility-wide CCS that identifies critical control points and evaluates how design, procedures, technical controls, organizational controls and monitoring work together. Gowning is therefore one control among several: personnel flow, airlocks, garment systems, environmental monitoring, cleaning and disinfection all interact.
Pour la sélection des outils de nettoyage par zone GMP, voir MIDPOSI Guide de sélection des qualités de vadrouille pour salle blanche GMP. Pour un examen axé sur l'approvisionnement des composants du système, des options de stérilité et de la documentation du fournisseur, voir le Cadre d'évaluation des acheteurs de systèmes de vadrouille pour salles blanches.
Questions fréquemment posées
L'annexe 1 des BPF de l'UE exige-t-elle exactement 42 étapes d'habillage pour le grade B ?
L'annexe 1 définit les contrôles en matière d'habillage, les attentes en matière de vêtements et les exigences de qualification du personnel, mais la séquence exacte d'enfilage dépend de l'établissement. Une séquence de 42 étapes doit être traitée comme un exemple de SOP, à moins qu’il ne s’agisse de la procédure approuvée et validée de votre site.
Quels vêtements sont généralement requis pour le grade B ?
Annex 1 describes sterilised Grade B protective clothing that includes sterile headgear enclosing all hair, a sterile facemask, sterile eye coverings, sterilised footwear and appropriately sterilised gloves. The exact garment configuration should be appropriate to the process and facility.
How often should Grade B personnel be reassessed for aseptic gowning?
At least annually under EU GMP Annex 1, using both visual and microbial assessment. More frequent reassessment may be justified by facility risk, monitoring trends, deviations or internal procedures.
Should a Grade B gown touch the floor during donning?
No. Annex 1 says garments should be packed and folded so operators can don them without contacting the outer surface and without allowing the garment to touch the floor.
Le port d'une blouse suffit-il à lui seul à contrôler la contamination au grade B ?
Non. L’habillage fait partie du CCS du site. La conception des installations, les flux de personnel et de matériaux, le nettoyage et la désinfection, la surveillance environnementale, la qualification et les procédures d'exploitation doivent fonctionner ensemble pour contrôler les risques microbiens, particulaires et endotoxines/pyrogènes.
Références principales
Besoin d'aligner les outils de nettoyage avec vos zones BPF ?
Utilisez les SOP sur l’habillage comme partie du système de contrôle de la contamination. Si vous évaluez également les têtes de vadrouille, les cadres, les manches, les options de stérilité ou la documentation du fournisseur pour les zones de qualité A/B/C/D, continuez avec les ressources dédiées aux outils de nettoyage ci-dessous.
