VWR Sterile Protective Gowns and Coveralls (Model 414004-443 Series)

Overview

VWR Sterile Protective Gowns and Coveralls (Model 414004-443 Series) are engineered for critical aseptic processing environments requiring validated microbial barrier protection, low particle generation, and operator comfort. Manufactured in an ISO 8 (100,000 / M3.5) cleanroom facility in the United States, these gowns comply with international standards for sterile medical device packaging and personnel protective equipment in pharmaceutical manufacturing, biotechnology cleanrooms, and compounding pharmacies. Each garment undergoes terminal gamma irradiation at a validated dose (25–35 kGy), achieving a Sterility Assurance Level (SAL) of 10⁻⁴ — consistent with ISO 11137-2 requirements for sterile barrier systems used in aseptic filling operations. The microporous nonwoven fabric provides bidirectional protection: outward barrier against microbial ingress and inward barrier against operator-derived particulates and microorganisms, while maintaining high water vapor transmission rate (WVTR ≥ 2,500 g/m²/24h) to support thermal regulation during extended wear.

Key Features

• Terminal gamma irradiation with full batch traceability and CoA (Certificate of Analysis) provided per lot
• Microporous polyethylene-laminated SMS (spunbond-meltblown-spunbond) fabric enabling >99% bacterial filtration efficiency (BFE) and ≥99% viral penetration resistance (per ASTM F1671)
• Validated liquid barrier performance against synthetic blood (ASTM F1670) and viral penetration (ASTM F1671)
• Ultra-low particle shedding (<10 particles ≥0.5 µm per m³ per minute under ISO 14644-1 Class 5 airflow conditions)
• Ergonomic design with reinforced seams, elastic wrists, and optional integrated hood + bootie configurations for full-body coverage
• Available in standard collar gowns and hooded coveralls; multiple sizing options from S to 5X-Large to accommodate diverse anthropometric profiles
• Individually sealed in ISO 8-compliant packaging with peel-open sterilization indicator tape and lot-specific labeling

Sample Compatibility & Compliance

These sterile gowns are compatible with ISO 5 (Class 100) and ISO 7 (Class 10,000) aseptic workstations when donned using validated gowning procedures per USP <797> and EU GMP Annex 1 (2022). They meet material compatibility requirements for use with common disinfectants including 70% isopropyl alcohol, hydrogen peroxide vapor (HPV), and quaternary ammonium compounds. Documentation packages include ISO 13485-certified manufacturing records, biocompatibility data per ISO 10993-5/-10, and conformity declarations to Regulation (EU) 2017/745 (MDR) Class I non-sterile / Class Is sterile classification. All lots are auditable under FDA 21 CFR Part 820 and support GLP/GMP traceability through VWR’s global quality management system.

Software & Data Management

While this is a physical PPE product without embedded electronics, VWR provides full digital traceability via its Enterprise Resource Planning (ERP) platform. Each gown lot is assigned a unique UDI-DI (Unique Device Identifier – Device Identifier) compliant with FDA UDI Rule and EU MDR Annex VI. Customers access real-time lot history, CoA, sterilization reports, and cleanroom environmental monitoring logs through VWR’s secure customer portal. Integration with LIMS or ERP systems is supported via CSV/Excel export and RESTful API endpoints for automated inventory reconciliation and audit readiness. All documentation meets 21 CFR Part 11 requirements for electronic records and signatures where applicable.

Applications

• Aseptic processing of parenteral drugs, vaccines, and cell/gene therapies in ISO 5 isolators and RABS
• Preparation of hazardous drug compounds under USP <800> containment protocols
• Quality control microbiology testing in ISO 7 microbiological laboratories
• Cell culture and stem cell expansion workflows requiring low-bioburden apparel
• Cleanroom qualification and media fill simulation studies (per PDA TR13 and ISO 14644-3)
• GMP manufacturing environments subject to FDA, EMA, PMDA, or NMPA inspections

FAQ

What is the Sterility Assurance Level (SAL) for these gowns?
Each gown is sterilized by gamma irradiation to achieve SAL 10⁻⁴, verified per ISO 11137-2:2013 Annex D.

Are these gowns compliant with USP <797> and EU GMP Annex 1?
Yes — their low particle shedding, validated barrier performance, and ISO 8 manufacturing environment align with the apparel requirements specified in both standards.

Can these gowns be autoclaved or re-sterilized?
No. These are single-use, terminally sterilized garments. Re-sterilization is not validated and will compromise structural integrity and barrier performance.

Do you provide validation support for gowning qualification?
Yes. VWR offers technical dossiers, particle shedding test reports, and collaboration with qualified third-party labs for site-specific gowning procedure validation.

What is the shelf life and storage requirement?
Shelf life is 36 months from date of sterilization when stored unopened in dry, ambient conditions (15–25°C, <60% RH) away from UV exposure and ozone sources.