Biopharma & Healthcare Cleanroom Solutions

I. Pharmaceutical Manufacturing

1. Vaccine/Injectable Production

   • ISO Class 5 Aseptic Fill-Finish:
     RABS (Restricted Access Barrier Systems) with FFUs maintain ≤3,520 particles/m³ for vial/syringe filling (EU GMP Annex 1 compliance).

   • CIP/SIP Pass Boxes:
     Sterilize stoppers and caps via steam-in-place transfers.

2. Biologics (Monoclonal Antibodies/CAR-T)

   • Modular Grade B/C Cleanrooms:
     Seamless epoxy floors + ULPA filtration for cell culture harvest (viable particles <1 CFU/m³).

   • Closed-Process Transfer Systems:
     Single-use bioreactor connections via alpha/beta ports.

II. Medical Device Manufacturing

1. Implants (Stents/Prosthetics)

   • ISO Class 7 Machining Zones:
     FFUs with oil-mist filters maintain <100,000 particles/m³ during titanium CNC milling.

   • Cleanroom-Compatible 3D Printers:
     PEEK polymer deposition in nitrogen-purged laminar flow hoods.

2. Surgical Instrument Packaging

   • Gamma-Irradiation Pass Boxes:
     Transfer sterilized tools to ISO Class 5 EO gas chambers.

   • VHP (Vaporized Hydrogen Peroxide) Airlocks:
     Terminal sterilization for robotic surgery device trays.

III. Healthcare Facilities

1. OR (Operating Room) HVAC

   • Laminar Flow Ceilings:
     Unidirectional airflow (0.25-0.35m/s) over surgical tables (ISO Class 5 during procedures).

   • Antimicrobial Wall Panels:
     Cu-ion infused modular cleanroom surfaces for MRSA prevention.

2. IV Admixture Centers

   • ISO Class 5 Compounding Isolators:
     FFU-integrated glove boxes for chemotherapy drug preparation.

   • Negative Pressure Hazardous Drug Rooms:
     Contain cytotoxic particle exposure with HEPA exhaust.

IV. CRO/CDMO Services

1. Clinical Trial Manufacturing

   • Rapid-Change Modular Cleanrooms:
     Switch between OSD (Oral Solid Dose) and aseptic lines in 72 hours.

   • Phase-Appropriate Monitoring:
     IoT particle counters with 21 CFR Part 11 compliant data logging.

2. ATMP (Advanced Therapy Medicinal Products)

   • Cryogenic Pass Boxes:
     -80°C transfer of viral vectors for gene therapy fill-finish.

   • GMP++ Cleanrooms:
     ISO Class 4 with continuous viable monitoring (MAS-100NT systems).

V. Core Advantages

• Regulatory Mastery: Compliance with USP <797>, EU GMP Annex 1, ISO 13485.

• Contamination Control: Achieve <0.1% media fill failure rates in aseptic processes.

• Energy Smart: 40% lower lifecycle costs via heat recovery FFU systems.

• Digital Twin Integration: 3D cleanroom modeling for airflow optimization pre-deployment.