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Essential Systems for GMP Compliance
In biopharmaceutical cleanroom engineering, disinfection and cleaning equipment are critical facilities to ensure the production environment meets GMP requirements. Below are 8 core systems and their applications:
1. BIBO (Bag-In/Bag-Out) Containment System
The BIBO system is a safety protection device for replacing HEPA filters, complying with ISO 14644-1 cleanroom standards. Key features:
· Fully enclosed operation to prevent contamination spread
· Suitable for biosafety cabinets and HVAC systems
· Compliant with EU GMP Annex 1 stringent requirements for sterile products
2. Cleaning Workstation
Specialized cleaning systems designed for cleanroom utensils, meeting USP <1072> and GMP requirements:
· Integrated washing, rinsing and drying functions
· Uses WFI (Water for Injection) as final rinse medium
· Complies with ASTM E3106-18 validation requirements
3. Sterile Isolator
Closed system designed according to ISO 14644-7 and EU GMP Annex 1:
· Provides ISO Class 5 (Class 100) sterile environment
· Integrated VHP (Vaporized Hydrogen Peroxide) sterilization system
· Suitable for aseptic filling and product transfer operations
4. Sterile-Negative Pressure Filling Isolator
Specially designed isolator system compliant with:
· US FDA Aseptic Processing Guidance (2004)
· Maintains negative pressure to prevent cross-contamination
· Integrated online particle monitoring system (PMS)
5. VHP HVAC Sterilization System
Vaporized hydrogen peroxide-based HVAC sterilization solution:
· Complies with ISO 14937 sterilization validation standard
· Achieves 6-log reduction of Geobacillus stearothermophilus
· Suitable for Grade B and C cleanroom sterilization
6. VHP Hood Fumigation Pass-Through
Special transfer device for cleanroom hood sterilization:
· Compliant with IEST-RP-CC003.4 standard
· Completes sterilization cycle within 30 minutes
· Integrated biological indicator verification system
7. Cell Therapy Production Isolator
GMP production system specifically designed for cell therapy products:
· Compliant with FDA CGT Guidance (2020) and EMA ATMP requirements
· Integrated CO₂ incubator and cryogenic operation module
· Meets 21 CFR Part 11 electronic records requirements
8. GMP Utensil Washer-Dryer
Professional cleaning equipment meeting GMP Annex 1 requirements:
· PQ validation compliant with ASTM E3106 standard
· Provides traceable cleaning records
· Suitable for stainless steel and plastic utensil cleaning
Relevant International Standards:
· ISO 14644-1:2015 Cleanrooms and associated controlled environments
· EU GMP Annex 1:2022 Manufacture of Sterile Products
· USP <1072> Disinfection of Cleanrooms and Other Controlled Environments
· FDA Guidance for Industry Sterile Drug Products (2004)
· ISO 14937:2009 Sterilization of health care products - Requirements for validation
