Disinfection and Cleaning Equipment in Biopharmaceutical Cleanroom Engineering

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

Frequently Asked Questions (FAQ)

1. Do Food Processing Facilities Need Cleanrooms?

2. The Importance and Global Applicability of Installing Air Showers in Food Processing Plants

3. In-depth Analysis of the Specifications of High-Efficiency Air Supply Outlets and Their Corresponding Air Volumes

4. Global Cleanroom Cooperation Proposal

5. Unlocking the Outstanding Mysteries of the FFU Test Bench

6. Calculation Method of Cooling Capacity in Clean Room

7. The Selection of Air Conditioning Control Systems for Cleanrooms

8. Convenient Food Factory Pass Windows: Strengthening Food Safety Barriers and Significantly Boosting Production Efficiency with a Core Solution

9. What is an Air Shower? Understand How It Purifies Air in One Article

10. Common Issues and Solutions for Food Factory Changing Rooms