Customized Hvac system for pharmaceutical clean rooms
Achieve seamless sterilization and contamination control in clean rooms with an integrated HVAC system designed to maintain environmental standards and enhance operational efficiency through advanced monitoring and automation technologies.
Sterilizes and Purifies Clean Room Environments
The STERIS VHP M1000-T4 and STERIS VHP DC-A are specialized solutions for maintaining sterile environments in biopharmaceutical and pharmaceutical production facilities. The M1000-T4 VHP generator integrates seamlessly with HVAC systems for thorough decontamination, using a 35% H2O2 solution that vaporizes and disperses evenly through the airflow. This system offers efficiency in reducing biological load while providing electronic records compliant with CFR Title 21 Part 11 for validation.
The DC-A VHP system is a standalone atmospheric pressure purification room designed for material transfer between aseptic zones, featuring a unique particle monitoring process and fast cycle times to enhance operator safety and production efficiency. Both systems are constructed with high-grade stainless steel for durability and compliance with ISO 14644 and PDA TR13 standards, ensuring compatibility across global regulatory frameworks.
Ideal for producing vaccines, insulin, and monoclonal antibodies, these systems accommodate a variety of end-products including pre-filled syringes and sterile intravenous solutions. The energy-efficient design promotes sustainability while the intuitive control systems facilitate integration into existing production workflows, offering comprehensive solutions for contamination control and operational excellence.
Benefits
- Ensures aseptic conditions with reliable sterilization processes, enhancing product safety and quality.
- Integrates with existing HVAC systems for comprehensive decontamination, minimizing installation costs.
- Reduces biological load quickly with fast cycle times, boosting productivity and efficiency.
- Provides verifiable electronic records, supporting regulatory compliance with ease.
- Constructed with durable stainless steel, ensuring long-term operational reliability in demanding environments.
- Applications
- Medical equipment,Aseptic pharmaceutical production,Laboratory equipment,Biopharmaceuticals,Pharmaceutical products,Biological products
- End products
- Rubber stoppers,Biopharmaceutical cultures,Vaccines,Insulin,Monoclonal antibodies,Sterile intravenous solutions,Glass ampoules,Lab animal supplies,Laboratory glassware,Pre-filled syringes,Aseptic filling containers,Penicillin bottles
- Steps before
- Material Transfer,Chemical Preparation,Biological Product Handling
- Steps after
- Biological Decontamination,Material Transfer,Quality Assurance,Environmental Monitoring
- Input ingredients
- 35% H2O2 solution,pre-disinfected heat sensitive material bags,penicillin bottles,glass bottles,rubber stoppers,precision tools,instruments,computers
- Output ingredients
- sterilized air,sterilized surfaces,verifiably purified materials,reduced hydrogen peroxide concentration
- Market info
- Austar is known for specializing in the design and manufacture of engineered-to-order industrial equipment, particularly in the pharmaceutical and biotechnology sectors, offering solutions that focus on quality, innovation, and meeting specific customer requirements.
- Air velocity range
- 40-140 scfm
- Filling rate
- 4-96 g per minute
- Operating voltage
- 230V,50/60Hz,single phase
- Cabinet material
- Stainless steel
- Cycle time for full load
- 45 minutes
- Dimensions
- 1130 mm x 1803 mm x 406 mm
- Weight
- 600 lbs. (272 kg)
- Printer type
- Stylus printer
- Cycle temperature
- Room temperature
- Hydrogen peroxide concentration
- 35% H₂O₂ solution
- Airflow organization
- Uniform distribution
- Automation level
- Integrated BMS/EMS control
- Energy efficiency
- Energy saving control
- Space sterilization system
- VHP integration
- Monitoring capabilities
- Dust particle and bacteria monitoring
- Compliance,Validation
- ISPE documentation,electronic records
- Corrosive resistance (e.g. acids)
- VHP (Vaporized Hydrogen Peroxide) compatibility
- Cleanability
- Highly cleanable surfaces
- Biological compatibility
- Non-reactive with biological materials
- Material construction
- Stainless steel (AISI 316L)
- Non-corrosive material
- No corrosion from sterilization agents
- Density/particle size
- Compatible with particulate monitoring systems
- Decontamination System Type
- VHP Generator
- Cabinet material
- Stainless Steel
- Dimensions
- 44½" x 71" x 16" (1130 mm x 1803 mm x 406 mm)
- Weight
- 600 lbs. (272 kg)
- Drawer/door type
- Stainless Steel Door
- Footprint
- Compact
- Control system integration
- BMS / EMS
- Sterilization system integration
- VHP space sterilization
- HVAC Customization
- For various engineering applications
- Document customization
- ISPE commissioning,validation documents