Superheated water sterilization autoclave for pharmaceutical applications
Ensure precise sterilization of sensitive liquid formulations with superheated water, optimizing both safety and efficacy before final conditioning or packaging.
Sterilizes and Dries Biopharmaceutical Liquids and Solids
The Superheated Water Sterilization Autoclave from Actini Group offers unparalleled precision in sterilizing both liquid and solid biopharmaceutical products. Utilizing superheated water technology, it performs sterilization and drying, making it indispensable for producing vaccines, IV solutions, and other sterile medical formulations. Capable of processing between 30 to 24,000 liters per cycle, this autoclave integrates seamlessly into high-capacity production lines, whether batch or continuous. It features a PLC-controlled system ensuring precision and automation, with options for remote monitoring to enhance operational efficiency. Designed for robust performance, it minimizes energy consumption and complies with stringent GMP standards, assuring pharmaceutical-grade sterilization. The autoclave is designed with versatility, offering configurations such as single or double doors and various loading mechanisms, from trolleys to automatic conveying systems. For added hygiene and ease of maintenance, it includes features like a servo steam generator and sterilizing fluid filtration with in-place integrity testing. Customizable to specific production demands, it is ideal for diverse operations in pharmaceutical, biotech, and healthcare industries.
Benefits
- Enhances production efficiency by processing between 30 to 24,000 liters per cycle.
- Reduces energy costs with optimized superheated water technology.
- Ensures product safety and quality with GMP-compliant sterilization.
- Versatile integration options to fit existing production line configurations.
- Minimizes contamination risks with CIP system and fluid filtration.
- Applications
- Pharmaceutical liquids,Liquid formulations,Sealed vials,Nutraceuticals,Blisters,Biopharmaceuticals,Solute bags,Parenteral nutrition
- End products
- Protein injections,Nutritional supplements in liquid form,Vaccines,Antiviral medications,Multivitamin liquids,Amino acid infusions,Chemotherapy drugs,Insulin delivery solutions,Intravenous (iv) solutions,Nasal sprays
- Steps before
- Washing,Loading,H2O2 cycle
- Steps after
- Drying,Unloading,Packing
- Input ingredients
- solid products,liquid products,sealed full vials,blisters,solute bags,parenteral nutrition bags
- Output ingredients
- sterilized products,dried containers
- Market info
- Actini is known for its expertise in manufacturing advanced thermal treatment systems, notably for biowaste decontamination, ensuring biosafety and compliance with rigorous environmental standards. They hold a strong reputation for innovative and reliable engineered-to-order solutions.
- Capacity
- 30 to 24,000 liters per cycle
- Cycle Temperature
- Below 105°C
- Loading Method
- Transport trolley,Height-adjustable trolley,Automatic conveying,Floor-level loading
- Opening Type
- Single or double door,Side,vertical downward or upward opening,hinged
- Containment Requirement
- P3/P4
- Operating Environment
- cGMP Environment
- Utility and Scalability Studies
- Electricity,steam,demineralized water,compressed air,N2
- Automation
- Recipe management system and historization
- Sterilizing Fluid Filtration
- In-place integrity testing option
- Sterilization capacity per cycle
- 30 to 24,000 liters
- Technology type
- Superheated water
- Temperature range
- Below 105°C
- Opening type
- Single or double door,side,vertical downward or upward
- Loading method
- Transport trolley,height-adjustable trolley,loading basket,automatic conveying,floor-level loading
- Containment requirement
- P3/P4
- CGMP environment compatibility
- Yes
- Recipe management system
- Batch reports,raw data exportable
- Utility requirements
- Electricity,steam,demineralized water,compressed air,N2
- Sterilizing fluid filtration
- In-place integrity testing option
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Container size and shape
- Sealed vials,blisters,bags
- Load size
- Batch studies required
- Containment Requirement
- P3/P4
- Machine Shape
- Parallelepiped or Cylindrical
- Opening Type
- Single or double door,side,vertical,hinged
- Loading Method
- Transport trolley,height-adjustable trolley,floor-level loading
- Door Opening Direction
- Side,vertical downward or upward
- Capacity
- 30 to 24,000 liters per cycle
- Opening direction
- Side,vertical downward or upward,hinged
- Door type
- Single or double door
- Loading method
- Transport trolley,height-adjustable trolley,loading basket,automatic conveying,floor-level loading
- Containment Requirement
- P3/P4
- Sterilizing fluid filtration
- With in-place integrity testing option
- Recipe management system
- Exportable to client server,batch reports,raw data historization