OverviewThe AV Series is a GMP steam sterilizer for pharmaceutical and laboratory applications including formulation, fill-finish, biotech, vaccines, labs and terminal sterilization. Available in 25 standard chamber sizes (195–10,000 L) with more than 400 pre‑engineered validated options to match process, layout and automation requirements.
Typical loads- Machine parts
- Filter housings
- Closure components (stoppers, plungers, caps)
- Liquids in open or vented containers
- Liquids in closed containers (SVP in vials, ampoules)
- Glassware
- Vessels with vent filter
- Textiles
- Contaminated materials
Layout that fits your facilitySelectable sliding or hinged doors, configurable technical-area placement and optional remote installation of the electrical cabinet allow adaptation to building constraints while maintaining straightforward access for operation and maintenance.
Sanitary GMP constructionDesigned for regulated environments: fully drainable layouts, non‑retentive surfaces and 316L stainless steel product-contact surfaces with smooth finish. Welds are ground flush; fabrication and weld records can be provided. Process-contact materials have EN 10204 traceability and elastomers comply with USP Class VI.
Barrier containment solutionsOptions include Air Differential Seal for aseptic areas (controlled pressure differential) and hermetic Bioseal for high-containment use up to BSL‑4. Seals can be fitted on one or both sides to separate process and technical areas.
Features- Flexible design with 400+ pre-engineered validated options to match specific requirements without extensive custom engineering
- EN 285 compliance options: independent monitoring, air detector, steam sampling ports, leak and Bowie‑Dick tests
- Thermal insulation choices: ceramic wool with cladding, clip‑on removable insulation, closed‑cell elastomeric insulation for cleanrooms
- Cycle development and validation support with qualification documentation and risk‑based cycle definition
- Manufactured with non‑proprietary, globally available industry‑standard components
- AVD Series option: combined steam sterilization and HPV biodecontamination
Certifications and complianceDesigned and manufactured following cGMP principles within an ISO 9001 quality system. Systems can be configured to meet applicable international pharmaceutical regulations including FDA and EU GMP, and relevant electrical, EMC and safety requirements.
Technical specifications- Denomination: AV Series
- Manufacturer / brand: SteelcoBelimed
- Chamber volume: 25 standard sizes from 195 to 10,000 L
- Validated options: over 400 pre-engineered validated options
- Construction materials: 316L stainless steel product-contact surfaces
- Process-contact materials: EN 10204 traceability; USP Class VI compliant elastomers
- Standards / compliance: cGMP design; configurable to meet EN 285 and applicable FDA / EU GMP requirements
- Door options: sliding, hinged; multiple front layouts
- Insulation options: ceramic wool with cladding; quick clip-on removable insulation; closed-cell elastomeric insulation for cleanrooms
- Optional combined system: AVD Series (steam sterilization + HPV biodecontamination)