Closing machine for the pharmaceutical industry SPE series

for vialsfor bottlesfloor-standing

Overview
Processes container closures — vial stoppers and caps, syringe plungers and needle shields, cartridge lined seals — combining washing, siliconization, sterilization and drying in one GMP solution. A wide range of closure transfer methods is available to reduce contamination risk associated with handling. Automated line clearance and closure counting support batch integrity and faster changeovers. More than 200 systems are installed worldwide.

Typical loads
Suitable for processing a wide range of container closures, including:

• Vial stoppers and caps
• Syringe plungers and needle shields
• Cartridge plungers and lined seals

Key features

• Sanitary GMP construction: Fully drainable design, non-retentive surfaces and 316L stainless steel with smooth finish. Welds ground flush and fabrication documented in a complete logbook. Process-contact materials with EN 10204 traceability and USP Class VI compliant elastomers.
• Site-specific layout options: Multiple discharge options support site-specific layouts, including multi-level installations with separate process and machinery floors to optimize space and maintain separation between operational and technical areas.
• Cycle development and validation support: Development of cycles around specific loads and acceptance criteria, documented in a qualification package with risk-based cycle definition, mapping and test support.
• Remote diagnostics and support: Secure, on-demand remote gateway for controlled diagnostic access to support faster troubleshooting while meeting industrial cybersecurity requirements.
• Gentle handling for delicate closures: Small quantities processed within basket compartments mounted on a rotating carousel. Polished stainless steel parts with smooth edges ensure uniform fluid distribution and help prevent abrasion and clumping, including for delicate components such as aluminium-lined cartridge seals.
• Automated line clearance: Synchronized cameras verify baskets are empty before each batch to provide automated and documented line clearance, reducing cross-contamination risk and protecting batch integrity.
• Particle and endotoxin removal: Advanced washing concept with full dynamic coverage of every closure and optimized alternating flow patterns for improved cleaning performance in less time. Supported by studies and validation data for very low residuals.
• High-performance drying: Rotating basket compartments distribute air evenly across the load, cutting drying time by over 60% versus traditional systems and reducing energy consumption. For demanding applications, SPE can achieve residual relative humidity below 0.03%.
• Integrated automation: Automation integrates with Siemens, Rockwell and Proficy iFix environments; platform developed in accordance with GAMP 5 to support data integrity and compliance expectations.

Dimensions / Models
Model | Useful volume | Volume per basket | Number of baskets
SPE-40 | 40 L | 10 L | 4
SPE-80 | 80 L | 10 L | 8
SPE-120 | 120 L | 10 L | 12
SPE-180 | 180 L | 10 L | 18
SPE-240 | 240 L | 12 L | 20

Certifications and compliance
Equipment for pharmaceutical applications is designed and manufactured in accordance with cGMP principles within an ISO 9001–certified quality system. Systems are developed to meet applicable international pharmaceutical regulations (FDA, EU GMP) and relevant electrical, EMC and safety requirements.

Characteristics / technical specifications

• Series name: SPE Series
• Processes combined: washing, siliconization, sterilization, drying
• Five standard chamber capacities: 40, 80, 120, 180, 240 L (1.4 to 8.5 cu ft)
• Volume per basket: 10 L (most models) or 12 L for SPE-240
• Number of baskets: SPE-40 (4), SPE-80 (8), SPE-120 (12), SPE-180 (18), SPE-240 (20)
• Basket system: rotating carousel with individual basket compartments for gentle handling and uniform fluid/air distribution
• Typical residual relative humidity achievable: below 0.03% (for demanding applications)
• Materials: 316L stainless steel process-contact components; EN 10204 traceability for materials; USP Class VI compliant elastomers
• Hygienic design: fully drainable, non-retentive surfaces, ground-flush welds
• Line clearance: automated camera-verified basket inspection and documented clearance
• Aseptic transfer options: ported bags, transfer containers, pneumatic transport, thermo-sealable bags (site-specific aseptic discharge solutions)
• Automation: integration-ready for Siemens, Rockwell, Proficy iFix; platform aligned to GAMP 5
• Support services: cycle development, validation documentation and qualification packages
• Installed base: more than 200 systems worldwide