Seamless data integration and visualization for your isolator processes
Real-time data access
Immediate response to deviations and accelerated batch release
Data-driven decision-making
Real-time KPIs and advanced analytics that enable data-driven decisions
Long-term archiving
FDA- and GxP-compliant storage for auditability and traceability
Enterprise-wide integration
Centralized data usage for quality assurance, validation, maintenance, and management
Efficient connectivity
Preconfigured PI connectors, tags, and Asset Framework included
Intuitive dashboards
Standardized visualization of system status and process data
Broad data coverage
Capture of alarms, audit trails, cycle data, and operating states
Remote services
Global access for support, maintenance, and system management
Application
sphere connect creates the foundation for digital process reliability
For pharma and biotechnology
sphere connect can be integrated into both new and existing systems. FDA-compliant long-term archiving of critical process data including audit trails to ensure data integrity and GxP compliance.
For process and quality management
Structured real-time and historical data for KPI monitoring, trend analysis, and continuous process improvement.
Process
Foundation for a valid data infrastructure
1
Consulting and design
Together, we analyze the use case, map existing systems, and define the target structure and scope of integration. A workshop is available upon request.
2
Data connection
sphere connect enables seamless data integration by collecting data via OPC UA, while alarms and events are accessed through SQL databases using an RDBMS interface.
3
Data modelling
SKAN provides a structured asset framework as well as labeled PI tags for relevant parameters and events.
4
Visualization and analysis
Preconfigured dashboards enable immediate access to system and process data. Extensions and customer-specific dashboards are available optionally.
5
Commissioning and maintenance
The integration includes configuration, testing, documentation, and (optionally) Installation and Operational Qualification (IQ/OQ). SKAN provides maintenance, updates, and ongoing support upon request.
Service highlights
sphere connect as a holistic platform
Complete solution from a single source
As an AVEVA Partner and certified PI Integrator, SKAN offers consulting, connectivity, visualization, and support from a single source for smooth and compatible system integration without external providers.
Verifiable data history
Automated interface integration replaces manual data entry and enables early intervention in the event of deviation. In accordance with GxP, the platform ensures complete data integrity from recording to archiving, thereby providing assurance for audits and process controls.
Structured data, clear visualization
Standardized dashboards and well-designed data models enable efficient analysis and easily understandable reports from the operational to the strategic level.
Easy integration with the PI system using a preconfigured OPC UA connector, a preset asset framework, and labeled PI tags, plus two preconfigured dashboards
Consulting and implementation
Implementation and migration of existing PI systems
Customization (optional)
Additional dashboards (PI Vision) tailored to your needs, including audit trail and KPI integration
Validation
Validation services (IQ, OQ, PQ)
Documentation
Technical documentation
Notifications
Real-time alarm and event notifications for proactive monitoring and faster response
Reporting
Automated reports with visual graphs and tables for intuitive data analysis. Supports Electronic Batch Records (EBR) to ensure structured documentation, traceability, and compliance
Advanced analytics and KPIs
Predefined and customizable KPIs for performance tracking, trend analysis, and continuous improvement
FAQs
Data is primarily collected via the isolator’s programmable logic controller (PLC). Expansion packages also allow for the integration of data from the Human-Machine Interface (HMI).
The responsibility for validation lies with you. The basic package does not include on-site validation services, but these can be booked additionally.
Yes, the package can also be implemented retroactively for existing systems. A technical review to ensure compatibility is required prior to implementation.
Since Allen Bradley PLCs do not natively support OPC UA, middleware such as the Kepware OPC UA Server is used. sphere connect is prepared and tested for this configuration.
Yes. A range of WirelessGTs is available in the sphere connect product portfolio.
No. Instead, the OPC UA license integrated into the WirelessGT software can be activated.
