GMP compliance support
Single-use technology
Single-use disposables ensure aseptic processing and eliminate any risk of cross-contamination.
Aseptic connectors
Fast, reliable connectors suitable for low-grade environments. Welding option available when needed.
Safe sampling
One-way valves integrated into the NANT Modular Cartridge sampling syringes allow safe, aseptic sampling of reagents and intermediates at any time.
Continuous & remote monitoring
Key process parameters are monitored in real time through the dedicated web application allowing users to oversee culture progress remotely, without accessing the cleanroom.
Full process traceability
An integrated barcode reader ensures full identification of cartridge components and operators. All critical operations, warnings, and alarms are automatically logged for complete traceability.
Downloadable cell culture report
Every run generates an automated Cell Culture Report with an Audit Trail section. Reports are available as PDFs easily integrable into any QMS, raw data logs are also available through downloadable LOG file.
Electronic Records & Electronic Signatures
Event-based user authentication ensures secure, traceable interactions. All electronic records are stored with their corresponding electronic signature.
Validated according to reference standards
- Manufactured in ISO 8 clean room.
- Animal-origin free.
- Proved to be biocompatible according to ISO 10993 standard.
- Tested for bacterial endotoxins and pyrogens.
- Tested for the presence of residual metals and elemental impurities.
- Tested for chemicals of concern.
- REACH compliant.
- Validated sterile according to ISO 11137-1 standard.
21 CFR Part 11 compliance support
NANT Maestro On-Premises is designed to support GMP and 21 CFR Part 11 compliance while keeping your data secure and accessible only to authorized users. Each user has unique credentials and robust password protection, with administrators able to require changes as needed to maintain security.
The system features multi-level user permissions, ensuring that everyone can access only the functions they are authorized for, while sensitive actions remain restricted to assigned personnel.
Every change in the system is fully tracked, with a complete audit trail showing who made each change and when, giving your team full visibility and confidence in data integrity.
