Feature
- Wireless /Pipeless / WIFI Connection
- Compliant with GAMP guidelines for CSV (Computerized System Validation)
- Compliant with 21 CFR Part 11 for electronic records and electronic signatures
- Equipped with non-deletable and non-editable audit trail functionality
- Adopts pressure decay test procedures matching glove performance specifications
- Flexible on-site configuration of user authorities
- Custom test flanges available per customer’s glove port
- Removable batteries with complete transportation certification
Application
- Industry：Sterile Injectables，Biologics，Ophthalmic Preparations，Highly Potent Drugs (HPAPI) and etc.
- High Containment & Aseptic Processing Equipment: Isolators, Restricted Access Barrier Systems (RABS), High-containment Tablet Presses, High-containment Capsule Fillers, Class III Biological Safety Cabinets
Advantage
- Compliance to EUGMP Annex 1
- Compliance to FDA 21CFR Part 11 Electronic Records and Electronic Signature
- Full traceability with secured data management
- Flexible authority management and robust security policies
- Support domain account management
- Compliant batch records and batch reports
- Offline Data Recovery
- Design strictly in accordance with 1SO14644-7 regulations
- Test recipe development based on glove micropore verification, capable of detecting micro-leakage down to 100 μm
- Self-developed software featuring visualized data analysis for optimized glove usage procedures
Specification
- Test pressure：0 to 2500Pa up to 1%FS
- Pressure display resolution ：0.1Pa
- Test flange size：Customized
- Certifications：CE、Calibration、IP67(Tablet)
- Documentation ：DQ, IQ, OQ and etc.
- Size：306×328×105mm，weight：about 4.5kg
- Removable Battery：Charing time：≥2 hours，Working time: 2-3 hours
