Pressure calibrator EF631

temperaturefor the pharmaceutical industryfor bags

Product overview
The EF631 is a portable pressure and temperature calibrator designed to verify, record and correct sealing temperature and pressure during heat-sealing operations in pharmaceutical and biotechnology production. Built for on-site use, it adapts to multiple models of heat-sealing machines to provide objective measurements required for process control and documentation.

Key features

• Portable calibrator for simultaneous measurement of pressure and temperature during heat sealing
• Detects compliance of sealing parameters with process documentation
• Suitable for on-site verification across various heat-sealing machine models
• Optional micro-printer for immediate printout of test parameters
• Optional PC connection for data transfer and archiving
• Dedicated recording software to store, review and export test reports
• Supports traceability of sealing parameters for quality systems

Applications
Intended for verification, adjustment and routine quality checks of sealing temperature and pressure during the manufacture of pharmaceutical and biological products, including process validation, preventive maintenance and production line audits.

Compliance
Helps document process parameters to meet Good Manufacturing Practice requirements (GMP/cGMP/GSP) by enabling repeatable measurement, recording and export of sealing data for regulatory dossiers and internal quality records.

Technical specifications

• Model type: Portable pressure and temperature calibrator
• Measured parameters: Sealing temperature and pressure
• Primary functions: Measurement, verification, correction, recording and printing of sealing parameters
• Recording options: Optional micro-printer; PC connection (optional); dedicated software for storage and report generation
• Use case: On-site testing and documentation for multiple heat-sealing machine models
• Purpose: Provide traceable records for process control and regulatory compliance