Healthcare & Pharmaceutical

CRITICAL MONITORING

FOR OUR GLOBAL ENVIRONMENT

HEALTHCARE & PHARMACEUTICAL

Facility Monitoring Systems provide and support environmental monitoring equipment and systems. These range from handheld instruments to extensive monitoring systems covering the largest sites. Software development is conducted entirely to the latest GAMP guidelines and enables 21 CFR part 11 compliance. FMS software is designed to meet the regulatory requirements of: - MHRA, US FDA, BSI ISO9000 and EU Tissue and Cells Directive (HFEA regulated).

This type of monitoring system provides the pharmaceutical industry with the ability to meet rigorous audit and regulatory standards. It can be used as part of a Process Analytical Technology (PAT) initiative to aid process improvement.

Within hospital pharmacy production units, the same requirements apply. Other hospital and healthcare applications include blood and tissue products, embryology, infection, immunology, virology and pathology.

Major initiatives within hospitals to provide effective infection control are provided with monitoring and management information by FMS.

FMS provides a secure and robust management and reporting system for all environmental data. Individual handheld air samplers and particle counters provide routine and spot checks to ensure that best practice is applied.

• Particle counting

• Micobiological air sampling

• Other enironmental sensors for temperature, relative humidity, pressure etc.

• Enables 21CFR part 11 compliance

• Full GAMP4 lifecycle documentation

• Assists in Process Analytical Technology (PAT)

• Meets All regulatory requirements for GMP pharmaceutical production