Serviços de Monitoramento de Microcontaminação
na indústria Farmacêutica

Project Management

Particle Measuring Systems has the experience of project managing over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices. Project Management includes:

Facility monitoring system design (particles, pressure cascades, T/RH, air velocity, air changes/HR)
Design reviews
Documentation:
- User requirement specification
- Design qualification
- Installation qualification
- Operational qualification
Installation
Factory acceptance testing
Site acceptance training (IQ/OQ)
Training

Compliance Training

Training of personnel in principles of particle counting fundamentals and applications. Use of particle counters including the requirements of testing to cleanroom standards (FED209E, ISO 14644 parts 1 and 2).

Computer Validation

Full computer validation in compliance with GAMP and cGMP regulations. Validation packages include documented proof of design and testing of particle counting applications. Our field proven standards can be adopted to meet in-house styles if required.

Facility Monitoring Validation

Full system validation in compliance with GAMP and cGMP regulations. Site application testing of PMS installed Facility Monitoring Systems, including particle counting, differential pressure, temperature, humidity, and other attached sensors.

Parenteral Validation

Validation of small and large volume parenteral samples using the SamplerSight-Pharma system.

Pharmaceutical Engineering

In association with our project management, we offer full installation and integration engineering of pharmaceutical environmental monitoring projects.