Particle Measuring Systems’ Advisory Experts support you with the tools and implementation strategies to control contamination in your clean operations from idea to post-implementation applications. Our team helps you by designing quality into your operations using gold standard PMS tools and Advisory Services.
Facility Monitoring Systems - FacilityPro®
- FacilityPro Process Mapping: Creation of the specifications for configuration and system settings (for example: recipes, alarms and warning limits, equipment, user types, etc.).
- FacilityPro Performance Qualification (PQ) document creation and execution: Defining, creating, and performing the PQ documents and test procedures.
- FacilityPro SOP Creation
- FacilityPro data management system SOP document. The Standard Operating Procedure may include:
- FacilityPro use and operation
- Support for defining trends and creating reports
- Audit trail retrieval and review
- User management processes
- Support for new lines and FMS installations: In compliance with regulations, this service may include optimizing tubing design using Quality-by-Design solutions, and ensuring the accuracy of collected data with documented revaluation of alert/action limits if severe loss is measured.
- Advisory support for legacy EMS systems: May include helping customers demonstrate compliance with new Annex 1 and ISO standard requirements, focusing on sterility assurance actions to address gaps.
Microbial Monitoring - BioCapt® Single Use
- Performance Qualification protocol (PQ) for standard applications
- Performance Qualification protocol (PQ) for non-standard applications
- Support for the review and interpretation of qualification results.
- Rationale for the removal of settle plates with the implementation of Biocapt Single Use
Compliant Data Management and Trend Analysis - PharmaIntegrity™
User Requirement Specifications including:
- Process Mapping
- Performance Qualification (PQ) protocol writing and assistance performing the approved procedure
- SOPs
