Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products. For example, sterile drugs produced by aseptic processing are subject to FDA Aseptic Guidelines and EU GMP Annex 1, and are classified using ISO 14644-1 standards. Strict regulations help ensure safety and consistency for end consumers.
The Lighthouse line of Particle Counters, including handhelds, portables, and remotes, are designed to meet the rigid requirements for life science clean room applications. Lighthouse Particle Counters comply with the stringent requirements set forth in ISO 21501-4. These particle counters are calibrated to NIST traceable PSLs using world-class Classifier and Condensation Particle Counters, the recognized standard for particle measurements. Backed with long-standing reputation for high quality and accuracy, Lighthouse Particle Counters provide the best measurement and data to help keep your processes in control.
Facility Monitoring Has Never Been So Easy. The Lighthouse Facility Monitoring Software is compliant environmental monitoring system software for the Pharmaceutical, Medical Device and Life Science industries. All software development activities at Lighthouse follow the ISPE GAMP® lifecycle model. LMS Express or Express RT is assigned current GAMP® as configurable software. It is specifically intended for use where compliance to EU GMP Annex 1 and the aseptic processing FDA cGMP is required. Full project based validation lifecycle documentation based on the latest ISPE GAMP® guidelines is available from Lighthouse and is tailored to meet your requirements.