Description:
Environmental controls and monitoring are important to ensure regulatory compliance standards are met for the manufacture of pharmaceuticals and medical devices. Through our years of experience, Charles River Singapore has helped many pharmaceutical and medical device manufacturers develop and oversee successful environmental monitoring plans. This includes development of a sampling plan through detailed analysis of the clients’ floor plans and critical areas of product contact or manufacturing activities, conducting validation studies for risk analysis and to establish baseline parameters for alert and action limits as well as environmental isolates.
Charles River Singapore offers a comprehensive array of services to help manufacturers overcome the regulatory hurdle through scientific and cost-effective solutions:
- Non-viable particle air sampling
- Viable particle air sampling by automatic air sampler
- Viable particle air sampling by settle plates
- Viable particle surface monitoring by contact plates
- Viable particle suface monitoring by swabbing
- Personnel monitoring
- Microbial identification of environmental isolates
Please submit your floorplan to us today to request for a quote.