At Environmental Specialties, we offer complete installation, operational, and performance qualifications solutions that help ensure your equipment is functioning properly. We can prepare, execute, and complete all qualification tests, walking you through the entire validation process and providing a comprehensive final report to help you gain a thorough understanding of your equipment.
Our trained technical personnel are experienced in servicing and validating a wide range of equipment brands, including our systems and those from other manufacturers.
Our team can generate a standard protocol, customize one to meet your specific requirements, or execute your protocols and standard operating procedures. Whichever you choose, you’ll know your equipment is operating according to the most exacting specifications.
Along with specialty knowledge of the pharmaceutical and research industries, our technicians also have in-depth electrical and mechanical backgrounds. Our outstanding hands-on expertise helps guarantee the proper qualification of your equipment.
We establish that the equipment is properly and safely installed. All component model and serial numbers are verified and recorded, and all utility requirements are documented.
We establish that the chamber consistently meets design specifications by demonstrating performance in unloaded conditions. Temperature and relative humidity (RH) uniformities are verified using thermocouple and RH sensors.
We establish that the chamber consistently meets performance specifications in loaded conditions. This test is generally performed at the chamber’s operating set point and a simulated product load is used to replicate typical product storage. Temperature and RH uniformities are verified using thermocouple and RH sensors.
All collected test data is reviewed with you for completeness and accuracy. You retain the original data, and the multi-point data is transferred to the final report and presented in graphical form. All other information is written within the text and included in the final report.
To help expedite validation, we can perform OQ of chambers prior to shipment. All our documentation meets cGMP requirements and can be used as part of IQ. As a result, a significant portion of the validation process can be completed in our factory, dramatically reducing the time it takes to commission chambers once they arrive on site.