Quality and facilities in Research Triangle Park
If you are qualifying SmaBio for a program, start with the work you want the site to perform. A team sending analytical samples will need different records from a team planning a sterile manufacturing batch.
Analytical laboratory
SmaBio’s analytical laboratory in Research Triangle Park, North Carolina, is FDA-registered. If registration is part of your qualification review, ask for the details applicable to the laboratory and the testing you intend to place there.
Manufacturing rooms and equipment
The site has ISO 7 and ISO 8 cleanrooms, ISO 5 biosafety cabinets, segregated manufacturing rooms and isolators for handling potent materials. Discuss your product and process with the team to identify which equipment applies to your batch.
Fume hoods and laminar-flow hoods serve different handling needs. Potent-material isolators, segregated rooms and a monitored warehouse also form part of the facility review. Identify the specific room, containment system and material flow proposed for your operation before assessing fit.
Storage for stability studies
Storage options include controlled temperature and humidity, refrigeration and frozen storage down to −80 °C. Review the available conditions alongside the tests required by your protocol.
Request qualification information
Tell us which activity your team is assessing and which documents you need to review. For example, specify whether your request concerns a test method, a manufacturing room or a storage condition.
