US-based modular cleanroom specialist has been selected to design and build a multi-POD 503B outsourcing manufacturing facility
US-based G-CON Manufacturing, producer of prefabricated, flexible cleanroom solutions, has been selected to design and build a multi-POD 503B manufacturing space. The name of the company and location of the site of this project have not been disclosed.
Providing additional upgraded cleanroom capacity in the compounding pharmacy space is critical to ensuring sterile drugs are compounded under the appropriate cGMP conditions, as required by the FDA for 503B outsourcing facilities.
The PODs will provide approximately 1800 sq. ft of cleanroom space for use in the compounding and filling of sterile prescription drugs. The facility has been designed with future expansion in mind for projected additional capacity requirements.
“We are very excited and grateful for the opportunity to design and build PODs for this important project,” said Dennis Powers, director of sales engineering at G-CON Manufacturing.
He continued: “Providing additional upgraded cleanroom capacity in the compounding pharmacy space is critical in ensuring that sterile drugs are compounded under the appropriate cGMP conditions as required by the FDA for 503B outsourcing facilities.
“G-CON PODs are an ideal solution to meet the needs of the compounding industry at large as the necessary containment requirements are met. In addition, we see more requests for cloning of such sites, which can only be effectively done with POD structures,” Powers concluded.
This is the second 503B project awarded to G-CON in 2018. The company said other entities in the outsourced space have also expressed interest in the POD-based approach.
Outsourcing facilities that compound larger quantities of sterile medications must comply with 503B of the Federal Food, Drug, and 22 Cosmetic Act (FD&C Act).
A 503B registered outsourcing facility must also comply with the current good manufacturing practices (cGMP) mandated by the FDA. And finally, 503B entities must also comply with all applicable USP standards and State Board of Pharmacy regulations.