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.
COLLEGE STATION, Texas (PRWEB) May 02, 2018
G-CON Manufacturing, producer of prefabricated, flexible cleanroom solutions, announced today that is has been selected to design and build a multi-POD 503B manufacturing space. The PODs will provide approximately 1,800 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, Inc. “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.”
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.
This project is the second 503B project awarded to G-CON in 2018 and other entities in the space have also expressed interest in the POD-based approach.
Future details will be provided as the project matures.
G-CON Manufacturing designs, produces and installs prefabricated cleanroom PODs®. G-CON’s cleanroom POD portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose the PODs once the production process reaches the end of its lifecycle. For more information, please visit the Company's website at http://www.gconbio.com.