“At Pharmaceutic Labs,
our quality assurance seal means
excellence in quality and safety.
The people, process, and facility are held
to the highest possible standards.”
~ Ernesto Samuel, CEO
Facility
Pharmaceutic Labs state-of-the-art CGMP outsourcing facility was built to ensure sterile manufacturing for admixing products, segregated areas for non-sterile compounding and cosmetic lab. Our cleanrooms are ISO 7 certified with daily dynamic environmental monitoring. Sterile products are made in ISO 5 equipment to ensure complete patient safety.
Security is a main priority at Pharmaceutic Labs to ensure quality and safety. Pharmaceutic Labs uses DEA guided programs such as CSOS, for secure ordering, and ARCOS to ensure compliance with federal regulations with all controlled substance production. The facility is equipped with advanced technology for full security disclosure in all areas of the building.
Ante Room
Pharmaceutic Labs’ Ante Room is the first pressurized clean space at the entrance of the certified clean rooms that reduces the amount of contaminants entering from the outside environment. This room also serves as a storage area for clean rooms gowning materials such as bouffants and booties, which are donned prior to entering the gowning room to decrease the potential for contamination of the clean rooms.
Gowning Room
The gowning area of the clean rooms is the first classified space within the clean rooms setting at Pharmaceutic Labs. This critical area serves as the designated gowning area and storage of personal protective equipment for clean rooms technicians. Sterile personal protective equipment are used to ensure that product integrity is not compromised.
ISO 7 Cleanrooms
Pharmaceutic Labs employs highly trained and qualified pharmacists, chemists and laboratory technicians to perform sterile admixing duties within certified ISO 7 cleanrooms. Our quality program is managed by dedicated quality assurance managers. While complying with our robust aseptic technique procedures laboratory technicians use cutting edge technology and techniques to prepare IV bags, syringes, PCA glass, cassettes and pumps within ISO 5 enclosures. Our commitment to quality and safety exceeds industry norms and is based on the highest CGMP standard 21 CFR Part 211.
Non-Sterile Compounding
Pharmaceutic Labs’ compounding process is performed with superior quality guided by the FDA and industry standards. Creams, gels, suspensions, solutions, and troches are compounded in a controlled environment by highly trained pharmacists and laboratory technicians whose mission is to create quality products with patient safety in mind.
Quality Control
Each product undergoes full quality control testing as per US Pharmacopeia test methods and approved standardized operating procedures.
All in process product and finished goods are verified for quality, potency and patient safety per the FDA guidelines. Before each product is shipped, it undergoes sterility testing, endotoxin testing and impurity analysis.