Pooyesh Darou has a variety of facilities and technologies used to manufacture clinical and commercial finished products in various quantities. All activities are performed in a full cGMP environment, meeting the highest international quality standards. Pooyesh Darou sterile manufacturing facility includes an 11000 sq. ft. production site. Our aseptic fill and finish manufacturing facilities are capable of filing over 13 million low volume parenteral sterile unit per year and utilizes five high-speed filling lines and two lyophilizers. The site also includes separate facilities for chemistry, sterility testing, and analytical method development.
Our filling Capabilities
- Pre-filled syringes
- Vials (liquid & lyophilized)
- Ampules
- Cartridges
- Powders
The Aseptic Manufacturing Facility maintains a static and operational Grade A (ISO Class 5) environment. All areas of our aseptic processing facility, including ancillary support areas, are routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination by our QC Microbiology Laboratory. The area is also supported by our Analytical Chemistry Laboratory and Quality Assurance Department. Supporting our process equipment are validated services including a USP water system, pure steam generator, autoclave and depyrogenation oven. Validation capabilities include, but are not limited to, media aseptic fill simulation studies, terminal sterilization loads, autoclave equipment loads, depyrogenation oven loads, container closure integrity and process validation.