HPPE manufactures pharmaceutical grade biopolymers in a class 1000 cleanroom. The clean room includes a 400 liter glass lined reactor, mix tanks, ion exchange columns, multiple filtration systems and a hydro MS75 spray dryer. The spray dryer has multiple nozzles including a supersonic nozzle to produce extremely fine powders.
To support the pharmaceutical grade cleanroom, a USP grade water system has been installed and validated to produce 30 gallons per minute of water.
Quality assurance for HPPE biopolymers are based on pharmacopeia standards or method validations at HPPE. HPPE has been successfully audited by major pharmaceutical companies for our quality system standards used to develop our products in medical devices and in fermenters that produce drug substances.
HPPE produces multiple biopolymers in the clean room. A select list is:
Designed without the use of pyridine solvent at any point in the manufacturing process.