Case Study: Large Pharmaceutical Formulation And Sterile Storage System

IPEC provided a turnkey Formulation and Sterile Storage System to a large pharmaceutical company in Clayton, NC.

The system consisted of (3) 2000 liter and (2) 300-liter formulation tanks, (3) 2000-liter sterile storage tanks, (2) 2-tank CIP systems and (14) tank process/utility piping modules. The utility modules were designed and constructed to allow for the addition of (6) 2000-liter formulation and sterile storage tanks in the future.

The formulation tanks were designed and constructed to prepare products in a Class C (100,000) formulation room. Each of the formulation tanks and associated piping can be cleaned-in-place (CIP'd) and sterilized-in-place (SIP'd). After formulation, the products or sub-fractions of the products are transferred to the sterile storage tanks in the Class A zone via a sterile transfer line.

All formulation tanks are equipped with integrated bottom mount magnetic drive agitators, sterile vent filters, flush mount outlet valves, insulation on the tank sidewall and bottom and include cooling jackets to cool the tank after SIP operations.

The 2000 liter formulation tanks are located on fixed load cells. The portable 300 liter tanks are placed on stainless platform scales. These tanks are used to dissolve small amounts of ingredients, which after dissolving, can be transferred to the stationary formulation tanks or directly to the sterile storage tanks.

All formulation tanks and associated process piping is cleaned-in-place by a 2-tank CIP system. This system includes a wash/rinse tank and final rinse tank. The system includes a heat exchanger to maintain or elevate the rinse water and solution circulating through the system and a caustic addition system.