Pharmaceutical Production Suite

formulation system

Formulation System

In 2005, IPEC completed a major turnkey project for an entire Formulation and Sterile Storage process. Based on the success of that installation, the customer returned to IPEC when they determined that a process expansion was required to increase production capacity. The suite of equipment includes a Formulation Skid, Sterile Storage Skid, two (2) Utility Skids, two (2) Clean-in-Place (CIP) skids, and a Water For Injection (WFI) Cooling skid.

The Formulation process consists of several fixed and portable vessels designed to prepare products in a Class 100,000 (ISO 8) clean room. The formulation process includes batching of liquid and dry ingredients, mixing, temperature control, CIP and steam-in-place (SIP). The system then transfers the product to Sterile Storage.

sterile storage system

Sterile Storage System

The Sterile Storage System includes three (3) vessels used for final product storage prior to filling. Both this and the Formulation System are designed for CIP and steam-in-place (SIP).

IPEC worked closely with this customer on each system to customize the design for maximum efficiency while minimizing hold-up volume, system footprint and energy requirements for the specific processing application.

utility system

Utility Module

Each production system includes a dedicated Utility and CIP Module. A common WFI Cooler serves both systems. The Utility Modules route process utilities including clean steam, CIP, process air and chilled water to the process skids.

The Formulation process consists of several fixed and portable vessels designed to prepare products in a Class 100,000 (ISO 8) clean room. The formulation process includes batching of liquid and dry ingredients, mixing, temperature control, CIP and steam-in-place (SIP). The system then transfers the product to Sterile Storage.

clean in place system

CIP System

The 2-tank CIP Skids prepare and deliver heated or ambient detergent or rinse solutions to the various tanks and piping circuits. Chemical addition equipment and heat exchangers on the CIP Systems control solution temperature and chemical concentration.

This project provides another example of IPEC’s ability to deliver a large order on time to meet a customer’s production schedule. Through the use of modular assemblies we were able to minimize the on-site time required for reassembly and start-up, allowing the end-user to begin operations quickly.

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