New Aseptic Manufacturing Process

New Multi-Step Aseptic Manufacturing Process

(£1.7 m Detailed Design, Validation Services, Project Management)

Pharmaceutical Manufacturing Facility, UK

The Problem

The existing process had been operated at bench and semi-commercial scale. Sales opportunities demanded that the operation be fully scaled up. The operations included protein extraction, modification and formulation into final drug substance.

The new plant had to be integrated into existing Class A and C clean rooms with a minimum of disruption to the ongoing operations.

The Solution

BPE provided the Project Management, Engineering and Validation expertise supported by Client representatives in an integrated team environment.

A new small scale manufacturing concept was proposed. Key technical areas were identified as process critical requiring scale up data to ensure that product conformity was maintained. BPE staff assisted the client in a range of developmental process tests from which data was obtained and used to define the full scale equipment requirements.

The operations included a complex addition and mixing stage as well as CIP and SIP. To ensure repeatability the process was automated with batch sequences recipe driven by a PLC programme. From an intimate knowledge of the process, BPE prepared the FDS to include all process control sequences. The control system included several HMI’s, local and remote PC’s and a Data Logger meeting the requirements of 21 CFR 11 and GAMP.

To minimise disruption to the ongoing operations within the facility, the new process was broken into 8 skids which could be built on a stand alone basis and delivered pre-assembled and tested. In these tests, BPE took a lead role in ensuring that all automated operations fully met process requirements.

On delivery to site, the skids were placed in two rooms which had been previously modified and fitted out with services. This enabled the equipment to be quickly brought into service for start-up activities.

The new processing techniques identified at the development stage were smoothly introduced to the new plant enabling the start-up to proceed efficiently through PQ to product launch.

BPE delivered this technically complex project against tight timelines and within budget.