Pharmaceutical 1

Aseptic Filling Machine Process Services: Management, Commissioning & Qualification - Phase 1 & 2

Client: A well-known, respected global pharmaceutical company

As-found situational analysis: With completed design and procurement phases the client required downstream management of:

Mechanical piping, both GMP and GEP installations;

Electrical and data cabling installation;

3rd party building services contractor management;

Installation of all associated equipment, valves and instruments;

Including:

Commissioning of all equipment, valves, instruments & lines and executing associated documentation; and

Execution of Installation and Operational Qualification of GMP systems.

Fig. 1 - Representative image of aseptic filling machine.

Opportunity

Identification of pitfalls during installation, commissioning and qualification; reducing contractor lost time and ensuring heightened coordination between process piping contractor and 3rd party civil & mechanical contractors.

Items to consider:

Phase 1 (2013): Existing facility upgraded to house new process equipment.Phase 2 (2015): New purpose-built GMP facility to house expansion. Piping and equipment layout to replicate existing (phase 1); process piping improvements based on phase 1. Commissioning and qualification requirements and timeline considerations.

Outcome:

From September 2013 (phase 1) and February 2015 (phase 2) our personnel were on-site for the duration of the on-site works and directly responsible for the subcontracted mechanical piping and electrical trades to ensure their installation work was according to specification and subsequent correct functionality. Commissioning of the services specifically involved:

Writing individual process-specific documents for each service considering both installation and functionality;
Executing commissioning documents to confirm:
- Correct installation of equipment, valves, instruments and lines;
- Correct functionality of installed devices including safety devices; and
- System commissioning (pressures and flowrates) and PID control loop tuning.

Client drafted Installation qualification (IQ) was executed on direct-impact, GMP systems: Product, Pure Steam, Water For Injection, Compressed Air and Nitrogen. The Process IQ included a complete review of the mechanical piping contractor's QA pack for: material certificates, surface finish, weld map, pressure testing and passivation reports. Operational Qualification (OQ) was executed to ensure that:

1): The automated process sequences functioned according to functional specification (green path); and

2): The critical alarms functioned appropriately according to upper and lower limits (red path).