Project Details
Client Agila Specialities
Date 2015 – 2017
Location Warsaw, Poland
Service Lifecycle Management, FAT & SAT Support, CQV
Project Overview
SysComm provided the Project Management, Lifecycle Management Support and CQV Execution services into the Site Project Team for the Vial and Ampoule Manufacturing Line Project at Agila Specialities, Warsaw, Poland.
The Project consisted of two individual element which ran concurrently and involved full project management support, a flexible approach to in-country execution services and design review support for out-of-scope interfering projects. SysComm demonstrated it client focussed approach by ensuring that the Project was provided with key resources as was required to ensure its success, including the continuous provision of remote, back-office support.
The Vial Line element was a retrofit project which consisted of the replacement of an existing vial filler and vial capper with an entire new suite of equipment. SysComm’s scope commenced at the requirements definition stage and concluded with its successful delivery. For this element, SysComm personnel generated all project documentation, executed all test protocols and delivered an operational, qualified and compliant equipment suite.
Project Details
Client Agila Specialities
Date 2015 – 2017
Location Warsaw, Poland
Service Lifecycle Management, FAT & SAT Support, CQV
For the Ampoule Line element, SysComm was required to provide project management, procurement & vendor management and CQV execution services for the installation and qualification of a new high-speed ampoule filling line. This line incorporated the following equipment into the existing cleanroom envelope:
- Ampoule Washer
- Ampoule Tunnel
- Ampoule Filling Machine
In addition, the Ampoule Line element incorporated the management and delivery of the procurement, installation, testing and qualification of a 1.6m3 Porous Load Autoclave and a 400L Sanitary Mobile Vessel.
SysComm also delivered this Project element successfully and handed-over an operational and qualified ampoule filling line to the Client.
Throughout the lifetime of the Project, SysComm provided the Client with design review support for on-site non-Project related facility and utility upgrade works, as and when it was requested.
