Life Science Automation Solutions
Life Sciences Automation Solutions
XOR Automation are a new company providing process automation consultancy to clients in the Life Science industry in Ireland.Where Life Science companies do not maintain a sufficient pool of automation resources to cope with large scale expansion, or do not have the in-house expertise to deliver projects, XOR Automation join forces with the existing client team to successfully deliver their automation projects.
Engineers
Our small team of highly qualified engineers have over 60 years' combined experience in the Life Science industry and are highly regarded by our clients and our industry peers. Our engineers have been at the forefront of many projects for our clients over the last two decades, understanding their requirements and developing automation solutions to meet their needs.
Our engineers have experience throughout the project lifecycle and have been embedded on client sites executing projects for years, this has given them a client centric focus allowing them to gain an insight that is simply not possible as a system integrator or equipment vendor. This focus means they have developed a process and operations proficiency to complement their automation expertise.
Process Knowledge
With a gained process knowledge of all aspects of BioPharma, our engineers have detailed understanding of the following systems;- Bioreactors (stainless steel and disposable technology)
- Media Preparation
- Buffer Preparation / Hold
- Harvest (Depth Filtration, Virus Filtration, Centrifuge etc).
- Purification (Initial and Final – Chromatography, Ultra/Diafiltration etc).
- Utilities (CIP, WFI etc).
Project Expertise
Our role is to define the automation aspects of broader project scope and to ensure the software delivered at the end of the project meets the needs of the Operations/Manufacturing teams. Our team are familiar with the full software development lifecycle model (SDLC);
- User Requirements Specification
- Functional Specification
- Detailed Specification
- Factory Acceptance Test
- Software Test Specification
- Change Management
Clients Standards
To ensure consistency across our client sites;
- Quality Standards
- Safety Standards
- Programming Standards
- Documentation Standards
- Project Standards
Industry Standards
GAMP®5 : Good Automation Manufacturing Practice
21 CFR Part 11 : Electronic Records; Electronic Signatures
EudraLex Annex 11 : Computerised Systems
ISA88 : Batch Control
Preliminary Design
Assist in requirement gathering, feasibility studies and initial design.
Define elements of automation scope for Project Execution and Verification Plan
Detailed Design
Work closely with System Integrators to ensure the design meets the requirements of the project.
Software Development
Monitor System Integrator progress and adherence to project schedule
Testing
Attend equipment and software FATs/SATs.
Commissioning
Troubleshoot issues as they occur, determine solutions and implement. Review/approve automation changes. Manage software changes and downloads
Managed Service
Ensuring systems maintain a validated state and continuously improve
