Regular servicing and maintenance keeps a pharmaceutical production facility compliant and prevents equipment failure.
The stages of validation
We validate equipment when it goes in and revalidate it after major maintenance, upgrades or process changes.
1
Installation qualification
It comes first, once the equipment is in place, to check it meets the manufacturer’s guidelines.
2
Operational qualification
It comes next, with each test run against the acceptance criteria set out in its protocol.
3
CQV procedures
Commissioning, qualification and validation run as one sequence, from installation to final approval.
4
HEPA filter integrity test
It shows when a filter needs replacing. Cleanroom filters are often tested every 6 to 12 months.
5
Pressure decay test
It checks that sealed equipment, such as a containment or aseptic isolator, stays airtight.
6
Documentation and records
We record the results of each test against its protocol to show the equipment complies.
The sectors we work in
Pick your sector to see the work we have done for businesses like yours.
What our clients say
Over the last 18 months Xeenie have provided PSL with a number of different services, including Main Control Panel builds and on-site IQOQ validation at client sites. All work has been performed to a very high standard and their breadth of knowledge and experience is clear to see
Powder Systems Ltd
The team is friendly, professional, and always quick to respond if we had any questions or changes. You can tell they actually care about doing a good job, not just ticking boxes. We’ve seen a big improvement since bringing them on board, and I wouldn’t hesitate to recommend them to anyone looking for a reliable, down-to-earth company to work with.
CHEP UK
Xeenie Group are our preferred Installation and commissioning company when our in house team are fully utilised. Jared and Dan are always professional and have a wealth of knowledge and experience in the Healthcare and Pharma equipment industry
ESCO GB Ltd
It was a pleasure working with both Jared and Daniel who showed their determination and drive to succeed and achieve the desired result. This was an easy project to deliver due to their enthusiasm and passion for their business growth and development. Achieving ISO9001:2015 registration was an important step towards that goal. Well done guys. Onwards & Upwards
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