Who are QualUs?
QualUs is a commissioning and validation contract service company servicing the bio-pharmaceutical, medical device, hospital/dental and related life science and healthcare industries. It’s main office is located in the Acorn Business Centre, Mahon Industrial Park, Blackrock, Cork. Ireland T12K7CV.
QualUs offer a range of services including:
Trained Contract Thermal Validation Personnel
Warehouse & Stability Chamber Mapping
Thermal Validation Equipment Rental & Sales
Thermocouple Loom Preparation & Repairs
Steam Quality Testing & Condensate Sampling
Thermal Validation Consumable supplies
Steam Quality Test Kit Sales & Training
Oven/Tunnel, SIP Thermal Mapping Rigs
Thermal Validation Training
Validated Cooler Boxes for sample/product transport
Why choose QualUs to support your Commissioning and Validation requirements?
QualUs provide personnel with previous experience in the area that you require so they can hit the ground running with minimum project time wastage for you the customer. QualUs have successfully executed and delivered large scale validation exercises for multinationals in Ireland and the UK such as Schering-Plough, Janssen, Centocor, Eli-Lilly, Vistakon, Cordis, Taro, Patheon, Elanco, GE Healthcare, MSD, Boston Scientific, Regeneron and Takeda. All QualUs equipment is calibrated by an accredited laboratory that is traceable to national standards.
The following are some of the additional benefits:
We provide a diverse range of services to satisfy all your thermal validation requirements so no need for multiple suppliers for personnel & equipment
No additional training required as all staff are trained in validation and thermal mapping procedures
Vast experience and global validation knowledge of current regulatory requirements, all within local reach
Proximity to your site means we can deliver at short notice so no long lead times for consumables & equipment
Proven ability to successfully deliver large & small scale projects within schedule & budget
Proximity to your site means we can be on your site at short notice so minimal disruption to production/project schedules
Local workforce – 100% Irish owned and run
QualUs dedicated to providing a Quality service that you can rely on
QualUs utilise the latest 21 CFR 11 compliant data logging hardware and software from GE Sensing, Hanwell and Fluke which means that study setup, study execution and report generation time has been reduced. This leads to a greater choice and more cost effective solution for you the client.
All of our loggers allow logged data to be viewed in real time. This minimises equipment downtime as problems can be identified at an early stage. All QualUs equipment is calibrated to national standards and can be calibrated pre-study execution and verified post-study execution.
Another key area that we excel in is Good Documentation Practices (GDP). Our engineers recognise the importance of GDP and are fully trained on all applicable regulations (such as EN285, HTM2010, HTM01) to ensure customers are compliant from a thermal validation perspective.
Our validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols in either a QualUs format or in a client specific format.
Contract Services
QualUs can provide you with a broad range of engineers to suit your requirements. We understand the roles and responsibilities of Engineering & Validation in the Biotech, Medical Device and Pharmaceutical sector so we are best placed to provide you with an engineer to complete any project to the highest standard.
Discovery
QualUs has vast experience in the validation industry and specializes in the thermal validation of all types of equipment such as Autoclaves, Steam In Place (SIP) of Bioreactors & process equipment/lines, Depyrogenation Tunnels, Ovens, Fridges, Freezers, Warehouses, Incubators, Stability Chambers etc.
Analysis
Our validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols and subsequent reports in either a QualUs format or in a client specific format.
Testing
QualUs has the ability to perform Steam Quality Testing of your steam test points to EN285 standards. QualUs also has the ability to take steam condensate samples for laboratory analysis. Our proximity to your site means that we are available to you when you need us, so impact to manufacturing is limited.
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See What Qualus Can Do for You
Our validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols in either a QualUs format or in a client specific format