We offer qualification and validation services for the pharmaceutical industry. We are happy to handle complete validation projects, as well as the procurement and qualification of e.g. new laboratory equipment, larger climate facilities, autoclaves or similar.
Our capabilities cover all project phases, from design to commissioning. We have experts in both automation and validation, so we can facilitate the validation process by working across disciplines.
Confirm has extensive experience in both the preparation of documentation and the practical execution of validation and qualification tests according to Danish, European and American requirements.
Project management
Design, design documentation and design review
Risk analysis - FMECA, HACCP and FMEA
Validation plans
Change requests
Requirements specification (URS)
Commissioning (FAT/SAT)
Qualification (IQ/OQ/PQ)
We are a group of specialized validation consultants with knowledge and expertise in qualification and validation. Use us for what we are good at: adding experience and knowledge to the validation work.
We have deep experience in DQ, IQ, OQ, PQ, PV and Cleaning Validation. We can offer consultancy services in the form of specialists, project managers and project staff for specific tasks for shorter or longer periods of time.
At Confirm, we understand the importance of qualification and validation work. Therefore, we take a risk-based approach to qualification/validation, focusing on processes where they can have a critical impact on the product.
All types of SIP (Steam in Place) systems
Bioreactors & fermenters
SIP stations
Fuel tank
Bottle Pack
Bulk process equipment
Insulators
Depyrogenation tunnels
Dry sterilization tunnels
Autoclaves
Qualification of loggers, e.g. Yokogawa and similar.
VHP (Vaporized Hydrogen Peroxide)
Cycle development
Temperature distribution
BI test incl. D-value calculations
Qualification and validation
Cycle and load development
F0 value calculations
Bioburden, overkill & half-and partial-cycle approach
D-value calculations
Rehabilitation
Checking effective air removal and vapor permeation (Bowie-Dick test)
Qualified program changes
Cycle development and changes
Copying and migrating existing programs
We work according to standards such as EN 285, HTM 2010 and PDA technical report (no. 48) etc.
E-ValTM Pro is a validator from Ellab that can be used for temperature studies, for example, and is a small, compact validator that, at only 3 kg, can be used in most places. Despite its size, the validator is equipped with a large display where the validation can be set up and followed via real-time data and graphs during validation. E-ValTM Pro can be fitted with up to 40 thermocouples, which can be calibrated with an accuracy down to ±0.2°C. The data acquisition frequency can be set between 1 second and 24 hours.
In addition to temperature mapping, E-ValTM Pro can be used for mapping pressure, relative humidity, conductivity andCO2.
Rental of Ellab's validator E-VALTM Pro. Up to 40 thermocouples can be used with the validator. The thermocouples can be calibrated to a range that you specify.
E-VALTM Pro is compatible with ValSuiteTM Pro reporting software, where professional reports can be generated, with many individual solution options, such as calculating F0 values and graphs.
It is possible to rent a fully qualified PC with ValSuiteTM software without renting Pro.
of course help with the entire project, such as setup, operation, dismantling and reporting, but it is also possible to rent the validator and make the measurements yourself.
Whether you are a customer or an employee at Confirm, you should feel that it is the best place to be.
Quality, integrity, flexibility, trust, and collaboration are key.
Our vision is to become the preferred business partner - the one you want to call.