Services
Our Services
Freeze Dryer Maintenance
Preventive Maintenance
Preventive maintenance aims to reduce unforeseen freeze dryer breakdown to zero. Therefore, the implementation and success of a preventive maintenance programme makes operations more reliable, minimises unplanned stoppages and increases the service life of the equipment.
Usifroid’s preventive maintenance plan includes one or two annual visits to carry out inspections and change consumable parts, as well as any minor repairs or adjustments.
The direct benefits of preventive maintenance can be summarised as follows:
- Fewer breakdowns
- Reduced downtime
- Improved production
- Maintained safety
Usifroid’s teams work in collaboration with client services to design and implement preventive maintenance plans based on equipment condition and performance requirements.
Full preventive maintenance visits include:
- Replacement of wear parts
- Comprehensive performance tests
- Equipment safety audit
- Audit of the client’s stock of spare parts
- Recommendations for short and long-term maintenance activities
- Sharing preventive activities with the client
Corrective Maintenance
Thanks to our pool of technicians and our international presence, we can intervene quickly in the event of an emergency around the world.
Our team of qualified and experienced engineers and technicians are on hand to help you worldwide.
- Remote assistance
- Emergency site visits
Calibration
Our on-site calibration service is designed to help you meet your metrology and quality standards. Our technicians are trained to a high standard in the calibration of freeze dryer instruments such as:
- Temperature probes (ovens down to -100°C)
- Pressure sensors
- Vacuum sensors
- Vial stoppering pressures
We use different equipment (baths, -100°C ovens, COFRAC calibrated gauges) to cover the necessary measurement ranges.
Performances
Temperature Mapping
Verifying the temperature homogeneity of the freeze dryer shelves at the process critical points is essential for the correct monitoring of your equipment or following an intervention that may impact on performance. Our team of professionals are experts in this field and will reliably conduct the measurements, limiting equipment downtime.
Stoppering Pressure Test
Stoppering pressure is an important parameter in the freeze drying process in order to ensure that all vials are hermetically sealed for complete product safety. We are able to verify stoppering pressure with COFRAC calibrated probes and, if necessary, offer corrective solutions.
Freeze Dryer Relocation
Our multi-disciplinary team of engineers and technicians have a wealth of experience in handling the transfer and re-commissioning of freeze dryers. Our expertise enables us to take care of the whole process from the dismantling to the installation at the new location.
In addition, our start-up and validation services provide full support for commissioning and qualification after the transfer.
Cycle Development
Our state-of-the-art freeze drying laboratory is fully equipped with the most up-to-date equipment for conducting detailed studies. Our comprehensive studies allow our specialists to clearly identify the main points and critical temperatures of thermal change during the freeze drying cycle.
- DSC (Differential Scanning Calorimetry): Detection of freezing point, glass transition temperature, recrystallisation, eutectic melting point.
- Cryogenic microscopy: Detection of collapse temperature, eutectic melting.
Thermal study data obtained from DSC and cryogenic microscopy provide extremely accurate and valuable information on the thermal characteristics of the product. The data will be analysed and a product-specific recipe will be formulated before commencing testing in the freeze dryer.
Automatic freeze drying cycles are carried out with product samples in LyoBeta (3PS, mini, 6PL) laboratory freeze dryers. Samples of the freeze-dried products are then carefully studied to further optimise recipes. Residual moisture is also measured for all samples. Freeze drying cycles are repeated until a good “cake” is obtained with a reasonable and reliable recipe.
A detailed report containing all the collected data (results of the thermal studies, results of all freeze drying cycles, etc.) is delivered with the samples.
Qualification and Training
Qualification
As part of the qualification of a freeze dryer, our team offers support services for SAT, IQ and OQ.
Site Acceptance Tests (SAT)
The aim is to ensure that the freeze dryer, or specific parts of the freeze dryer, meet the pre-defined requirements specified by the user and the design.
This verification generally includes the conformity of the construction and installation to the design documents, standards, specified construction materials, and other regulatory requirements. In addition, to check whether the system will function in accordance with the design criteria, functional and performance tests must also be carried out.
Installation Qualification (IQ)
The purpose of installation qualification is to ensure that the equipment has been installed in accordance with the supplier’s recommendations and GMP rules, that it corresponds to the design specifications and that all relevant aspects have been properly documented.
Operational Qualification (OQ)
The objective of operational qualification is to verify the conformity of the operational parameters of the equipment with the functional specifications, and whether they correspond to the acceptance criteria in each case, according to the established test conditions, including boundary conditions.
Training
The regular training of our clients’ personnel guarantees that they achieve maximum performance from their freeze dryer. All our courses are designed to provide participants with detailed and practical insights.
Our training is tailor-made for each client, after an in-depth analysis of the client’s specific needs and requirements. Examples of training courses offered:
- Operator training
- Technical training
- Maintenance training
- Simulation training in freeze dryer operation (in the case of a SCADA retrofit)
- Process training