LYOPHILIZATION
WHAT IS FREEZE-DRYING?
Freeze-drying is a widely used technique for drug conversion in the pharmaceutical industry. trust your global freeze-drying project to net-pharma 360° support.
EXPERTS IN THE PROCESS, OPERATION AND HANDLING OF FREEZE DRYERS.
Know in detail the best way to execute it.
LYOPHILIZATION PROCESS IMPLEMENTATION DESIGN
We look for the best plan to implement the process in your company.
FREEZE DRYER SELECTION
We choose the freeze-drying option that best suits your project and your needs.
SPECIALIZED TRAINING
We create and develop specific training so that your workers can undertake the process.
PREVENTIVE AND CORRECTIVE MAINTENANCE
We make sure that everything works properly throughout the life of the project.
REMOTE FREEZE DRYER SUPERVISION
We remotely supervise the process and provide assistance in case of any incident.
QUALIFICATION
We seek to comply with the technical requirements set.
SERVICIOS
01/06
RECIPE DESIGN AND OPTIMIZATION
PROCESS DEVELOPMENT:
Development of freeze-drying processes from the Product R&D phase.
PROCESS OPTIMIZATION:
Reduce the duration of the process without affecting the quality of the final product. Solve possible problems associated with the freeze-drying process that may affect the specifications of the final product.
PRE-TESTING:
Option to perform pre-testing in a freeze dryer external to the customer to eliminate the impact of in-plant activity.
PHARMACEUTICAL DEVELOPMENT
GALENIC DEVELOPMENT OF LYOPHILIZED PRODUCTS:
Physicochemical characterization of the active ingredient.
Selection of excipients suitable for sterile forms and lyophilization.
Compatibility with excipients.
Formula and manufacturing process development (compounding).
Analysis of tests during galenic development.
Pre-stability studies of selected prototypes.
Technology transfer support.
PHARMACEUTICAL DEVELOPMENT
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS:
Development of physicochemical methods for product characterization (titration, related substances, microbial load, sterility, endotoxins, bacterial, etc.) as well as setting specifications based on compendial guidelines and/or pharmacopoeias.
Validation of the developed methods based on ICH Q2 (R1).
EXTRACTABLES & LEACHABLES STUDIES
SCALED TO INDUSTRIAL PLANT
SCALING UP TO INDUSTRIAL PLANT:
Scale-up of the lyophilization process from laboratory lyophilizer to industrial lyophilizer.
Support for the choice of a new freeze dryer: collaboration in the establishment of URS (User Requirements) and FATs (Factory Acceptance Testing).
PREVENTIVE AND CORRECTIVE MAINTENANCE
SERVICES:
Installation: study and advice on the project according to the user's requirements, to provide a complete supply suitable according to the characteristics of the equipment and the operation.
Start-up and advice in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).
Permanent professional preventive and corrective maintenance to guarantee the optimal operation of the equipment, avoiding incidents.
QUALIFICATION OF THE FREEZE DRYER FAT, SAT, URS, AR, DQ, IQ, OQ, PQ
Qualification and periodic adjustment of sensors.
Standards for on-site calibration and adjustment of temperature probes down to -100°C and high vacuum pyrani and capacitive sensors down to 0.00011mBar.
Qloud Calibrates with on-site calibration certificate issuance
Qualification (IQ, OQ and PQ) by controlling the critical parameters of the equipment (temperature, pressure and time), through temperature mapping at all stages of the process (Freezing, primary drying, secondary drying).
Validation of the control, monitoring and recording system associated with the equipment to ensure full traceability and data integrity.
Compliance with CFR 21 part 11.
SPECIFIC TRAINING
Customized Training.
Online / Onsite.
Practices with real lyophilizer.
