From A to Z Validation at FertiPro
FertiPro sought and found a partner in Agidens for the annual revalidation and initial validation of a new cleanroom and autoclaves. After several exploratory discussions, Agidens proved to be the perfect fit with its proven expertise in life sciences. Our Validation & Testing Engineers conducted a series of tailor-made validation tests based on carefully designed test protocols to ensure high-quality process and equipment validation.
About FertiPro
FertiPro is a well-established and reliable producer of in vitro diagnostics and cell culture media. These products are used in assisted reproduction technologies and the diagnosis of male infertility. In their pursuit of delivering the best possible quality at all times, FertiPro designed a production facility that complies with all quality standards.
Agidens plays a crucial role by ensuring reliable and high-quality validation of all processes and equipment.
The communication with Agidens was excellent, and we are extremely satisfied with the overall collaboration.
A to Z Validation
CLEANROOM VALIDATION
FertiPro’s new cleanroom, consisting of various smaller spaces (ISO 7 / ISO 8 – 146644-3), underwent a series of rigorous validation tests:
- 15 x containment leak tests
- 4 x segregation tests
- 42 x filter integrity checks of the HEPA filters
- 42 x air velocity measurements and calculation of air changes per hour
- 96 x particle concentration measurements
- 18 x differential pressure measurements
- 15 x decontamination and recovery time measurements
Each test was meticulously documented following Good Documentation Practices (GDP), ensuring the integrity and quality of the cleanroom.
LAMINAR AIRFLOW (LAF) CABINETS
Agidens took on the challenge of conducting a series of comprehensive validation tests on FertiPro’s LAF cabinets.
- Technical control of pre-filter (visual inspection)
- FIT-tests
- Air velocities on the filters
- Particle count ISO class 5
- Differential pressure measurement across the filters
- General technical inspection
- Alarms
These rigorous tests confirmed the reliability and efficiency of the LAF cabinets.
COLD STORAGE ROOM
For the 9m² cold storage room (2-8°C), we collaborated closely to determine the positions in the room where loggers would be placed for a 24-hour mapping.
These tests prove that the Controlled Temperature Unit (CTU) remains within specified temperature ranges, guaranteeing optimal storage of sensitive pharmaceutical products.
AUTOCLAVES
Our consultants also validated 7 autoclaves, ranging from tabletop models to large steam sterilizers. During these tests, the proper functioning of the autoclaves was verified in combination with specific loading patterns, in accordance with international regulations and standards (ISO-EN-17665-1, EN-285). The protocol always included:
- Detailed description of the tests to be performed per program
- General description of the test methods developed by Agidens
- Listing of the programs to be performed
- Description of the placement of loggers in the autoclave/loading pattern
After conducting the tests (temperature and pressure measurements) and data processing, we reported whether all requirements were met: is the overshoot not too high, is the holding time achieved, and is the autoclave sensor working correctly?
This project once again proves that Agidens is a reliable partner in supporting companies like FertiPro with their validation needs. Whether it’s cleanrooms, LAF cabinets, cold storage rooms, or autoclaves, Agidens is committed to ensuring its customers’ equipment and processes are always reliable and of high quality, meeting all quality standards.