After 3 weeks trials with an iCaps capsule polisher, a Swiss company conclude that the machine fits they requirements for an OEB5 product.
The main decision factors were:
- Quality of the polishing,
- 100% line clearance with large capsules having low weight dosage
- Containment security
- Efficiency of the WIP “Washing In Place” cycle
High Containment Pharma production requires reliable equipment to guarantee efficiency, product containment, process repeatability, and smooth handling.
Before sending the equipment to customer site, it is usually fully inspected and tested by the customer during a Factory Acceptance Test. This FAT being performed at manufacturer site.
However, the current travel measures put in place in the context of Covid-19 no longer allow the carrying out of this test… Or at least, not in that form!
The Solution
Thanks to today’s communication technology, an online FAT protocol has been created between customer and Pharma Technology.
This protocol ensures that all aspects of a standard FAT are verified as in a “face to face” meeting. All needed documents were submitted prior to the online FAT for engineer’s reviews and comments
On the day of the FAT inspection process, the iCaps “HC” High Containment unit was installed in a professional FAT numeric studio to conduct the test with the representatives. Throughout this process, documents were shared and inspected, while remotes high-quality camera were transmitting the tests live.
The following people were participating on the customer site:
- Project engineer
- Production engineer
- Process automation engineer
- Quality & GMP compliance engineer
The Results
As everything was well prepared and professionally organized from both sides, the FAT took 1 ½ days and reached a very efficient level in terms of quality and time.
In front of the High-Quality camera lens, engineer achieved the following inspections:
- All documents
- Equipment’s finish
- Quality of the polishing
- Metal detector accuracy & functionality (including Auto-Check device)
- Run product at hi-speed
- 100% line clearance of the equipment
- Test pressure monitoring system
- Run pressure decay to prove equipment tightness
- Run a washing cycle
- Assist to dismantling and re-assembly
In Summary
Pharma Technology Customer Service completed a great and very efficient work thanks to a very proactive attitude, an attentive response, and a very professional online FAT service offer.
FAT passed successfully and the iCaps “HC” machine has been delivered. Customer can now finalize line installation and validation in a safe way.
THANK YOU to this Swiss customer for his testimony ! “HC” High Containment ≤OEB5 – iCaps capsule polisher with metal check