We manufacture all implants on Sliding head CNC machine. Dimensional calibration of every cutting tool is done on daily basis, if not proper we change the cutting tool. Apart from that machine software calibration & moving part calibration is done at monthly basis. The purpose to provide you dimensionally accurate Implants.
We have 3 class 10000 Clean rooms & 1 class 100 area, each clean room has separate air handling unit with 2 pre filters of 5 micron and 0.3 micron HEPA filters. Clean room validation is done quarterly includes HEPA filter Integrity test, Air velocity test, differential pressure test, particle count and environment monitoring test by microbiological method. We follow GMP standards. The aim is to provide bio burden & foreign particle free sterile product.
No human interface or error in QC and it is done by computerize Coordinate Measuring machine. It is to measure profile, geometry & dimensional of final product.
We follow ASTM & ISO testing standards for batch release. There are in total 22 types of mechanical, biological & chemical tests. By doing this we can assure the quality of product and if any medico legal condition will be arise then we can protect us & dental surgeon by documented evidences.
We follow 100 sops, 74 documented check points and 22 tests to manufacture a single batch.
- SOP indicates how to perform some task correctly. So human can perform a task correctly without any confusion or human error. We follow more than 100 sops.
2. As per Good manufacturing practice guideline, there are 74 files in that we record our all activities, it is required for Traceability
Clinical follow up is required to prove safety and efficiency of product.
We have adopted best skilled practices in industry and consistently improving our selves.
If you are looking for best clinical results then our product is definitely for you.