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ODONTIT is a company founded in 1990 having a lab facility that has been authorized by the appropriate authorities. We are in a position to provide your company and your medical devices with Contract Manufacturer services, which are: |
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All this is under a strict confidentiality agreement and in total compliance with GMP (Good Manufacturing Practice), thus guaranteeing a correct traceability of the finished product. For that reason, we have an efficiently trained staff and a Class 1000 clean room. If you think we can be useful to you, please contact us. |
| LIST OF TASKS | ||
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For a better understanding of our services, we will now list the tasks your medical devices could require. |
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| A) | Drawing-up and initiation of Standard Operation Procedures (SOP) |  |
| A.1) | Suppliers | |
| A.2) | Finished-product requirements | |
| A.3) | In-process product specifications | |
| A.4) | Finished-product control and distribution | |
| A.5) | Record, accuracy and content of labels | |
| A.6) | Computer-made tags and labels | |
| A.7) | Special-equipment identification and qualification | |
| A.8) | Special-equipment preventive maintenance service | |
| A.9) | Treatment of preproduction-parts | |
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| B) | Drawing-up and initiation of Shop Orders | |
| B.1) | Assembling | |
| B.2) | Packaging | |
| B.3) | Labeling | |
| B.4) | AutoCAD generation of assembly drawings and labels | |
| B.5) | Instructions for use | |
| B.6) | Sterilization | |
| B.7) | Quality Controls: receiving, in-process and finished product | |
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| C) | Validations | |
| C.1) | Of assembling and packaging processes | |
| C.2) | Of sterilization process: | |
| 1) Dose Determination | ||
| 2) Dose Mapping | ||
| C.3) | Of packages | |
| C.4) | Of Sterile-Barrier Integrity | |
| C.5) | Final validation report (of each validation required) | |
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| D) | Short- or long-series production | |
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