Client Testimonials
While in a time pinch and requiring an updated GLP study, I called Gibraltar Labs for a quote. The sales department was very knowledgeable and fast in responding to my requirements and the m... Heather Bell
Koven Technology Inc.
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Koven Technology Inc.
Terms and Conditions
| S.No: | Service Name | Turn Around Time | Sample Quantity |
|---|---|---|---|
| 1. | 1,4-DIOXANE | Varies | Varies |
| 2. | 21 CFR SEC 111.65 (C ) (4) CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS; REQUIREMENTS FOR MANUFACTURING | Varies | Varies |
| 3. | 9 CFR 113.28 MYCOPLASMA TEST | 7 Days | Varies |
| 4. | AAMI METHOD 1/ISO 11137 BIOBURDEN (METHOD I, METHOD 2 AND VDMAX) | 7 Days | 1 Lot of 10 Units |
| 5. | AAMI METHOD 1/ISO 11137 STERILITY (METHOD I, METHOD 2 AND VDMAX) | 14 Days | 100 Units |
| 6. | AAMI ST77 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION | Varies | Varies |
| 7. | AAMI TIR 12:DESIGNING, TESTING AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR DEVICE MANUFACTURERS | Varies | Varies |
| 8. | AAMI TIR 30:A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES. | Varies | Varies |
| 9. | AAMI TIR 33:STERILIZATION OF HEALTH CARE PRODUCTS — RADIATION SUBSTANTIATION OF A SELECTED STERILIATION DOSE — METHOD VDMAX | ||
| 10. | AAMI TIR 37:STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – GUIDANCE ON STERILIZATION OF HUMAN TISSUE BASED PRODUCTS |