Microbial Characterization Report Guide
Thorough characterization of the microbial population in the manufacturing environment allows for rapid and definitive resolution of sterility failures and investigations into excursions. Accugenix offers automated ribotyping utilizing the DuPont Qualicon RiboPrinter® for strain-level characterization of bacterial isolates (BacRib). Characterization is a test utilized for the comparison of organisms below the species level. Isolates are assigned to a RiboGroup (a collection of banding patterns or “fingerprints”) whose similarity is ≥0.90 to a reference pattern. A reference pattern is a composite based on the average data of its RiboGroup members. Every time a sample is tested on the RiboPrinter® system, the RiboPrint™ pattern (“fingerprint”) generated is compared to all existing RiboGroups. If the similarity is ≥0.90 to an existing RiboGroup, then the sample is assigned to that RiboGroup. If the similarity is <0.90, a new RiboGroup will be created.
Section Descriptions
1. Your company name
2. “Ship To” address from your Identification Request Form
3. Unique sample code (C#) assigned by Accugenix
4. Your sample ID, as provided on the Identification Request Form
5. Your 6-digit Account #, followed by a 4-digit alpha-numeric codein ( )
6. Each ID Request Form received with samples has a unique number
7. The due date of your Identification Report
8. Customer code
9. Number automatically assigned by the RiboPrinter®, consisting of instrument, batch and lane numbers
10. Unique C# and Customer Sample ID (R# in this example)
11. Customer code and current RiboGroup assigned
12. RiboPrint™ pattern obtained after digestion with restriction enzymes (EcoRI or PvuII, both are utilized and shown separately)
13. Place holder for additional comments
14. Electronic signatures in compliance with FDA regulation CFR 21 Part 11
