Quality Assurance and Quality Control
Proligo Reagents are manufactured under a strict quality system. All key intermediates controlled with stringent in-process controls and/or quality specifications in order to exercise maximum control on final product quality.
In-process controls are established for critical parameters and manufacturing processes are constantly monitored and routinely reviewed. A dedicated process technology group provides the basis for continuous improvement.
SAFC Hamburg has several years of experience supplying pharmaceutical and diagnostic industries, including and history of successful site audits. The change control and notification program through all the manufacturing steps, supports our industrial customers who have validated our reagents as raw materials in their process.
|
ISO 9001 QM system since 1993 |
|
Consistently high quality of products |
|
Traceability of all processes |
|
Continuous process improvement |
| Certificates of Analysis |
|
Product data RP HPLC, NMR |
|
Tests performed on bulk product |
|
UV/VIS base identity test performed on finished good product |
All products are stringently tested for purity and identity against set specifications.
| State of the art analytical methods |
|
RP & SAX HPLC |
|
LC-MS |
|
NMR (31P, 1H, 13C, 19F) |
|
Nucleic acid synthesis test |
|
FT-IR |
|
Titration & "Wet Chemistry" |
|
UV/VIS |
|
Karl Fischer water analysis |
|
Mercury porosimetry |
To order or speak with a Customer Service Representative,
contact your local SAFC office.
|
|
|
