AmpleLogic HPLC Column Management offers users to create an inventory of their HPLC columns. Each Chromatography column listed in the inventory has its own record card for details, performance and history. In addition, related record cards display details on column care, validation tests, storage conditions and restrictions on use.
AmpleLogic QC (Quality Control) automation meets all the standards such as 21 CFR Part 11 compliant from the Food and Drug Administration (FDA United States), EU Annex 11 and also Good Laboratory practice (GLP) and Good Manufacturing Practices (GMP) rules.
Pharma Industry Challenges:
The major problem faced by pharmaceutical companies and labs in column usage is maintaining the continuous updates on cumulative injections and duplicate mapping of the same column for different products at the same time.
HPLC (High-Performance Liquid Chromatography) Columns used in pharma or biotech laboratories may be either an expensive consumable item, or the least expensive component of your HPLC system to replace, but regardless of the cost, they are the most critical component as far as the analysis goes. Currently the analyst doesn’t know what solvents are currently in the column, any buffers in the column and the samples went through the column to ensure it is not contaminated.
Sometimes the column is retired without even using as there is no track on the column and at times using the column which are too old.
AmpleLogic HPLC Colum Usage Tracking Software Features:
- Tracks the record of cumulative injections.
- Individual column booking for the product; expired columns are not displayed for booking.
- Columns are connected to the software for auto generation of column usage time which helps in optimizing the column life.
- When a column is in use, the same column cannot be used or initiated for booking system and it gives an error if we try to book the same column.
- System displays status of column as allotted/not allotted and idle/in use to track this, helps the analyst while selecting the column for analysis.
- When a column retires its status changes to retired column and that column will no longer be available for booking.
- Tracks the solvents and buffers in the column by the previous user.
- System generates notification on washing cycles of the column at assigned intervals.
- Keep track record on column back pressure which is one of the critical factor to monitor while using columns.
- Prints Inventory report, Column Usage report and Audit Trail for reference.
- The benefits offered are to know about the column location, added benefits automated reminders and warnings on the columns usage or early life. It also offers ease of reporting and summarizing, for stock and inventory control.
- Helps in avoiding the confusion caused by the multiple booking of the same column which is common while using excels sheets or registers.
- Notification on washing cycles to prolong the column life.
- Constant observation on column back pressure for better understanding on the performance of the column.
- HPLC Colum Usage Tracking Software records the information that allows verification of history & to locate the location of the product to avoid any non-compliance, which improves the synchronization, visibility & security.