The Optimized Path to Pharmaceutical Production
Documented water quality is essential, but many labs can’t move to total organic carbon detection analyzers because they aren’t able to provide secure data that meets 21 CFR 11 controls for platform access.
The ANATEL PAT700 addresses these challenges by providing a single-unit solution for TOC and conductivity monitoring that ensures protocol compliance with its catalog of pre-programmed automated electronic SOPs.
Cell volume, an indicator of cell health, requires diligent attention through bioproduction, but commonly used imaging equipment aren’t sensitive enough to detect volume changes below 10%.
With the Multisizer 4e, sensitive volume measurement using the Coulter principle enables detailed analysis of cell concentration and volume, all while meeting defined standards.
For wide-scale analysis of cell viability and concentration, standard practice relies on a manual, variable process and sacrifices a large volume of cells to ensure sample-to-sample consistency. These methods also preclude the use of 96 well plates.
The Vi-CELL BLU enables rapid, automated cell viability and concentration analysis from single discrete samples as well as from 96 well plates.
Bioproduction workflows stress the importance of bioreactor media analysis, but in-line sensors lack the sensitivity needed to assess media composition changes that may impact cell health and, in turn, expression.
Equipment like the Vi-CELL MetaFLEX can rapidly assess bioanalyte levels in small samples of culture media, letting you know if your cells are growing under optimal conditions.
Clean-in-Place systems are a perennial challenge for laboratories, leading some inventive researchers to use flow-through analyzers for the task. These tend to fail, either due to small final rinse sample volumes or the need for reagent replenishment and recalibration.
The PAT700 enables rapid confirmation that your production vessel is clean and ready to accept a fill.
Air particle limits are a requirement for cleanrooms, but the process for monitoring and documenting them is still manual in most labs, inviting human error, data loss, and the risk for untrained technicians to jeopardize entire studies-worth of logs.
The new MET ONE 3400+ portable air particle counter offers SOP sampling maps and sampling instructions, loaded into the counter itself to create an interactive map to guide the user, reducing errors in manual sampling. Injectable pharmaceuticals must adhere to narrow specifications for a lot to pass. Errors in pass/fail calculations leading to false positives result in batch destruction, losing time and money.
Beckman Coulter Life Sciences offers several options for air quality monitoring devices, each offering secure electronic records straight from the counter and traceability.
Injectable pharmaceuticals must adhere to narrow specifications for a lot to pass. Errors in pass/fail calculations leading to false positives result in batch destruction, losing time and money.
To help minimize missing specification on a given batch of drug, the HIAC 9703+ Liquid Particle Counter provides pre-programmed automated electronic SOPS for testing final drug quality, allowing you to feel confident in your data integrity.
The final step of production control is to monitor the stability of your product across time and different storage conditions. Destructive testing requires the pre-partitioning of dozens of samples for each timepoint and condition, introducing a source of variability.
The DelsaMax series of light-scatter analyzers enables repetitive, non-destructive testing on the same sample over time, avoiding inter-sample variability.
If you’ve had a hard time finding your way to pharmaceutical production control, we hope this map helps get you there sooner.
For more details about pharmaceutical production control, or details on any of the products shown here, please visit www.beckman.com/resources.