Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR). Other elements for the EBR which also have high data integrity...
Exceptions in batch manufacturing processes are the deviations that occur outside the prescribed specifications. For pharmaceutical and biopharmaceutical manufacturers, quality and manufacturing personnel must review these exceptions. Traditionally, this quality...
We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process...
Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing...
Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything. In batch...
In an earlier post, Managing the Chain of Identity in Cell Therapeutics Manufacturing, we highlighted how the manufacturing process of these cell therapies must be performed with absolute accuracy the first time since each batch is produced for a specific patient....
Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as: …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing...
The pharmaceutical and biotechnology manufacturing industries are challenged with errors in manual entries in the production process, getting batches right the first time, reaching final signoff for batch release, and managing the data accumulated throughout the...
For manufacturers in highly-regulated industries, such as pharmaceutical and biopharmaceutical manufacturing, it is critical to keep track of raw materials as part of the production records. To minimize or avoid waste, it's also important to use the first-to-expire...
Author: Jonathan Lustri I have previously written about a design strategy where the process control system (PCS) is the primary system driving all procedural batch activity within a pharmaceutical process. In this architecture, the PCS ISA-88 procedural model must...
Author: Jonathan Lustri Manufacturing Execution System (MES) Life Sciences projects can be costly and be a challenge to keep in control. The biggest contributor to these challenges are the defining and design of manufacturing workflows. A Workflow is an MES procedural...
One of the trends in the biopharmaceutical industries that have taken root over the past decade and a half is the use of single-use, disposable equipment in the manufacturing process. Prior to their use, these facilities relied on inflexible, hard-piped equipment. An...
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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.