Biomedical Engineering Reference
In-Depth Information
actions are defined. Each of these requires different skills and tools for effective
storage, retrieval and management of its lifecycle.
1.3 Understanding Bioprocess Data
1.3.1 Data Sources
Processes involved in commercial manufacture of therapeutic proteins are mostly
batch processes that involve process data generated from diverse sources, often
isolated by data ownership across various departments and functions within an
organization. Information regarding a single process batch is located within the
following business systems:
• Batch production record (BPR): A BPR is a record of process execution, pro-
viding a step-by-step account of product-specific processing. BPRs are usually
paper based, but many organizations are adopting electronic BPR systems.
• Log books and operator notebooks: The information within these notebooks and
logs provides important contextual information regarding the chronological
sequence of events, activities, material exchanges, equipment status etc. which
may prove to be vital information in identifying root causes and resolving
process non-conformances.
• Supervisory control and data acquisition (SCADA) system: SCADA systems on
process equipment monitor and control the processes in real time. The system
captures streaming data from the sensors [e.g. temperature, pH, dissolved
oxygen (DO) etc.] installed on this equipment. The raw data are usually stored
within these systems, where the raw data storage format varies for each vendor
supplying the process equipment. Due to limited storage capacity in these
systems and the sheer volume of data generated, organizations sometime deploy
data historians to extract the data from these SCADA systems, and compress
and store the raw data.
• Laboratory information management systems (LIMS): In a pharmaceutical
manufacturing organization, LIMS is typically utilized to capture and manage
information from analytical tests performed on test samples of product inter-
mediates, bulk drug substances and all raw materials utilized in a manufacturing
process. Along with the test results, the LIMS also tracks the logistics of the test
samples (who, what, when, and where) throughout the sample lifecycle. If LIMS
is not deployed in test laboratories inside organizations, this information usually
resides in various spreadsheets and paper test reports.
• ERP systems: An ERP system within an organization captures all supply-chain
and inventory-related information. This is important in providing useful logis-
tics information regarding quality of raw materials, intermediate products and
process equipment. Organizations that do not have an ERP system deploy
manual procedural control, workflow and paper records to achieve this goal.
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