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PAS-X Full Scope Packages
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| The best MES for biopharmaceutical and fine chemicals API Production |
 download Prospect
(pdf, 677 KB)
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PAS-X BIOTECH is a state-of-the-art Manufacturing Execution System for the biopharmaceutical
and fine chemicals production of APIs (Active Pharmaceutical Ingredients)
in the biopharmaceutical industry.
As a Full Scope Package, PAS-X BIOTECH, with its comprehensive array of business functions,
offers the complete range of features for
reliable, fast, and cost-effective biopharmaceutical production procedures.
PAS-X BIOTECH meets all the very specific requirements involved in this particular area of process engineering
and manufacturing in the most appropriate way. PAS-X BIOTECH meets these demanding requirements and creates the
basis for paperless production by means of Electronic Batch Recording (EBR). The system ensures compliance with
21 CRF Part 11 rules for the handling of electronic records and electronic signatures (ER/ES), and guarantees
safe and reliable archiving of process data.
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| Biopharmaceutical Manufacturing Processes |
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Source: Boehringer Ingelheim |
The production of active pharmaceutical ingredients is based on technically demanding
biochemical fermentation processes and has to meet stringent validation requirements.
In any processes involved, high procerss safety is a key factor in complex process
descriptions, such as inoculum, fermentation, purification, or filling. This is
achieved by integrating special quality management procedures which enable objective
approvals within a short time and ensure process data documentation in compliance with
GxP/FDA. It is particularly important to detect deviations as early as possible, and so
avoid harmful effects on the production process which could cause delays of several days
or even weeks.
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Apart from automated production processes, biotechnological API production also requires the integration of manual
workflows. In this context it is vitally important to guide the user in a reliable and accurate way through the
process. These manual workflows must also comply with cGMP/FDA documentation requirements. |
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| Supporting Manufacturing Processes in the Fine Chemicals Industry |
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PAS-X can, due to its modular structure, also be used to produce APIs for the fine chemicals
industry. Special recipe functions allow for direct integration with all leading DCS/SCADA
systems, which Werum, as an independent MES supplier, also supports in heterogeneous automation
landscapes. This flexibility is the basis for your global MES strategy: You can fulfill
site-specific automation requirements, as well as those related to DCS and SCADA systems
whilst, at the same time, standardizing to MES Level 3 (according to ISA S95).
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| Vertical Integration |
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Since process engineering in biopharmaceutical and API production is characterized by
a high level of automation involving complex automation systems to control processes,
an integrated overall approach is required. This approach should be based on the vertical integration of ERP
level and automation level. The aim of this concept is to manage the administration of manufacturing
specifications, control in-plant material flows, manage master batch records, generate control recipes,
and ensure their downloading to the process control and automation level in an integrated way.
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| Recipe Management: Centralized Graphic Generation of Recipes |
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The META recipe model describes the full process for bulk production of a biopharmaceutical product. META recipes include all the recipes required, from the first fermentation step through to the last, as well as corresponding recipes for producing media, their processing, final purification, and drying.
The recipe control functions of PAS-X BIOTECH cover comprehensive process engineering and control functions
- for n steps of fermentation/manufacturing
- for CIP/SIP procedures
- for operating MES and DCS/SCADA systems
- providing flexible user prompting, e.g. by means of mobile workstations/terminals
- providing complex material flow management, e.g. with pipelines, containers, reactors
- for cGMP/FDA-compliant documentation.
The MES administers the recipes centrally and downloads them to the DCS and SCADA systems as required. In addition, PAS-X BIOTECH is able to distribute recipe building blocks flexibly to process levels, as required by the applied automation systems.
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| Order and Material Flow Management |
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Integration of material flow management into the process workflows
is of utmost importance. Approximately 70-80 sub-formulas are required
to produce finished product batches, e.g. for the media which are to be
manufactured. In this context, PAS-X BIOTECH takes charge of order
control and the administration and labeling of any materials involved
in the production process. The system provides "where-used" lists for
batch input materials, administers materials down to transport container
level and takes into account special requirements such as the
administration of silos or tanks. This function is particularly
relevant if automated processes are combined with manual user
inputs, manual activities, or manual adding of material.
PAS-X BIOTECH coordinates and controls the interaction
between users and automation systems. Material
identification and verification are facilitated
by the system, since operators can work with mobile
data acquisition devices or workstations, and are
guided through the required operations by the system.
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Source: Boehringer Ingelheim |
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Biopharmaceutical Manufacturing Processes