In advanced apple-pie apartment which accommodated the requirements of all-embracing authorities, the drugs are abounding aseptically into vials or syringes. Source: Boehringer IngelheimStore this angel in big sizeMES by Werum for BioPharma Operations in Biberach (Germany)
Lueneburg, Germany, June 16, 2009 - At its Biberach assembly website in Germany, Boehringer Ingelheim is now accustomed out its antibacterial ample & accomplishment processes and 100% beheld analysis in BioPharma Operations with PAS-X Manufacturing Execution System (MES) software. Boehringer Ingelheim had already been application Werum's MES back 2002 to accomplish biopharmaceutical breath capacity in the better corpuscle ability bulb in Europe. When it started production, this bulb aswell set new abstruse standards.
Maximum Sterility
Specific belief and altitude have to be advised for ample and accomplishment processes. All accordant advice on above-mentioned assembly stages with a cogent aftereffect on the sterility of the accomplished artefact have to be documented, such as casual airlocks, autoclaving, or decontamination. Defined procedures and accomplishment dates accept to be observed. In advanced apple-pie rooms, which accommodated the standards defined by all-embracing authorities, the breath additive batches produced with PAS-X are aseptically abounding into vials or syringes and some are freeze-dried.
A amount of articles are temperature-critical and accept a bound accomplishment date at allowance temperature.The arrangement have to ensure that their accomplishment dates are not exceeded. When the bushing action is complete, all articles are appropriate to abide a 100% beheld analysis afore they are packaged and released.
Filling and Visual Inspection with PAS-X
PAS-X has accurate its account in biopharmaceutical breath additive manufacturing. Now it is aswell acceptable the hub of accessible action ascendancy in ample & accomplishment and beheld analysis operations. The a lot of important MES functions in this across cover MASTER BATCH RECORDS MANAGEMENT, which defines all action specifications, and ELECTRONIC BATCH RECORDING, which is amenable for the absolute beheading processes.
PAS-X ensures that accessories statuses and accumulation or log advice about alone altar are exchanged aural the accumulation chain. In addition, the FINITE SCHEDULING action in PAS-X enables bound planning of processes, and its WAREHOUSE MANAGEMENT action controls all in-company acumen operations.
Integrated System Landscape
PAS-X has fabricated it accessible to accommodate the ample and accomplishment action seamlessly into the IT mural of Boehringer Ingelheim. In particular, this affiliation plan complex the ERP arrangement (SAP), the LIMS arrangement and the systems for aberration and certificate management.
Werum Software & Systems (www.werum.com) is the arch supplier of Manufacturing Execution Systems (MES) for the biologic and bio-pharmaceutical industries worldwide. Fourteen of the world's top 20 biologic companies and arch biotech companies use Werum's MES artefact apartment PAS-X to run their accomplishment business. Outstanding PAS-X appearance are the functions ensuring acquiescence and advocacy performance. Werum's solutions and casework ambit from software consulting, conception of anatomic specifications, and software development to turn-key accumulation of chip and accurate MES. A all-around accomplice arrangement ensures reliable bounded abutment services. Founded in 1969, the IT aggregation employs 315 humans at altered locations. Werum is headquartered in Lueneburg (Northern Germany) and has bounded offices in St. Augustin and Hausach. Its U.S. accessory Werum America is headquartered in Parsippany, New Jersey, and has added offices in Cary, North Carolina, and in Pasadena, California.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com
2009年12月16日星期三
Werum Software & Systems - Rottapharm's Documentation goes paperless with PAS-X
Rottapharm's assembly website in Dublin (Source: Rottapharm)Store this angel in big sizeWerum to bear a anatomic complete PAS-X-based MES
Lueneburg, Germany, September 8, 2009 - The Italian pharma accumulation Rottapharm is introducing PAS-X at its Irish assembly website in Dublin. With the alteration appear paperless assembly and documentation, the bunch aggregation will be authoritative its assembly processes added able and accretion achievement levels. Werum will be implementing a complete PAS-X-based MES, including affiliation with the SCADA level.
Rottapharm articles ethical pharmaceuticals, over the adverse and non-prescription drugs, claimed affliction articles and comestible supplements. The ameliorative focus of the biologic articles is cardiology, gastroenterology, gynecology, urology and rheumatology.
Rottapharm accustomed operations in Ireland in 1999. In Dublin, Rottapharm is advance seven actor Euros in three new accomplishment and associated packaging lines, which will actualize 35 jobs and add 2000 aboveboard meters. The website employs 150 humans in absolute and primarily articles capsule, aroma and book forms of the Glucosamine Sulfate Dona, a biologic for alleviative osteoarthritis. The ability aswell produces the API for Dona.
Werum Software & Systems (www.werum.com) is the arch supplier of Manufacturing Execution Systems (MES) for the biologic and bio-pharmaceutical industries worldwide. Fourteen of the world's top 20 biologic companies and arch biotech companies use Werum's MES artefact apartment PAS-X to run their accomplishment business. Outstanding PAS-X appearance are the functions ensuring acquiescence and advocacy performance. Werum's solutions and casework ambit from software consulting, conception of anatomic specifications, and software development to turn-key accumulation of chip and accurate MES. A all-around accomplice arrangement ensures reliable bounded abutment services. Founded in 1969, the IT aggregation employs 315 humans at altered locations. Werum is headquartered in Lueneburg (Northern Germany) and has bounded offices in St. Augustin and Hausach. Its U.S. accessory Werum America is headquartered in Parsippany, New Jersey, and has added offices in Cary, North Carolina, and in Pasadena, California.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com
Lueneburg, Germany, September 8, 2009 - The Italian pharma accumulation Rottapharm is introducing PAS-X at its Irish assembly website in Dublin. With the alteration appear paperless assembly and documentation, the bunch aggregation will be authoritative its assembly processes added able and accretion achievement levels. Werum will be implementing a complete PAS-X-based MES, including affiliation with the SCADA level.
Rottapharm articles ethical pharmaceuticals, over the adverse and non-prescription drugs, claimed affliction articles and comestible supplements. The ameliorative focus of the biologic articles is cardiology, gastroenterology, gynecology, urology and rheumatology.
Rottapharm accustomed operations in Ireland in 1999. In Dublin, Rottapharm is advance seven actor Euros in three new accomplishment and associated packaging lines, which will actualize 35 jobs and add 2000 aboveboard meters. The website employs 150 humans in absolute and primarily articles capsule, aroma and book forms of the Glucosamine Sulfate Dona, a biologic for alleviative osteoarthritis. The ability aswell produces the API for Dona.
Werum Software & Systems (www.werum.com) is the arch supplier of Manufacturing Execution Systems (MES) for the biologic and bio-pharmaceutical industries worldwide. Fourteen of the world's top 20 biologic companies and arch biotech companies use Werum's MES artefact apartment PAS-X to run their accomplishment business. Outstanding PAS-X appearance are the functions ensuring acquiescence and advocacy performance. Werum's solutions and casework ambit from software consulting, conception of anatomic specifications, and software development to turn-key accumulation of chip and accurate MES. A all-around accomplice arrangement ensures reliable bounded abutment services. Founded in 1969, the IT aggregation employs 315 humans at altered locations. Werum is headquartered in Lueneburg (Northern Germany) and has bounded offices in St. Augustin and Hausach. Its U.S. accessory Werum America is headquartered in Parsippany, New Jersey, and has added offices in Cary, North Carolina, and in Pasadena, California.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com
Werum Software & Systems - Astellas decides to apparatus Werum's PAS-X
Astellas website in Meppel, The NetherlandsStore this angel in big sizeSecond better Japanese biologic accumulation installs PAS-X at its Dutch assembly site
Astellas is implementing PAS-X as an EBR (Electronic Batch Recording) at its Dutch assembly website in Meppel. PAS-X will be set up in Astellas’ biologic debris assembly and packaging departments. The activity includes PAS-X Business Functions Master Batch Records, Electronic Batch Recording, Weighing & Dispensing, Material Tracking, additional KPI functions. In addition, PAS-X is chip in Astellas’ all-embracing IT environment.
Astellas is the second-largest biologic accumulation in Japan with three European assembly sites, the Dutch website in Meppel and two sites in Ireland. The Meppel website was complete in 1995 and broadcast in 2000. It will become Astellas’ avant-garde for implementing an EBR system.
Werum is the all-embracing arch supplier of Manufacturing Execution Systems (MES) for the biologic and biopharmaceutical industries. Its acknowledged and absolute MES artefact PAS-X is installed at 16 of the world’s top 30 biologic and biotech companies. The absolute ambit of functions complete into PAS-X is the key to above and acquiescence and lays the foundation for operational arete initiatives in the accomplishment and packaging of biologic products. The company’s MES-related casework cover consulting, activity management, validation support, arrangement integration, training, maintenance, hotline support, and activity aeon management. The software provider food turnkey, chip and ready-to-be-validated Manufacturing Execution Systems. A all-around arrangement of bounded Werum offices and anxiously called bounded band-aid ally guarantees reliable on-site abutment for clients. Founded in 1969, the IT aggregation currently employs 380 humans at its address in Lueneburg, Germany, and at eight added locations in Germany, France, the United States, Japan, and Singapore.
Werum Software & Systems
Wulf-Werum-Strasse 3
21337 Lueneburg, Germany
Press Contact:
Volker Mensing
Director Corporate Communications
Tel. +49 4131 8900-689
E-mail: mensing@werum.com
U.S. Contact:
Jude Andrade
Director Sales & Marketing
Phone: 973.644.4000 (x28)
E-mail: jude.andrade@werum.com
Astellas is implementing PAS-X as an EBR (Electronic Batch Recording) at its Dutch assembly website in Meppel. PAS-X will be set up in Astellas’ biologic debris assembly and packaging departments. The activity includes PAS-X Business Functions Master Batch Records, Electronic Batch Recording, Weighing & Dispensing, Material Tracking, additional KPI functions. In addition, PAS-X is chip in Astellas’ all-embracing IT environment.
Astellas is the second-largest biologic accumulation in Japan with three European assembly sites, the Dutch website in Meppel and two sites in Ireland. The Meppel website was complete in 1995 and broadcast in 2000. It will become Astellas’ avant-garde for implementing an EBR system.
Werum is the all-embracing arch supplier of Manufacturing Execution Systems (MES) for the biologic and biopharmaceutical industries. Its acknowledged and absolute MES artefact PAS-X is installed at 16 of the world’s top 30 biologic and biotech companies. The absolute ambit of functions complete into PAS-X is the key to above and acquiescence and lays the foundation for operational arete initiatives in the accomplishment and packaging of biologic products. The company’s MES-related casework cover consulting, activity management, validation support, arrangement integration, training, maintenance, hotline support, and activity aeon management. The software provider food turnkey, chip and ready-to-be-validated Manufacturing Execution Systems. A all-around arrangement of bounded Werum offices and anxiously called bounded band-aid ally guarantees reliable on-site abutment for clients. Founded in 1969, the IT aggregation currently employs 380 humans at its address in Lueneburg, Germany, and at eight added locations in Germany, France, the United States, Japan, and Singapore.
Werum Software & Systems
Wulf-Werum-Strasse 3
21337 Lueneburg, Germany
Press Contact:
Volker Mensing
Director Corporate Communications
Tel. +49 4131 8900-689
E-mail: mensing@werum.com
U.S. Contact:
Jude Andrade
Director Sales & Marketing
Phone: 973.644.4000 (x28)
E-mail: jude.andrade@werum.com
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