Latest Media

KENX to host complimentary webinar on cutting timelines by 50%

This webinar will walk you through a novel solution for early-phase GMP manufacturing, which accelerates phase-appropriate manufacturing through the utilisation of on-demand cleanrooms

Merck webinar: How to avoid cross-contamination during viable active air sampling in cleanrooms

The webinar will cover the essential points of air sampling units for use in high-grade cleanrooms, along with the requirements for the prevention of cross-contamination

KENX to host complimentary webinar

'Setting Cleaning Validation Carryover Limits for Multiproduct Equipment' will be hosted on 19 November, 4pm-5pm GMT

DuPont webinar: Quality Risk Management for cleanroom garment qualification

Steve Marnach, Training expert Protective Apparel EMEA from DuPont Personal Protection division, will host the webinar on 25 November 11 am (CET)

Merck webinar: Environmental monitoring in aseptic isolator manufacturing

Dr Anne-Grit Klees and Tony Ancrum of Merck KGaA, Darmstadt, Germany, are hosting the webinar 'Air Samplers and Media for Biocontamination Control: Environmental Monitoring in Aseptic Isolator Manufacturing' on 12 September

Energy efficiency case study – laboratory EPD compliance

Study to determine what the effect of changing the primary heating fuel from waste heat to natural gas would be on the Energy Performance Certificate rating, and letability of the property portfolio after 2018.

Burkert universal control head delivers cost savings through standardisation

Burkert\'s new Type 8681 control head is ideal for applications on valves used in the hygienic processing industries, where it cuts costs for users by virtue of its ability to be fitted to any manufacturer\'s valves. It has a range of adapters that allows it to be fitted to any actuator currently on the market. It also offers the advantages of easy installation and checking.

Retrofit solution to an expensive conundrum

Bespoke retrofit systems are a cost-effective alternative to upgrading tablet and capsule machinery to cope with higher potency APIs, says PSL

Case study: Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA™ Solution

Paper-based processes still burden most QC micro programs with paper scheduling, lab marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations. These steps are labor-intensive, time consuming, and yield duplication of tasks and high error rates. Amylin, a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines, has successfully implemented MODA™—a paperless QC Micro solution by Lonza. As a result, Amylin is achieving their goal to automate their QC processes and regulatory compliance at their manufacturing facility.

Case study: XOMA's QC Micro Automation Using MODA Solution

Paper-based processes still burden most QC micro programs with paper scheduling, lab marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations. These steps are labor-intensive, time consuming, and yield duplication of tasks and high error rates. XOMA, a proven leader in the discovery, development, and manufacture of therapeutic antibodies successfully implemented MODA™—a paperless QC micro solution by Lonza. As a result, XOMA achieved their goal to automate their QC process for improved environmental monitoring and compliance across their lab and manufacturing operations.

Case study: Paperless QC Micro Implemented by Talecris Biotherapeutics

Paper-based processes still burden most QC micro programs with paper scheduling, lab marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations. These steps are labor-intensive, time consuming, and yield duplication of tasks and high error rates. Talecris, a global biotherapeutic and biotechnology company that discovers, develops, and produces biotherapeutics for people with life-threatening disorders, successfully implemented MODA™—a paperless QC micro solution by Lonza. As a result, Talecris was able to automate their QC process for improved environmental monitoring (EM), utility testing, and product testing.

Case study: Automating QC Micro Processes with MODA™ Platform Improves Efficiency, Ease of Compliance and Costs for Lonza

In 2007, Lonza Walkersville chose to automate the EM program using mobile, wireless and informatics technologies by MODA™—a paperless QC micro solution. The effort was a part of a company-wide Lean Six Sigma (LSS) initiative to eliminate waste, reduce lead and labor time, and improve overall compliance. The MODA™ solution quickly proved successful, giving Lonza the confidence to initiate a global deployment across all of its manufacturing plants. In May 2010, Lonza acquired MODA Technology Partners and added MODA™ as a key component to its product and service offerings.

ImClone Systems Improves Environmental and Utility Monitoring Efficiency and Accuracy with MODA™

Paper-based processes still burden most QC micro programs with paper scheduling, lab marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations. These steps are labor-intensive, time consuming, and yield duplication of tasks and high error rates. ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company committed to advancing oncology care by developing targeted biologic treatments designed to address the medical needs of cancer patients, successfully implemented MODA™—a paperless QC micro solution by Lonza. As a result, ImClone improved the productivity of its QC Analysts, thus reducing the hiring requirements to support the expanded facility – a significant cost savings. ImClone also improved accuracy of the new workflow, giving them a more robust QC operation.

The Gap Between LIMS Capabilities and Environmental Monitoring Needs (White Paper)

While laboratory tests are an important part of environmental monitoring (EM) operations, the EM workflow is complex and the EM workplace presents a unique set of challenges. Commercial Off-The-Shelf (COTS) LIMS products bring a wide range of functions to help automate the analytical laboratory, but struggle to meet the unique challenges of the EM operation. This paper reviews the workflow typically found in EM operations to identify the needs of the EM organization. It matches the capabilities of commercial LIMS to these needs, and discusses the LIMS customizations that would be required to close these gaps. It also discusses two alternative approaches to building an interface between an EM-specific product, such as the MODA™ solution, and a commercial LIMS.

MODA™ Software Version 3.0

View the list of capabilities for the MODA™ solution’s Version 3.0. This release enables quality control (QC) organizations to further automate their regulated manufacturing processes.

Latex or nitrile?

Latex gloves have many advantages for employees working in contamination control environments but there are alternatives. Jaime Cassar, Kimberly-Clark Professional, reviews the options

The Micronclean Big Blue Cleanroom Handbook

Based on 30 years of contamination control experience, a new edition will soon be available

Download a selection of FCSG's here

ILC Dover downloadable PDF\'s

Boldly going into the future

Cavendish Engineers has designed and upgraded cleanrooms for technically advanced clients around the world. Managing Director Steve Allen shares his insight into the future of the cleanroom industry

Customised valve solutions revolutionise steam sterilisation

Steam sterilisation of medical instruments requires a total evacuation of air from the chamber. Bürkert has developed a compact system solution based on an innovative multi-functional block design

Compliance, risk and cost of ownership comparisons for pharmaceutical continuous monitoring

Ken Appel, Manager Regulated Markets, Vaisala, evaluates the different methods and presents the risks and cost of ownership for wired, wireless and standalone monitoring systems

Cleanroom undergarments

Carsten Moschner of Dastex asks whether they are an extravagance or an effective contamination reducer

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Upcoming event

ISPE Singapore

28-30 August 2024 | Conference and exhibition | Singapore See all