Introduction
This document is the second issue of CALIBRATION WORLD for 2007, published by Beamex, focusing on calibration in the pharmaceutical industry. It includes a message from Raimo Ahola, Managing Director of Beamex Group, highlighting the company's achievements and new product introductions.
Calibration in the Pharmaceutical Industry
The pharmaceutical industry requires stringent calibration processes due to their direct impact on human health. Regulatory bodies enforce strict guidelines to ensure product integrity and safety. Calibration is crucial for maintaining product quality, and documentation is essential for verifying proper calibration.
Manual vs. Electronic Documentation
Traditionally, calibration documentation was manual, leading to potential errors. Electronic documentation systems, like Beamex's CMX software, offer automated solutions that reduce human error and improve efficiency. These systems comply with regulations such as 21 CFR Parts 11 and 211, ensuring secure and traceable records.
Calibration SolutionsBeamex offers various calibration solutions, including the MC5 Multifunction
Calibrator and CMX Calibration
Management Software, designed for use in pharmaceutical environments. These tools facilitate efficient calibration management, integrating with systems like SAP/R3 and Maximo.
Calibration Frequency
Determining the calibration frequency involves considering factors like uncertainty needs and stability history. International standards require documented calibration programs, and Beamex provides guidelines for establishing suitable calibration periods.
Conclusion
Automated electronic calibration systems enhance efficiency and accuracy in the pharmaceutical industry. Beamex's products and services are tailored to meet industry standards, ensuring safe and effective calibration processes.
Calibration Management and Optimization
Calibration management involves balancing the costs of recalibration against the risks of out-of-tolerance situations. In critical applications, such as pharmaceuticals, frequent calibration is recommended due to high risks associated with out-of-tolerance conditions. Factors influencing calibration frequency include measurement uncertainty needs, equipment stability history, manufacturer recommendations, and the significance of measurements.
Case Study: Eli Lilly and Company
Eli Lilly's Speke plant in the UK performs over 11,000 calibrations annually using Beamex equipment. Calibration is crucial for ensuring product quality and compliance with international standards. The plant uses the Beamex MC5 Multifunction Calibrator for its accuracy and multifunction capabilities, aiming for a paperless calibration system.
Beamex Calibration SolutionsBeamex offers a range of calibration solutions, including
portable calibrators, workstations, and calibration software. The MC5 Multifunction Calibrator is highlighted for its accuracy and robustness. Beamex's CMX calibration software family includes CMX Light, Professional, and Enterprise, catering to different company sizes and needs.
Customer Feedback and Expansion
A customer survey revealed high satisfaction with Beamex products, particularly in measurement accuracy and reliability. Beamex has expanded its operations in the USA with new offices in Texas and the Northeast to enhance sales and customer service.
Company Background
Sarlin, the parent company of Beamex, celebrates its 75th anniversary. Founded in 1932, Sarlin has grown into a group of companies, with Beamex being the most international. The company focuses on long-term development and customer satisfaction.
Introduction of New Director
Alex Maxfield has been appointed as the Director of Beamex Limited in the UK. With 18 years of experience in instrumentation and sales, he is expected to enhance Beamex's presence in the UK, one of the three countries where Beamex operates, alongside Finland and the USA.
Control Magazine Recognition
Beamex achieved 3rd place in the 'Portable Calibrators' category in Control Magazine's 2007 Readers’ Choice Awards, marking a significant achievement for the company in the US market.
Upcoming Events
Beamex will be exhibiting at various international events throughout 2007, including Offshore Europe in the UK, Automaatio 07 in Finland, and Emerson Exchange 2007 in the USA, among others.
AMS Instrumentation & Calibration Pty Ltd
An interview with Dirk Kuiper, General Manager, highlights AMS's expansion in Australia and its partnership with Beamex to provide comprehensive calibration solutions.
Beamex Products and Services
Beamex offers a wide range of calibration solutions, including portable calibrators, workstations, calibration software, and professional services. Their products are available in over 60 countries through a global partner network.