Offerings include local validation services, educational seminars, and technologies
MEXICO CITY (April 24, 2009) -- Foreign competition and the global economic downturn are placing increased pressure on Mexico’s pharmaceutical manufacturers to speed their times to market. In addition, evolving regulatory requirements are poised to change the way that Mexican pharmaceutical manufacturers do business both domestically and abroad.
At EXPOFARMA INTERPHEX 2009, Pall Corporation (NYSE: PLL) is helping Mexico’s pharmaceutical industry meet these challenges with the launch of its local validation services, available at Pall’s Mexico City validation laboratory, which is a joint effort between Pall Corporation and SIMEX. By conducting their validation tests domestically, Pall’s customers will receive the company’s high-quality, reliable test services while eliminating the risks of global regulatory incompatibilities, shipping times, and customs delays. As a result, companies will be able to bring their products to market faster and more aggressively compete in the global marketplace.
The following two validation tests are available locally to the Mexican market as part of the comprehensive package of services that Pall now offers to Mexico’s pharmaceutical industry:
Compatibility Assessment: ensures that filter cartridges are chemically and physically resistant to process stream, chemical, and operating conditions according to FDA, EMEA, NOM-059-SSA1-1993, and future NOM standards.
Product Wet Integrity Test Value Determination: performed on critical filters immediately before and after batch filtration to ensure filter security.
In addition, Pall Corporation’s Monica Cardona is delivering the following two educational seminars:
Guidelines for the Sterilization of Pharmaceutical Products and Filter Validation Strategies, on Thursday April 23 from 4:00-4:45 p.m. in Montalban Hall. This presentation emphasizes aspects of aseptic processing guidelines beginning with the basic requirements in World Health Organization (WHO) report 32, followed by the international regulations of FDA and EMEA with regard to sterilization, filling, and filtration of sterile pharmaceutical products.
Technologies for Process Optimization and Cost Reduction in Pharmaceutical Product Manufacturing on Friday April 24 from 5:00-5:45 p.m. in Montalban Hall. This presentation defines how the synergistic use of technologies improves drug manufacturing economics.
“Mexico is among the leaders of the Latin American pharmaceutical evolution, and it is critical that its manufacturers are prepared to meet the coming regulatory and market challenges on a global scale,” said Ian Sellick, director of marketing for Pall Life Sciences. “Enabling this market’s growth, including through local accessibility to compatibility assessment and product wet integrity test value determination tests, is a key step in the right direction.”
In addition to the new services and the seminars, Pall is highlighting the following technologies at the event:
The new Pall Stax™ single-use depth filter platform, the most flexible system for demanding pre-filtration and clarification processes in biopharmaceutical applications.
Pall Q and S HyperCel™ ion exchange sorbents, the most advanced chromatography sorbents for processing large amounts of protein during the capture and intermediate steps of purification.
Pall Fluorodyne® EX grade EDT filter, a 0.1 micron sterilizing grade filter designed for high throughput culture media applications that require secure mycoplasma control.
Pall Allegro™ 1000 and 1500 liter 3D biocontainers, which complement the 100, 200 and 500 liter sizes introduced last year and deliver a scalable product line that enhances the performance of Pall’s single-use systems for large-scale biotechnology and pharmaceutical manufacturing applications.
Editor's Notes: For full abstracts of Monica Cardona’s seminars and to schedule an interview with Ms. Cardona or Mr. Sellick at the event, contact Megan Maguire Kelly at 1-610-269-2100, ext. 225 or email@example.com.
About Pall Corporation Pall Corporation is the global leader in the field of filtration, separation and purification. Pall is organized into two businesses: Life Sciences and Industrial. These businesses provide leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, energy, electronics, water purification, aerospace, transportation and broad industrial markets. Total revenues for fiscal year 2008 were $2.6 billion. The Company is headquartered in East Hills, New York and has extensive operations around the world. For more information visit Pall at http://www.pall.com.
Megan Maguire Kelly
(610) 269-2100, ext. 225 firstname.lastname@example.org