PORT WASHINGTON, N.Y., April 20, 2010 – Biotech companies and pharmaceutical manufacturers large and small are being forced to do more with less, and are facing ever-tightening financial constraints. That puts additional pressures on dwindling internal resources and staff. But essential tasks such as filter process validation and instrument maintenance are still regulated and required. As companies look to outsource more of these tasks, Pall Corporation (NYSE: PLL) has enhanced the filter process validation and instrumentation services offered through its Scientific and Laboratory Services (SLS) Group. With a focus on its global customer base, the company is making it even easier for customers to do business with Pall.
Pall is creating new training and support materials to ensure a common language with its customers. Standardized qualification and validation documentation, and customized protocols are available. The company is investing in more training for its technical and sales representatives to make Pall more responsive than ever before. By aligning Pall services globally, the company is able to deliver uniform services at all their customer facilities worldwide.
“For more than 40 years we’ve been helping customers assure that product quality, manufacturing processes and regulatory requirements are met under worst-case conditions,” said Sharon Klugewicz, Pall senior vice president for global services. “Our goal is to help our customers keep their facilities online and functioning at peak performance.”
Pall’s SLS group provides filter process validation and instrumentation services in support of R&D, process development, and outsourced and in-house production efficiency. Sample service areas include chromatographic purification, viral clearance, liquid or air filtration, microbiological process monitoring, tangential flow filtration, depth filtration, active ingredient purification and blood processing.
The group’s validation services can help companies meet Food and Drug Administration compliance for current Good Manufacturing Practices (cGMP) in areas including:
Process-specific filter validation;
Filter compatibility assessment;
Bacterial viability/flush testing;
Bacterial or bacteriophage retention studies;
Microbiological challenges with process isolates;
Leachables/migrants analyses; and
Endotoxin and particulate testing.
Pall provides all validation customers with thorough data and test protocol documentation, and scientific rational supporting methodology. Reports are formatted for regulatory submission and target first-time regulatory acceptance.
Pall’s instrumentation qualification (IQ/OQ/PQ) includes calibration, training, troubleshooting and other services that make instrument ownership easy. These include:
Instrument qualification and documentation;
Preventative maintenance and repair (including parts);
Operator training; and
The continuing enhancements to Pall’s Scientific and Laboratory Services are key to the company’s global strategy of working as a partner with the pharmaceutical and biotechnology industries to provide them with a full range of total process management solutions for improved optimization.
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. Pall technologies are also used to collect and process blood components and help protect patients from hospital-acquired infections. The company’s membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics and proteomics markets. Pall is a leading provider of separation systems, and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer, and require less energy and water to produce.
About Pall Corporation
Pall Corporation (NYSE: PLL) is a filtration, separation and purification leader providing Total Fluid ManagementSM solutions to meet the critical needs of customers in biopharmaceutical; hospital, transfusion and veterinary medicine; energy and alternative energy; electronics; municipal and industrial water; aerospace; transportation and broad industrial markets. Together with our customers, we foster health, safety and environmentally responsible technologies. The company’s engineered solutions enable process and product innovation and minimize emissions and waste. Pall Corporation, with total revenues of $2.3 billion for fiscal 2009, is an S&P 500 company with more than 10,000 employees servicing customers worldwide. Pall has been named a top "green company" by Newsweek magazine. To see how Pall is helping enable a greener and more sustainable future, visit www.pall.com.