Consulting Services
Biopharmaceutical filtration, separation, and purification systems, when correctly designed and installed, should operate successfully without problems. Even the best biopharmaceutical systems, however, may be affected by unpredictable events such as variations in the quality of process fluid or environmental factors - and often at the most critical time. Such events can result in costly down-time or even loss of a product batch. In addition, continuous improvement is a necessary requirement today, with increasing pressure on process efficiency and costs. Whether your needs are for troubleshooting or process improvements, Pall Life Sciences' specialized advice and troubleshooting experts can bring significant benefits and cost savings to your biopharmaceutical projects.
Introduction to Our Consulting Services
- Our biopharmaceutical specialists provide the best available professional advice to ensure a rapid and effective consultation.
- We have state-of-the art equipment to assist in problem solving and process monitoring.
- Our worldwide laboratories offer analytical services for the widest range of fluids.
- Our biopharmaceutical specialists can visit your site to review the process in more detail and to perform studies locally.
- We can develop with you intranet/internet systems to assist troubleshooting and information exchange.
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Features & Benefits of the Consulting Services
- An approach to troubleshooting that is quick and cost-effective
- A unique biopharmaceutical consultancy service that can achieve improved process efficiency and cost savings
- A global capability that ensures local support when and where you need it.
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Typical Projects
- Biopharmaceutical plant filtration surveys
- Improved life of filtration system
- Investigating non-sterility in a sterile filtration process
- Evaluation of integrity test methodology
- Variable product activity after purification
- Poor separation of protein components
- Reduction of endotoxin contamination in final product
- Malfunction of control sensor in process
- Improved steam-in-place procedures
- Filter steaming process validation
- Scale-up of processes
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Biopharmaceutical Consulting Capabilities & Resources
Laboratories
We maintain over forty well-equipped laboratories worldwide to help solve your filtration, separation, and purification problems.
People
We are a network of more than four hundred trained scientists within Pall as well as links with many specialists in
biopharmaceutical industry and academia.
Equipment
Our equipment includes scanning electron microscopy, HPLC, mass spectrometry, TOC analysis, FTIR spectroscopy, GC, filterability kits, integrity test instruments and many more.
Databases
We maintain a comprehensive range of internal databases for troubleshooting. We also subscribe to external databases to ensure the broadest capability and fastest response.
Communications
We operate a Lotus Notes and Intranet system to ensure fast and efficient communications worldwide, twenty four hours a day.
Documentation
- Our biopharmaceutical consultations are fully documented in the form of a technical report.
- This report can be of special importance in regulatory audits and in management of change control. The report can be prepared to your specific format, if required, to maintain consistency within your documentation.
- In all cases, the report will be reviewed, approved and signed by the Pall specialist. You may choose to countersign the document as confirmation of receipt and acceptability of content.
- Our aim is to ensure not only that your problems are resolved or processes improved, but that the investigations are fully documented and comply with appropriate manufacturing practices.
- If required, we will present a summary of the report in a formal meeting with you.
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Consulting Service Charges
- The variable nature of biopharmaceutical troubleshooting and consultancy work means that we have to assess projects individually.
- Wherever possible, we provide a fixed price in advance.
- Where this is not possible, we will give an estimate to assist you in budgeting and cost control.
- The final invoice gives details on items such as labor and materials.
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Ordering Information
Contact your local Pall representatives, or contact Pall at 800-717-7255 or
biotech@pall.com. We will contact you todiscuss your specific requirements and forward your enquiry to Pall biopharmaceutical consultancy specialists.
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