Instrument Services Instruments Serviced

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Instrument Services

USD 2678

Pall Corporation offers a comprehensive range of services that provide a convenient and reliable way to assure worry-free instrument operation and minimal downtime. Our instrument services team is comprised of engineers and technical specialists certified in instrument calibration, qualification and repair.

Your local Pall instrumentation service location will assure that your instruments comply with the most recent regulations and that industry best practice is incorporated throughout instrument service life.

Instruments Serviced

Palltronic ® Flowstar Filter Integrity Test Instrument

(all models)

Palltronic AquaWIT System

Palltronic FlowMod Filter Integrity Test Device

Palltronic Flowstar MUX

Palltronic Flow Check Unit

Pallchek™ Rapid Microbiology System

Minim™ II Tangential Flow Filtration System

Instrument Service Categories

Instrument Qualification Services

Repair Services

Preventative Maintenance Agreements

Calibration Services

Instrument Training Courses

Technical Support Services

Service Contracts

Spare Parts

Documentation

Instrumentation Upgrades

1. Instrument Qualification Services

The increasing requirements for accuracy, documentation, and data security have resulted in a wider use of automated test instruments. Use of such instruments must be qualified to ensure that they satisfy both process and regulatory requirements.

Pall provides expert protocols and support for Installation

Qualification (IQ) and Operational Qualification (OQ) of test instruments in GMP compliant environments.

Installation Qualification (IQ) Service

Pall checks all instrument components and documentation.

The suitability of the testing environment and services are also checked if the instrument is qualified on your site.

Operational Qualification (OQ) Service Options

GAMP* Option: GAMP guidelines state that the

OQ of standard instruments can be divided into two parts. The first part requires a completed OQ1 protocol containing extensive qualification studies on a reference instrument. The second part requires performance of a shorter OQ2 protocol on your specific instrument, thus saving time and money.

SAT Option: Alternatively, all OQ tests in the form of a standard system acceptance test (SAT) can be performed on your specific instrument. Customized

SAT protocols can be prepared if required.

Performance Qualification (PQ) Service

Specialists will work with your key stakeholders to develop and customize PQ protocols for you. We will review test standard operating procedures, confirm test parameters, and help you select the proper test methodology. We will also assist with overseeing tests, as requested.

2. Repair Services

Vital to any automated facility is complete confidence in system performance and integrity. Regular servicing helps maintain high standards of accuracy and precision as well as minimizing instrument downtime. Pall provides the user with peace of mind knowing that – in the event of system failure or catastrophic user error – there is a rapid, reliable and economic solution available. Options range from simple repairs, at the cost of parts plus a fixed labor charge, to annual or three-year service contracts with a fixed price.

3. Preventative Maintenance

Preventative maintenance agreements cover the inspection and replacement of valuable system components that are known to experience extreme wear and tear. Moreover, instruments maintained annually experience considerably fewer failures, thus eliminating instrument downtime as well as the need for costly repairs. Options range from one-year to three-year contracts that include preventative maintenance and repair services.

*Good Automated Manufacturing Practice guidelines issued by the

GAMP Forum and ISPE.

4. Calibration Services

Pall strongly recommends that scientific test instruments be calibrated at least once per year to ensure the accuracy of testing. Due to the delicate interior nature of these electronic devices, and the special instruments required for the job, qualified Pall technical personnel should complete this calibration. Pall can provide calibration services on customer sites or at Pall sites. Typically, an automated integrity test instrument can be serviced within five (5) business days if calibrated at Pall. A calibration certificate and instrument service record is always provided.

6. Technical Support Services

Telephone assistance is available. Should you require extensive assistance and the phone is not sufficient, a Pall technician will be available for on-site service calls. If on-site service is required, a standard rate per day or instrument plus travel and expenses are billed to the customer.

7. Service Contracts

Pall offers comprehensive annual and three-year service contracts that cover preventative maintenance, repair, and calibration services. These agreements are designed to provide a convenient way to maintain and prolong instrument operation during and after the initial instrument warranty.

8. Spare Parts

Pall maintains a spare parts inventory for all instruments and devices along with qualified technical support to help select the correct replacement part numbers.

9. Documentation

We offer thorough IQ, OQ, or PQ documentation for compliance with GAMP requirements.

10. Instrumentation Upgrades

Upgrades typically involve the installation of new software.

Charges

Generally, we provide a fixed price quote in advance for instrument services. On repair services involving diagnostics, we will provide an estimated price quote to assist you in budgeting and cost control. The final invoice provides itemized detail on labor and materials.

Part Number Structure

Pall's part number structure is for reference during the ordering process. A Pall representative will assign the specific service part number applicable to your service requirements.

PTS 02 ***

Our international servicing centers are purpose-designed and fully equipped for calibration and repair. All flow and pressure references used are regularly recalibrated against national reference standards. Full traceability and documentation are maintained to the highest standards in the pharmaceutical industry.

5. Filter Integrity Test Instrument Training

Operator Training

Typical attendees are operators, process engineers and supervisors. The training is a four-hour course emphasizing hands-on practice accompanied by classroom lectures on the use of their filter integrity test instrument.

Attendees receive a personalized certificate of training upon completion of the course.

Training can be provided at a customer site or at

Pall Corporation’s Port Washington, New York, facility.

Visit our website for details on this and other training courses from Pall Life Sciences.

Pall Technical

Services

Qualification of

Test Equipment

Type of

Qualification

Typical Part Number PTS02PM, Flowstar Preventive Maintenance Service.

Contact Us

Contact your local Pall representative or email us at biopharm@pall.com to discuss your specific requirements.

Global Expertise... Delivered

www.pall.com/biopharm

United States

1.800.717.7255 toll free (USA)

1.516.484.5400 phone

1.516.801.9548 fax biopharm@pall.com E-mail

Europe

+41 (0)26 350 53 00 phone

+41 (0)26 350 53 53 fax

LifeSciences.EU@pall.com E-mail

Visit us on the Web at www.pall.com/biopharm

E-mail us at biopharm@pall.com

International Offices

Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria,

Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,

Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world.

The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

© 2010, Pall Corporation. Pall, , Minim, Pallchek and Palltronic are trademarks of Pall Corporation.

® indicates a trademark registered in the USA. Filtration. Separation. Solution.

SM is a service mark of

Pall Corporation.

03/10, 3K, UK GN10.3448

USD 2678

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