- palltronic® Flowstar Filter Integrity Test Instrument (all models)
- palltronic AquaWIT 系统
- palltronic FlowMod Filter Integrity Test Device
- palltronic Flowstar MUX
- palltronic Flow Check Unit
- pallchek 快速微生物系统
- Minim II 切向流过滤系统
Instrument Service Categories
1.仪器确认服务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.
颇尔 provides expert protocols and support for Installation Qualification (IQ) and Operational Qualification (OQ) of test instruments in GMP compliant environments.
Installation Qualification (IQ) Service颇尔 checks all instrument components and documentation.如果在您的现场使用检测仪，则还将检查测试环境和服务的适用性。
Operational Qualification (OQ) ServiceGAMP指南建议，对于标准检测仪的操作认证，供应商测试应纳入认证文档中以减少重复工作。因此，颇尔已将 OQ 分为两部分：
- 第一部分 (OQ1) 包括内含对参考检测仪所做各类认证研究的完整方案。
- 第二部分 (OQ2) 要求对具体检测仪履行精简方案，以节省时间和经济成本。
Performance Qualification (PQ) ServiceSpecialists 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.维修服务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.颇尔 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.预防性维护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.
4.校准服务颇尔 strongly recommends that scientific test instruments be calibrated at least once per year to ensure the accuracy of testing.Due to the delicate nature of the pressure and flow calibration, and the special instruments required for the job, qualified 颇尔 technical personnel should complete this calibration.颇尔 can provide calibration services on customer sites or at 颇尔 sites.Typically, an automated integrity test instrument can be serviced within five (5) business days if calibrated at 颇尔.A calibration certificate and instrument service record is always provided.
我们的国际服务中心专为校验和维修而设计，并配备有全套所需设备。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 Operator TrainingTypical 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 颇尔 Corporation’s Port Washington, New York, facility.Visit our website for details on this and other training courses from 颇尔 Life Sciences.
6.技术支持服务Telephone assistance is available.Should you require extensive assistance and the phone is not sufficient, a 颇尔 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.服务合同颇尔 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.配件颇尔 maintains a spare parts inventory for all instruments and devices along with qualified technical support to help select the correct replacement part numbers.
9.文件材料We offer thorough IQ, OQ, or PQ documentation for compliance with GAMP requirements.
10.仪器升级Upgrades typically involve the installation of new software.
*Good Automated Manufacturing Practice guidelines issued by the GAMP Forum and ISPE.
费用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颇尔's part number structure is for reference during the ordering process.A 颇尔 representative will assign the specific service part number applicable to your service requirements.
Typical Part Number PTS02PM, Flowstar Preventive Maintenance Service.