颇尔 has established a worldwide network of filtration validation laboratories that are staffed with highly trained and experienced scientists and engineers.颇尔 maintains close working relationships with government and industry organizations around the world to ensure that we are up-to-date with the latest GMP1 requirements and industry best practices.
Wherever you are located, 颇尔’s scientific staff is available to provide comprehensive knowledge and expertise to examine unique product and process characteristics and to select the correct test methods and conditions to validate your process.
Our validation programs include thorough documentation of test protocols with issuance of final reports that are ready for regulatory submission targeting first-time approval.
1Good Manufacturing Practices
Filtration Validation Objectives为证明一种过滤器适合某种工艺，应回答以下问题：
- In sterilizing filtration applications, does the product affect microbial retention by the filter?
2Technical Report No.26, Revised 2008:Sterilizing Filtration of Liquids, Supplement to the PDA Journal of Pharmaceutical Science and Technology, Vol 62, No. S-5, Parenteral Drug Association, Bethesda, MD 2008
Filtration Validation PackageFiltration validation packages are tailored to meet customer specific needs and may include some or all of the following:
- Filter Compatibility Assessment
- Bacterial Viability / Filter Flush Testing
- Bacterial Challenge Study
- Generation of Product Wet Integrity Test Parameters
- Bacterial Retention Studies with Process Isolates
Filter Compatibility AssessmentCompatibility testing evaluates filter integrity after exposure to “worst-case” fluid and process conditions.The filter is exposed to the process fluid for a specified period under pre-determined conditions that include:simulated filter sterilization conditions, exposure times exceeding the maximum process time, temperatures exceeding maximum process temperature, and differential pressures that exceed process pressures.
Compatibility is determined by comparing integrity test results using the reference fluid.Tests are performed on the filter prior to and after worst-case exposure.A visual examination for damage or deformation is also conducted.
细菌生存性/冲洗试验许多药物产品具有杀菌性。This test verifies the survival capacity of the organism selected for microbial challenge testing, either in the actual product formulation or a suitable product simulant, for the process time.The appropriate methodology is then chosen for the bacterial challenge study.
Bacterial Challenge StudyThis study qualifies the ability of a filter medium to produce sterile filtrate in the process.A solution of the product or simulant is inoculated with the challenge organism at a concentration > 1 x 107 viable organisms/cm2 of filter membrane area.The challenge is performed on three filter membranes from different production batches, with at least one having a pre-filtration physical integrity test value at or near the filter production limit.
溶出物分析必须得到溶出材料的定量和定性信息。Typically, extractables cannot be evaluated directly in the actual product, in which case a ‘Model Solvent’ approach must be developed.颇尔 validation laboratories use filters tested with the appropriate ‘Model Solvent’ to reproduce a worst-case situation.
过滤器吸附影响评估挑选具有吸附性最低和产品成分损耗量最小的过滤器十分重要。Laboratory-scale filter tests can be used to generate adsorption profiles to help with filter selections and process qualification.
Product Wet Filter Integrity Test Parameters批次过滤前后进行对关键过滤器实施的完整性检测确证性能与规格说明相符。In order to optimize processing, it may be more convenient to integrity test the filter cartridge wet with the product or process fluid.
颇尔 Validation Services establish filter integrity test values for process filtration assemblies wet with process fluid.The values are correlated to a reference fluid-wet value (typically water).
The reference fluid-wet value is correlated to bacterial retention information published in the filter validation guide.Product-wet values are then derived from actual test data, not theoretically calculated values, and correspondingly correlated to bacterial retention.
Bacterial Retention Studies with Process Isolates颇尔 has extensive experience developing customized microbiological procedures to challenge filters using process-specific isolates.开始任何测试前，将提交一份详细说明测试方法和接受标准的方案以供批准。测试完成后，将提供一份包含所有实验数据的综合报告。
颇尔 has a well defined process for two-way, written communications with customers that assures test protocols and timelines are developed to meet the needs of your product, process and regulatory requirements.Once test protocols are established, we provide a fixed price quote in advance for most projects.When changes to original test protocols are required, we work with clients to revise the protocol and provide an amended price quotation.In cases where test results determine next steps, we provide an estimate to assist in budgeting and cost control.
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:PTS01BA2, Bacterial Challenge Study (47 mm discs) using process specific bacteria.