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Filter integrity tester Integtest V6.5
Filter Integrity Tester —— Integtest seriesDongguan Puno Filter Integrity Tester Integtest series are special instruments of integritytesting for sterile filtration membrane and filter system, where the testing method and instrumentdesign fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.◎ Regulatory requirements1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterilefilter on the test method, where the commonly used methods include bubble point test, diffusionflow test or pressure holding test. GMP regulates that the test is required after the use of sterilefiltration. EP regulates that the test is required before and after the use, and at the same time EPregulates that the critical gas and air filter must be confirmed after use, while other filters must betested on a regular basis.2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article310, two appendices of Computerized System and Confirmation and Validation are now issued,as the supportive documents for Drug Manufacturing Quality Management Standard (revised in2010), effective as of December 1, 2015.3. The requirements for electronic records and electronic signatures as specified in 21 CFRPart 11. -
Filter integrity tester Integtest V8.0
Filter Integrity Tester —— Integtest seriesDongguan Puno Filter Integrity Tester Integtest series are special instruments of integritytesting for sterile filtration membrane and filter system, where the testing method and instrumentdesign fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.◎ Regulatory requirements1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterilefilter on the test method, where the commonly used methods include bubble point test, diffusionflow test or pressure holding test. GMP regulates that the test is required after the use of sterilefiltration. EP regulates that the test is required before and after the use, and at the same time EPregulates that the critical gas and air filter must be confirmed after use, while other filters must betested on a regular basis.2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article310, two appendices of Computerized System and Confirmation and Validation are now issued,as the supportive documents for Drug Manufacturing Quality Management Standard (revised in2010), effective as of December 1, 2015.3. The requirements for electronic records and electronic signatures as specified in 21 CFRPart 11. -
Filter integrity tester Integtest V8.0
Filter Integrity Tester —— Integtest seriesDongguan Puno Filter Integrity Tester Integtest series are special instruments of integritytesting for sterile filtration membrane and filter system, where the testing method and instrumentdesign fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.◎ Regulatory requirements1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterilefilter on the test method, where the commonly used methods include bubble point test, diffusionflow test or pressure holding test. GMP regulates that the test is required after the use of sterilefiltration. EP regulates that the test is required before and after the use, and at the same time EPregulates that the critical gas and air filter must be confirmed after use, while other filters must betested on a regular basis.2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article310, two appendices of Computerized System and Confirmation and Validation are now issued,as the supportive documents for Drug Manufacturing Quality Management Standard (revised in2010), effective as of December 1, 2015.3. The requirements for electronic records and electronic signatures as specified in 21 CFRPart 11. -
filter integrity tester
Integtest ® Serials Integrity Tester are designed for testing integrity of filters and filter systems . The test meet to verify the sterilizing filter in the FDA, the State Pharmacopoeia and GMP specification requirements. The V4.0 Integrity Tester is compact, handy to use, and fully automated integrity test instrument, which performs bubble point, diffusion flow, enhanced bubble point, and water-based test for hydrophobic filters.The first domestic launch of integrity test for waterbased test for hydrophobic filters to meet different customer needs.
