FlexAct BT (Bag Tester) Service November, 2015

Transcription

1 FlexAct BT (Bag Tester) Service November, 2015

2 Agenda Introduction Installation Qualification & Operational Qualification Performance Qualification & Operator Training 4 Product Configurator 5 Liabilities

3 FlexAct BT Point-of-use leak test for Flexboy 2D bags from 50mL to 50L. Pressure decay leak test method with Sartocheck 4 plus Bag tester. Constrained plate test method and porous spacers with FlexAct BT. Safe, Fast & Easy, Reliable and Easy-to-Validate leak test system at customer production facility to enhance assurance of Single-use Container Closure Integrity

4 Restraining Plate Flexboy Restraining Plate FlexAct BT Bag Tester Description FlexAct BT with Sartocheck 4 plus Bag tester & MultiUnit Inside Filter holder Restraining plates Weight: 375kg (826 lbs) Porous spacer

5 FlexAct BT Services: IQ, OQ, PQ, Operator Training Full certified documentation provided with evidence that the process is validated with qualified equipment 100% traceable documentation right from the beginning Compliance with cgmp requirements On-site training of the operators to ensure correct use of FlexAct BT

6 Agenda 1 Introduction 2 3 Installation Qualification & Operational Qualification Performance Qualification & Operator Training 4 Product Configurator 5 Liabilities

7 Installation Qualification (IQ) / Operational Qualification (OQ) Process validation prerequisite: any equipment needs to be qualified by an installation and operational qualification Sartorius service experts provide GLP/GMP compliant device qualification for the Sartocheck 4 plus Bag tester and for the FlexAct BT The IQ/OQ documentation can easily be included in existing Quality Management systems Seite 3

8 Agenda Introduction Installation Qualification & Operational Qualification Performance Qualification & Operator Training 4 Product Configurator 5 Liabilities

9 FlexAct BT Performance Qualification FlexAct BT Performance Qualification Based on the robust validation protocol used to determine the test parameters and specifications for the detection of a 30µm leak in a Flexboy 2D bag Test Reproducibility: three non defective bag samples tested three times to demonstrate the capability of the system to reproducibly achieve a leak test result within test specifications Test Sensitivity: a 30µm master leak used to deliberately create a calibrated leak on three conform bag samples and to establish the capability of the system to detect bag leak test failures

10 FlexAct BT Performance Qualification (PQ) Responsibility The Performance Qualification is performed after the Installation Qualification and the Operational Qualification A certified Fluid Management Technologies (FMT) Application Specialist (AS) is in charge of performing the PQ The AS fills in a Request For Quotation (RFQ) for the creation of the Flexboy, designed and validated for the FlexAct BT leak test system Customer places an order for the PQ test samples using the ETO (Engineered to Order) quotation process

11 Flexboy Bag Designs and Samples for PQ If existing bag: the design will have to be modified via ETO to add the filter test line (connection to the bag tester to keep sterility) If non existing bag: the design will have to be created via ETO based on leak test design rules An order has to be placed for 3 sterile PQ bag samples via ETO IN PQ will guarantee the system functionality to leak test Flexboy 2D bags Final connection Final connection scope of the PQ for the 30µm leak detection Filter Test Line During PQ, the AS will train and certify the operator(s) for the best use of the Flexboy bag leak testing on the FlexAct BT system

12 Agenda Introduction Installation Qualification & Operational Qualification Performance Qualification & Operator Training Product Configurator 5 Liabilities

13 FlexAct BT Product Configurator The FlexAct BT system is quoted via the Product Configurator: add the link to the PC Fast and easy quoting configurator to ensure all pieces needed for the system are included IQ, OQ, PQ mandatory and systematically included in the quotation Assurance of complete system delivery in 8-10 weeks upon receipt of order FlexAct BT (Bag Tester) Sartocheck 4 Plus Bag tester & MultiUnit

14 Agenda Introduction Installation Qualification & Operational Qualification Performance Qualification & Operator Training Product Configurator Liabilities

15 FlexAct BT Liabilities The FlexAct BT must be operated by operators trained and certified by Sartorius Stedim Biotech IQ, OQ, PQ and training must be performed by a Sartorius Stedim Biotech (SSB) Service person for IQ and OQ and by a SSB Application Specialist (FMT) for PQ and operator training A claim is raised when the test set up fails 2 times: First fail: the connection to the Sartocheck 4 plus Bag tester must be visually checked and test to be performed a second time Second fail: a claim must be filled in and sent to SSB with the bag sample for investigation The certified operator must be identified in the claim

16 Thank you for your attention Any questions?