With the growing implementation of single-use bags into commercial production and critical process steps, SUS Integrity (SUSI) has become a critical quality attribute for both end-users, regulatory authorities, and suppliers of SUS, as an integrity failure can significantly impact drug safety, availability, and costs. The ASTM E3244-20 표준 practice on SUSI assurance recommends 품질위험관리 (QRM) and life-cycle approach. This is in-line with the EU GMP Annex 1 for manufacturing sterile medicinal products, proposing a risk assessment for QRM and Contamination Control Strategy (CCS). Thus, depending on customer 어플리케이션 and criticality of a SUSI breach, specific integrity and leak tests may be needed.
In addition to the high-quality 표준 manufacturing process and control, 싸토리우스 offers additional Supplier Integrity Testing (SIT) performed at our manufacturing sites as well as point-of-use leak test (PoU-LT) at end-user’s site. These can be implemented upon request to ensure the relevant level of SUSI in critical process steps.
The assurance of single-use system integrity (SUSI) is the result of QbD, process 밸리데이션, process controls, and integrity testing along the entire product life cycle. For critical process steps, a supplier integrity test (SIT) using helium as a tracer gas can be performed. SIT is available upon request on 2D Flexboy and Flexsafe assemblies, 3D Flexsafe assemblies up to 500L, and Flexsafe Mixers up to 650 L. In addition, the new generation of freeze and thaw containers Celsius FFT/FFTp with Safecore Technology are available in some 표준 configurations tested by SIT. The test is validated to detect defects as small as 2 µm and is performed in-line on 100% of the SUS during manufacturing to ensure the absence of microbial ingress and liquid leak in the intented use-case conditions, such as during storage and shipment of liquid or frozen drug substances or drug products.
Flexboy® 2D bags for Storage | Shipping: 50mL to 50LFlexsafe® 2D bags for Storage | Shipping: 50mL to 50LFreeze and thaw containers Celsius® FFT /FFTp with Safecore Technology
Flexsafe® 3D for Storage | Shipping: 100, 200 and 500LFlexsafe® for Mixing: 50L, 100L, 200L, 400L, 650L
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In a fast, easy and reliable way, an additional 100% PoU-IT reduces the risk of losing high-value product and protects patient and operator by ensuring that no damage would have occurred during shipping, storage, handling or installation of the Flexsafe® or Flexboy® 2D bags. PoU-IT using the FlexAct BT (Bag Tester) Solution with the Sartocheck® 4 Plus Bag Tester, has a validated detection limit of 10 µm.
Explore Sartocheck® Integrity Testing
The well-established Sartocheck® 4 plus Bag tester technology provides a non-destructive leak test for Flexsafe® 3D storage and mixing bags already installed in the Palletank. The unique patented porous spacers perfectly fit the Palletank shape and avoid any masking effect due to direct contact between the bag and its container, assuring the test reliability. Robust 밸리데이션 with a 6-sigma confidence level applied to pressure decay leak test allows to guarantee the absence of leaks with sizes greater than the detection limit post-installation and just prior to filling.
Sartocheck® 4 Plus Bag Tester
Sartocheck® 4 Plus Bag Tester MultiUnit
Flexsafe® STR Bioreactors used in cell culture can also be tested at their point of use, following the same test method principles as for 3D bags and Mixers point of use leak test.
Proven integrity of SUS in drug processing steps improves production costs, drug quality and availability.
The science behind the integrity of single-use systems.
Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing
Flexsafe® 2D and 3D single-use bags are designed to store and transport all bioprocessing fluids.
Celsius® FFT (Flexible Freeze and Thaw) is a unique, single-use bag-in-shell system that replaces traditional freezing and thawing methods.
BioProcess International Special Report
싸토리우스, through its Confidence® 밸리데이션 Services, performs process-specific 밸리데이션 studies considering the SUS 어플리케이션 and the impacts o...
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