Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)

Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)
•Void, gap, crack, hole, porosity or breach in a container closure system allowing the passage of microorganisms
•Main factor that affects critical leak size is whether or not the micro-leak is filled with liquid: microorganisms penetrate a liquid filled defect by motility or pressure differentials
•Still a lot of controversy discussions about the leak size at which the sterility may be jeopardized
–10 μm for fused silica capillary (Burrel, 2000)
–50 μm for channel leaks (Yam, K. 1995)
–0.4 μm Glass Micro-Pipettes (Kirsch, 1997)
–4 μm pinhole in steel plate (Morrical, 2007)
–20 μm OD Wire (Morrical, 2007)

Integrity performance assessment of a closed system transfer device syringe adaptor lock as a terminal closure for Luer-Lock syringes

Integrity performance assessment of a closed system transfer device syringe adaptor lock as a terminal closure for Luer-Lock syringes
To investigate the container closure integrity of a closed system transfer device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK National Health Service (NHS) Pharmaceutical Quality Assurance Committee (PQAC) requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored before use, as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination close system/Luer-Lock syringe containers at syringe sizes of 1 mL, 20 mL, and 50 mL.

A case study for seal quality and container closure integrity testing across the life cycle of sterile products

A case study for seal quality and container closure integrity testing across the life cycle of sterile products
•USP is a major update and a gap assessment is recommended between it and the current way of working
•A case study was presented for the following:
Building a strategy for closing gaps and mitigating risks
Rationalizing CCIT and seal quality methods as part of the quality assurance with a scientific- and risk-based approach
Applying various test methods across the product life cycle for specific CCS formats

Introduction to CCI Testing for Freeze-Dried Products

Introduction to CCI Testing for Freeze-Dried Products
Ability of a container closure system (CCS) to maintain the sterility and product
quality of sterile final pharmaceutical, biological, and vaccine products
throughout their shelf-life.
CCI strategy includes different steps:

Qualification of CCS

QC sampling (Microbial Ingress Test, Blue Dye Test,…) as release
testing

QC stability testing (testing at expiry)

100% routine testing

How the adoption of Single Use systems (SUS) improves Safety, Efficiency and Flexibility of Final Filling Processes

How the adoption of Single Use systems (SUS) improves Safety, Efficiency and Flexibility of Final Filling Processes
Industry Challenges
Single Use Systems (SUS)for Final Filling operations
How SUS Improves Safety, Efficiency and Flexibility
SUS Supplier approachto enhanceprocesssafety