CAPA-012917
This machine was identified as a root cause for the knot tensile performance issue within the PDS Clear 2-0/3-0 product due to insufficient maintenance.
What is Rackwinder?
This system uses laser technology for raw material verification and identifying unknown substances.
What is the RAMAN system?
Many people think there’s only one lab at this location, but there are actually this number of labs.
What is five?
How fast does it take for NearIR to identify material?
Within seconds
What was the assessed risk level from a regulatory and quality management system perspective regarding the identified issue?
What is Medium?
In the past year, the RAMAN system validated this number of materials.
What is 43?
This lab conducts raw material inspection at the dock and distributes samples across the plant.
What is the Receiving/Inspection Lab?
Has this device been validated in the lab?
No, it is still undergoing validation.
Which line showed a slightly higher tensile strength, elongation, and knot tensile strength overall, across both Clear PDS sizes 2-0 and 3-0?
What is Line 3?
The RAMAN system can measure materials through this type of packaging, including foils and glass vials.
What is (semi-)transparent packaging?
In this lab, finished sutures are tested for qualities such as tensile strength, knot integrity, and elongation.
What is the Physical Lab?
This device can identify materials even through containers made of these two substances.
What are plastic and glass?
The assessment concluded that there was no need to update this procedure for clarity on sampling processes.
What is PS104-020?
The RAMAN system has reduced paperwork and time investment by shifting from this technology.
What is FTIR?
This lab operates independently and tests for bacteria, endotoxins, and particulates.
What is the Micro Lab?
RAMAN & NearIR can both analyze materials without opening or removing them from their packaging, such as glass vials and plastic containers.
What is measuring through packaging?
This factor was identified as a contributing cause alongside equipment maintenance issues.
What is application error?
By allowing scanning of materials directly on this, the RAMAN system aims to eliminate lab-based testing.
What is the spool?
Dermabond, raw material, and chemical suture tests, including dye and color fastness tests, are conducted in this lab.
What is the Analytical Lab?
What factors help maximize mobility of the NearIR?
1. Lightweight
2. Portable
3. Battery Power