Stability Test linked to Limulus Amebocyte Lysate (LAL) Testing?

E

Ethan Loh

#1
Hi,

Does anybody know about any stability test which link to Limulus Amebocyte Lysate (LAL) Test?

I know it is all about sterility testing only. Can anybody help?
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#3
Hi,

Does anybody know about any stability test which link to Limulus Amebocyte Lysate (LAL) Test?

I know it is all about sterility testing only. Can anybody help?
Hi Ethan.
The LAL testing concerns to the endotoxin limits in a solution or for a product after the extraction from it into a solution.
We have the same LAL tests done on our pure water which corelates well with the pooled endotoxin test of the medical devices that are subjected with this water during the calibration, leak test and final cleaning process. This is a sort of stability test for our pure water system performance.
Sterility concerns to distruction of bacteria while LAL test concerns to level of dead bacteria shell of the gram negitive which in excess to some limit is disease causing
 
Thread starter Similar threads Forum Replies Date
M Electrosurgical Electrodes - Stability Test Other Medical Device Related Standards 1
S Stability test - primary packaging EU Medical Device Regulations 7
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
C How to Quantify Significant Change for a Shelf Life Stability Test Other Medical Device Related Standards 15
V For an MDI, is leak-test a stability parameter ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Drug product physical properties stability studies - which properties to test? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S Calculate expiration date of a product by studying stability test Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D What is the acceptance criteria/requirement for Stability Study? General Measurement Device and Calibration Topics 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
G Accelerated stability of medical devices Other Medical Device Related Standards 1
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
S Stability accelerated vs. real-time Other Medical Device Related Standards 3
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
V System suitability or stability during continuous usage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
F Extension of a stability study for an API Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
A Accelerated Stability Studies - Class III Medical Gloves Other Medical Device and Orthopedic Related Topics 1
ernieto On going Stability for IVDs Other US Medical Device Regulations 5
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N Sampling for stability studies - Class II surgically invasive devices Other Medical Device and Orthopedic Related Topics 1
K Food Shelf Life Stability Study Statistical Analysis Tools, Techniques and SPC 1
C IQ and OQ for a "Dormitory" Refrigerator - Temperature Stability Qualification and Validation (including 21 CFR Part 11) 4
R Holding time stability study of intermediates of drug substances US Food and Drug Administration (FDA) 2
L MSA - Stability - Part of our PQ (performance qualification) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Sample Size for Stability Testing Other Medical Device and Orthopedic Related Topics 2
E EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagents ISO 13485:2016 - Medical Device Quality Management Systems 2
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
P Specification and Tolerance in Stability Control Chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
P The correct way to do a Linearity and Stability Study on a Critical Dimension Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
M How to provide Stability Study for micron-precision tool Misc. Quality Assurance and Business Systems Related Topics 2
R Convincing Management Cpk without Stability is Meaningless Capability, Accuracy and Stability - Processes, Machines, etc. 7
M A question on Measurement System Analysis - Stability to measure got Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Drug Stability Data at the time of Filing US Food and Drug Administration (FDA) 3
V Can we apply bracketing & matrixing simultaneously for stability studies @ ICH Q1D US Food and Drug Administration (FDA) 1
M Ownership of Pre-Clinical cGMP Stability Testing Other Medical Device and Orthopedic Related Topics 2
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
B How to Demonstrate Stability and Repeatability in very Short Run Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
J How do you perform a S3 Stability Study for a Non-Replicable Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Company-wide MSA - Measurement Equipment Bias, Linearity & Stability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
V ICH - Stability studies, alternate conditions... Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Stability of the Process vs Improvement during Auditing General Auditing Discussions 8
B Interpretation of Stability Study Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Bias, Stability, and Linearity studies required by TS 16949 7.6.1? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
I Statistical Stability for the PQ of Analytical Equipment Qualification and Validation (including 21 CFR Part 11) 1

Similar threads

Top Bottom