Cleaning and Disinfection Validation Sample Size of 3?

P

Phloogy

#1
#1
I will be outsourcing a cleaning validation study as well as a disinfection validation study for our medical device. AAMI TIR12 and TIR30 both say to use at least three replicates and that three is relatively standard.

From TIR30 7.3.2 -
NOTE—A minimum of three replicates and one concurrent positive control and one concurrent negative control is relatively standard in validation studies.

Why is three called out when it isn’t statistically significant? Wouldn’t we need a lot more considering this is attribute data?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
I think that by "replicates" they mean test groups, not test units, but I don't have these documents in front of me.

It is common to do "3 repetitions" in validation studies, meaning repeating something 3 times (3 batches etc.).
 
P

Phloogy

#3
#3
Ronen E said:
I think that by "replicates" they mean test groups, not test units, but I don't have these documents in front of me.

It is common to do "3 repetitions" in validation studies, meaning repeating something 3 times (3 batches etc.).
Click to expand...
Ronen,
I went back to those standards to verify if "replicate" was defined or what was meant by it. In this case, it appears the word replicate is synonymous to test sample. The standard uses the word sample to indicate what was extracted (e.g. swab sample).

I got a response back from a test lab last night and they have not had any issues with the FDA regarding studies with samples ranging from 3 to 11 while not being statistically significant. I just have difficulty providing a statistical rationale for such a small sample size, unless I don't provide one altogether and cite the standard instead. Thoughts?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Reprocessing, Cleaning, Disinfection and Sterilization Validation EU Medical Device Regulations 4
C Third-party lab needed to validate cleaning & disinfection? EU Medical Device Regulations 12
D Glassware cleaning validation Qualification and Validation (including 21 CFR Part 11) 3
P Cleaning Agents to be Used on Metals & Plastics Qualification and Validation (including 21 CFR Part 11) 1
C Nerve stimulation Implant cleaning services ISO 13485:2016 - Medical Device Quality Management Systems 3
D Preventive Maintenance vs. General Cleaning ISO 13485:2016 - Medical Device Quality Management Systems 2
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
C Cleaning of electronic transmitter Other Medical Device Related Standards 2
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
M Cleaning Process after laser marking on orthopaedic implants Other Medical Device and Orthopedic Related Topics 3
John Broomfield Cleaning plastic from our oceans - The Ocean Cleanup Venture Sustainability, Green Initiatives and Ecology 33
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
E Labware cleaning validation protocol example Qualification and Validation (including 21 CFR Part 11) 1
A Cleaning plastic parts for sterilized medical devices ISO 13485:2016 - Medical Device Quality Management Systems 15
C Documenting Cleaning Production Lines in Medical Device Pkg facility ISO 13485:2016 - Medical Device Quality Management Systems 1
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485 production cleaning requirements of reusable devices ISO 13485:2016 - Medical Device Quality Management Systems 2
P Production Line Pump Cleaning Validation Method Question Qualification and Validation (including 21 CFR Part 11) 0
S ISO 7 and 8 Clean Room Cleaning Other Medical Device Related Standards 2
I Material for PUW used to cleaning Other Medical Device and Orthopedic Related Topics 1
I Implantable medical device cleaning validation Other Medical Device Related Standards 3
S Looking for ISO Class 8 Cleanroom Cleaning Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
O Cleaning API Rotary Shoulder Connections Working Mates exposed to Outside Weather General Measurement Device and Calibration Topics 1
R Cleaning validation for Molding Tools? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
P Best Method of Cleaning of Thread Ring Gages Calibration Frequency (Interval) 5
E Cleaning Validations for Reusable Products - ANSI/AAMI TIR30:2011 Requirements Other Medical Device Related Standards 3
C Small Cast Iron Part Cleaning Manufacturing and Related Processes 7
S Cleaning Fluids and RoHS2 Declaration Requirements RoHS, REACH, ELV, IMDS and Restricted Substances 2
A Cleaning of Medical Device Storage Areas ISO 13485:2016 - Medical Device Quality Management Systems 1
N Using Ozone as a Cleaning Agent in Purified Water Manufacturing and Related Processes 2
R Best Practices in the Control of Cleaning Materials Document Control Systems, Procedures, Forms and Templates 1
W Production Equipment Cleaning Protocol Example Needed Other Medical Device and Orthopedic Related Topics 2
V Standard for Cleaning and Washing Metal Stampings Other ISO and International Standards and European Regulations 2
A Cleaning instructions for our non sterile, single use products EU Medical Device Regulations 6
W Cleanroom Cleaning Agents for cleaning a Class 7 Cleanroom Other Medical Device and Orthopedic Related Topics 9
G ISO 17664 Reusable Low Risk Medical Device Cleaning Other Medical Device Related Standards 2
B Isopropyl Alcohol cleaning of Peek Optima ISO 13485:2016 - Medical Device Quality Management Systems 5
N Seeking information on use of Byotrol Cleaning Chemicals in Pharma Industry Manufacturing and Related Processes 1
S Glass Bead Blast Cleaning Spec TT-C-490 Rev D Various Other Specifications, Standards, and related Requirements 1
L Can I produce Cosmetics and Household Cleaning Products in the same Facility? US Food and Drug Administration (FDA) 4
L Nutritional, Cosmetics and Cleaning Products in Same Facility Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
G Sampling Plan - Sample Size Justification for a Bottling Cleaning Process Validation Qualification and Validation (including 21 CFR Part 11) 2
M Cleaning Resuable Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
I Cleaning Validation for Durapore Tape Cutting Machine EU Medical Device Regulations 2
R Cleaning Validation Protocols for a Pharmaceutical Company Qualification and Validation (including 21 CFR Part 11) 2
S Using 93 % alcohol for cleaning Printer Head Manufacturing and Related Processes 2
E Ultrasonic Cleaning of Orthopedic Implants - Detergents and Frequency - How? Other Medical Device and Orthopedic Related Topics 3

Similar threads

Top Bottom