SBS - The Best Value in QMS software

Best Practices - small volume medical device tube cutting (0.020" to 0.080" OD)?

#1
Question on small volume medical device tube cutting (0.020" to 0.080" OD).

What are Best Practices for medical device tube cutting at very small volumes i.e. < 100 parts (soft, flexible, various lengths from 0.5mm - 100 cm with tight tolerances +/-0.1mm, and durometer).

What is the best way / practice to cut typical medical device tubing that people have found?
Currently, we are doing cuts by hand with a very sharp razor blade. It's "Ok" for now but we want more precision, repeatability, and less effort. We have a hard time avoiding "Fish mouth" on the ends of the cut. We don't want to go to an outside vendor since our volumes are so low. I am thinking of a simple cutting fixture to do this.

Some thoughts I had:
Make a fixture a "roll cutter". Tubing would roll as blade cuts it. Might have issues with spiraling.
Use Teflon Beading to support tubing to be open during the cut? (we would have to pull / push the beading out of each piece).
Mount a razor blade on a conventional linear slide to move the blade across the tube.
Capture the tubing on both sides of the blade.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I don't have an answer but I would look in issued patents. You might find something useful where the patent is already expired.
I wouldn't limit my initial search to medical.
 

somashekar

Staff member
Super Moderator
#3
Question on small volume medical device tube cutting (0.020" to 0.080" OD).

What are Best Practices for medical device tube cutting at very small volumes i.e. < 100 parts (soft, flexible, various lengths from 0.5mm - 100 cm with tight tolerances +/-0.1mm, and durometer).

What is the best way / practice to cut typical medical device tubing that people have found?
Currently, we are doing cuts by hand with a very sharp razor blade. It's "Ok" for now but we want more precision, repeatability, and less effort. We have a hard time avoiding "Fish mouth" on the ends of the cut. We don't want to go to an outside vendor since our volumes are so low. I am thinking of a simple cutting fixture to do this.

Some thoughts I had:
Make a fixture a "roll cutter". Tubing would roll as blade cuts it. Might have issues with spiraling.
Use Teflon Beading to support tubing to be open during the cut? (we would have to pull / push the beading out of each piece).
Mount a razor blade on a conventional linear slide to move the blade across the tube.
Capture the tubing on both sides of the blade.
Try using smooth Teflon or Nylon rollers to draw tube to the required length.
Have a lock down clamp of Tefon or Nylon to hold the tube and have a moving sharp knife to cut (like a photo cutting table top frame)
A adjustable guide to move the tube straight from the rollers.
The roller rotation controls the length, the clamp down gives the support, the tube is nor pulled or stretched.
Have the cutting knife as close to the lock down clamp as practically possible.
The tube squeezing due the the roller and clamp down will eventually not change the round shape of the tube as the compression is for a short time. Experiment settings to get desired results.
 
#4
I was thinking more in terms of manual tube cutting fixtures with length controls. I know there are many machines that are capable of cutting tubing using very precise rollers and advancement control.

We came up with this pretty simplified manual tubing cutter. Our tubing runs between 40-80D hardness. Dimensions are between .025" -.080" OD with about .002-.004" wall thickness. We're using those premium razor blades for safety razors.

Any feedback? Green part is a ruler. Purple is a swappable cartridge for different size tubing.
 

Attachments

Thread starter Similar threads Forum Replies Date
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
A What are Practical data center best practices IEC 27001 - Information Security Management Systems (ISMS) 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
optomist1 Mobility Field Manufacturing Best - Worst Practices Manufacturing and Related Processes 5
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
M Over-labelling - Any requirements or best-practices? Other Medical Device Regulations World-Wide 0
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0
P How to have employees buy-in of quality procedures. Best practices? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
M PCBA Drawing Best Practices IPC Class 3 ISO 13485:2016 - Medical Device Quality Management Systems 1
Ron Rompen Best Practices in CMM Correlation Studies General Measurement Device and Calibration Topics 3
S Referencing procedures on Control Plans - Best Practices FMEA and Control Plans 3
Roberticus Best practices for parts washer conveyor to belt transitions Manufacturing and Related Processes 2
M What do the terms "Lessons Learned" and "Best Practices" mean ? Preventive Action and Continuous Improvement 2
U Nonconformance Training in Best Practices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D ESD Policy Content Best Practices Manufacturing and Related Processes 8
S Best Practices - Form Completion Document Control Systems, Procedures, Forms and Templates 9
D Best Engineering Practices related to Top Assembly Drawings Document Control Systems, Procedures, Forms and Templates 6
kedarg6500 Best Practices for Receipt Quality (Automotive Industry) Supplier Quality Assurance and other Supplier Issues 7
kedarg6500 Receiving Inspection Documentation Best Practices Supplier Quality Assurance and other Supplier Issues 2
R Medical Device Software - Final Field Testing Best Practices IEC 62304 - Medical Device Software Life Cycle Processes 5
D ISO 14971 - Risk Analysis Best Practices ISO 14971 - Medical Device Risk Management 5
R Best Practices in the Control of Cleaning Materials Document Control Systems, Procedures, Forms and Templates 1
J Three Best Practices and Lessons Learned in APQP APQP and PPAP 1
B FMEA Ranking Rating Best Practices FMEA and Control Plans 10
G ISO 9001 Clause 5.5.3 Communication "Best Practices" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
F Promoting Best Practices in a Company Quality Manager and Management Related Issues 22
N Control of External Documents - Best Practices for Control of External Forms Document Control Systems, Procedures, Forms and Templates 2
M Best Practices for Oncology Services - New Breast Patients (Surgery) Clinic Hospitals, Clinics & other Health Care Providers 4
H Quality Management Best Practices for Internal Auditing Internal Auditing 6
M Approval of Procedures - Best Practices Document Control Systems, Procedures, Forms and Templates 34
N Sheet Metal Identification Ideas - Best Practices for Identifying Raw Material Document Control Systems, Procedures, Forms and Templates 8
N What are Best Practices for Safe Handling and Storage of Oily Rags? Occupational Health & Safety Management Standards 7
T Gage R & R Study "Best Practices" - More than three operators? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
D Best Practices for Safe Handling of Rented Hospital Mattresses Hospitals, Clinics & other Health Care Providers 4
D Industry Standard or rules or best practices pertaining to Automotive Process Flows? APQP and PPAP 3
M Marketing Communication Change Control - Identifying best practices ISO 13485:2016 - Medical Device Quality Management Systems 4
M Information Technology Record Retention time best practices Quality Management System (QMS) Manuals 2
M Do anyone have a book or a guidelines or best practices about Iso9001:2000 in service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
W Lean in the UK - Seeking contacts to share best practices Lean in Manufacturing and Service Industries 5
K AS9100 6.2.2 - Internal ISO 17025 Laboratory - Clause 5.2 Personnel Best Practices ISO 17025 related Discussions 1
P Best practices for GMP training US Food and Drug Administration (FDA) 5
K Fastener bolt torque Best Practices - Assembling electronics components Manufacturing and Related Processes 7
L Injection Molding Quality Assurance - Best methods, practices, tools, education Manufacturing and Related Processes 10
K Best practices on the criteria to issue CAPA & expected response time? Preventive Action and Continuous Improvement 2
C I am looking for the best practices on calibration labeling General Measurement Device and Calibration Topics 5
S Certificate of Conformance/Compliance (CofC) - Share your best business practices AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 23

Similar threads

Top Bottom