PVC Tubing Extrusion - Class I medical device

G

Gert Sorensen

#11
I share the opinion of Chris1price that the product coming out of the extruding machine is almost sterile. There is only an issue what happens next and how the product is dealt with.
I beg to differ, if the cooling water for the extrusion process is not clean, then it will add significantly to the bio-burden. However, if the tubing is not invasive it may not be a problem, IMO.
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#12
Hi Gert, for thermoplastic extrusions you are right, the cooling water needs to be kept clean, but silicone extrusions are heated to high temperature to cure them, typically well over 200C.

BTW, IPA= Isopropyl Alcohol, usually mixed 50/50 or 70/30 with water. I'm told its a better disinfectant when used with water, but no one could ever tell me why!
 
G

Gert Sorensen

#13
Hi Gert, for thermoplastic extrusions you are right, the cooling water needs to be kept clean, but silicone extrusions are heated to high temperature to cure them, typically well over 200C.

BTW, IPA= Isopropyl Alcohol, usually mixed 50/50 or 70/30 with water. I'm told its a better disinfectant when used with water, but no one could ever tell me why!
Thanks, I were not aware that the challenge is different when extruding silicone, I'm from the PVC-world :thanx:

However, the original question was related to PVC, and in that case the quality of the water has as stated an influence.
 
M

motygo

#14
If you use PVC tubing and you manufacture it in an environment that is not a clean room, consider washing the tubes in Ethyl alcohol or Iso-Propyl alcohol. This will reduce the CFU (colony forming unit)count per device significantly. If you can validate that you get a low CFU count ( up to a few hundred) every time you do this alcohol-wash, your'e sure to get by with one cycle ETO. I don't know your'e product but generaly I would not recommend using radiation as means for sterilization for PVC tubing. There are all sorts of effects resulting from polymer cross-linking, including change of color and loss of elasticity, so I would say stay with ETO.

Best of luck

Moty
 
G

gereard_kgb

#15
Coming back to washing in alcohol.

Do you mean washing it in ultrasonic washing machine or without it?
Do you know any standard procerdures for washing medical devices? are there any norms available?

there is also one more point that botheres me - flamability of alcohol... I'm afraid it could explode or start to burn (I'm afarid it already happened - it started to burn - we used ethyl alcohol in ultrasonic machine - no causalties nor loss this time). is IPA safer?

what do you think?

:thanks: :thanks:
 
M

motygo

#16
Remember - your aim is the reduction of CFU count. In order to do this, you don't need to use an ultrasonic bath. Of course you will have to test whatever method you choose. To the best of my knowledge there are no standards to washing but rather common practices depending on the type of material used (metal, plastic, etc.) and the type of soiling affecting your product. I'd suggest start with a 20 second immersion in a 70% IPA (Iso-Propyl-Alcohol) bath. If you have lumens (secondary channels in the tube wall) make sure they are immersed too. After drying and packaging, send for CFU count testing. At the same time send for testing an untreated sample. Compare the results. Ideally, you should get a TNCT (too numerous to count) result from the untreated sample and a result of up to 200 CFU per device in the treated sample. If the result of the IPA-treated sample is larger, increase the immersion time and test again. Remember to wash your gloved hands with IPA. The same goes for every surface you put your device on. Good luck, and please keep me posted on the results.
 
G

gereard_kgb

#17
Thank you very much for your comments.
We will try it that way.

How about the characteristics of IPA? Is it more or less flamable than ethyl alcohol?

In the meantime I was wondering about using Benzalkonium Bromide for this purpose. What do you think?

:)
 
M

motygo

#18
Sorry, I can't help you here, because I don't use them. Check the Technical Data Sheets and the Material Safety Data sheets (MSDS) that can be found on the web.

Good Luck!

Moty
 
Thread starter Similar threads Forum Replies Date
chris1price Naturally Occurring DEHP in PVC Tubing - Statements about tubing being DEHP-Free EU Medical Device Regulations 6
R How to bond PVC (Tygon) Tubing and Validate the Process ISO 13485:2016 - Medical Device Quality Management Systems 13
rob73 Advice/recommendations for equipment to measure a soft pvc tube - Optical Measuring? General Measurement Device and Calibration Topics 4
T What Test Certificate should accompany supply of Cable XLPE/SWA/PVC 4CX150MM2 Document Control Systems, Procedures, Forms and Templates 2
P IEC 60601 Clause 57.3 / 8.11.3.2 - PVC Flexible Cords IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K How to define PVC Pellet Quality Manufacturing and Related Processes 8
R Standard Relevance & Updating - ASME B&PVC Various Other Specifications, Standards, and related Requirements 4
S Benchmarking PVC Profile Extrusion Metrics Benchmarking 2
somashekar DEHP vs. DINP as Plasticizer in PVC (Emerging Health hazard) Other Medical Device and Orthopedic Related Topics 3
somashekar Material Compatibility - PVC (halogenated polymers) and Santoprene (TPE) Manufacturing and Related Processes 4
M PVC balls fail out laquered process drying Manufacturing and Related Processes 3
F Conical gauges (ISO 5356) how to use on PVC (soft part) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started Labelling Devices EU Medical Device Regulations 71
K Any adhesive needed for PVC and PC natural bond? ISO 13485:2016 - Medical Device Quality Management Systems 1
ScottK ASME B&PVC Section VIII Div 1 question regarding "Seal" Various Other Specifications, Standards, and related Requirements 0
ScottK The term "Quality Control Manual" - ASME B&PVC question Various Other Specifications, Standards, and related Requirements 2
D PVC Packaging on Pass Through Parts - An environmental issue? Miscellaneous Environmental Standards and EMS Related Discussions 3
R PVC Profile Extrusion - Custom Profile Extrusion company Manufacturing and Related Processes 4
D Measuring fine tubing (< 0.100") "Wall by weight" General Measurement Device and Calibration Topics 11
A Tubing Clog Tester - Convert from Air Bubble to Flow Rate Reliability Analysis - Predictions, Testing and Standards 1
M Butt welding of 13Cr tubing Manufacturing and Related Processes 0
M Regulations for oxygen/air-tubing and connectors inside of ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Insufflation Tubing & Filter Set Product Classification question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J Micro Tubing Concentricity Checking using Crosshairs Manufacturing and Related Processes 1
J Mechanical Tubing Mill Tolerance Reference Manufacturing and Related Processes 5
R Fuses that in series with each supply lead are only housed by Heat Shrink Tubing IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
T API 5CT PSL1 & PSL2 Levels - Specification for Casing and Tubing Oil and Gas Industry Standards and Regulations 5
B Profilometer Damages Parts? Extruded Plastic Tubing General Measurement Device and Calibration Topics 5
B SAE AS81914 - Convoluted Tubing Tensile Stress Various Other Specifications, Standards, and related Requirements 5
Ron Rompen Very Unique Prototype Requirement - Cutting Holes in Tubing Manufacturing and Related Processes 2
G Standard to use as a guide in measuring surface "roughness" of aluminum tubing General Measurement Device and Calibration Topics 1
N Grilamid L25 vs. L20 for Nylon 12 Balloon Tubing Manufacturing and Related Processes 1
J Inspection Equipment for Checking Serrated Steel Tubing Depths Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Health Canada Device Classification - Close-off clip for use with a tubing set Canada Medical Device Regulations 9
D Calculating Cpk for Tubing Wall Thickness - Extrusion Process - How to approach? Statistical Analysis Tools, Techniques and SPC 16
P Outsourced Process or Supplier? Purchased Formed Metal Tubing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Looking for MIL-P-15147 - Ink marking copper-nickel tubing Other ISO and International Standards and European Regulations 4
J ASTM D709 - Does D709 give a wall thickness tolerance for tubing? Various Other Specifications, Standards, and related Requirements 5
apestate Tolerances for cold rolled, hot rolled, DOM tubing Other ISO and International Standards and European Regulations 10
Nicole Desouza Plastic Extrusion of Medical Device Components - No ISO or AS 9100 Certifications Other Medical Device and Orthopedic Related Topics 7
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
F AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Injection & Extrusion Process FMEA FMEA and Control Plans 1
A 1st Time Purchase of Aluminum Extrusion - First Article? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Improving Quality in an Extrusion Blow Molding Company Quality Manager and Management Related Issues 2
K Is there any specific Standard on visual defects for extrusion and machined parts ? Quality Tools, Improvement and Analysis 6
D Chemical Training in use of Sodium Hydroxide to clean Extrusion Dies Training - Internal, External, Online and Distance Learning 2
H Is there a Standard on the Reuse of Resin in Extrusion Process? ISO 13485:2016 - Medical Device Quality Management Systems 1
QMMike Extrusion Dies - Perishable Tooling? APQP and PPAP 4
T How clean should the water be needed during extrusion as a cooling agent - Catheters Other Medical Device and Orthopedic Related Topics 5

Similar threads

Top Bottom