1. J

    Studies conducted on the amount of autoclave sterilization of a PEEK implant

    Does anyone know or provide a link to studies conducted on the amount of autoclave sterilization a PEEK implant can withstand before material degeneration or other complications could occur? I'm searching for data to justify a given life expectancy for a PEEK spinal implant that could...
  2. P

    Colorant leaching out of Nylon in Autoclave

    We have recently had a customer seeing color leaching out of our Nylon parts into surrounding plastics during autoclaving. The nylon parts they have noted seem to have a colorant with some oil based components, our colorant supplier says that the colorant SHOULD be inert once mixed during...
  3. I

    Biocompatibility Impact on Autoclaved Silicone

    Hi everyone, We currently manufacture an accessory made of silicone, to be used with our parent MD. The accessory is not intended to be sterilized and its biocompatibility has been assessed as such. We would like now to assess to possibility to autoclave it. According to the silicone...
  4. G

    Digital Autoclave Accuracy Requirements

    Hello, We are manufacturing medical device (Contact lenses) and using two digital autoclaves for sterilize the products. One of the autoclave is considered big (85 litters) and the other considered to be small (23 litters). What is the accuracy, according to the standard, of the digits of the...
  5. F

    Designing a Hollow Medical Device for Autoclavability

    Hi all, My company is designing a new device to be autoclaved. We were wondering if are meeting all of the necessary requirements. It is a hollow device with several openings. Parameters we are trying to meet: Wide openings no corners no seams autoclavable materials We were...
  6. K

    Autoclave Log - Do we have to monitor the usage for every load?

    In order to be compliant with ISO 17025, I made an autoclave log to track the usage of each load. There are weekly maintenance checks that they are required to fill out. Lab techs are required to record the results of the autoclave tape, and the sterilization start/end times, as well as...
  7. Mohammed Gouda

    The General Parameters of IQ, OQ & PQ - Depyrogenation Tunnels and Autoclaves

    Dear friends... I am confused that some customers need to execute IQ, OQ and PQ of depyrogenation tunnels and autoclaves.... the question is ::notme: "What are the headlines which I must check for executing these qualifications??" Also, if it were any references please notify me if you...
  8. H

    Reusable Soft Tissue Surgical Laser Fiber Sterilization Method

    Hi there! I'm hoping someone can point me in the right direction to handle the sterilization of a reusable laser fiber. Right now we have a soft tissue surgical laser with a single-use tip that slips onto a hand piece. That one is easy. However now the requirement is to develop a reusable...
  9. B

    Autoclave Revalidation Methods

    Hello, I am currently trending information for every single production autoclave run during the year (ster start time, end time, length of sterilization, temp (drain for wrapped, load probe for liquid), F0 for liquid) to review for adverse trends during regular use. If I also set up a trend...
  10. samsung

    What to do if no further control possible to reduce the OHS risk?

    We had an observation during the stage -1 assessment. "Organization needs to have adequate management program in place to control / reduce the severity level of risk associated with the operation of autoclave." Scenario - We have an autoclave used to test the expansion of cement under the...
  11. L

    Autoclave Test for Instrument Validation

    We have a request to perform a repeated autoclave exposure during our instrument validation. The number of repeatition is 25 minimum. Do you know why 25 and is it linked to a standard?
  12. SteveK

    Autoclavable Adhesive for Medical Grade Polycarbonate ? suggestions?

    Autoclavable Adhesive for Medical Grade Polycarbonate – suggestions? Hi, We have two (medical device) components – male and female tube type fittings. Traditionally we have solvent welded the male into female with an interference fit. When the assembly was autoclaved (up to 138 C)...
  13. F

    Composite AutoClave Internal Audit Checklist - needed

    Hi there, i'm now working in a composite manufacturing industry, supply our parts and panel to Boeing. Currently we are developing and growing our QMS section (internal auditors). I would like to ask elsmar members, if anyone can share audit checklist for AutoClave operation?
  14. B

    Autoclave Duration Requirements at 135?C within Italian Hospitals

    Autoclave Duration Requirements at 135ºC within Italian Hospitals I know this is slightly off of the 13485 topic, but I was just wondering whether anyone knew what the autoclave duration at 135C is within Italian hospitals? In the UK, US and pretty much everywhere else its 3 minutes but...
  15. V

    Can we use same autoclave (sterilizer) for media preparation & waste disposal?

    What is the normal practice in pharma industry? Are they using same sterilizer for preparing & disposal of media? If yes, how to prove that disposal is not causing any contamination when we go to next media cycle. Is there any guideline suggesting the validation for use of same autoclave to...