06-23-2014 06:38 PM
When conducting large volume batching, how many times do you allow a syringe and/or needle to be used before changing it out?
IE. If a technician is reconstituting 100 vials, how often should they be changing out the syringe and needle?
I've read everywhere from "each and every single time" to "every 8-10 vials"
07-03-2014 12:36 PM
Great question but all of the rules are legacy/urban legend stuff. What is the concern with using a needle multiple times? The tip will blunt and increase the risk of coring. It will also lose its lubricant on the needle shaft and be harder to penetrate the septum. If you Google dull needles, this is what you will see. Based on the picture, I would say every 5 punctures to minimize coring.
01-09-2018 12:41 PM
Couple of question when batching a product such as Fentanyl 1000 mcg / 100 ml due to backorders.
01-09-2018 01:59 PM
As far as I know, there are no studies that specifically address your questions. The sterility issue depends on the person working in PEC, who should be properly trained, aseptically qualified and always working in first-air. I know that a needle tip will start curving (microscopically) after its first use and continues to get worse the more times a needle is reused. I don't use a needle more than 5 times. Needles may contain medical-grade silicone and this will wear off over time, making penetration through a septum/stopper more difficult. The plunger of the syringe will also start to "stick" after prolonged use. The fluid from the bag can be dumped down the drain outside of the cleanroom (because you don't have a sink in a cleanroom :-) ) Hope this helps.