Kirsch’s accepted criterion, a helium-based deterministic approach that Datwyler uses to measure contamination, can stumble upon “microbial penetration” of up to 0. 2 microns.
Essentially, Ventura said, deterministic threat considers the effect of an individual threat scenario, while probabilistic threat considers all imaginable scenarios, their probability and related effects.
In deterministic tests, there is a correct answer and an answer, while probabilistic tests are based on what is supported by existing evidence.
For example, if the weather forecast predicts a 70% chance of rain, is it okay if it rains or doesn’t rain?
The answer, according to Dataspire, a science literacy website, is none, as the forecast is based on the likelihood of rain.
“Both have qualitative and quantitative principles,” Ventura said. When the judgment is made through the operators of the device, it is probabilistic. . . and we checked to move to deterministic (proof).
“The integrity of the container closure is critical.
A moment of deterministic verification comes to a laser diode that fires through a vial for aging and using bloodless garage for all stages of the life cycle, Ventura said.
This specification can measure microbial penetration and leakage degrees down to 0. 01 microns.
“And that’s pretty low,” Ventura said.
For his part, Datwyler specializes in helium detection, where he is the tracer fuel used for incredible leak detection.
“It’s for maximum sensitivity, where you have your tracer feeding the vial itself,” Ventura said. “It is then sent through a very fast pump to a mass spectrometer, which detects the leakage rate. “
The problem with this form of testing, Ventura said, is that it has to be done offline or outside the production process.
Datwyler provides helium verification in its Middletown and uses some of the other verification protocols in Belgium, measuring plugging and diving conditions.
When using to check helium leakage rates, you will need to enter the vial somehow.
Holes can be drilled in the lid to introduce He, but this can allow other contaminants and variables to enter.
Following a case study, Datwyler now uses a flavor that brings He’s holes into the glass bottle, knowing that “we can seal the glass with a sticker. “
“Regardless, we discovered the one that works best,” Ventura said. “We discovered a shape that bypasses gaps in the lid or by fusing a gap in the lid to determine leakage rates. “
Another form of “orthogonal” testing, or a statistically independent approach that can be adapted to production, is the residual sealing strength test, Ventura said.
“Helium has to be done offline, but it can be done online,” he said. “What are their borderline situations? When you have situations of setting and RSF values, you now have evidence to give your consumers (who are) going through the production process. “
RSF is helping to measure the “release force”, which occurs when the plunger of the syringe is under tension and begins to move; and sliding force profiles, which can be obtained when the drug is extruded when the plunger is moved.
“A registered nurse might have to apply a lot of force to get the plunger to start moving,” Ventura said. “Would you like a doctor or nurse to insist on it?
“I know I wouldn’t. “
An inconsistent and “uneven” piston is also news.
“If it’s your child, that child is going to cry with this uncertainty and inconsistency,” Ventura said. “There’s an explanation for why we want to make sure certain homes are well maintained. We are in favour of meaningful and quantitative acceptance criteria.
“No one enjoyed having a problem. “
Ventura warned that the U. S. Pharmacopeia is not going to do so. The U. S. government no longer has official and meaningful acceptance criteria designating a one-size-fits-all product and packaging distribution systems.
“They don’t have any approach that they think deserves to be used at all levels,” Ventura said. “And it’s because all programs are different (for the thigh, arm or mouth, for example) that the developer of the final product wants to know what the acceptance criteria are. “
And to further complicate the issues, strength and speed agree.
“A control can pass but it can fail, as the blue tint control may show ‘pass’ while the He control may show ‘fail,'” he said. “And vice versa.
“Finally, there is an evolution towards deterministic techniques because integrity assessments, such as through official rules and regulations, have a purpose to make sure that there is a validated program. The end user is guilty of building the criteria with the manufacturer, and you have to think about all the parts you want to worry about (validating) in order to do this specific test. “
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