Love this

Thank you, I'm working on this for my project

Thanks Sir

Very nice presentations and more helpful to pharma companies

*promosm*

I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that KZfaq is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!

I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that KZfaq is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!

Hi how have you setup this exposure chamber. Please guide me.

very useful, thank you

According to your initial wordings, if this was to be applied to EUMDR 2017/745 , All the tests mentioned in endpoints chart need to be conducted right?

Great talk

This can't be real

Informative

Thank you for a very informative talk

I want to set up in india

Question: If my company makes only the HDPE bottle, which level of testing am I required to execute? 661.1 or 661.2? Thanks!

The perdiatrics volume is 5 m3 per day

I agree, in a lab setting , disinfectants and sanitizers are very effective against microbes when their toxic levels (dose) could be maintained and delivered. That's a big leap to the real world where the products are used and unfortunately this doesn't always happen in the field and some sanitizers for food contact surfaces provide sub-lethal levels of the residual active ingredients for toxicity reasons whereby the microbes have been shown to adapt. Just look at all the evidence of pseudomonas spp. pumping out QAC's. Also failure to maintain the required contact time set's up conditions for adaptation. Sanitizer test methods claiming 99.9% kill are also NOT representative of real world efficacy because they are tested in solution instead of a real surface or with ASTM 2197. I would give them 30% efficacy in the real world at most and that's equivalent to much less than 1 log.

Is it a risk assessment or equipment operation demonstration

Somos más que pronosticadores Hípico, somos un grupo de amigos que amamos el hipismo; por ser un espectáculo de atletas pura sangre de carreras, desde el año 1975 ya éramos aficionados y ahora defensores del hipismo, sin fines de lucro, y les pasaremos totalmente gratis la información obtenida por múltiples colaboradores, la analizamos y la resumimos para Venezuela. www.youtube.com/@ChichosClubHipico

What is surrogate in extractable leachable?

Nice

Can invitro testing be used as a cheaper screening test? Not for regulatory submission?

This was a very informative video and certainly supports how important it is in following the IFU's.

what's that KZfaq video you were trying to show? Can you put the link in the description of this video?

Excellent presentation. Thank you

Great webinar! A question I had: If a packaging lot size of a commercial validated packaging process needs to be increased by 5x, would this require packaging validation on the 5x lot size? What's the requirement in such a case?

thanks for sharing

I attend it live it was awesome and I came here to watch it again particularly Q&A session

How do you make sure you don't contaminate the sterile coupons during the testing process. If you need to lie the coupon flat to apply the target organism on the top how do you keep the bottom sterile so if you are immersing the coupon fully you don't get contamination. How do you achieve that? Thanks

What standard is this being done to? Thanks

I know this is 3 years old, but I do have a question. Let's say that a system extracts fluid from the patient into a bag. What type of contact characterizes parts that are outside the body such as external tubing and bags that collect blood? Thanks!

How can I download this presentation hands out ? Thank

Good 👍

Pouvons-nous acheter ce produit ?

Thank you so much for this great service .. this will help many scientists all over world..❤️ from India 🇮🇳

Thank you for such an informative presentation.

very important thank you

Awesome (as always). Great source of information. Thank you for sharing!

so its bad ?

kzfaq.info/love/yB3GFq6cWuAZzGWpnTX70A

Great presentation. I laughed too on the Cytotox failures which are driving we engineers insane by proxy!

Can u please video offline mode also clarity to reading

I am down load this video but I am reading time show blurred

The bacterial endotoxin test (BET) is an important part of assuring safety of par enteral pharmaceuticals and medical devices that contact blood or cerebrovascular fluid. Endotoxin (in the form of LPS) is a naturally occurring product of bacterial metabolism, most often shed

とうございます」、

Thank you so much

Cu

20:32 'Peal Test' #facepalm

How can I get the dye solution ?