BCSU 10 Years of Success_final

hello , today i'm here with giulia attali , the global product line manager of the biocap single use microbial impactor .

giulia is based in italy .

hi giulia .

hi , meghanna .

so it's been about 10 years since the launch of the biocap single use .

can you tell me about how things may have changed and developed since that launch 10 years ago ?

yeah , megan , already 10 years .

i still remember the first customer that decided to validate and use the biocap single user for microbial active air sampling .

of course , i cannot share the name of the company , but the biocap single user is still in use .

and every year they increase the consumption because they decided to use the bio-cap single use in different field in line .

let me say then , 10 years ago , the use of the single use technology for environmental monitoring was not really a common concept .

but our customers trust in pms , and in this solution , we were offered to the pharmaceutical production .

and now we have a customer in all countries where we are present , direct or with our partners , distributors .

oh wow .

and can you outline what you think are the key factors that drive such a success ?

which are the key factors ?

i think that there are different factors of this success .

for sure , the requirements of regulation and in particular the annex 1 have forced the pharmaceutical companies to consider a different solution for environmental monitoring and to consider the bio-cap single user as a solution of these new requirements .

we know that in the chapter 9.24 of the annex , the monitoring continuous of hair from microbial point of view , of course , is strongly recommended .

i would say it's a must , but it's within should in the annex .

and even a sector plates , so the passive assembling is still part of the indication of the annex , and more and more pharmaceutical companies are considering the use of an active assembling instead of the passive .

the limits of the set or place used for the passive continuous monitoring are well known .

and for this reason , our clients are implementing the biocapsing user for ever inactive sampling of the hair .

why ?

the question is and the answer of this question is very obvious , let me say , because the active sampling can better capture the microorganism if they are present .

we can be sure that the drug producer is not exposed to any potential contamination for the air .

but coming back to the question , which are the key factors , for sure we have also considered the future of the product itself .

our end users appreciate that the biocap single user is easy to handle even with only one end , and this is very useful for example in the isolator .

the media is well protected by any potential secondary contamination that can occur during the sampling .

and the disinfections and the wipes that are necessary to be used for the disinfection of the impact are not longer necessary .

so this means easier sop and less material in the filling line as well the cost .

and so there are so many other futures of the biocafes single use that are the base of the suses .

we can summarize as a combination of regulatory compliance and the biocap single use itself , the futures of the biocap single use itself .

okay .

and then in the pms portfolio , we have both the biocap stainless steel as well as the bio-cap single use .

can you explain how the two products are linked ?

we can say that they are brother each other or cousin each other so the bio-cap stainless steel is part of our offer since years .

the unique design of the impactor with the slit help and helps our customers to have the highest physical and biological efficiency as well as offering the possibility to have an immediate recognition of false positives .

based on this great experience and extremely positive feedback from our customer , more than 10 years ago , we decided to create a single-use version of the biocap stand-in-steel .

that is the biocap single-use .

in fact , the biocap single-use is the combination of the impactor stand-in-steel with the agar plate .

it's clear that it's used for microbial active air sampling in the pharma company .

and it's primarily installed in grade a .

this is really the core of the production where the biocap single use is used .

even we have experience of customer that decided to extend the use of the biocop single user in grade b as well as in the going rooms .

wow .

you had mentioned that the bcsu can be used in a continuous setting .

is there a limit for how long it can be used like this ?

i imagine that the implementation cannot be particularly easy .

how can our product line managers perhaps help with this implementation ?

okay , so let me say that we have several companies globally , so not only in one region , not only in one country , but we have in asia , we have in europe , in america , so that already implemented that , and of course validated the biocap single user in continuous .

so the use of the biocap single user in continuous in line with the requirements of the next one .

our experience with this customer is that the biocapsingle use can work up to four hours .

but the real total time of the user must be evaluated with the performance qualification .

so in other words , it's necessary to evaluate the performance of the product based on the parameters inside the filling line or the isolator .

based on the parameters like humidity , temperature , and flow rate that can change the total time of the use of the bio-caf single use in continuous .

this validation is not difficult , let me say , but it's really important to evaluate all the different aspects of the validation before proceeding with the use of the biocaf signal used during the production .

as particle measurement system , we have a complete documentation that we can , documentation related to the validation we perform before the release of the product that of course we can , we share with our customer .

and in addition and more important , there is also the advisory team where our experts can support our customers for this validation for the performance qualification of the biocap single use .

thank you , giulia .

finally , where can our audience find more information about this topic ?

i would suggest that you visit our website .

that is really full , let me say , of useful information , not only for the biocap single user , but in general about all our products , of course , but also about regulatory requirements .

there are webinars , application notes , and so on .

in addition , of course , they can stay in contact with our sales rep locally .

and of course , contact me at my email that is grtalli at pimisciolin.com .

fantastic .

thank you so much , julia .

my pleasure , meghanna .