IMA Pharma on LinkedIn: AQUARIA - IMA PHARMA @ACHEMA 2024 (2024)

Occupational Safety Awareness is one of key challenges in emerging countries’ pharma industry. Oral solid dosages are of very common formations in those countries. From drug authorities to corporate leaders, the urgency and importance of safeguarding operators from the highly potent drugs exposure daily are still far away from the leadership agendas as ignorance in containment requirements and process, and lack of proper industrial Labour safety regulations & knowledge in Pharma sector are the key factors , especially for those drugs being produced for Domestic markets instead of regulated markets with supervision by authorities with serious due diligence process implemented. Anyone who can contribute on educational work on drug OEBs levels shall be highly appreciated. It has been our obligations as pharmaceutical engineering professionals to play a role on such containment knowledge awareness improvement.

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In the last two weeks, I've been confronted twice to this situation: a serious affirmation has been made trying to discredit and disqualify a solution or one of the competitors. In the one case, it has been told, that laws have been breached by one of our suppliers, in the other case it has been told that the H2O2 decontamination process from Solidfog Technologies, SRL leaves residues after decontamination so that a mechanical cleaning would be required after it which would not be the case with some other technologies.In the first case, the targeted supplier has proved to be a pioneer in setting up high standards and being audited regularly by different organizations such as Sedex. In the second case, I personally have performed several hundreds of thousands of m3 decontamination in Switzerland and Europe in the last ten years or more in the pharmaceutical, food-tech, med-tech, chemical, and cosmetic industry. In none of them I could have noticed any residues after decontamination. Neither did the clean-room-users I was working with. The producer of the generators - Solidfog with a much bigger experience than I - also hasn't been faced with such situations. This also applies to their customers and partners. We should know in the bio-decontamination area that the NF 72281 has been the basis for the EN 17272. The goal is to evaluate the generators together with the biocides used to make sure that the decontamination process is effective. One of the parameters is about the residues. The biocides used need to be evaluated and registered according to the BPR.In both cases, we're missing any evidence of the affirmations done. I though that the clean-room market in Switzerland had been protected from unfounded affirmations. Those might just be episodic cases, what I really do hope. I would prefer a competition market in which the players concentrate on their own strengths and inner values instead of spreading some non-evidence-based information. If there are however any evidence of it, I would much appreciate to get access to them. With a scientific background we know that things we believe to be true right now might change with time but this requires more than just opinions. I believe that the clean-room users are aware enough to those risks and use their critical mind to question back when such affirmations are done instead of taking them for granted. The goal of this post is in a quite humble way to sensitize all the players. Competition should be fair and we don't need this negativity.Credit picture: ©Shutterstock/M-SUR

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I had a(nother) conversation with an industry regulatory colleague about the lack of awareness in brand owners about the importance of good documentation when manufacturing and selling cosmetic products. We shared some war stories, and I thought I would share one of the worst cases I have encountered. There is a test called a challenge test that takes at least 28 days to complete. I asked my client to get the challenge test report from the manufacturer. The manufacturer asked 'What's a challenge test?' I explained that it is the 28-day microbial preservative efficacy test (it also has this name so I thought that maybe they knew it by this other name). Next question 'What does a challenge test report look like?' I sent a brief description of the kind of thing I was looking for.Two days later, a signed, stamped, completed challenge test report landed in my inbox 🤔.Do we trust this manufacturer?(image: https://lnkd.in/eCA8FNFv)

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Here is a very good posting that illustrates how important it is to select suitable primary packaging materials if you want to be successful in your CCI-test.👌💪It’s not just a rubber stopper, vial and aluminum cap - it’s the complete system that has to fit 100%!If you need help choosing a suitable packaging system for your drug product 👉 www.dedecke-gmbh.de/en#PharmaIndustry #Lyophilization #Biotechnology #pharma#primarypackaginglovers

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#Freeze_drying of Milk leads to interesting insight #update1This picture shows my little test set, initially not aimed for anything else then trying to train my freeze drying ability and to be able to measure water content later. For this reason I decided to stopper under a partial pressure of inert gas, because this allows to check easily for integrity, which is important to know if the container potentially took in any moisture from surrounding air, which would quickly change the water content.This works at least if you use a competent CCI-Test.One more important information, that was maybe lacking before: I used a Christ Epsilon 2-4 which allows for a Pharma like vial closure. Experts may have guessed so from the time lapse shown in part one.When I then checked for integrity, I detected that the typical defects that occur in pharmaceutical freeze drying, were well represented in my sample set. Of course these issues occur with a drastically lower frequency in comparison to my sample set. This is why I decided to write about the lesson learned:When I measured the same sample set approx. 4 hours after venting the freeze dryer I found additional failures, and that is what can be expected. Those vials that showed no gas ingress at the beginning and then were crimped did not change.I now crimped the vials from sample 16 to 25 (ten more containers). Among these there were two additional leakers. They leaked rather slowly, so my assumption is, that it is likely that the crimping might now close them totally. Of course this is not certain, please remember that I described already that the process of filling was quite suboptimal, and I had to wipe the vials neck as sometimes milk was spilled on the glass walls up to the neck. This means that there may be gas pathways by residual product on the neck. And please also consider that we did not do any package development, as this was not planned.I will report soon on the next development as I want to understand if those vials that are now still not crimped will show any gas ingress after approx. 24 hours, as this is from my experience the maximum time that it takes in Pharma to crimp the last containers of a large production batch.Stay tuned if you want to get more of my lessons learned.

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Freeze Check - Irreversible Descending or Freezing Temperature Indicator#Logistics #SupplyChain #ColdChain #Warehouse #Pharma #Medical #Food #Import #Export https://lnkd.in/dne5qvs

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Discover how you can significantly reduce the risk of mycoplasma contamination and spread in your cell-culture lab. In this Application Note, Sartorius describe good cell-culture practices, from selecting easy-to-clean pipettes and sterility promoting consumables to testing regularly. Download it here >>> https://bit.ly/3RbERUP