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German to English translations [PRO] Tech/Engineering - Medical: Pharmaceuticals / Certification of seals
German term or phrase:BSE-Freiheitsbescheinigung
All, I am translating a spec sheet for equipment used in the chemical, food and beverge and pharmaceutical industries.
The following statement is about materials used in seals: "Als Dichtungswerkstoff wird EPDM mit FDA, alternativ mit USP-Class VI und BSE-Freiheitsbescheinigung eingesetzt."
I have researched the USP-Class VI standard and I further believe that "BSE-Freiheitsbescheinigung " refers to certified absence of Bovine Spongiform Encephalopathy causing agents. What I do not understand is how EPDM as a synthetic rubber would be contaminated with BSE causing agents. I could understand if the seals were made from an animal-derived raw material but that is not the case here.
That's where we're headed. No more animal fats, but next time someone wants to steal your money, they need to kidnap you too. Not sure whether I should look forward to this.
thank you for your contributions - this was amazing to watch. I agree with the comment about sloppy or - perhaps - even incorrect writing of the source text. We as translators face such situations quite often. Still, my task here is not to use the translation to correct any inconsistencies of the source text but to convey 'the good, bad and ugly' of the source. I have gone with Rainer's suggestion as I think it conveys the source best. !Gracias a todos!
So, we're circling back. The EPDM is "ADI-free" but other stuff might not be. It's guaranteed BSE-free after being heated in autoclave or by never coming into contact with animal tissue to begin with. I don't know about "statement" if they are also mentioning FDA and USP __. Agree with the sloppy writing; I expected some hyphens and another comma in the source text.
Thus, it IS possible to have additives that contain ADIs. So while the "Dichtungswerkstoff" itself is ADI-free, the process to create the seals may include "Fettsäuren tierischen Ursprungs"!
So I think you're right that you should call it the former if it concerns the entire production process and the latter if it's about the material only. But you may still find both used.
Does that answer all questions? I hope, haha. Thank you for the discussion; it was very interesting and I do hope Peter hasn't given up on reading it in the meantime.
I suppose you mean this one here: "ALL IMPAK Corporation Oxygen Absorbers are manufactured completely from synthetic or manufactured materials and do not contain any raw materials produced from, or substances derived from animal origin. Moreover, these products are not derived from specific-risk materials as defined in European Commission Decision 97/534/EC.
The manufacturing process does not use any ingredient of animal origin nor do our products come in contact with animal products during storage and transportation.
We further declare that our products are Dioxin Free.
The UK one was: "Declaration that PPE elastomers contain no Animal Derived Ingredients (ADI) and are therefore BSE / TSE free with respect to source, manufacture and treatment." https://www.prepol.com/certificates
Both of those adress your concerns, do they not (e.g, storage/transportation)? This is why I'd say use either and explain it if you think it's necessary.
That info is very helpful. Actually, I am inconclusive about the proper translation. At the top of the endmillipore reference is "BSE/TSE Certification," followed by all of the ways they reduce contamination and risk. If you need assurance, you can obtain a "certificate" with the necessary info. "ADI-free" doesn't have the same reduction of contamination from other sources in the area implication. It pertains to the source and processing of the product only.
The Dutch company I linked to below said this: "The only product (compound) that is made manufactured with animal derived ingredients is NBR (buna). All other products such as EPDM, FKM, PTFE and Silicone are Animal Derived Ingredient free."
So unless Peter objects, I'd go for "ADI-free" because the German sentence is by one company only and someone just seemed to have messed up there. It's kind of like "shorthand" for what they really wanted to say.
"This mainly concerns drugs and vaccination shots" THIS is exactly what I was referring to.
"but contaminants can spread to other areas of the facility or during transport" They can't if the product doesn't even contain ADIs.
As you pointed out further below: "should only be a concern in cosmetics and maybe encapsulated pharmaceuticals."
+
"It wouldn't be impossible to use animal products in PDME synthesis, but I can't imagine anyone doing so"
So I wanted to make a link here, including your observations and concluding that this is about ADI-free (which is used by German companies too), which implies TSE/BSE-free, but is not the standard expression in the plastics industry.
"It is saying that a third party is testing and certifying the product" Yes, that's the concise explanation I didn't get to :)
Michael's answer is different. It is saying that a third party is testing and certifying the product... There is a term for in-house certification of a material, I think, but I can't remember it.
You are probably right about TSE/BSE. Your link to the Merck reference doesn't work for me. Merck and GlaxoSmithKline are two of the (German) companies that are under scrutiny by the FDA for using animal products from countries with high BSE risk. This mainly concerns drugs and vaccination shots, which should be tested, but contaminants can spread to other areas of the facility or during transport, etc. I'm fairly certain the "certificate" here is saying that the *risk* of contamination has been dealt with, and it does seem to be a piece of paper. "Pharmaceutial Industry: Certificates can be ordered for a broad range of products, both for production purposes as well as for laboratory use. They inform about the origin and, where applicable, the animal species, the type of tissue, the country of origin as well as the inactivating treatment." emdmillipore.com/US/en/support/regulatory-support/certification/bse-tse/nO.b.qB.ingAAAFAFPUQWSuk,nav
"Um das alimentäre und iatrogene Kontaminationsrisiko gering zu halten, muss Material mit einem BSE/TSE-Infektionsrisiko aus der menschlichen und tierischen Nahrungskette möglichst ausgeschlossen werden. Hierbei gilt es vor allem den Ursprung einer Substanz (synthetisch, mineralisch, vegetabil oder tierisch) zu berücksichtigen. Im Falle von Substanzen tierischen Ursprungs geschieht dies durch sorgfältige Beachtung der Herkunft (Tierspezies, Region oder Land) und durch inaktivierende Behandlungen (Temperatur, pH-Wert)." http://www.merck-performance-materials.com/de/candurin/regul...
If I read this correctly, this is again about products that may contain animal-derived ingredients, so they need to be tested and you need some kind of certificate of origin. But in this context(!), I see no reason to call it anything else than "ADI-free" because that's what EPDM is.
"I was wondering if the PDME was reused." - Good question. I have no idea.
To my last point in the first of the most recent posts: "The German term in question gets very few hits."
There are between 9 and 25 Ghits for "BSE-Freiheitsbescheinigung"--if you look closely, two of those are links to Peter's question and the others reference the exact same sentence in connection with the same product by the same company over and again. This means to me that this is not the right way to express it.
It's an international standard, thus originally in English and German companies won't really translate it. I don't find it helpful to say BSE to begin with because TSE and BSE are two different types of disease, aren't they? You need to exclude both by saying ADI-free.
One more explanation why my suggestion is indeed a different one: [see next d.box post]
I suppose we all make overly blunt comments... I was wondering if the PDME was reused. I agree that this is likely a "guarantee" of compliance by the manufacturer and not a "certification" by a certifying body.
This is not the same as Michael's answer. If I correctly understood the explanation at the link he gave, the products in cosmetics may contain bovine materials, just not "prohibited" ones. However, in this context, there aren't any, so there's no testing for BSE/TSE either.
American: "An additional requirement some of our O-Rings and materials meet is free from animal derived ingredients (ADI-free) [...] FDA CFR 21.177.2600 paragraphs A through D describe the relevant regulations for ‘Rubber articles intended for repeated use’. This lists the ingredients, and any quantitative limits, that may be used in a rubber compounds for molded products intended for repeated use in all stages of food manufacture, preparation and transportation.
FDA CFR 21.177.2600 paragraphs E and F also specify limits on extractible products if the FDA rubber seal is to be used in contact with aqueous or fatty foods. [...] It is important to note that for an FDA rubber material to be compliant to these requirements, and then this claim must be supported with appropriate documentation such as a manufacturer’s FDA Compliance Certificate.
FDA does not ‘approve’ products to CFR 21.177.2600. It is for the manufacturer of the finished FDA rubber product to demonstrate compliance by issuing a FDA certificate." http://www.marcorubber.com/medical-o-rings.htm
How about "ADI-free"? There's even a seal for that if I'm not mistaken. The German term in question gets very few hits.
I will apologize to Phil, since one of my posts below may have come across as a bit rude. Now I know why I wasn't comfortable with an explanation like his.
The point is not that they're testing whether something is free of BSE, but whether something is free of Animal Derived Ingredients = ADI. Otherwise, you could use ADIs if you tested them for carrying a risk of BSE - that makes little or no sense.
Cf German: "Animal Derived Ingredients können BSE hervorrufen und sind daher in Erzeugnissen zu vermeiden, die mit Produkten für den menschlichen Verzehr in Kontakt kommen. Dichtungswerkstoffe und Prozesshilfsstoffe können ADI enthalten. [...] kann jetzt eine größere Bandbreite an ADI-freien Werkstoffen anbieten." https://tss-static.com/remotemedia/media/globalformastercont...
UK: ADI-free Certificate "Declaration that PPE elastomers contain no Animal Derived Ingredients (ADI) and are therefore BSE / TSE free with respect to source, manufacture and treatment." https://www.prepol.com/certificates
I think your profound knowledge of chemistry is what led me to ask you for some explanation, so thanks a bunch. I may take a look at it again over the weekend, maybe I'm confused now. But I'll maintain that Phil's comment is missing the point; your "legal requirement" is, of course, a good way to approach the subject. I also agree with your last sentence.
I looked at your first reference again http://www.pharma-food.de/heikle-aufgaben-raue-bedingungen/ ... The mention of animal fatty acid derived raw materials is pertinent to being ADI-free and should only be a concern in cosmetics and maybe encapsulated pharmaceuticals. BSE is likely caused by prions, or pathogenic proteins, which can be destroyed under high temperature and pressure. The PDME rubber can withstand these conditions, but I no longer think that there is any connection with this being BSE-free here. I think that this is just a legal requirement, since the material is in contact with food. FDA approval covers the guarantee that there are no BSE causing agents in the product, but it may be faster and less costly to get USP... + BSE... certification, and I would call this a "certification," since a "certificate" is a piece of paper.
Thanks for posting that. It's how I thought they intended the first link I gave to be understood: "Über die Polymerisation können tierische Bestandteile [...] in die Werkstoffe gelangen."
It wouldn't be impossible to use animal products in PDME synthesis, but I can't imagine anyone doing so: https://www.tut.fi/ms/muo/vert/5_rubber_chemistry/SR_ethlene... The sources for the ethylene, propylene and diene are likely fossil fuels and/or living plants.
I wasn't entirely sure either, which is why I gave both options - certificate and statement. I may be overly cautious here, but I don't like using "certificate" unless it's at least "semi-official." Talk about deceiving customers and such.
That doesn't change the fact that the equation "synthetic rubber = BSE free" is missing the point. If there were no way any biological component could ever be used in combination with PDME (and, I think, there is: see the two links below), there would be no need for this kind of statement. Or do you have a certificate that your wooden clock is free of BSE contamination?
Phil said: "It's synthetic rubber, so it's BSE free."
Just because they're using EPDM doesn't mean you don't need a certificate/statement on BSE/TSE here. If turned on its head, Phil's statement would mean that they require a certificate regardless and that's neither logical nor apt.
Maybe this part wasn't clear?
"mit FDA, alternativ mit USP-Class VI und BSE-Freiheitsbescheinigung eingesetzt"
= either you got it approved by the FDA or you need USP Class VI and a BSE certificate (I assume "certificate" is more likely).
Well, the description is basically what Phil said. Are you trying to say that you don't need the certification if using this material (als... alternativ)? I agree a DE-DE classification is appropriate here.
Here's another reference: "Dies betrifft auch die Werkstoffe von Dichtungen, die in solchen Produktionsanlagen eingesetzt werden. Vielfach wurden hierfür in der Vergangenheit Zusatzstoffe wie Trennmittel, z. B. Stearate, Solvatisierungs- und Dispergierhilfsmittel oder Fettsäuren, die sowohl aus tierischer oder pflanzlicher Herstellung stammen können, eingesetzt. Nur wenn diese Substanzen nicht aus tierischer Produktion gewonnen werden, kann garantiert werden, dass sie frei von BSE-Erregern sind." http://prozesstechnik.industrie.de/chemie/anlagen-chemie/pas...
No offense to Michael, but I don't think it's wrong to point out that the question wasn't actually answered because it was just "skimmed through." This does happen to me as well, so it's not like I can't understand it.
The only other suggestion I could make is that you post this kind of question in DE-DE or EN-EN; there, it's about explanations only.
However, the statement Phil added to his agreement was--as Germans would say--"zu kurz gegriffen" and quite frankly, came across as a little insulting, even if that wasn't his intent.
Why would Germans, who want to be hypercorrect most of the time, insist on "oderly" classifications, and may use two separate words for what may look like the same technical process in English, be inclined to add a certificate just for the sake of having one?
This is like suggesting you need a TSE certificate for rollercoasters.
thank you for your contribution - that is definitely a very interesting link and I now can understand a possible route of contamination in the manufacturing process and that BSE certification might therefore be required for certain applications.
To be fair to Michael, he has proposed a translation and a correct one by the looks of it. I guess the way this "Ask question" forum is typically used is to get translations of terms. What I am after in this case is not so much the translation (I probably could have come up with it myself) but an explanation of the logic in the source text. I still think that using this forum for such questions is an appropriate use and thanks to your and other discussion entries we seem to be getting the question answered. I just wish I could award points for the most useful discussion entry.
I'm afraid your question hasn't been answered yet: "What I do not understand is how EPDM as a synthetic rubber would be contaminated with BSE causing agents."
Would the following do?
"Frei von tierischen Bestandteilen (ADI-free): Es wurden Rezepturen für Dichtungswerkstoffe entwickelt, die frei von tierischen Bestandteilen (ADI-free = free from Animal Derived Ingredients) sind. [...] Über die Polymerisation können tierische Bestandteile – zum Beispiel als Stearinsäure, sofern diese aus tierischen Fetten und Ölen gewonnen wird – in die Werkstoffe gelangen." http://www.pharma-food.de/heikle-aufgaben-raue-bedingungen/
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Answers
34 mins confidence: peer agreement (net): +1
BSE Certificate
Explanation: "A BSE Certificate issued by a cosmetic association, such as ACMA, declares that the products listed do not contain any prohibited materials and that the manufacturing process and packaging are equally free of contamination." http://www.acma.us/certificates/bovine-spongiform-encephalop...
Michael Martin, MA United States Local time: 19:33 Native speaker of: German, English PRO pts in category: 32
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peer agreement (net): +1
