Talk:Depyrogenation

Student Project Dec 4-15, 2006

This article is part of a student project on Downstream_processing. Please do not edit until after December 14, 2006. Thank you. (The preceding unsigned comment was made by Jhsuosu on 12:19, 4 December 2006. )

Thanks Jon. This article on Depyrogenation is being created by Jhsuosu as part of a WP:SUP student project on Downstream_processing at Cornell University. The article is slated for scientific peer review by the user's classmates and instructor over the next two weeks and will be finalized (for the purposes of the class) by 15 Dec 2006.

If you would like to help, please hold off from the normal "bold editing" process until after December 15, and instead leave comments and suggestions for Jhsuosu here on the article discussion page. Your thoughtful review will be very much appreciated!

Jean Hunter, instructor, BEE 464 susato 18:47, 4 December 2006 (UTC)

Reviews

Hey Jon, I read your article and it looks really good. I just found a few things you may want to look at (more on mechanics of the paper, not content) Some of the words/concepts in the paper may not be easily understood buy someone with no background in biology/microbiology so maybe more of the terms should be linked. For example: link anion exchange which goes to ion-exchange...you could link colorimeter, lipid, polysaccharide and so on just to make it more understandable.

Also, the internal pyrogen link produces the message "This disambiguation page lists articles associated with the same title. If an internal link led you here, you may wish to change the link to point directly to the intended article." So maybe you could add a blurb on pyrogens or redirect it. All the concepts/content looks nice. Good job!

Priya Shoor 17:11, 6 December 2006 (UTC)

Hey Jon, seems like you fixed the broken links so thats good. I thought your article flowed well and you broke down the different parts in an organized way. I remember in your presentation due to time, you didnt get to address all the points you made in your slides so maybe you could incorporate some of those things in your article. You have a good summary right now but it wouldnt hurt to elaborate on the content if you already have the info from your slides at your disposal. Overall well written and organized though :)

Snickerr291 20:46, 7 December 2006 (UTC)

Hey Jon, I really like your writing style—very clear and to the point, which is very appropriate for wikipedia. Another real strength of your article is the organization. The way you broke down your subject makes a lot of sense, and makes the article easy to read and understand. I would suggest adding a diagram of an LPS molecule (like the one from your presentation). This would really help with the beginning of the Inactivation/destruction section because the reader would be able to visualize how the molecule is being cleaved. You could also maybe expand the last section on prevention, as there is only one sentence on how prevention can be done. Perhaps you can describe each one in a little more detail with a phrase or quick sentence. Also, have you considered a more specific title for the first section “Limits”? I know what you mean by the title, but since your article is on depyrogenation, the reader might think you’re talking about depryogenation limits. Overall, great article and great writing style.

Wwc26 03:38, 8 December 2006 (UTC)

Hi jon, great article. I really liked your content and the amount of detail you went into it without being to confusing. I also thought that it was well organization. You had a great presentation during class, so i would suggest to incorporate of the pictures and diagrams into the article. Another suggestion is to expand the removal process into slightly more detail. Great job!

Emk39 20:16, 8 December 2006 (UTC)

Jon - good article overall, but I have a correction. Autoclaving is not a depyrogenation method. The standard of 250 °C for 30 minutes occurs in a dry heat oven, and is not suitable for depyrogenation of solutions. Autoclaves typically operate at 121 °C (250 °F), and are used for sterilization only. Also, you should note that in the biotech and pharmaceutical industries, depyrogenation processes are often used for primary packaging (vials) for parenteral solutions.

Comment by User:anonymous reader 30 Jan 2012 (responsible for endotoxin testing in pharmaceutical company): In the section "Maximum acceptable endotoxin level" the allowed EU are wrongly defined. kg ist not kg product but kg body weight. It has to be acc. to USP chapter <85> Bacterial endotoxin test:

Endotoxin Limit— The endotoxin limit for parenteral drugs, defined on the basis of dose, equals K/M2, where K is a threshold pyrogenic dose of endotoxin per kg of body weight, and M is equal to the maximum recommended bolus dose of product per kg of body weight. When the product is to be injected at frequent intervals or infused continuously, M is the maximum total dose administered in a single hour period. The endotoxin limit for parenteral drugs is specified in the individual monograph in units such as EU/mL, EU/mg, EU/Unit of biological activity, etc.

K is 5 USP-EU/kg for any route of administration other than intrathecal (for which K is 0.2 USP-EU/kg body weight). For radiopharmaceutical products not administered intrathecally, the endotoxin limit is calculated as 175/V, where V is the maximum recommended dose in mL. For intrathecally administered radiopharmaceuticals, the endotoxin limit is obtained by the formula 14/V. For formulations (usually anticancer products) administered on a per square meter of body surface, the formula is K/M, where K = 5 EU/kg and M is the (maximum dose/m2/hour × 1.80 m2)/70 Kg. — Preceding unsigned comment added by 195.244.232.250 (talk) 15:28, 30 January 2012 (UTC)

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