洁净室空调系统为什么用纯蒸汽加湿？

nemochenyb

今天翻帖子，一不小心刨出一个老坑来：
https://www.ouryao.com/thread-306972-1-1.html  空调加湿用纯蒸汽是否应该取样检测
在原帖中也没看到大家聊的多透彻，一时手痒，开个贴和大家聊聊（已经懂的老鸟请回避，能看出我是菜鸟的可以扔砖继续砸）：


我们常规理解的纯蒸汽是工艺用纯蒸汽，是以纯化水为原料，制备的蒸汽，纯蒸汽指标主要包括两部分：一是冷凝水需要符合注射用水的标准；二是不凝性气体、干度、过热度指标要合格。

空调加湿用的纯蒸汽明显没必要监控这么多指标，所以也不用这么豪华配置，而且为了避免交叉污染，也不建议在你的工艺纯蒸汽管路上引过来一个用点。简单的做法就是在空调机房安装一个小型的蒸汽发生器（可以考虑使用工业蒸汽，用换热的方式加热纯化水，或电加热），制备蒸汽就够了。这里的纯蒸汽指的是去除了工业蒸汽中的杂质（天然水本身杂质，以及添加的除垢、防锈等作用的添加剂）。

顺着标准往前追，为什么大家会提到用纯蒸汽加湿呢？有法规依据吗？谁对这个了解的多一些？这个卖个关子，原谅我先不曝光我找到的标准了。

cj619

关键性HVAC系统加湿用纯蒸汽，防止蒸汽中有胺类和肼类杂质，会严重污染药品。非关键性HVAC系统加湿可以用工业蒸汽。但是要求在每一种情况下用特定的蒸汽比较麻烦，所以部分企业会选择质量标准更高的纯蒸汽来代替工业蒸汽

截竹为笛

加湿后的空气要进入洁净区，对微生物限度有要求，当然要用纯蒸汽啊

lailiang

工业蒸汽中一般有添加物，而且这些都是不可知的，从无菌的角度来说用纯蒸汽更合适，但是加湿的量非常大（当然看当地的气候），投入是个问题。

紫幻剑雨888

说实话我们之前用的是工业蒸汽，但是后来一次国外检查，人家提出不合适，就改了，但是真没查查哪里的标准和出处。

小小男人

有标准吗？

leasua

因为纯蒸汽冷凝后就是纯化水，你平时打扫卫生用的是纯化水吧

nemochenyb

leasua 发表于 2017-5-24 23:01
因为纯蒸汽冷凝后就是纯化水，你平时打扫卫生用的是纯化水吧

这是一个好思路暂且看看还有没有人站出来继续分析

joshua

领导好学求知！ 好榜样

nemochenyb

好久不发帖，自己回来填填坑，供各位参考讨论：

2011-45-WHO TRS 961-Annex5-非无菌制剂暖通空调GMP补充指南：

4.9.9 Humidifiers should be avoided if possible as they may become a source of contamination (e.g. microbiological growth). Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification.
应尽可能避免使用加湿器，因为加湿器可能成为污染的来源（例如，微生物滋生）。如果需要加湿装置，则应采用适当的方式，如蒸汽注射进入空气流。应进行产品污染评估，确定加湿器是否需要使用纯蒸汽或洁净蒸汽。
4.9.10 Where steam humidifiers are used, chemicals such as corrosion inhibitors or chelating agents, which could have a detrimental effect on the product, should not be added to the boiler system. Only appropriate additives should be added to the boiler system.
如果使用蒸汽器，化学的例如防腐蚀剂或螯合剂，可能会对产品产生不利影响，不应加入锅炉系统。只有适当的添加剂才可以加入锅炉系统。

对于锅炉用水，FDA 21CFR专门有一个章节规定了锅炉用水添加剂含量限值，我忘记章节编号了，熟悉21CFR的谁给补充下。

beiwei5du

nemochenyb 发表于 2017-9-15 15:53
好久不发帖，自己回来填填坑，供各位参考讨论：

2011-45-WHO TRS 961-Annex5-非无菌制剂暖通空调GMP补 ...

§173.310   Boiler water additives.

Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions:

(a) The amount of additive is not in excess of that required for its functional purpose, and the amount of steam in contact with food does not exceed that required to produce the intended effect in or on the food.

(b) The compounds are prepared from substances identified in paragraphs (c) and (d) of this section, and are subject to the limitations, if any, prescribed:

(c) List of substances:

Substances	Limitations
Acrylamide-sodium acrylate resin	Contains not more than 0.05 percent by weight of acrylamide monomer.
Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copolymer having a minimum weight average molecular weight of 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS”	Total not to exceed 20 parts per million (active) in boiler feedwater.
Ammonium alginate
Cobalt sulfate (as catalyst)
1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4) and its sodium and potassium salts
Lignosulfonic acid
Monobutyl ethers of polyethylene-polypropylene glycol produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol	Minimum mol. wt. 1,500.
Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. 71050-62-9), produced from a 4:1 to a 16:1 mixture by weight of acrylic acid and sodium hypophosphite	Total not to exceed 1.5 parts per million in boiler feed water. Copolymer contains not more than 0.5 percent by weight of acrylic acid monomer (dry weight basis).
Polyethylene glycol	As defined in §172.820 of this chapter.
Polymaleic acid [CAS Reg. No. 26099-09-2], and/or its sodium salt. [CAS Reg. No. 30915-61-8 or CAS Reg. No. 70247-90-4]	Total not to exceed 1 part per million in boiler feed water (calculated as the acid).
Polyoxypropylene glycol	Minimum mol. wt. 1,000.
Potassium carbonate
Potassium tripolyphosphate
Sodium acetate
Sodium alginate
Sodium aluminate
Sodium carbonate
Sodium carboxymethylcellulose	Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 °C; by the “Viscosity of Cellulose Gum” method prescribed in the Food Chemicals Codex, pp. 1128-1129.
Sodium glucoheptonate	Less than 1 part per million cyanide in the sodium glucoheptonate.
Sodium hexametaphosphate
Sodium humate
Sodium hydroxide
Sodium lignosulfonate
Sodium metabisulfite
Sodium metasilicate
Sodium nitrate
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate
Sodium polymethacrylate
Sodium silicate
Sodium sulfate
Sodium sulfite (neutral or alkaline)
Sodium tripolyphosphate
Sorbitol anhydride esters: A mixture consisting of sorbitan monostearate as defined in §172.842 of this chapter; polysorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as defined in §172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, pp. 825-827.	The mixture is used as an anticorrosive agent in steam boiler distribution systems, with each component not to exceed 15 milligrams per kilogram in the steam.
Tannin (including quebracho extract)
Tetrasodium EDTA
Tetrasodium pyrophosphate

(d) Substances used alone or in combination with substances in paragraph (c) of this section:

Substances	Limitations
Cyclohexylamine	Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
Diethylaminoethanol	Not to exceed 15 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
Hydrazine	Zero in steam.
Morpholine	Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
Octadecylamine	Not to exceed 3 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
Trisodium nitrilotriacetate	Not to exceed 5 parts per million in boiler feedwater; not to be used where steam will be in contact with milk and milk products.

(e) To assure safe use of the additive, in addition to the other information required by the Act, the label or labeling shall bear:

(1) The common or chemical name or names of the additive or additives.

(2) Adequate directions for use to assure compliance with all the provisions of this section.

(f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:

(i) “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS” (October 23, 1987).

(ii) [Reserved]

(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):

(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.

(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827.

[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, June 1, 1999; 78 FR 71466, Nov. 29, 2013]

Need assistance?

贝克汉豆

我们这有个韩国的企业就采用纯蒸汽加湿，对于这种做法除了有钱还能说什么。

lengyuehan7

beiwei5du 发表于 2018-2-1 21:09
§173.310   Boiler water additives.Boiler water additives may be safely used in the preparation of ...

请问这个出处在哪里啊

wys22639

lengyuehan7 发表于 2018-12-12 13:57
请问这个出处在哪里啊

楼上已经说了：
FDA 21CFR专门有一个章节规定了锅炉用水添加剂含量限值，我忘记章节编号了，熟悉21CFR的谁给补充下。
当然是FDA-21CFR 173.310章节

负重爬行

leasua 发表于 2017-5-24 23:01
因为纯蒸汽冷凝后就是纯化水，你平时打扫卫生用的是纯化水吧

确定纯蒸汽冷凝后是纯化水?

poppy铛铛

纯蒸汽冷凝后不应该是注射用水么？

十二月的雪

nemochenyb 发表于 2017-9-15 15:53
好久不发帖，自己回来填填坑，供各位参考讨论：

2011-45-WHO TRS 961-Annex5-非无菌制剂暖通空调GMP补 ...

这个是独立的加湿器，不是指AHU系统，不要搞混了。

乌托邦1

工业蒸汽一般以饮用水为原料，大概是因为工业蒸汽洁净度不够，会影响洁净室的洁净度？

乌托邦1

刚看了下资料，不必要用纯蒸汽给洁净室空调系统加湿，用工业蒸汽中的无化学添加蒸汽即可。

浦发精英喙公主

乌托邦1 发表于 2019-6-17 21:36
刚看了下资料，不必要用纯蒸汽给洁净室空调系统加湿，用工业蒸汽中的无化学添加蒸汽即可。

请问哪里的资料，可以反驳这个纯蒸汽论。真心求教。谢谢啊

乌托邦1

浦发精英喙公主 发表于 2019-6-20 15:09
请问哪里的资料，可以反驳这个纯蒸汽论。真心求教。谢谢啊

张功臣老师的制药蒸汽系统