Pharmaceutical Clean Room Classification
ブログネタ：一番好きな虫は？
参加中Pharmaceutical Clean Room Classification
EU GGMP
The most recent set of standards for use in Europe came into operation on the 1st of January 1997. This is contained in a ‘Revision of the Annex to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products’. The following is an extract of the information in the standard that is relevant to the design of clean rooms:
For the manufacture of sterile medicinal products four grades are given. The airborne particulate classification for these grades is given in the following table.
Notes:
(a) In order to reach the B, C and D air grades, the number of air changes should be related to the size of the room and the equipment and personnel present in the room. The air system should be provided with appropriate filters such as HEPA for grades A, B and C.
(b) The guidance given for the maximum permitted number of particles in the "at rest" condition corresponds approximately to the US Federal Standard 209E and the ISO classifications as follows: grades A and B correspond with class 100, M 3.5, ISO 5; grade C with class 10 000, M 5.5, ISO 7 and grade D with class 100 000, M 6.5, ISO 8.
(c) The requirement and limit for this area will depend on the nature of the operations carried out. The particulate conditions given in the table for the "at rest" state should be achieved in the unmanned state after a short "clean up" period of 15-20 minutes (guidance value), after completion of operations. The particulate conditions for grade A in operation given in the table should be maintained in the zone immediately surrounding the product whenever the product or open container is exposed to the environment. It is accepted that it may not always be possible to demonstrate conformity with particulate standards at the point of fill when filling is in progress, due to the generation of particles or droplets from the product itself. Examples of operations to be carried out in the various grades are given in the table below. (see also par. 11 and 12).
會呼吸的痛
ブログネタ：恋人に会うのは週何回がいい？
参加中在東京鐵塔 第一次眺望
看燈火模仿 墜落的星光
我終於到達 但卻更悲傷
一個人完成 我們的夢想
你總說 時間還很多 你可以等我
以前我不懂得 未必明天 就有以後
想念是會呼吸的痛 它活在我身上所有角落
哼你愛的歌會痛 看你的信會痛 連沈默也痛
遺憾是會呼吸的痛 它流在血液中來回滾動
後悔不貼心會痛 恨不懂你會痛 想見不能見最痛
沒看你臉上 張揚過哀傷
那是種多麼 寂寞的倔強
你拆了城牆 讓我去流浪
在原地等我 把自己捆綁
你沒說 你也會軟弱 需要倚賴我
我就裝不曉得 自由移動 自我地過
我發誓不再說謊了 多愛你就會抱你多緊的
我的微笑都假了 靈魂像飄浮著 你在就好了
我發誓不讓你等候 陪你做想做的無論什麼
我越來越像貝殼 怕心被人觸碰 你回來那就好了
能重來那就好了
C'est La Vie
ブログネタ：何色が似合う人になりたい？
参加中Ne laisse pas le temps,te décevoir...
....ll ne peut être conquis...
Dans la tristesse, dans la douleur...
Aujourd'hui, demain...
Au fil du temps... Le temps... C'est La Vie...
也許我會再遇見你 像戀人般重逢美麗
看你滿臉胡渣的笑意 爽朗一如往昔
C'est La Vie C'est La Vie C'est La Vie
走一個城市的陌生 走到了
曙光無知無覺的黎明
一路微笑的滿天繁星 消失在日出裏
C'est La Vie C'est La Vie C'est La Vie
oh 塞納馬恩省河的水 是心的眼淚
流過了你笑的 每個樣子(一去不回)
我會在你的記憶 看到我自己
看到了結局 愛在錯過後更珍惜
都將走向新的旅途 Au rev oir
說好不為彼此停留
看車窗外的你沈默不語 我不再哭泣
C'est La Vie C'est La Vie C'est La Vie
oh 塞納馬恩省河的水 是心的眼淚
流過了漂泊的 人生風景
願我們各自都有 美好的一聲
美好的憧憬 愛在遺憾裏更清晰