复杂设备的擦拭取样问题

hyogazlin

APIC清洁验证指南中的一段话，看不懂，请教大神解释！

对于复杂的API设备，这种取样方法的缺点是，通过擦拭有些很难接触的地方可能不容易进行取样。然而这些地方对设备残留量的确定又是很关键的。

方程6：

M = (1 / WF) * (Ftot * Σ (Mi / Fi) / N) = (1 / WF) * (Ftot * Σ((Ci - CBi) / Fi) / N

M 应清洗的设备中残留量

WF 整个擦拭/分析方法的回收率（例如0.8）

Ftot 设备的内表面 ，单位dm2

Mi  样品中残留量，单位mg

Ci  样品中残留物的总量，单位mg

CBi 空白样品，单位mg。为了建立一个空白，按照擦拭取样的方法进行，只是不能擦拭被污染的表面。通常同一个空白可以用于所有的样品。

Fi 擦拭的面积，单位dm2

N  擦拭样品数

i  样品标示符（从1到n）

例外地，后面产品的第一个生产批次可以被取样，并对其杂质（前面的产品）进行分析。 通常采用色谱分析法（如HPLC,GC,TLC）.

标识

在这个特殊的取样方法中，在前面产品生产和清洗过程中，在设备的取样点都要印上“coins”（标识）。清洗后，对标识上的污染物进行分析。整个设备的污染物就根据标识上的污染物进行推断。对于定量，首先对标识进行擦拭，然后在对样品进行分析。

原文：
The disadvantage of this sampling method for the often complex API equipment is, that difficult to reach areas (e.g. sealings, slots, condensers, piping) may not be
accessible by swabbing. Nevertheless these areas may be the critical areas for the determination of the amount of residue in the equipment.
Equation 6:
M = (1 / WF) * (Ftot * Σ (Mi / Fi) / N) = (1 / WF) * (Ftot * Σ ((Ci - CBi) / Fi) / N
M   Amount of residue in the cleaned equipment in mg.
WF   Recovery rate for the whole chain swab/analytical method (e.g. 0.8 for 80%).
Ftot   The entire inner surface of the equipment in dm2.
Mi   Amount of residue (e.g. previous product) in the sample i in mg.
Ci   Gross amount of residue in the sample i in mg.
CBi   Blank of the sample i in mg. To establish the blank, a swab (or several swabs) can be treated in the similar way as a sampling swab except swabbing of the contaminated surface. Usually one and the same blank can be used for all N sampling swabs.
Fi   Area swabbed by the swab i in dm2.
N   Number of swab samples.
i   Sample identifier (current number from 1 to N).
Exceptionally the first production batch (placebo batch) of the following product (or  another placebo product) may be sampled and analyzed for impurities (for preceding
product). As analytical methods usually chromatographic methods will be used (e.g.HPLC, GC, TLC).
Stamps
In this exceptionally used sampling method, “coins“ (stamps) will be placed on appropriate sampling points in the equipment during the manufacturing of the
previous product and during cleaning. After cleaning the contamination of the coins will be analyzed. The overall equipment contamination will be calculated by extrapolation of the coin’s contamination to the whole equipment. For quantitation the coins may be first swabbed and the samples further analysed.

mini520

来看看的呢！！呵呵！

icedy

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