洗浄バリデーションとは？(EP抜粋含む)
薬物の交叉汚染や異物混入を防止する目的で必ず実施される。
（手順）
(1)洗浄後の製造装置から試料をサンプリング
(2)濃縮処理
(3)全有機体炭素計（TOC）や高速液体クロマトグラフィー（HPLC）などを用いた定量分析により，医薬品などの残留量を算出
(4)残留量を許容値と比較して適否判する
適否判定の際には，医薬品の薬効量や投与量，製造バッチのサイズ，装置サイズなど，さまざまな要因を考慮して許容値を設定することが必要になります。
「EP抜粋」
CLEANING VALIDATION
36. Cleaning validation should be performed in order to confirm the effectiveness
of a cleaning procedure. The rationale for selecting limits of carry over
of product residues, cleaning agents and microbial contamination should be
logically based on the materials involved. The limits should be achievable
and verifiable.
37. Validated analytical methods having sensitivity to detect residues or contaminants
should be used. The detection limit for each analytical method
should be sufficiently sensitive to detect the established acceptable level of
the residue or contaminant.
38. Normally only cleaning procedures for product contact surfaces of the
equipment need to be validated. Consideration should be given to noncontact
parts. The intervals between use and cleaning as well as cleaning and
reuse should be validated. Cleaning intervals and methods should be determined.
39. For cleaning procedures for products and processes which are similar, it is
considered acceptable to select a representative range of similar products and
processes. A single validation study utilising a “worst case” approach can
be carried out which takes account of the critical issues.
40. Typically three consecutive applications of the cleaning procedure should be
performed and shown to be successful in order to prove that the method is
validated.
41. "Test until clean". is not considered an appropriate alternative to cleaning
validation.
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42. Products which simulate the physicochemical properties of the substances to
be removed may exceptionally be used instead of the substances themselves,
where such substances are either toxic or hazardous.
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