很多行業(yè)會使用無塵室，只要是小顆粒會對生產(chǎn)過程產(chǎn)生不利影響的地方都會有潔凈室的身影。它們的尺寸和復(fù)雜度各不相同，廣泛應(yīng)用于半導(dǎo)體制造，制藥，生物技術(shù)，醫(yī)療設(shè)備和生命科學(xué)等行業(yè)，以及航空航天，光學(xué)，軍事和能源部中常見的關(guān)鍵工藝制造。

對于用于無菌產(chǎn)品生產(chǎn)的潔凈室和潔凈空氣設(shè)備，需要按照GMP相關(guān)法規(guī)要求，去進行定期檢測或驗證，確保適當(dāng)?shù)臐崈舳人?，今天中邦興業(yè)小編，跟大家分享一下關(guān)于無菌產(chǎn)品生產(chǎn)的潔凈室和潔凈空氣設(shè)備驗證標(biāo)準(zhǔn)及要求。

Cleanrooms and clean air equipment such as unidirectional airflow units (UDAFs), RABS and isolators, used for the manufacture of sterile products, should be qualified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate environmental cleanliness level in the operational state in order to minimize the risk of contamination of the product or materials being handled. Appropriate cleanliness levels in the “at rest” and “operational” states should be maintained. 

用于無菌產(chǎn)品生產(chǎn)的潔凈室和潔凈空氣設(shè)備，如單向流單元（UDAF）、RABS 和隔離器，應(yīng)根據(jù)所要求的環(huán)境特性進行確認。每個生產(chǎn)操作都要求在動態(tài)條件下達到適當(dāng)?shù)沫h(huán)境潔凈度水平，最大程度降低所處理的產(chǎn)品或物料的污染風(fēng)險。應(yīng)維持“靜態(tài)”和“動態(tài)”下的適當(dāng)潔凈度水平。

Cleanrooms and clean air equipment should be qualified using methodology in accordance with the requirement. Cleanroom qualification (including classification) should be clearly differentiated from operational environmental monitoring.

 應(yīng)使用符合要求的方法對潔凈室和潔凈空氣設(shè)備進行確認。潔凈室確認（包括分級）應(yīng)與動態(tài)環(huán)境監(jiān)測明確區(qū)別開來。

Cleanroom and clean air equipment qualification is the overall process of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use. As part of the qualification requirements, the qualification of cleanrooms and clean air equipment should include (where relevant to the design/operation of the installation):

潔凈室和潔凈空氣設(shè)備的確認是評估分級的潔凈室或潔凈空氣設(shè)備與其預(yù)期用途的符合程度的整體過程。作為的確認要求的一部分，潔凈室和潔凈空氣設(shè)備的確認應(yīng)包括（與設(shè)施的設(shè)計/運行相關(guān)的）：

潔凈室和潔凈空氣設(shè)備的確認可參考 ISO 14644 系列標(biāo)準(zhǔn)。

Cleanroom classification is part of the cleanroom qualification and is a method of assessing the level of air cleanliness against a specification for a cleanroom or clean air equipment by measuring the total particle concentration. Classification activities should be scheduled and performed in order to avoid any impact on process or product quality. For example, initial classification should be performed during simulated operations and reclassification performed during simulated operations or during aseptic process simulation (APS). 

潔凈室分級是潔凈室確認的一部分，是一種根據(jù)潔凈室或潔凈空氣設(shè)備的標(biāo)準(zhǔn)通過測定總微粒濃度來評估空氣潔凈度水平的方法。分級活動的安排和執(zhí)行，應(yīng)避免對工藝或產(chǎn)品質(zhì)量產(chǎn)生任何影響。例如，應(yīng)在模擬操作期間進行初步分級，在模擬操作或無菌工藝模擬試驗（APS）期間進行再分級。

For cleanroom classification, the total of particles equal to or greater than 0.5 and 5 μm should be measured. This measurement should be performed both at rest and in simulated operations in accordance with the limits specified.

對于潔凈室分級，應(yīng)測定等于或大于0.5μm 和 5μm 的微?？倲?shù)。應(yīng)按照規(guī)定的限度，在靜態(tài)和模擬操作中進行測定。