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          您的位置:首頁 >> 資訊 >> 主編視角 >> 淺析2022版歐盟GMP附錄《無菌藥品的生產》中無菌藥品常見術語

          淺析2022版歐盟GMP附錄《無菌藥品的生產》中無菌藥品常見術語

          http://www.shima-uma.com   2022-08-30 17:07 來源:CPHI制藥在線 作者:滴水司南

          2022年8月25日,由歐盟牽頭,WHO和PIC/S參加修訂的《無菌產品生產》正式發布(成文時間2022年8月22日),2023年8月25日生效,其中第8.123條的最后實施期限為2024年8月25日。這部法規的修訂和實施,必將對國內外無菌制藥行業產生深遠影響。筆者整理了《無菌藥品的生產》中無菌藥品常見術語,本文中文譯文,僅供參考。

                 歐盟GMP附錄《無菌藥品的生產》長期以來一直是無菌藥品制造企業的GMP圣經,中國無菌藥品自上版發布以來已經過去了10多年,面對日益更新的制造技術水平,當前無菌附錄的更新勢在必行。2022年8月25日,由歐盟牽頭,WHO和PIC/S參加修訂的《無菌產品生產》正式發布(成文時間2022年8月22日),2023年8月25日生效,其中第8.123條的最后實施期限為2024年8月25日。這部法規的修訂和實施,必將對國內外無菌制藥行業產生深遠影響。筆者整理了《無菌藥品的生產》中無菌藥品常見術語,本文中文譯文,僅供參考。

                 一、歐盟GMP vs中國GMP附錄1章節內容框架

                 2022版歐盟GMP附錄《無菌藥品的生產》與2011年版中國GMP附錄《無菌藥品》的章節內容框架是大部分章節可找到相應的對照關系,歐盟GMP附錄共11章295條款,2011年版中國GMP附錄《無菌藥品》共15章81條款,梳理如下表:

          2022版歐盟GMP附錄《無菌藥品的生產》

          2011年版中國GMP附錄《無菌藥品》

          共11章295條款

          共15章81條款

          1.Scope范圍

          第一章范圍

          2.Principle原則

          第二章原則

          3.Pharmaceutical Quality System(PQS)制藥質量體系PQS

          /

          4.Premise設施

          第七章廠房

          第四章隔離操作技術(部分)

          5.Equipment設備

          第八章設備

          6.Utilities公用系統

          /

          7.Personnel人員

          第六章人員

          8.Production and specific technologies生產和特定技術

          第四章隔離操作技術(部分)

          第五章吹灌封技術

          第九章消毒

          第十章生產管理

          第十一章滅菌工藝

          第十二章滅菌方法

          第十三章無菌藥品的最終處理

          9.Environmental and process monitoring環境和工藝監測

          第三章潔凈度級別及監測

          10.Quality control(QC)質量控制(QC)

          第十四章質量控制

          11.Glossary術語

          第十五章術語

                 二、《無菌藥品的生產》高頻詞分析

                 在2022版歐盟GMP附錄《無菌藥品的生產》涉及的關鍵術語中,"Cleanroom-潔凈室"是出現頻次最高的詞語,高達91次。此外Aseptic preparation/processing-無菌制備/加工 58次、Aseptic Process Simulation(APS)-無菌過程模擬(APS) 53次、Contamination Control Strategy(CCS)-污染控制策略(CCS) 51次、Sterile Product-無菌產品 48次、Isolator-隔離器 48次、Operator-操作員 35次、Pyrogen-熱原 32次、Disinfection-消毒 31次、Endotoxin-內毒素 29次、Cleaning-清潔 29次、Restricted Access Barrier System(RABS)-限制進入屏障系統(RABS) 27次、Critical zone-關鍵區域 25次、Unidirectional airflow-單向氣流 22次、Airlock-氣閘 20次、Bioburden-生物負荷 19次,在2022版歐盟GMP附錄《無菌藥品的生產》備受關注,初步統計如下表。

          關鍵詞

          頻數

          Cleanroom - 潔凈室

          91

          Aseptic preparation/processing - 無菌制備/加工

          58

          Aseptic Process Simulation (APS) - 無菌過程模擬 (APS)

          53

          Contamination Control Strategy (CCS) - 污染控制策略 (CCS)

          51

          Sterile Product - 無菌產品

          48

          Isolator - 隔離器

          48

          Operator - 操作員

          35

          Pyrogen - 熱原

          32

          Disinfection - 消毒

          31

          Endotoxin - 內毒素

          29

          Cleaning - 清潔

          29

          Restricted Access Barrier System (RABS) - 限制進入屏障系統 (RABS)

          27

          Critical zone - 關鍵區域

          25

          Unidirectional airflow -單向氣流

          22

          Airlock -氣閘

          20

          Bioburden - 生物負荷

          19

          Sterilising grade filter - 滅菌級過濾器

          18

          Decontamination - 去污

          18

          Bio-decontamination - 消毒

          18

          Single Use Systems (SUS) -一次性使用系統 (SUS)

          17

          Colony Forming Unit (CFU) - 菌落形成單位 (CFU)

          17

          Alert level - 警戒限

          17

          Barrier - 隔離技術

          16

          Lyophilization - 凍干

          15

          Gowning qualification - 更衣確認

          15

          Blow-Fill-Seal (BFS) - 吹灌封技術

          15

          Action limit -行動限

          15

          Manual aseptic processing- 手動無菌處理

          14

          Closed system - 密閉系統

          12

          Worst case - 最差情形

          11

          Form-Fill-Seal (FFS) -成型-灌裝-密封 (FFS)

          10

          Clean area -潔凈區

          10

          Water system -水系統

          9

          Terminal Sterilisation - 終端滅菌

          8

          Parison - 半成品

          8

          Grade A air supply -A 級送風

          7

          First Air - 首過空氣

          7

          Biological Indicators (BI) - 生物指示劑

          7

          Patient - 患者

          6

          Pass-through hatch - 傳遞艙

          6

          Intrinsic sterile connection device - 內在無菌連接裝置

          6

          Cleanroom classification - 潔凈室分類

          6

          D-value - D

          5

          Depyrogenation -去熱原

          5

          Critical intervention - 關鍵干預

          5

          Contamination - 污染

          5

          Cleanroom qualification - 潔凈室確認

          5

          Turbulent airflow - 湍流

          4

          Raw material - 原材料

          4

          HEPA filter - HEPA 過濾器

          4

          Critical surfaces - 關鍵表面

          4

          Classified area - 分類區域

          4

          Bacterial retention testing -細菌截留測試

          4

          Sporicidal agent - 殺孢子劑

          3

          Post-aseptic processing terminal heat treatment- 無菌加工后終端熱處理

          3

          Leachables - 浸出物

          3

          Isokinetic sampling head - 等速采樣頭

          3

          Filter Integrity test -過濾器完整性測試

          3

          Asepsis - 無菌

          3

          Z-value - Z

          2

          Unidirectional Airflow (UDAF) unit - 單向氣流 (UDAF) 單元

          2

          Rapid Transfer System/Port (RTP) - 快速轉移系統/端口 (RTP)

          2

          Overkill sterilisation - 過度殺滅滅菌

          2

          Local isolates - 本地分離物

          2

          Inherent interventions - 常規干預

          2

          Extractables - 可提取物

          2

          Equilibration time - 平衡時間

          2

          Decommission - 報廢

          2

          Dead leg - 死角

          2

          Corrective intervention - 糾正性干預

          2

          Campaign manufacture - 連續生產

          2

                 三、《無菌藥品的生產》關于無菌藥品術語分享

                 歐盟GMP指南的附錄1 "無菌藥品的生產"被視為無菌藥品生產領域最權威的歐洲監管標準,在2022版歐盟 GMP 附錄《無菌藥品的生產》總共有71個關鍵術語,本文羅列了附錄中71個關鍵術語中英文對照及其定義,以方便制藥人查閱和學習無菌藥品相關知識。

          關鍵術語

          Airlock - An enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an airlock is to preclude ingress of particle matter and microorganism contamination from a lesser controlled area.

          氣閘 - 帶有互鎖門的封閉空間,用于保持相鄰房間之間的氣壓控制(通常具有不同的空氣清潔度標準)。氣閘的目的是防止顆粒物質和微生物污染從控制較少的區域進入。

          Action limit - An established relevant measure (e.g. microbial, or airborne particle limits) that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.

          行動限 - 既定的相關措施(例如微生物或空氣中的顆粒物限制),當超過該限制時,應觸發適當的調查和基于調查的糾正措施。

          Alert level - An established relevant measure (e.g. microbial, or airborne particle levels) giving early warning of potential drift from normal operating conditions and validated state, which does not necessarily give grounds for corrective action but triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are established based on routine and qualification trend data and are periodically reviewed. The alert level can be based on a number of parameters including adverse trends, individual excursions above a set limit and repeat events.

          警戒限 - 一種既定的相關措施(例如微生物或空氣中的顆粒物水平),對從正常操作條件和驗證狀態的潛在漂移發出早期警告,不一定為糾正措施提供理由,但會觸發適當的審查和后續行動以解決問題潛在的問題。警戒限是根據常規和確認趨勢數據建立的,并定期進行審查。警報級別可以基于多個參數,包括不利趨勢、超出設定限制的個別偏移和重復事件。

          Aseptic preparation/processing - The handling of sterile product, containers and/or devices in a controlled environment in which the air supply, materials and personnel are regulated to prevent microbial, endotoxin/pyrogen and particle contamination.

          無菌制備/加工——在受控環境中處理無菌產品、容器和/或裝置,在該環境中對空氣供應、材料和人員進行監管,以防止微生物、內毒素/熱原和顆粒污染。

          Aseptic Process Simulation (APS) - A simulation of the entire aseptic manufacturing process in order to verify the capability of the process to assure product sterility. Includes all aseptic operations associated with routine manufacturing, e.g. equipment assembly, formulation, filling, lyophilization and sealing processes as necessary.

          無菌過程模擬 (APS) - 整個無菌生產過程的模擬,以驗證該過程確保產品無菌的能力。包括與常規生產相關的所有無菌操作,例如必要時進行設備組裝、配制、灌裝、凍干和密封過程。

          Asepsis - A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbial contamination of the exposed sterile product.

          無菌 - 通過使用無菌工作區域并以排除暴露的無菌產品的微生物污染的方式進行活動而獲得的控制狀態。

          Bacterial retention testing - This test is performed to validate that a filter can remove bacteria from a gas or liquid. The test is usually performed using a standard organism, such as Brevundimonas diminuta at a minimum concentration of 107 Colony Forming Units/cm2.

          細菌截留測試- 執行此測試以驗證過濾器是否可以從氣體或液體中去除細菌。該測試通常使用標準生物體進行,例如最小濃度為 107 個菌落形成單位/cm2 的缺陷短波單胞菌。

          Barrier - A physical partition that affords aseptic processing area (usually grade A) protection by separating it from the background environment. Such systems frequently use in part or totally the Barrier Technologies known as RABS or isolators.

          隔離技術 - 通過將無菌處理區(通常為 A 級)與背景環境隔開來提供無菌處理區(通常為 A 級)保護的物理分區。此類系統經常部分或全部使用稱為 RABS 或隔離器的屏障技術。

          Bioburden - The total number of microorganisms associated with a specific item such as personnel, manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, or finished products.

          生物負荷 - 與特定項目相關的微生物總數,例如人員、生產環境(空氣和表面)、設備、產品包裝、原材料(包括水)、加工材料或成品。

          Bio-decontamination - A process that eliminates viable bioburden via use of sporicidal chemical agents.

          消毒 - 通過使用殺孢子化學試劑消除可行生物負載的過程。

          Biological Indicators (BI) - A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closure) and placed within a steriliser or load or room locations to determine the sterilisation or disinfection cycle efficacy of a physical or chemical process. The challenge microorganism is selected and validated based upon its resistance to the given process. Incoming lot D-value, microbiological count and purity define the quality of the BI.

          生物指示劑 (BI) - 接種到合適介質(例如溶液、容器或封閉物)上并放置在滅菌器或負載或房間位置的微生物群,以確定物理或化學過程的滅菌或消毒循環效率。挑戰微生物是根據其對給定過程的抗性來選擇和驗證的。進貨批次 D 值、微生物計數和純度決定了 BI 的質量。

          Blow-Fill-Seal (BFS) - A technology in which containers are formed from a thermoplastic granulate, filled with product, and then sealed in a continuous, integrated, automatic operation. The two most common types of BFS machines are the Shuttle type (with Parison cut) and the Rotary type (Closed Parison).

          吹灌封技術(BFS) - 一種技術,其中容器由熱塑性顆粒制成,填充產品,然后在連續、集成、自動操作中密封。兩種最常見的 BFS 機器類型是梭式(帶型坯切割)和旋轉型(封閉型坯)。

          Campaign manufacture - A manufacture of a series of batches of the same product in sequence in a given period of time with strict adherence to established and validated control measures.

          連續生產 - 在給定的時間段內按順序生產一系列批次的相同產品,并嚴格遵守既定且經過驗證的控制措施。

          Classified area - An area that contains a number of cleanrooms (see cleanroom definition).

          分類區域 - 包含多個潔凈室的區域(參見潔凈室定義)。

          Cleaning - A process for removing contamination e.g. product residues or disinfectant residues.

          清潔 - 去除污染物的過程,例如產品殘留物或消毒劑殘留物。

          Clean area - An area with defined particle and microbiological cleanliness standards usually containing a number of joined cleanrooms.

          潔凈區 - 具有明確的顆粒和微生物潔凈度標準的區域,通常包含多個相連的潔凈室。

          Cleanroom - A room designed, maintained, and controlled to prevent particle and microbial contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness level.

          潔凈室——設計、維護和控制以防止藥物產品受到顆粒和微生物污染的房間。這樣的房間被分配并且可重復地滿足適當的空氣清潔度水平。

          Cleanroom classification - 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.

          潔凈室分類 - 一種通過測量總顆粒濃度來根據潔凈室或潔凈空氣設備規范評估空氣潔凈度水平的方法。

          Cleanroom qualification - A method of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use.

          潔凈室確認 - 一種評估分類潔凈室或潔凈空氣設備是否符合其預期用途的方法。

          Closed system - A system in which the product is not exposed to the surrounding environment. For example, this can be achieved by the use of bulk product holders (such as tanks or bags) that are connected to each other by pipes or tubes as a system, and where used for sterile products, the full system is sterilised after the connections are made. Examples of these can be (but are not limited to) large scale reusable systems, such as those seen in active substance manufacturing, or disposable bag and manifold systems, such as those seen in the manufacture of biological products. Closed systems are not opened until the conclusion of an operation. The use of the term “closed systems” in this Annex does not refer to systems such as RABS or isolator systems.

          密閉系統 - 產品不暴露于周圍環境的系統。例如,這可以通過使用通過管道或管子相互連接的散裝產品支架(例如罐或袋子)作為一個系統來實現,并且在用于無菌產品的情況下,整個系統在連接后進行消毒被制作。這些示例可以是(但不限于)大規??芍貜褪褂孟到y,例如在活性物質生產中看到的那些,或一次性袋子和歧管系統,例如在生物產品生產中看到的那些。在操作結束之前,封閉的系統不會打開。本附錄中使用的術語“封閉系統”并不指 RABS 或隔離系統等系統。

          Colony Forming Unit (CFU) - A microbiological term that describes a single detectable colony that originates from one or more microorganisms. Colony forming units are typically expressed as CFU per ml for liquid samples, CFU per m3 for air sample and CFU per sample for samples captured on solid medium such as settle or contact plates.

          菌落形成單位 (CFU) - 一個微生物學術語,描述源自一種或多種微生物的單個可檢測菌落。對于液體樣品,菌落形成單位通常表示為每毫升 CFU,對于空氣樣品,每立方米 CFU,對于在固體介質(如沉降或接觸板)上捕獲的樣品,菌落形成單位通常表示為每樣品 CFU。

          Contamination - The undesired introduction of impurities of a microbiological nature (quantity and type of microorganisms, pyrogen), or of foreign particle matter, into or onto a raw material, intermediate, active substance or drug product during production, sampling, packaging or repackaging, storage or transport with the potential to adversely impact product quality.

          污染 - 在生產、取樣、包裝或重新包裝過程中,將微生物性質的雜質(微生物的數量和類型、熱原)或外來顆粒物質不希望地引入原材料、中間體、活性物質或藥物產品中或之上,可能對產品質量產生不利影響的儲存或運輸。

          Contamination Control Strategy (CCS) - A planned set of controls for microorganisms, endotoxin/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.

          污染控制策略 (CCS) - 一套針對微生物、內毒素/熱原和顆粒的計劃控制,源自對當前產品和工藝的理解,可確保工藝性能和產品質量??刂瓶梢园ㄅc活性物質、賦形劑和藥品材料和組件、設施和設備操作條件、過程控制、成品規格以及相關的監測和控制方法和頻率相關的參數和屬性。

          Corrective intervention - An intervention that is performed to correct or adjust an aseptic process during its execution. These may not occur at a set frequency in the routine aseptic process. Examples include such as clearing component jams, stopping leaks, adjusting sensors, and replacing equipment components.

          糾正性干預——在執行過程中糾正或調整無菌過程的干預。這些可能不會在常規無菌過程中以設定的頻率發生。示例包括清除組件堵塞、停止泄漏、調整傳感器和更換設備組件。

          Critical surfaces - Surfaces that may come directly into contact with, or directly affect, a sterile product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing.

          關鍵表面 - 可能直接接觸或直接影響無菌產品或其容器或封閉件的表面。關鍵表面在生產操作開始前進行無菌處理,并在整個加工過程中保持無菌狀態。

          Critical zone - A location within the aseptic processing area in which product and critical surfaces are exposed to the environment.

          關鍵區域——無菌加工區內產品和關鍵表面暴露于環境中的位置。

          Critical intervention - An intervention (corrective or inherent) into the critical zone.

          關鍵干預 - 對關鍵區域的干預(糾正或固有)。

          D-value - The value of a parameter of sterilisation (duration or absorbed dose) required to reduce the number of viable organisms to 10 per cent of the original number.

          D 值 - 將活生物的數量減少到原始數量的 10% 所需的滅菌參數值(持續時間或吸收劑量)。

          Dead leg - Length of non-circulating pipe (where fluid may remain static) that is greater than 3 internal pipe diameters.

          死角 - 大于 3 個內部管道直徑的非循環管道(流體可能保持靜止)的長度。

          Decommission - When a process, equipment or cleanroom are closed and they will not be used again.

          報廢  - 當工藝、設備或潔凈室關閉且不再使用時。

          Decontamination - The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms) from an area, object, or person. The method of decontamination used (e.g. cleaning, disinfection, sterilisation) should be chosen and validated to achieve a level of cleanliness appropriate to the intended use of the item decontaminated. See also Bio-decontamination.

          去污——從一個區域、物體或人中去除或減少任何污染物(化學物質、廢物、殘留物或微生物)的整個過程。應選擇并驗證所使用的去污方法(例如清潔、消毒、滅菌),以達到適合去污物品預期用途的清潔度水平。另見生物凈化。

          Depyrogenation - A process designed to remove or inactivate pyrogenic material (e.g. endotoxin) to a specified minimum quantity.

          去熱原 - 旨在將熱原物質(例如內毒素)去除或滅活到指定的最小量的過程。

          Disinfection - The process by which the reduction of the number of microorganisms is achieved by the irreversible action of a product on their structure or metabolism, to a level deemed to be appropriate for a defined purpose.

          消毒——通過產品對其結構或新陳代謝的不可逆作用,將微生物數量減少到被認為適合特定目的的水平的過程。

          Endotoxin - A pyrogenic product (i.e. lipopolysaccharide) present in the Gram negative bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death.

          內毒素 - 存在于革蘭氏陰性細菌細胞壁中的熱原產物(即脂多糖)。內毒素可導致接受注射的患者出現從發燒到死亡的反應。

          Equilibration time - Period which elapses between the attainment of the sterilisation temperature at the reference measurement point and the attainment of the sterilisation temperature at all points within the load.

          平衡時間——在參考測量點達到滅菌溫度和負載內所有點達到滅菌溫度之間經過的時間。

          Extractables - Chemical entities that migrate from the surface of the process equipment, exposed to an appropriate solvent at extreme conditions, into the product or material being processed.

          可提取物 - 從工藝設備表面遷移到極端條件下暴露于適當溶劑中的化學實體,進入正在加工的產品或材料中。

          First Air - Refers to filtered air that has not been interrupted prior to contacting exposed product and product contact surfaces with the potential to add contamination to the air prior to reaching the critical zone.

          首過空氣 - 指在接觸暴露的產品和產品接觸表面之前沒有中斷的過濾空氣,有可能在到達關鍵區域之前對空氣增加污染。

          Filter Integrity test - A test to confirm that a filter (product, gas or HVAC filter) retain their retentive properties and have not been damaged during handling, installation or processing.

          過濾器完整性測試 - 確認過濾器(產品、氣體或 HVAC 過濾器)保持其保持性能并且在處理、安裝或加工過程中沒有損壞的測試。

          Form-Fill-Seal (FFS) -An automated filling process, typically used for terminally sterilised products, which constructs the primary container out of a continuous flat roll of packaging film while simultaneously filling the formed container with product and sealing the filled containers in a continuous process. FFS processes may utilize a single web system (where a single flat roll of film is wrapped around itself to form a cavity), or a dual web system (where two flat rolls of film are brought together to form a cavity), often with the aid of vacuum moulds or pressurised gases. The formed cavity is filled, sealed and cut into sections. Films typically consist of a polymeric material, polymeric coated foil or other suitable material.

          成型-灌裝-密封 (FFS) - 一種自動灌裝工藝,通常用于最終滅菌的產品,該工藝由連續扁平的包裝薄膜卷構成主容器,同時用產品填充成型容器并將填充的容器密封在連續過程。 FFS 工藝可以使用單幅系統(其中單個扁平薄膜卷纏繞在自身周圍以形成空腔)或雙幅系統(其中將兩個扁平薄膜卷放在一起以形成空腔),通常使用借助真空模具或加壓氣體。形成的空腔被填充、密封并切成段。薄膜通常由聚合物材料、聚合物涂層箔或其他合適的材料組成。

          Gowning qualification - A programme that establishes, both initially and on a periodic basis, the capability of an individual to don the complete gown.

          更衣確認 - 一項計劃,在初始和定期的基礎上,確定個人完整更衣的能力。

          Grade A air supply - Air which is passed through a filter qualified as capable of producing grade A total particle quality air, but where there is no requirement to perform continuous total particle monitoring or meet grade A viable monitoring limits. Specifically used for the protection of fully stoppered vials where the cap has not yet been crimped.

          A 級送風 - 通過過濾器的空氣能夠產生 A 級總顆粒質量空氣,但不需要執行連續總顆粒監測或滿足 A 級可行監測限制。專門用于保護瓶蓋尚未壓接的全塞小瓶。

          HEPA filter - High efficiency particulate air filter specified in accordance with a relevant international standard.

          HEPA 過濾器 - 根據相關國際標準指定的高效微??諝膺^濾器。

          Inherent interventions - An intervention that is an integral part of the aseptic process and is required for either set-up, routine operation and/or monitoring (e.g. aseptic assembly, container replenishment, environmental sampling). Inherent interventions are required by procedure or work instruction for the execution of the aseptic process.

          常規干預——作為無菌工藝不可分割的一部分,設置、常規操作和/或監控(例如,無菌組裝、容器補充、環境采樣)所需的干預。執行無菌過程的程序或工作指令需要固有的干預措施。

          Intrinsic sterile connection device - A device that reduces the risk of contamination during the connection process; these can be mechanical or fusion sealing.

          內在無菌連接裝置——在連接過程中降低污染風險的裝置;這些可以是機械密封或熔接密封。

          Isokinetic sampling head - A sampling head designed to disturb the air as little as possible so that the same particles go into the nozzle as would have passed the area if the nozzle had not been there (i.e. the sampling condition in which the mean velocity of the air entering the sample probe inlet is nearly the same (± 20 percent) as the mean velocity of the airflow at that location).

          等速采樣頭 - 一種采樣頭,設計用于盡可能少地擾動空氣,以便進入噴嘴的相同顆粒在沒有噴嘴的情況下會通過該區域(即采樣條件中的平均速度進入樣品探針入口的空氣幾乎與該位置的平均氣流速度相同(± 20%)。

          Isolator - An enclosure capable of being subject to reproducible interior bio-decontamination, with an internal work zone meeting grade A conditions that provides uncompromised, continuous isolation of its interior from the external environment (e.g. surrounding cleanroom air and personnel). There are two major types of isolators:

          隔離器 - 能夠進行可重復的內部生物凈化的外殼,其內部工作區滿足 A 級條件,可將其內部與外部環境(例如周圍的潔凈室空氣和人員)毫不妥協地持續隔離。有兩種主要類型的隔離器:

          i. Closed isolator systems exclude external contamination of the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations. 封閉式隔離器系統通過與輔助設備的無菌連接完成材料轉移,而不是使用通往周圍環境的開口,從而排除了隔離器內部的外部污染。封閉系統在整個操作過程中保持密封。

          ii. Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g. using continuous overpressure) to exclude the entry of external contaminant into the isolator. 開放式隔離系統設計為允許材料在操作期間通過一個或多個開口連續或半連續進入和/或排出。設計開口(例如使用連續超壓)以排除外部污染物進入隔離器。

          Leachables - Chemical entities that migrate into products from the product contact surface of the process equipment or containers under normal condition of use and/or storage.

          浸出物 - 在正常使用和/或儲存條件下,從工藝設備或容器的產品接觸表面遷移到產品中的化學實體。

          Local isolates - Suitably representative microorganisms of the site that are frequently recovered through environmental monitoring within the classified zone/areas especially grade A and B areas, personnel monitoring or positive sterility test results.

          本地分離物——通過分類區域/區域內的環境監測,特別是 A 級和 B 級區域內的環境監測、人員監測或陽性無菌檢測結果,經?;厥盏木哂写硇缘默F場微生物。

          Lyophilization - A physical-chemical drying process designed to remove solvents, by way of sublimation, from both aqueous and non-aqueous systems, primarily to achieve product or material stability. Lyophilization is synonymous to the term freeze-drying.

          凍干 - 一種物理化學干燥過程,旨在通過升華從水性和非水性系統中去除溶劑,主要是為了實現產品或材料的穩定性。凍干是術語冷凍干燥的同義詞。

          Manual aseptic processing- An aseptic process where the operator manually compounds, fills, places and /or seals an open container with sterile product.

          手動無菌處理- 操作員手動混合、填充、放置和/或密封裝有無菌產品的開口容器的無菌過程。

          Operator - Any individual participating in the processing operation, including line set-up, filling, maintenance, or other personnel associated with manufacturing activities.

          操作員 - 參與加工操作的任何個人,包括生產線設置、灌裝、維護或與生產活動相關的其他人員。

          Overkill sterilisation - A process that is sufficient to provide at least a 12 logw reduction of microorganisms having a minimum D-value of 1 minute.

          過度殺滅滅菌 - 足以提供至少 12 logw 的微生物減少的過程,具有 1 分鐘的最小 D 值。

          Parison - The "tube" of polymer extruded by the BFS machine from which containers are formed.

          半成品 - 由 BFS 機器擠出的聚合物“管”,從中形成容器。

          Pass-through hatch - Synonymous with airlock (see airlock definition) but typically smaller in size.

          傳遞艙 - 與氣閘同義(參見氣閘定義),但通常尺寸較小。

          Patient - Human or animal including participants in a clinical trial.

          患者 - 人類或動物,包括臨床試驗的參與者。

          Post-aseptic processing terminal heat treatment- A terminal moist heat process employed after aseptic processing which has been demonstrated to provide a sterility assurance level (SAL) <10-6 but where the requirements of steam sterilisation (for example, Fq>8 min) are not fulfilled. This may also be beneficial in the destruction of viruses that may not be removed through filtration.

          無菌加工后終端熱處理——無菌加工后采用的終端濕熱工藝,已證明可提供 <10-6 的無菌保證水平 (SAL),但需要蒸汽滅菌(例如,FQ>8 分鐘)沒有實現。這也可能有利于破壞可能無法通過過濾去除的病毒。

          Pyrogen - A substance that induces a febrile reaction in patients receiving injections;

          熱原 - 一種在接受注射的患者中引起發熱反應的物質;

          Rapid Transfer System/Port (RTP) - A System used for the transfer of items into RABS or isolators that minimizes the risk to the critical zone. An example would be a rapid transfer container with an alpha/beta port.

          快速轉移系統/端口 (RTP) - 用于將物品轉移到 RABS 或隔離器中的系統,可最大限度地降低對關鍵區域的風險。一個例子是帶有 alpha/beta 端口的快速轉運集裝箱。

          Raw material - Any ingredient intended for use in the manufacture of a sterile product, including those that may not appear in the final drug product.

          原材料 - 用于生產無菌產品的任何成分,包括那些可能不會出現在最終藥品中的成分。

          Restricted Access Barrier System (RABS) - System that provides an enclosed, but not fully sealed, environment meeting defined air quality conditions (for aseptic processing grade A), and using a rigid-wall enclosure and integrated gloves to separate its interior from the surrounding cleanroom environment. The inner surfaces of the RABS are disinfected and decontaminated with a sporicidal agent. Operators use gloves, half suits, RTPs and other integrated transfer ports to perform manipulations or convey materials to the interior of the RABS. Depending on the design, doors are rarely opened, and only under strictly pre-defined conditions.

          限制進入屏障系統 (RABS) - 提供封閉但非完全密封的環境,滿足規定的空氣質量條件(用于 A 級無菌加工),并使用剛性壁外殼和集成手套將其內部與周圍環境隔開的系統潔凈室環境。 RABS 的內表面使用殺孢子劑進行消毒和去污。操作員使用手套、半套裝、RTP 和其他集成傳輸端口來執行操作或將材料傳送到 RABS 內部。根據設計,門很少打開,只有在嚴格預先定義的條件下。

          Single Use Systems (SUS) - Systems in which product contact components are used only once to replace reusable equipment such as stainless steel transfer lines or bulk containers. SUS covered in this document are those that are used in manufacturing processes of sterile products and are typically made up of disposable components such as bags, filters, tubing, connectors, storage bottles and sensors.

          一次性使用系統 (SUS) - 產品接觸部件僅使用一次以替換可重復使用的設備(如不銹鋼傳輸線或散裝容器)的系統。本文檔中涵蓋的 SUS 是用于無菌產品生產過程的那些,通常由一次性組件組成,例如袋子、過濾器、管道、連接器、儲存瓶和傳感器。

          Sporicidal agent - An agent that destroys bacterial and fungal spores when used in sufficient concentration for specified contact time. It is expected to kill all vegetative microorganisms.

          殺孢子劑 - 在指定接觸時間內以足夠濃度使用時可破壞細菌和真菌孢子的藥劑。預計會殺死所有的植物性微生物。

          Sterile Product - For purpose of this guidance, sterile product refers to one or more of the sterilised elements exposed to aseptic conditions and ultimately making up the sterile active substance or finished sterile product. These elements include the containers, closures, and components of the finished drug product. Or, a product that is rendered sterile by a terminal sterilisation process.

          無菌產品——就本指南而言,無菌產品是指一種或多種暴露于無菌條件下并最終構成無菌活性物質或無菌成品的無菌元件。這些元素包括容器、封閉物和成品藥的組件?;蛘?,通過最終滅菌過程變得無菌的產品。

          Sterilising grade filter - A filter that, when appropriately validated, will remove a defined microbial challenge from a fluid or gas producing a sterile effluent. Usually such filters have a pore size equal or less than 0.22 μm.

          滅菌級過濾器 - 一種過濾器,在經過適當驗證后,將從產生無菌流出物的流體或氣體中去除特定的微生物挑戰。通常此類過濾器的孔徑等于或小于 0.22 μm。

          Terminal Sterilisation - The application of a lethal sterilising agent or conditions to a product in its final container to achieve a predetermined sterility assurance level (SAL) of 10 6 or better (e.g. the theoretical probability of there being a single viable microorganism present on or in a sterilised unit is equal to or less than 1 x 1Q-6 (one in a million)).

          終端滅菌——在最終容器中對產品應用致命的滅菌劑或條件,以達到 10 6 或更高的預定無菌保證水平 (SAL)(例如,理論上存在單個活微生物的概率)滅菌單位等于或小于 1 x 1Q-6(百萬分之一)。

          Turbulent airflow - Air that is not unidirectional. Turbulent air in cleanrooms should flush the cleanroom via mixed flow dilution and ensure maintenance of acceptable air quality.

          湍流 - 非單向的空氣。潔凈室中的湍流空氣應通過混流稀釋沖洗潔凈室,并確保維持可接受的空氣質量。

          Unidirectional airflow - An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed, to reproducibly sweep particles away from the critical processing or testing area.

          單向氣流 - 以穩定且均勻的方式并以足夠的速度在單一方向上移動的氣流,可重復地將顆粒從關鍵處理或測試區域掃走。

          Unidirectional Airflow (UDAF) unit - A cabinet supplied with filtered unidirectional airflow (previously referred to as a Laminar Airflow Unit or LAF).

          單向氣流 (UDAF) 單元 - 提供過濾單向氣流的機柜(以前稱為層流單元或 LAF)。

          Worst case - A set of conditions encompassing processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared with ideal conditions). Such conditions have the highest potential to, but do not necessarily always result in product or process failure.

          最差情形 - 包含工藝限制和環境的一組條件,包括標準操作程序中的條件,這些條件造成工藝或產品故障的可能性最大(與理想條件相比)。這種情況最有可能但不一定總是導致產品或過程失敗。

          Water system - A system for producing, storing and distributing water, usually compliant to a specific pharmacopeia grade (e.g. purified water and water for injection (WFI)).

          水系統 - 用于生產、儲存和分配水的系統,通常符合特定藥典等級(例如純凈水和注射用水 (WFI))。

          Z-value - The temperature difference that leads to a 10-fold change in the D-value of the biological indicators.

          Z 值 - 導致生物指示劑 D 值變化 10 倍的溫差。

                 參考文獻

                 [1] 國家藥品監督管理局和歐盟藥監局、識林等網站       

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