【药厂】去生物医药公司面试前，你需要知道的一些基本概念

2023-08-06

去生物医药公司面试前，你需要知道的一些基本概念，赶紧学一学，说不定就用上了！英文是原文，来自于EU GMP（十分专业的）。

Depyrogenation

除热原

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

旨在将致热物质（例如内毒素）去除或灭活至规定最小量的过程。

Disinfection

消毒

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.

通过产品结构或代谢的不可逆作用，将微生物数量减少至被认为适合某特定用途的水平的过程。

Endotoxin

内毒素

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.

革兰氏阴性细菌细胞壁中存在的致热产物（即脂多糖）。内毒素能导致接受注射的患者发热至死亡的反应。

Equilibration time

平衡时间

Period which elapses between the attainment of the sterilization temperature at the reference measurement point and the attainment of the sterilization temperature at all points within the load.

从参考测量点达到灭菌温度到负载内所有点达到灭菌温度之间的时间。

Extractables

溶出物

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.

当在极端条件下暴露于适当溶剂中，从工艺设备表面迁移至被加工的产品或物料中的化学实体。

First Air

初始气流

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.

指在接触暴露的产品和产品接触表面之前没有被阻碍从而在到达关键区之前不太可能被污染的经过过滤的气流。

Filter Integrity test

过滤器完整性测试

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.

一种用以确认过滤器（产品，气体或 HVAC 过滤器）保持其截留特性并且在处理、安装或加工过程中没有被损坏的测试。

Form-Fill-Seal (FFS)

成型-灌装-密封（FFS）

An automated filling process, typically used for terminally sterilized 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 molds or pressurized 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.

一种自动灌装工艺，通常用于最终灭菌的产品。将连续的成卷的包装膜制成内包装容器，并同时对成型的容器进行产品灌装，然后对灌装好的容器进行密封，是一个连续的工艺过程。FFS工艺可以利用单网系统（单个成卷的薄膜自身缠绕形成腔体）或双网系统（两个成卷的薄膜一起形成腔体），通常借助真空模具或加压气体。成型的腔体进行灌装、密封并切割成单个包装。薄膜通常由聚合材料、聚合涂层箔或其它合适的材料组成。

Gowning qualification

更衣确认

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

确定个人穿戴完整工作服的能力的程序，需要首次和定期执行。

Grade A air supply

A级送风

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.

在没有要求进行总微粒连续监测、没有要求符合 A 级活性粒子监测限度的情况下，通过过滤器（经确认能够产生质量达到 A 级总微粒要求的空气）的空气。专门用于保护尚未轧盖的已完全加塞的西林瓶。

HEPA filter

HEPA 过滤器

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

符合相关国际标准的高效空气过滤器。

Inherent interventions

固有性干预

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.

无菌工艺不可或缺的、在组装、常规操作和/或监测（例如无菌装配、容器补充、环境采样）中必须要进行的干预措施。关于无菌工艺执行的程序或工作指令要求固有干预。

Intrinsic sterile connection device

内部无菌连接装置

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

一种降低连接过程中污染风险的装置；可以是机械密封或熔融密封。

Isokinetic sampling head

等速采样头

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).

一种几乎不会扰乱空气的采样头、使进入管口的粒子与管口不存在时通过该区域的微粒相同，即，采样条件为进入样品探针入口处的空气流速与该位置气流的平均流速几乎相同（±20%）。

Isolator

隔离器

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:

能够进行可重复的内部生物净化的外壳，内部工作区符合 A 级条件，提供其内部环境与外部环境（例如周围洁净室空气和人员）的无间断的持续隔离。隔离器主要有两种类型：

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.

密闭隔离器系统通过与辅助设备的无菌连接而不是对周围环境开放来完成物料转移，从而阻断外部污染物进入隔离器内部。密闭系统在整个操作中保持密封。

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.

开放隔离器系统的设计允许操作过程中物料通过一个或多个开口连续或半连续进出。开口的设计（如使用连续过压）可以阻断外部污染进入隔离器。

Leachable

浸出物

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.

在正常使用和/或储存条件下从工艺设备或容器的产品接触表面迁移到产品中的化学实体。

Local isolates

本地环境菌

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.

经常性从洁净区的环境监测（特别是 A 级和 B 级区）、人员监测或阳性无菌检验结果中回收到的、能代表场地微生物的微生物菌株。

Lyophilization

冻干

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.

一种通过升华方式去除水性溶液和非水性溶液系统中溶剂的物理化学干燥工艺，主要是为了达到产品或物料的稳定性。冻干是术语冷冻干燥（freeze-drying）的同义词。

Manual aseptic processing

手动无菌工艺

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

操作人员手动配制、灌装、放置和/或密封无菌产品敞口容器的无菌工艺。

Operator

操作人员

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

任何参与工艺操作（包括线组装、灌装、维护）的个人，或与生产活动有关的其他个人。

Overkill sterilization

过度杀灭灭菌

A process that is sufficient to provide at least a 12 log10 reduction of microorganisms having a minimum D-value of 1 minute.

一种足以将最小 D 值为 1 分钟的微生物至少降低 12 个对数值的工艺。

Parison

型坯

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

由 BFS 机器挤出的聚合物的“管”，用于形成容器。

Pass-through hatch

传递窗

Synonymous with airlock (see airlock definition) but typically smaller in size.

与气锁同义（参见气锁定义），但通常尺寸较小。

Patient

患者

Human or animal including participants in a clinical trial.

人或动物，包括临床试验的参与者。

Post-aseptic processing terminal heat treatment

无菌工艺后最终热处理

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 sterilization (for example, Fo≥8 min) are not fulfilled. This may also be beneficial in the destruction of viruses that may not be removed through filtration.

无菌工艺后采用的最终湿热工艺，已被证明可提供无菌保证水平（SAL）≤10-6但不满足蒸汽灭菌的要求（例如 F0≥8 分钟）。这也可能有利于破坏可能无法过滤去除的病毒。

Pyrogen

热原

A substance that induces a febrile reaction in patients receiving injections.

—种引起接受注射的患者发热反应的物质。

撰稿人 | 制药人职场加油站

责任编辑 | 胡静

审核人 | 何发