A comprehensive environmental monitoring program should include routine monitoring of both viable and non-viable airborne particulates. Viable particulates are generally of most concern in sterile product manufacturing environments; however, non-viable particulates should also be monitored as a reliable indicator of the proper function of the environmental control systems. Viable bacteria derived from people are typically associated with skin flakes, so higher non-viable particulate counts may be indicative of increased viable counts. Current techniques for monitoring viable particulates in air are limited by: (a) the equipment available, (b) the time necessary to demonstrate the presence of microorganisms in the sample of air taken, (c) the inability to re-sample the environment in a timely fashion when results warrant, and (d) difficulties in continuously monitoring the environment due to considerations such as drying out of the culture media.
一個全面的環境監測計劃應當包括活性和非活性空氣微粒的常規監測。活性微粒通常是無菌產品生產環境最關注的，但是，非活性微粒也應作為環境控制系統功能的一項可靠指標進行監測。來自人的活性細菌通常與皮屑有關，所以更高的非活性粒子數可能表明增加的活性粒子數。監測空氣中活性微粒的現有技術受以下限制：（a）現有設備，（b）證明所取空氣樣本中存在微生物的所需時間，（c）未能及時對環境進行再取樣和（d）連續監測環境的難度，如培養培養基幹燥等。
Although the use of high efficiency particulate air (HEPA) filters to remove particles from the air is a very effective way to reduce the particle load in an environment, especially under static conditions, normal activity levels of equipment and people in a room may greatly reduce their effectiveness. People are a major contributor of viable and non-viable particulates to the environment. The intent of an airborne environmental monitoring program is to determine if there are viable and/ or non-viable airborne particulates in locations that would allow them to settle on product contact surfaces and thereby find their way into process intermediates or final product. FDA expects monitoring under dynamic conditions (1), however outside of the United States, static monitoring may be necessary in addition to dynamic monitoring to satisfy regulatory requirements. 雖然使用高效空氣過濾器（HEPA）去除空氣中的粒子是減少環境中微粒負荷的一種非常有效的方法，尤其在靜態條件下，但設備和人員的正常活動水平可能會大大降低其有效性。人員是對環境產生活性和非活性微粒的重要因素。空氣環境監測計劃的目的是確定在粒子可能沉降的產品接觸表面，即可尋找到工藝中間體或最終產品途徑的位置是否有活性和/或非活性空氣粒子。FDA希望在動態條件（1）下監測，但對美國以外的區域，為滿足法規要求，除了動態監測外可能也需要進行靜態監測。For most older-model samplers, the sampling volume is less than one cubic meter. A sampling volume of ten cubic feet is considered insufficient in Europe. Many of the newer model samplers are also capable of sampling one cubic meter. 對於大多數舊型採樣器，取樣量不足1立方米。在歐洲，十立方英尺的取樣量被認為是不足的。許多較新的採樣器可對一立方米進行取樣。Non-Viable Monitoring 非活性微粒監測Monitoring of non-viable airborne particulates is a necessary component of an environmental monitoring program. Such monitoring demonstrates control of poten-tial contaminants in the environment to which the product, during the manufacturing process, is exposed. Classification of production areas is generally made based upon the level of non-viable particulates in the air. 非活性空氣微粒監測是環境監測計劃的必要組成部分。這種監測表明對生產過程中產品暴露環境中潛在汙染物的控制。一般根據空氣中非活性微粒等級進行生產區分級。Federal Standard 209E describes, in detail, classification of air cleanliness for clean-rooms and clean zones based on specified concentrations of airborne particulates. It prescribes methods for verifying air cleanliness in the traditional particulate size range(s) and also with respect to ultra-fine particles. This document has been commonly referenced with respect to non-viable particulate monitoring in the pharmaceutical, biological, biotechnology, and medical device industries as well as the electronics industry. More recent publications on the classification of air cleanliness are the ISO 14644 series of standards on "Clean rooms and associated controlled environments," and ISO 14698 series of standards on "Biocontamination in a clean room environment." Following the publication of the ISO 14644-1 and 14644-2 standards, Federal Standard 209E is expected to be retired (as a standard for conducting business with the US government) by the end of 2001. 聯邦標準209E根據空氣微粒的規定濃度詳細介紹了潔淨室和潔淨區空氣潔淨度的分級。它規定在傳統微粒及超細微粒大小範圍內確認空氣潔淨度的方法。本文件經常用於製藥，生物，生物技術，醫療設備行業以及電子行業的非活性微粒監測。空氣潔淨度分級的最近出版物為ISO 14644標準系列的「清潔室和相關受控環境」和ISO 14698標準系列的「潔淨室環境的生物汙染」。ISO 14644-1和14644-2標準出版後，聯邦標準209E預計將在2001年年底停止使用（與美國政府做生意的標準）。The 1987 FDA aseptic processing guide recommends daily monitoring for non-viables during operations, and in the United States, monitoring non-viable particles equal to or larger than 0.5μm during routine manufacturing operations is common (exceptions include aseptic powder filling operations). Although monitoring particles in different size ranges may seem prudent, particles of 0.5 μm and larger are generally recognized as indicators of environmental contamination. Requirements outside of the United States may also include monitoring 5.0μm particles. 1987年FDA的無菌工藝指南建議在運行過程中進行非活性微粒的日常監控，在美國，日常生產正常運行時監測等於或大於0.5μm的非活性粒子（例外包括無菌粉灌裝操作）。雖然監測不同尺寸範圍的粒子可能需謹慎，0.5μm及更大的顆粒通常認為是環境汙染的指示器。美國以外的需求可能還包括監測5.0μm粒子。A commonly used monitoring method is optical particle counting. It is based on the principle of passing an aerosol through a focused light source, which results in light scattering from single particles by refraction, reflection, and diffraction. In this way, both the size, based on the intensity of the scattered light, and the number of particles can be measured simultaneously. This method provides real-time data on the environment and provides a useful tool to demonstrate that the environment remains in a state of control with respect to particulate contamination.常用的監測方法是光粒子計數。根據氣溶膠穿過集中光源，從單個微粒折射，反射和衍射散射光的原理。這樣，根據散射光強度可同時測量和粒子尺寸和數目。此方法提供環境的實時數據，並為證明環境中微粒汙染仍處於控制狀態提供一個有用的工具。Selection of an optical particle counter for use in a clean room or other controlled environment is typically based on such factors as sensitivity, flow rate, particle size range, portability, data storage capability, alarm capability, construction, and sanitization compatibilities. Although there are technical differences between in-struments from different manufacturers, it is generally accepted that these instruments are interchangeable. However, when switching from one manufacturer's instrument to another's, it may be prudent to assess whether a change in alert or action levels is indicated, due to differences in equipment sensitivity. 潔淨室或其他受控環境中光粒子計數器的選擇通常根據靈敏度，流速，顆粒大小範圍，便攜性，數據存儲功能，報警功能，建設和衛生處理相容性等因素。雖然不同供應商的儀器之間存在技術差異，通常認為這些工具是可以互換的。然而，當從一個製造商的儀器切換到另一個時，由於設備靈敏度的差異，可能需審慎評估是否指示警戒或行動等級。In addition to portable particle counters, systems have been developed for permanent installation in manufacturing areas to allow continuous monitoring of the manufacturing process with centralized data storage and alarm capabilities. 除了可攜式顆粒計數器，系統適用於生產區的永久性安裝，以允許持續監測帶集中數據存儲和報警功能的生產工藝。免責聲明：上述內容僅供交流學習使用，對文中陳述、觀點判斷保持中立，不對所包含內容的準確性、可靠性或完整性提供任何明示或暗示的保證。僅作參考，並請各位自行承擔全部責任。版權歸原作者所有，如遇版權問題請聯繫小編刪除。