藥廠潔淨室暖通空調之設計與驗證分析 -以E公司為例-

Design and Qualification of Cleanroom HVAC System for Pharmaceutical factory Take E company as an example

黃崇育(Chung-Yu Huang)

指導教授 ： 鍾文仁

中原大學/工學院/機械工程研究所/碩士(2019年)

https://doi.org/10.6840/cycu201900044

摘要

暖通空調(Heating, Ventilation and Air-Conditioning，HVAC)技術可確保室內的溫度和濕度在相對室外環境的舒適性，因此近年來HVAC系統被廣泛的使用在工業廠房。然而，對於製藥工業來說，HVAC不僅僅為提供人員舒適性，更重要的是控制環境的溫濕度、氣流、微粒子等等來達到產品品質。
製藥工業大致可分類為原料、合成、製劑及調劑，本文是針對原料藥廠E公司的生產環境，提出「潔淨室」的HVAV建置與驗證，HVAC最佳化的使用對於藥廠「潔淨室」是非常重要，其目標就是用最小化的成本來滿足所需的環境條件。
醫療技術是國人健康保障的最後一道防線，而先進的醫療技術還需要高品質的藥物來支撐，設施規劃對於製藥廠是非常重要的，沒有良好設施，就無法生產高品質的藥物，製藥廠「潔淨室」不同於其他產業的「潔淨室」，因為其他產業通常是連續式的生產線，而製藥廠是以「批量」方式生產，製藥廠以「批次」生產，其批量和批次可能會有所不同，因此，其他產業設施的架構並不完全適用於製藥廠。
為了產出高品質的藥物，「優良製造規範」（Good Manufacturing Practice，GMP）對於製藥廠所的要求日趨嚴苛，除了要在「潔淨」的環境下生產外，對防止交叉污染、提供原物料及產品合適的存放條件以及防止有害物質對於人員的危害都有相當的要求，而一個設計良好的HVAC系統是可以滿足上述要求的。
製藥產業須經常面對官方查廠與客戶稽核，製藥廠所的規劃最主要原則就是降低污染。通常法規條文只會籠統的描述，並不會明確指導如何去達成，因此許多工程公司都無法提出符合原料藥廠需求的規劃方案。符合GMP製藥規定的廠所應軟硬體同時規劃，所以想藉著E公司的規劃經驗與管理來製訂出一個既符合PIC/S GMP、又能達到經濟效益的樣板。

關鍵字

暖通空調 ； 潔淨室 ； GMP ； 驗證

並列摘要

HVAC (Heating, Ventilation and Air-Conditioning) technology ensures indoor temperature and humidity in a relatively outdoor environment, so HVAC systems have been widely used in industrial plants in recent years. However, for the pharmaceutical industry, HVAC is not only to provide personnel comfort, but more importantly to control the temperature and humidity of the environment, airflow, particles, etc. to achieve product quality.
The pharmaceutical industry can be roughly classified into raw materials, synthetics, preparations and preparations. This article is aimed at the production environment of the raw material pharmaceutical company E, and proposes the "clean room" HVAV construction and qualification. The use of HVAC optimization for the pharmaceutical factory "clean room" It is very important that the goal is to meet the required environmental conditions with minimal cost.
Medical technology is the last line of defense for Chinese people's health, and advanced medical technology needs high-quality drugs to support. Facility planning is very important for pharmaceutical factories. Without good facilities, it is impossible to produce high-quality drugs. "Clean room" is different from the "clean room" of other industries, because other industries are usually continuous production lines, while pharmaceutical factories are produced in "batch" mode, and pharmaceutical factories are produced in "batch". Batches and batches may be The difference is that the structure of other industrial facilities is not fully applicable to pharmaceutical plants.
In order to produce high-quality drugs, the "Good Manufacturing Practice" (GMP) is becoming more and more demanding for pharmaceutical manufacturers. In addition to being produced in a "clean" environment, it is designed to prevent cross-contamination and provide raw materials. And the proper storage conditions of the product and the prevention of harmful substances to the human hazard have considerable requirements, and a well-designed HVAC system can meet the above requirements.
The pharmaceutical industry must often face official inspections and customer audits. The main principle of the pharmaceutical factory's planning is to reduce pollution. Usually, the provisions of the regulations will only be described in a general way, and there is no clear guidance on how to achieve them. Therefore, many engineering companies are unable to propose a plan that meets the needs of raw material pharmaceutical companies. The factories that meet the GMP pharmaceutical regulations should be planned at the same time, so they want to use the planning experience and management of E company to formulate a model that meets PIC/S GMP and can achieve economic benefits.

並列關鍵字

HVAC ； clean room ； GMP ； Qualification

參考文獻

[1] 衛生福利部食品藥物管理署風險管理組，GMP概述，2016年，https://www.fda.gov.tw/TC/siteListContent.aspx?sid=301&id=409&chk=f7ba5321-6a79-4527-b42f-9f9d985b13b1

[2] 衛生福利部食品藥物管理署，2017年，西藥藥品優良製造規範(第二部：原料藥)。

[3] WHO Expert Committee on Specifi cations for Pharmaceutical Preparations.,” Procedure for prequalifi cation of pharmaceutical products.”,” WHO Technical Report Series, p229, No. 961”2011.

[4] ISO 14644-1,” Cleanrooms and associated controlled environments — Part 1:Classification of air cleanliness by particle concentration”,p5,2015.

[5] ISPE, “Baseline Pharmaceutical Engineering Guides”,” Volume 1; Bulk Pharmaceutical Chemical p50,” 1996.