Historically, sterile bulk pharmaceutical manufacturing processes, prior to filling operations, have followed general bulk pharmaceutical guidelines. As technology and equipment have improved

Environmental laws and regulations including permits are reviewed in this chapter. Included are the Federal Clean Air Act Amendment (CAAA), the Federal Clean Water Act (CWA) regulations, the Resource Conservation and Recovery Act (RCRA) or, as it is also known, the Solid Waste Disposal

The widespread use of advanced control and process automation for biochemical applications has been lagging as compared with industries such as refining and petrochemicals whose feedstocks are relatively easy to characterize and whose chemistry is well understood and whose measure￾ments are relatively

The purpose ofthis chapter is to review various forms of solids dryers and auxiliary components. It is intended to be a practical guide to dryer selection (as opposed to the theory of drying, which is addressed in various technical manuals referenced in the bibliography). From a microscopic

Capital cost projects begin when a need is defined that cannot be satisfied in existing facilities. Thus begins the life cycle of a capital project (Fig. 1). Once started, the project will progress through all of the following phases or be canceled. It all starts with the recognition of a need that will require capital plant. In the conceptual phase of the project, multiple approaches will be evaluated and one or more plans will be evaluated for meeting these needs

Copyright 8 1997 by Noyes Publications No part of this book may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage and retrieval system, without permission in writing from the Publisher. Library of Congress Catalog Card Number: 96-29055 Printed in the United States

BIOREACTORS FOR PLANT CELL TISSUE AND ORGAN CULTURES (by Shinsaku Takayama) ...... 3.1 Background of the Technique-Historical Overview

一、胞内传质 二、细胞膜－胞外传质 三、超细胞传质

1. 使生物反应的基质或产物，因杂菌的消耗而损失，造成生产能力的下降。 2. 杂菌也会产生代谢产物，这就使产物的提取更加困难，造成得率降低，产品质量下降

定义：菌种的扩大培养就是把保藏 的菌种，即砂土管，冷冻干燥管中 处于休眠状态的生产菌种接入试管 斜面活化，再经过扁瓶或药瓶和种 子罐，逐级扩大培养后达到一定的 数量和质量的纯种培养过程。这些 纯种的培养物称为种子