Excerpt from the GMP MANUAL
The responsible work with solids plays a major role in the manufacturing of active pharmaceutical ingredients (APIs) as well as in the pharmaceutical production.
One important basic demand of GMP is to avoid impurity with foreign matters. The handling in closed equipment (Containment) and the construction of easily cleanable facilities vitally contribute to that.
In the GMP Paperback Containment and Hygienic Design you will find the following discussed elaborately:
The first part of the book on Containment illustrates solutions on how a manufacturing process can be performed in completely closed facilities to avoid (cross-) contamination. Containment systems are increasingly applied for the security of the personnel and therewith meet the obligations of the regulations for hazardous goods.
In the second part Hygienic Design suggestions for an ideal design of the facilities from a hygienic point of view are given. Herein, both the condition of the facilities and of product contact surfaces and the structure of the buildings are taken into account. Practical examples explain basic principles.
Apart from describing content you will find many tables, examples, forms, which can be used in the daily practice.
TOC Containment & Hygienic Design.pdf
The responsible work with solids plays a major role in the manufacturing of active pharmaceutical ingredients (APIs) as well as in the pharmaceutical production.
One important basic demand of GMP is to avoid impurity with foreign matters. The handling in closed equipment (Containment) and the construction of easily cleanable facilities vitally contribute to that.
In the GMP Paperback Containment and Hygienic Design you will find the following discussed elaborately:
The first part of the book on Containment illustrates solutions on how a manufacturing process can be performed in completely closed facilities to avoid (cross-) contamination. Containment systems are increasingly applied for the security of the personnel and therewith meet the obligations of the regulations for hazardous goods.
In the second part Hygienic Design suggestions for an ideal design of the facilities from a hygienic point of view are given. Herein, both the condition of the facilities and of product contact surfaces and the structure of the buildings are taken into account. Practical examples explain basic principles.
Apart from describing content you will find many tables, examples, forms, which can be used in the daily practice.
TOC Containment & Hygienic Design.pdf
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