"The Encyclopedia of Pharmaceutical Technology presents up-to-date and interdisciplinary contributions by leading international authorities in all areas of drugs. Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the. Encyclopedia of Pharmaceutical Technology, Second Edition - Three Volume Set James Swarbrick No preview available -
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Encyclopedia of. PHARMACEUTICAL. TECHNOLOGY. Third Edition. VOLUME 1. New York London edited by. James Swarbrick. Get this from a library! Encyclopedia of pharmaceutical technology. Volume 1. [ James Swarbrick;]. Encyclopedia of Pharmaceutical Technology, Volume 20 - Ebook download as PDF File .pdf), Text File .txt) or read book online.
The molded plastic is severed from the continuously extruding parison by a hot knife, and is shuttled within the mold set to the filling position. The filling mandrels are comprised of a set of filling tips which are held within a protective air shower; this is a small area within the filling machine which is typi- cally fed with sterile filtered air.
When the molds are beneath the air shower, the filling tips are lowered into the neck of the partially formed container and the containers are filled. The mandrels return to the protective air shower, and the containers are sealed 1 2 Blow-Fill-Seal Aseptic Processing by a second mold set head mold which forms the neck and closure of the BFS containers. The mold then opens and the filled containers surrounded by excess polymer are released.
Ex- cess plastic is removed typically on line by means of a mold-specific cropping tool. Liquid product is fed to the BFS machine from a holding tank or vessel. The pathway is sterilized in place prior to receiving product, and product is sterilized by means of in-line sterilizing-grade filters. There is usually more than one stage of sterile filtration required on the product pathway. Filling Environment Aseptic BFS machines are housed within classified clean areas of a minimum speci- fication of class M5.
The most recent BFS machines are also capable of operating with significantly lower particle levels. The localized filling environment or air shower is of a higher classification, meeting the specification of class M3.
Total particle levels should meet the required specifications and be measured, with the machine at rest, at defined intervals by means of a laser particle counter or other suitable instrument to demonstrate continued compliance. Levels of viable contamination are, however, of importance in operation. Microbi- ological monitoring for viable contaminants should be carried out to coincide with routine manufacture at normal levels of dynamic activity.
As with traditional aseptic filling, viable contamination within the clean area should be controlled by means of an effective routine cleaning and disinfection program and the adoption of appropriate clean room behavior and practices by trained personnel.
The BFS technology has the advantage of being able to operate without the continuous presence of personnel within the clean area. However, operators need to enter the area to start up the machin- ery and to attend the machine as necessary to make routine adjustments.
Within the European forum it is required that the clean room garments be worn to enter the class M5. A routine microbiological environmental monitoring program should be estab- lished and documented based on historical and operational data to demonstrate con- tinued compliance with specifications and to monitor trends.
A typical monitoring regime within the clean room would include quantitative air and surface monitoring. Semiquantitative air monitoring by the use of settle plates can also be useful in pro- ducing data associated with a longer period of time in operation up to 4 hr exposure.
Alert and action levels should be clearly defined based upon both operational data and published recommendations.
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