Automated manufacturing

Cassettes Cassette is a term used to describe two different cross-flow membrane devices. The less-common design is a usually large stack of membrane separated by a spacer, with flow moving in parallel across the membrane sheets. This variant is sometimes referred to as a flat spiral, since there is some similarity in the way feed and permeate are handled. The more common cassette has long been popular in the pharmaceutical and biotechnical field. It too is a stack of flat-sheet membranes, but the membrane is usually connected so that the feed flows across the membrane elements in series to achieve higher conversion per pass. Their popularity stems from easy direct sc e-up from laboratoiy to plant-scale equipment. Their hmitation is that fluid management is inherently veiy hmited and inefficient. Both types of cassette are veiy compact and capable of automated manufacture. 

Dong, Z. 1993 Design for Automated Manufacturing. In Kusiak, A. (ed.). Concurrent Engineering Automation, Tools and Techniques. NY Wiley. 

Figure 11.12 Categorisation of software systems according to Good Automated Manufacturing Practice guidelines (CAMP4).

Good Automated Manufacturing Practice 3, Supplier User Guide , 1998, ISPE. 

Nevertheless, the acquisition of a sufficiently detailed body of physical information can allow a formulator to go far beyond the mere ability to cope with crises when they develop at unexpected times. For a well-understood system, it is theoretically possible to design an automated or semi-automated manufacturing scheme for which the processing variables would be appropriately controlled so as to minimize the possibility of batch failure. Materials passing the hurdles of physical test specifications would be totally predictable in their performance, and they could therefore be blended, granulated, dried, compressed, and delivered into containers without operator intervention. 

Automated manufacturing processes, 70 12 Automated oligonucleotide synthesizers, 77 623... 

Source International Society for Pharmaceutical Engineering. Guide for Validation of Automated Systems GAMP 4—Good Automated Manufacturing Practice, ISPE, 2001. 

Good Automated Manufacturing Practice Good Agricultural Practice Good Clinical Practice... 

Wingate, G, Validating Automated Manufacturing and Laboratory Applications Putting Principles into Practice, Interpharm Press, Inc., Buffalo Grove, IL, 1997. 

International Society for Pharmaceutical Engineering (ISPE) (2005), GAMP (Good Automated Manufacturing Practice) Good Practice Guide Validation of Laboratory Computerized Systems, ISPE. 

Note The instruments used in the laboratories vary significantly in the design and operation complexity. The validation requirements should reflect the level of complexity of the instrument. It is obvious that the amount of effort required to validate a simple pH meter will be different from that required for a fully automated dissolution system. The Good Automated Manufacturing Practice (GAMP)... 

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

Most off-spec paint is generated by small shops manufacturing specialty paints. Better operating practices are useful in reducing off-spec products. These practices include better operator training, closer operator supervision, more rigorous equipment inspection and maintenance, and, where feasible, increased use of automated manufacturing systems. 

Case Study A—Instrument Application Design and Validation. T. de Claire and P. Coady. Validating Automated Manufacturing and Laboratory Applications—Putting Principles into Practice, Part 2 Case Studies, Guy Wingate. Interpharm Press (1997). 

The control system of the freeze-drying unit provides control, monitoring and documentation of the process. Such a system must be reliable and comply with GM P and GAMP (Good Automation Manufacturing Practice) demands with respect to computer validation. It should be SCADA (Supervisory Control and Data Acquisition) compatible. A possible hardware architecture is shown in Figure 2.55.1. 

Good Automated Manufacturing Practices (GAMP), February 1994... 

Deadlock Resolution in Automated Manufacturing Systems ZhiWu Li and MengChu Zhou... 

Automated manufacturing of the membrane modules has allowed for more membrane area per unit volume and for higher-quality modules. This is because automation allows for more precise glue line application on the membrane leaves. A typical industrial module that is 8-inches in diameter and 40-inches long can hold up to 440 ft2 of membrane area when automated manufacturing is employed (see Chapter 4.4.2.5). 

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