Equipment pharmaceutical processing

Many failures in pharmaceutical processing have arisen because of the inability of those responsible for its design to be aware of the distribution and survival potential of microorganisms in the environment and in the raw materials and equipment used in a pharmaceutical factory. 

Shifflet, M. J. and Shapiro, M., Validation of a cation-exchange method to test for residual amounts of a cleaning and sanitizing solution on pharmaceutical process equipment, BioPharm, 51, Jan. 2000. 

In addition to equipment, many processes/procedures undertaken during pharmaceutical manufacture are also subject to periodic validation studies. Validation of biopharmaceutical aseptic hlling procedures is amongst the most critical. The aim is to prove that the aseptic procedures devised are capable of delivering a sterile bnished product, as intended. 

For the above-described reasons, molecular spectroscopic techniques have become the most common choices for pharmaceutical analysis in addition to chromatography. The latter, however, are being gradually superseded by the former in some industrial pharmaceutical processes. Recent technological advances have led to the development of more reliable and robust equipment. The ubiquity of computers has enabled the implementation of highly powerful chemometric methods. All this has brought about radical, widespread changes in the way pharmaceutical analyses are conducted. 

In addition to equipment, many processes/procedures undertaken during pharmaceutical manufacture are also subject to periodic validation studies. Validation of biopharmaceutical... 

The purpose of the second edition is to meet the need for a ready-to-use text on the validation of aseptic pharmaceutical production and to provide general information and guidelines. It is a compilation of various theories, sterilization variables, and engineering and microbial studies that can be used independently or in combination to validate equipment and processes. The concepts and methods presented in this edition are not intended to serve as a final rule. Reciprocal methods for achieving this purpose exist and should also be reviewed and consulted, if applicable. 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

Since the middle of the twentieth century the pharmaceutical industry has been a leader in terms of quality and security of manufacturing, associating higher production efficiency with higher profits. Therefore, validation became essential, that is, the confirmation and evidence that all facilities, equipment and processes work as desired, generating quality products. 

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international journals dealing with products of pharmaceutical interest, their isolation, and structure development. He is a professional technical writer and author of more than 500 standard operating procedures based on FDA regulations, ISO 9000, and ISO 14000 standard. 

Most discussions of product and process validation that have been published [13-15] or that have been the subject of presentations at meetings have concentrated on validation associated with the full-scale manufacture of pharmaceutical processes and how equipment processing variables affect the overall quality of the finished product. Although this is certainly an important aspect of product validation, validation of numerous earlier aspects of development are critical to the subsequent phases of the process. 

The chemical industry uses numerous and often complex equipment and processes. In the fine chemical industries (including pharmaceuticals), the plants often have a multi-purpose character, that is, a given plant may be used for different products. When we consider a chemical process, we must do it in an extensive way, including not only the production itself but also storage and transportation. This includes not only the product, but also the raw material. 

Product quality is assured through the collection and analysis of samples taken from the process (see Sec. 6 on sampling) to establish the acceptability of the process. The optimal approach to validation considers process parameters and product attributes, as well as their relationship. The link between the defined independently established parameters (either variable or fixed process equipment set points) must be established during the developmental process. The PQ of a pharmaceutical process should demonstrate how conformance to the required... 

Eilbeck, J. Rowley, G. Carter, P.A. Fletcher, E.J. Effect of materials of construction of pharmaceutical processing equipment and drug devices on the triboelectrification of size-fractionated lactose. Pharm. Pharmacol. Commun. 1999, 5, 429 33. 

If the most critical utilities used in the pharmaceutical pilot plant are those that come in contact with the product, then water is most likely at the top of the list. Water is commonly used during processing of the product and also for cleaning of equipment and process areas. Water quality can be divided into two subcategories. The first is compendial, of which there are two types, USP purified water and USP water for... 

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