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Pharmaceutical engineering applications

Validation is described as proof that the system performs as stated. As an engineering control, the LAF system must demonstrably support the intended aseptic or controlled process. Validation of the aseptic manufacturing process and the LAF systems that support terminal sterilization in pharmaceutical manufacturing applications should be carried out in accordance with industry standards. Such validation should be accomplished in three phases, consisting of installation qualification (IQ), operational qualification (OQ), and process qualification (PQ), with full and detailed documentation of all activities and... [Pg.2188]

The third voluntary standard is The International Society of Pharmaceutical Engineer s (ISPE) Baseline Pharmaceutical Engineering GuideS This is one of a series of ISPE guidance documents that has limited endorsement by the FDA. It should be understood that only minimal standards are being endorsed and there are many reasons why specific sterile products and applications could be seen by the FDA to require compliance with higher standards. [Pg.2290]

Excipient Interaction Prediction application of the Purdue Ontology for Pharmaceutical Engineering (POPE)... [Pg.85]

As a biocompatible and biodegradable material, chitosan has found many and diverse medical, pharmaceutical, and therapeutic applications. Nevertheless, there is a lot of scope for improvisation in mechanical properties and biocompatibility of chitosan before it becomes an ideal biomaterial for tissue engineering applications. [Pg.547]

These are the pharmaceutical dosage forms which are converted into nanoform for their application by using various pharmaceutical engineering techniques. Transformation into nanoform offers the following advantages (Sahoo and Labhasetwar, 2003) ... [Pg.402]

This section ordy includes plasticizers which are used in paints and coatings used in civil engineering applications. Formation of permeable films, such as in controlled release applications is fully discussed in Section 13.21 devoted to pharmaceutical products. [Pg.433]

As will be discussed in the following sections, there are various diseased animal models, including spontaneous, chemically/surgically induced, or genetically engineered models for academic and pharmaceutical research applications. However, details of each existing or newer models are outside the scope of this chapter. Key perspectives discussed include strengths and weaknesses of commonly used animal models, potential causes/factors for poor translation of safety liabilities from animals to humans, and their application in the nonclinical mechanistic and safety studies. [Pg.263]

Major Applications Optical engineering applications, sensors, making masks, electrorheo-logicval materials, surface treatment of copper, coloring zinc, aluminum, " corrosion testing," adhesive," lubricants, textiles, food storage, determine bacterial growth, " pharmaceutical preparations"... [Pg.16]

Textile structures with embedded active agent—loaded microcapsules have found their application in many fields such as medicine, cosmetics, and wellness. Their role will grow with an increase in peoples needs and advances in disciplines such as materials science, textile engineering, pharmaceutical engineering, and transport phenomena. [Pg.110]


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