Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments
Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments
SAM A. HOUT
Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments
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Poglej vseISBN
9781119802327Mladinska knjiga ID
882324Leto izida
2022Datum izida
21.01.2022Velikost (šxdxv)
150 × 250 × 25Status dobavljivosti
Na zalogi pri dobaviteljuJezik
ANGTeža
550 gZaložnik
WILEY USAvtor
SAM A. HOUTOpis
Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements.
Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure.
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