Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments

Name: Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments
Brand: WILEY US
SKU: 882324
Price: 152.33 EUR
Availability: InStock

SAM A. HOUT

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152,33 €

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Trda

152,33 €

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Status dobavljivosti: 3-5 delovnih dni

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ISBN

9781119802327

Mladinska knjiga ID

882324

Leto izida

2022

Datum izida

21.01.2022

Velikost (šxdxv)

150 × 250 × 25

Status dobavljivosti

3-5 delovnih dni

Jezik

ANG

Založnik

WILEY US

Avtor

SAM A. HOUT

Opis

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.