Chapter: Water and air quality in sterile manufacturing facilities

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Home > Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality > Water and air quality in sterile manufacturing facilities

Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality |

Michael J. Akers

Routledge

Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality

Water and air quality in sterile manufacturing facilities

Chapter Info

Authors

Michael J. Akers

ARI Id

1666142501600_14860786

Access

Not Available Free

Pages

231-245

DOI

10.3109/9781420020564-17

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Chapters/Headings	Author(s)	Pages	Info
Introduction, scope, and history of sterile products	Michael J. Akers	11-20
Characteristics of sterile dosage forms	Michael J. Akers	21-29
Types of sterile dosage forms	Michael J. Akers	30-38
Sterile product packaging systems	Michael J. Akers	39-57
Overview of product development	Michael J. Akers	58-67
Formulation components (solvents and solutes)	Michael J. Akers	68-81
Sterile products packaging chemistry	Michael J. Akers	82-105
Formulation and stability of solutions	Michael J. Akers	106-124
Dispersed systems	Michael J. Akers	125-147
Formulation of freeze-dried powders	Michael J. Akers	148-178
Overcoming formulation problems and some case studies	Michael J. Akers	179-189
Overview of sterile product manufacturing	Michael J. Akers	190-203
Contamination control	Michael J. Akers	204-220
Sterile manufacturing facilities	Michael J. Akers	221-230
Water and air quality in sterile manufacturing facilities	Michael J. Akers	231-245
Personnel requirements for sterile manufacturing	Michael J. Akers	246-256
Sterilization methods in sterile product manufacturing	Michael J. Akers	257-276
Sterile filtration	Michael J. Akers	277-287
Sterile product filling, stoppering, and sealing	Michael J. Akers	288-303
Freeze-dry (lyophilization) processing	Michael J. Akers	304-322
Chapters/Headings	Author(s)	Pages	Info

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