Aseptic processing of health care products - Part 3: Lyophilization
Also Known As:
SKU184893849
Published by
Deutsches Institut für Normung
DIN
Publication Date2011-09
Pages CountPages22
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.
Details
| Descriptors | Aseptic, CE marking, Clean rooms, Cleaning, Containers, Definitions, Freeze-drying, Guide books, Health services, Insulators, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Occupational medicine, Personnel, Processing, Public health protection, Quality assurance, Quality management, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Surveillance (approval), Validation, Tanks |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| File Size | 532.5 KB |
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