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Aseptic Terminology
Common Aseptic Validation Protocol
1. Preface
2. Plant Pre-requisites
3. Validation Format
4. Products
5. Validation Medium
6. Thermal Treatment
7. Sample Size
8. Validation Sequence
9. Fill Level of the Bottles
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11a. Storage Conditions for Low Acid Products
11b. Storage Conditions for High Acid Products
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2. Initial Bioburden
3. Definition CIP/COP and SIP/SOP
4. Integrity Test
5. Inoculation methods
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Common Aseptic Validation Protocol
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7. Sample Size
7. Sample Size
The validation is based on three runs of the dedicated numbers of bottles and product
