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SOP-11355 Immune Cell Serum Replacement (ICSR) Thawing
SOP-11355 Immune Cell Serum Replacement (ICSR) Thawing
1. Purpose
1.1. This procedure provides instructions on how to thaw Immune Cell Serum Replacement
(ICSR) and its associated documentation.
2. Scope
2.1. This procedure applies to Immune Cell Serum Replacement (ICSR) thawing prior to IL-2
Growth Media Production at TCF-04.
This is an electronically controlled document. User is responsible for verifying and using the effective version.
3. References
3.1. MBR-00075: IL-2 Growth Media, 1L
3.2. FRM-13147: ICSR Thawing Form
3.3. FRM-08980: Equipment Use Logbook
3.4. FRM-08982: Refrigerator Use Logbook
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3.5. SOP-00704: Wiping of Materials and Equipment Prior to Entering and Leaving Grade D,
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Grade C, and Grade B.
4. Definitions
4.1. ICSR: Immune Cell Serum Replacement.
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5. Responsibilities
5.1. Manufacturing Lead/Supervisor:
5.1.1 Communicates the quantity of ICSR(s) to thaw for each of IL-2 Growth Media
Production to manufacturing personnel.
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8.1.2. Manufacturing personnel retrieves ICSR(s) required for each IL-2 Growth Media
production from -20°C freezer and completes step 1.1 on FRM-13147.
8.1.3. Manufacturing personnel transfers the frozen ICSR(s) to the 2-8°C refrigerator
to thaw overnight to dissolve into a solution and completes step 1.2-1.3.
8.1.3.1 Manufacturing personnel temporarily archives FRM-13147 in a plastic
sleeve overnight.
8.1.4. Manufacturing personnel removes ICSR(s) from the 2-8°C refrigerator prior to
This is an electronically controlled document. User is responsible for verifying and using the effective version.
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completion of step 2.0.
9. Attachments
9.1. N/A
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10. Revision History Summary
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Originator Version Summary of Changes Rationale for Changes
Classification:
Title: Immune Cell Serum Replacement (ICSR) Thawing
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Approved By | Verdict Capacity | Date Approved